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MIRTAZAPINE 45MG ORODISPERSIBLE TABLETS

Active substance(s): MIRTAZAPINE

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Mirtazapine 15 mg Orodispersible Tablets
Mirtazapine 30 mg Orodispersible Tablets
Mirtazapine 45 mg Orodispersible Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Mirtazapine is and what it is used for
What you need to know before you take Mirtazapine
How to take Mirtazapine
Possible side effects
How to store Mirtazapine
Contents of the pack and other information

• medicines for infections; medicines for bacterial infections (such as erythromycin); medicines for
fungal infections (such as ketoconazole), medicines for HIV/AIDS (such as HIV- protease inhibitors
e.g. ritonavir, nelfinavir); medicines for depression (such as nefazodone) and medicines for stomach
ulcers (such as cimetidine).
In combination with Mirtazapine these medicines can increase the amount of mirtazapine in your
blood. Inform your doctor if you are using these medicines. It might be needed to lower the dose
of Mirtazapine, or when these medicines are stopped, to increase the dose of Mirtazapine again.

These medicines decrease the amount of mirtazapine in your blood:

• carbamazepine and phenytoin, medicines for epilepsy
• rifampicin, medicines for tuberculosis.
In combination with Mirtazapine these medicines can reduce the amount of mirtazapine in your
blood. Inform your doctor if you are using these medicines. It might be needed to increase the dose
of Mirtazapine, or when these medicines are stopped to lower the dose of Mirtazapine again.
• warfarin, a medicine to prevent blood clotting.
Mirtazapine can increase the effects of warfarin on the blood. Inform your doctor if you are using
this medicine. In case of combination it is advised that a doctor monitors your blood carefully.

Mirtazapine with alcohol

You may get drowsy if you drink alcohol while you are taking Mirtazapine.
You are advised not to drink any alcohol.

Pregnancy and breast-feeding

Limited experience with mirtazapine administration to pregnant women does not indicate an
increased risk. However, caution should be exercised when used during pregnancy.

1. What Mirtazapine is and what it is used for
Mirtazapine is one of a group of medicines called antidepressants.
Mirtazapine is used to treat depressive illness in adults.

If you are taking Mirtazapine and you become pregnant or you plan to get pregnant, ask your doctor
whether you may continue taking Mirtazapine. If you use Mirtazapine until, or shortly before birth,
your baby should be supervised for possible adverse effects.

2. What you need to know before you take Mirtazapine

Make sure your midwife and/or doctor knows you are on Mirtazapine.

Do not take Mirtazapine:



Mirtazapine ODT
15, 30, 45 mg
579365

Mirtazapine ODT
15, 30, 45 mg
579365

These medicines increase the amount of mirtazapine in your blood:

PACKAGE LEAFLET: INFORMATION FOR THE USER

if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6)
if you are taking or have recently taken (within the last two weeks) medicines called monoamine
oxidase inhibitors (MAO-inhibitors).

Warning and precautions

When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in
babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe
faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is
born. If this happens to your baby you should contact your midwife and/or doctor immediately.

Talk to you doctor or pharmacist before taking Mirtazapine.

Ask your doctor whether you can breast-feed, while taking Mirtazapine.

Children and adolescents

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.

Mirtazapine should normally not be used for children and adolescents under 18 years because
efficacy was not demonstrated. Also, you should know that patients under 18 have an increased risk
of side effects such as suicide attempt, suicidal thoughts and hostility (predominately aggression,
oppositional behaviour and anger) when they take this class of medicine. Despite this, your doctor
may prescribe Mirtazapine for patients under 18 because he/she decides that this is in their best
interests. If the doctor has prescribed Mirtazapine for a patient under 18 and you want to discuss
this, please go back to your doctor. You should inform your doctor if any of the symptoms listed
above develop or worsen when patients under 18 are taking Mirtazapine. Also the long-term safety
effects concerning growth, maturation and cognitive and behavioural development of Mirtazapine
in this age group have not yet been demonstrated. In addition, significant weight gain has been
observed in the age category more often when treated with Mirtazapine compared with adults.

Thoughts of suicide and worsening of your depression

If you are depressed you can sometimes have thoughts of harming or killing yourself. These may
be increased when first starting antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
• if you have previously had thoughts about killing or harming yourself.
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal
behaviour in adults aged less than 25 years with psychiatric conditions who were treated with
an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go
to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed, and ask them
to read this leaflet. You might ask them to tell you if they think your depression is getting worse,
or if they are worried about changes in your behaviour.
Talk to your doctor or pharmacist before taking Mirtazapine if you have, or have ever had one
of the following conditions:
• seizures (epilepsy);
• liver disease, including jaundice;
• kidney disease;
• heart disease, or a family history of heart disease, including certain kinds of heart conditions
that may change your heart rhythm, a recent heart attack, heart failure, or if you are taking certain
medicines that may affect the heart’s rhythm;
• low blood pressure;
• schizophrenia;
• bipolar disorder (alternating periods of feeling elated/overactivity and depressed mood).
• diabetes (you may need to adjust your dose of insulin or other antidiabetic medicines);
• eye disease, such as increased pressure in the eye (glaucoma);
• difficulty in passing water (urinating), which might be caused by an enlarged prostate.

Elderly patients

• if you are an elderly person. You could be more sensitive to the side-effects of antidepressants.

During treatment

Driving and using machines

Mirtazapine can affect your concentration or alertness. Make sure these abilities are not affected
before you drive or operate machinery.

Mirtazapine contains aspartame and mannitol

Mirtazapine contain aspartame, a source of phenylalanine. May be harmful for people with phenylketonuria.
Mirtazapine also contains mannitol. May have a mild laxative effect.

3. How to take Mirtazapine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.

How much to take

The recommended dose is 15 or 30 mg every day. Your doctor may advise you to increase your
dose after a few days to the amount that is best for you (between 15 and 45 mg per day). The
recommended dose is usually the same for all ages. However, if you are an elderly person or if you
have kidney or liver disease, your doctor may change the dose.

When to take Mirtazapine

Take Mirtazapine at the same time each day.
It is best to take Mirtazapine as a single dose before you go to bed. However your doctor may
suggest to split your dose of Mirtazapine – once in the morning and once at night-time before you
go to bed. The higher dose should be taken before you go to bed.

Take the orodispersible tablet as follows
Take your tablets orally.

1. Do not crush the orodispersible tablet
In order to prevent crushing the orodispersible tablet, do not push against the tablet pocket (Figure A).

Fig. A.
2. Tear off one tablet pocket
Each blister contains tablet pockets, which are separated by perforations. Tear off one tablet pocket
along the dotted lines (Figure 1).

Talk to your doctor:

• if you develop signs of infection such as high fever, sore throat and mouth ulcers. In rare cases
these symptoms can be a sign of disturbances in blood cell production in the bone marrow. While
rare, these symptoms most commonly appear after 4-6 weeks of treatment.
Other medicines and Mirtazapine
Do not take Mirtazapine in combination with:
• monoamine oxidase inhibitors (MAO inhibitors). Also, do not take Mirtazapine during the two
weeks after you have stopped taking MAO inhibitors. If you stop taking Mirtazapine, do not take
MAO inhibitors during the next two weeks either.
Examples of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants) and
selegiline (used for Parkinson’s disease).

Fig. 1.
3. Peel off the lid
Carefully peel off the lidding foil, starting in the corner indicated by the arrow (Figures 2 and 3).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines including medicines obtained without a prescription, especially any of the following:
• antidepressants such as SSRIs (e.g. citalopram), venlafaxine and L-tryptophan, or triptans (used to
treat migraine e.g. sumatriptan), tramadol (a pain-killer), linezolid (an antibiotic), lithium (used to
treat some psychiatric conditions), methylene blue (used to treat some types of blood poisoning)
and St. John’s Wort – Hypericum perforatum preparations (a herbal remedy for depression). In very
rare cases Mirtazapine alone or the combination of Mirtazapine with these medicines, can lead to a
so-called serotonin syndrome. Some of the signs of this syndrome are: fever, sweating, increased heart
rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood
changes, and unconsciousness. If you get a combination of these signs, talk to your doctor immediately.
• medicines for anxiety or insomnia such as benzodiazepines e.g. diazepam, chlordiazepoxide
medicines for schizophrenia such as olanzapine;
medicines for allergies such as cetirizine;
medicines for severe pain such as morphine.
In combination with these medicines, mirtazapine can increase the drowsiness caused by these medicines.

Fig. 2.

Fig. 3.

Date: 28 May 2015
Description Mirtazapine 45 mg,15 mg,30 mg all
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 579365

SAP No. N/A

Superceded Affiliate Item Code 378162
TrackWise PR No. 579365
MA No.

04569/0794,
0795 & 0796

Packing Site/Printer N/A
Supplier Code TBC
Sign-offs

Vendor Job No. 247122
Proof No. 3
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

No. of colours 1

Time: 13:48
Page Count

Colours

Black

Non-Print
Colours

Text
Free

1
/2

Equate CMYK
with
Main Font
Dimensions

Myriad Pro
280 x 480 mm

Body Text Size 9 pt
Min Text Size used 8 pt

4. Take out the orodispersible tablet
Take out the orodispersible tablet with dry hands and place it on the tongue. (Figure 4).

Fig. 4.
It will rapidly disintegrate and can be swallowed without water.

When can you expect to start feeling better

Usually Mirtazapine will start working after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better.
It is important that, during the first few weeks of the treatment, you talk with your doctor about the
effects of Mirtazapine:
2 to 4 weeks after you have started taking Mirtazapine, talk to your doctor about how this medicine
has affected you.
If you still don’t feel better, your doctor may prescribe a higher dose. In that case, talk to your doctor
again after another 2 to 4 weeks. Usually you will need to take Mirtazapine until your symptoms of
depression have disappeared for 4 to 6 months.

Use in children and adolescents under the age of 18 years:

Mirtazapine should not be used in children and adolescents under the age of 18 years. (see section
2 “Children and adolescents under 18 years of age”).

If you take more Mirtazapine than you should

If you or someone else have taken too much Mirtazapine, call a doctor straight away.
The most likely signs of an overdose of Mirtazapine (without other medicines or alcohol) are
drowsiness, disorientation, changes to your heart rhythm (fast, irregular heartbeat) and/or fainting
which could be symptoms of a life-threatening condition known as torsade de pointes.

If you forget to take Mirtazapine

If you are supposed to take your dose once a day
• If you have forgotten to take your dose of Mirtazapine, do not take the missed dose. Just skip it.
Take your next dose at the normal time.
Do not take a double dose to make up for a forgotten tablet.
If you are supposed to take your dose twice a day
• If you have forgotten to take your morning dose, simply take it together with your evening dose.
• If you have forgotten to take your evening dose, do not take it with the next morning dose; just
skip it and continue with your normal morning and evening doses.
• If you have forgotten to take both doses, do not attempt to make up for the missed doses. Skip
both doses and continue the next day with your normal morning and evening doses.

If you stop taking Mirtazapine

Only stop taking Mirtazapine after speaking to your doctor.
If you stop too early, your depression might come back. Once you are feeling better, talk to your
doctor. Your doctor will decide when treatment can be stopped.
Do not suddenly stop taking Mirtazapine, even when your depression has lifted. If you suddenly stop
taking Mirtazapine you may feel sick, dizzy, agitated or anxious, and have headaches. These symptoms
can be avoided by stopping gradually. Your doctor will tell you how to decrease the dose gradually.

Common (may affect up to 1 in 10 people)
• lethargy
• dizziness
• shakiness or tremor
• feeling sick (nausea)
• diarrhoea
• being sick (vomiting)
• constipation
• rash or skin eruptions (exanthema)
• pain in your joints (arthralgia) or muscles (myalgia)
• back pain
• feeling dizzy or faint when you stand up suddenly (orthostatic hypotension)
• swelling (typically in ankles or feet) caused by fluid retention (oedema)
• tiredness
• vivid dreams
• confusion
• feeling anxious
• sleeping problems
Uncommon (may affect up to 1 in 100 people)
• feeling elated or emotionally ‘high’ (mania)
• abnormal sensation in the skin e.g. burning, stinging, tickling or tingling (paraesthesia)
• restless legs
• fainting (syncope)
• sensations of numbness in the mouth (oral hypoaesthesia)
• low blood pressure
• nightmares
• feeling agitated
• seeing, feeling or hearing things that are not there (hallucinations)
• urge to move
Rare: may affect up to 1 in 1, 000 people
• muscle twitching or contractions (myoclonus)
• aggressive behaviour
• increased liver enzymes, seen in a blood test
Not known: frequency cannot be estimated from the available data
• abnormal sensations in the mouth e.g. burning, stinging, tickling or tingling (oral paraesthesia)
• swelling in the mouth (mouth oedema)
• low sodium levels in the blood (hyponatraemia), seen in a blood test
• increased creatine kinase blood levels, seen in a blood test
• increased salivation
• sleep walking
• difficulty in speaking

Additional side effects in children and adolescents

In children under 18 years the following adverse events were observed commonly in clinical trials:
hives and increased blood triglycerides.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mirtazapine
Keep this medicine out of the sight and reach of children.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
The expiry date refers to the last day of that month.

4. Possible side effects

This medicinal product does not require any special storage conditions.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Do not throw away any medicines via wastewater or household waste.

If any of the following happen, stop taking Mirtazapine and tell your doctor immediately or go to
the casualty department at your nearest hospital:

Ask your pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.

Rare (may affect up to 1 in 1,000 people)
• inflammation of the pancreas. This causes moderate to severe pain in the stomach, which spreads
to the back.

6. Contents of the pack and other information

Not known (cannot be estimated from the available data)
• epileptic attack (convulsions)
• yellow colouring of eyes or skin; this may suggest disturbance in liver function (jaundice)
• a combination of symptoms such as fever, sweating, increased heart rate, diarrhoea,
(uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes
and unconsciousness. In very rare cases these can be signs of serotonin syndrome.
• thoughts of harming or killing yourself or attempting to kill yourself
• fever, followed by a widespread rash with blisters and peeling skin, particularly around the
mouth, nose, eyes and genitals (Stevens Johnson syndrome)
• a widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis)
• signs of infection such as sudden high fever, sore throat and mouth ulcers (agranulocytosis).
Mirtazapine can cause disturbances in the production of blood cells (bone marrow depression).
Some people become less resistant to infection because Mirtazapine can cause a temporary
shortage of white blood cells (granulocytopenia). In rare cases Mirtazapine can also cause a shortage
of red and white blood cells, as well as blood platelets (aplastic anemia), a shortage of blood platelets
(thrombocytopenia) or an increase in the number of white blood cells (eosinophilia)
• breakdown of muscle tissue, causing muscle pain, tenderness, stiffness and/or weakness and
darkening or discolouration of the urine (rhabdomyolysis)
• difficulty passing urine or emptying the bladder
• a lower than normal level of sodium in the blood, which may make you feel weak and confused
with aching of muscles. This may be due to inappropriate ADH secretion, a hormone that causes
the body to retain water and dilute the blood, reducing the amount of sodium.

What Mirtazapine contains

• The active substance is mirtazapine.
Each orodispersible tablet contains 15 mg mirtazapine.
Each orodispersible tablet contains 30 mg mirtazapine.
Each orodispersible tablet contains 45 mg mirtazapine.
• The other ingredients are:
crospovidone, mannitol (see section 2 “Mirtazapine contains aspartame and mannitol”),
microcrystalline cellulose, aspartame (E951) (see section 2 “Mirtazapine contains aspartame
and mannitol”), strawberry guarana flavour, peppermint flavour, colloidal anhydrous silica and
magnesium stearate.

What Mirtazapine looks like and contents of the pack

Mirtazapine 15 mg orodispersible tablets are round, white tablets marked with ‘A’ on one side and
marked ‘36’ on the other side.
Mirtazapine 30 mg orodispersible tablets are round, white tablets marked with ‘A’ on one side and
marked ‘37’ on the other side.
Mirtazapine 45 mg orodispersible tablets are round, white tablets marked with ‘A’ on one side and
marked ‘38’ on the other side.
Mirtazapine is available in blister packs containing: 6, 12, 18, 30, 48, 60, 90 ,96 and
100 orodispersible tablets
Not all pack sizes may be marketed

Marketing Authorisation Holder:

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Other possible side effects

Manufacturer:

Very common (may affect more than 1 in 10 people)
• increase in appetite or weight gain
• drowsiness or sleepiness
• headache
• dry mouth

McDermott Laboratories Ltd. t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland
Generics UK Limited t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary

This leaflet was last revised in 05/2015

Date: 28 May 2015
Description Mirtazapine 45 mg,15 mg,30 mg all
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 579365

SAP No. N/A

Superceded Affiliate Item Code 378162
TrackWise PR No. 579365
MA No.

04569/0794,
0795 & 0796

Packing Site/Printer N/A
Supplier Code TBC
Sign-offs

Vendor Job No. 247122
Proof No. 3
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

No. of colours 1

579365

Time: 13:48
Page Count

Colours

Black

Non-Print
Colours

Text
Free

2
/2

Equate CMYK
with
Main Font
Dimensions

Myriad Pro
280 x 480 mm

Body Text Size 9 pt
Min Text Size used 8 pt

Package leaflet: Information for the patient

ValgancicloVir Mylan
450 mg filM-coated tablets
(valganciclovir)

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Valganciclovir Mylan is and what it is
used for
2. What you need to know before you take
Valganciclovir Mylan
3. How to take Valganciclovir Mylan
4. Possible side effects
5. How to store Valganciclovir Mylan
6. Contents of the pack and other information
1. What Valganciclovir Mylan is and what it is
used for
Valganciclovir Mylan contains the active
substance valganciclovir (as valganciclovir
hydrochloride). Valganciclovir Mylan belongs
to a group of medicines, which work directly to
prevent the growth of viruses. In the body the
active ingredient in the tablets, valganciclovir,
is changed into ganciclovir. Ganciclovir
prevents a virus called cytomegalovirus (CMV)
from multiplying and invading healthy cells.
In patients with a weakened immune system,
CMV can cause an infection in the body’s
organs. This can be life-threatening.
Valganciclovir Mylan is used:
• for treatment of CMV infections of the
retina of the eye in patients with acquired
immunodeficiency syndrome (AIDS). CMV
infection of the retina of the eye can cause
vision problems and even blindness
• to prevent CMV-infections in patients who are
not infected with CMV and who have received
an organ transplant from somebody who was
infected by CMV.
2. What you need to know before you take
Valganciclovir Mylan
Do not take Valganciclovir Mylan:
• if you are allergic to valganciclovir or any of
the other ingredients of this medicine (listed
in section 6)
• if you are allergic to ganciclovir, aciclovir or
valaciclovir, which are medicines used to treat
other virus infections
• if you are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Valganciclovir Mylan:
• if you have low numbers of white blood cells,
red blood cells or platelets (small cells
involved in blood clotting) in your blood or a
history of low numbers of blood cells when
taking other medicines. Your doctor will
carry out blood tests before you start taking
Valganciclovir Mylan and more tests will be
done while you are taking the tablets
• if you are having radiotherapy or blood
dialysis
• if you have a problem with your kidneys. Your
doctor may need to prescribe a reduced dose
for you and may need to check your blood
frequently during treatment
• if you are currently taking ganciclovir
capsules and your doctor wants you to switch
to Valganciclovir Mylan or if your doctor
changes your dose during the treatment. It is
important that you do not take more than the
number of tablets prescribed by your doctor
or you could risk an overdose.
Other medicines and Valganciclovir Mylan
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
If you take other medicines at the same time as
taking Valganciclovir Mylan the combination
could affect the amount of medicine in your
blood stream or could cause harmful effects. Tell
your doctor if you are already taking medicines
that contain any of the following:
• imipenem-cilastatin (an antibiotic). Taking
with Valganciclovir Mylan can cause
convulsions (fits)
• zalcitabine, zidovudine, didanosine or similar
kinds of medicines used to treat AIDS
• probenecid (a medicine used to treat gout).
Taking probenecid and Valganciclovir Mylan
at the same time could increase the amount
of ganciclovir in your blood
• mycophenolate mofetil (used after
transplantations)
• vincristine, vinblastine, adriamycin,
hydroxyurea or similar kinds of medicines to
treat cancer

• cidofovir, foscarnet, or nucleoside analogues
used against viral infections
• trimethoprim, trimethoprim/sulpha
combinations and dapsone (antibiotics)
• pentamidine (medicine to treat parasite or
lung infections)
• flucytosine or amphotericin B (anti-fungal
agents).
Pregnancy, breast-feeding and fertility
You should not take Valganciclovir Mylan if you
are pregnant unless your doctor recommends it.
If you are pregnant, think you may be pregnant
or planning to have a baby, ask your doctor
for advice before taking this medicine. Taking
Valganciclovir Mylan when you are pregnant
could harm your unborn baby.
Do not take Valganciclovir Mylan if you are
breast-feeding. If your doctor wants you to
begin treatment with Valganciclovir Mylan you
must stop breast-feeding before you start to
take this medicine.
Women of child-bearing age must use effective
contraception when taking Valganciclovir
Mylan.
Men whose partners could become pregnant
should use condoms while taking Valganciclovir
Mylan and should continue to use condoms for
90 days after treatment has finished.
Driving and using machines
Do not drive or use any tools or machines if
you suffer from fits, feel drowsy or sleepy, dizzy,
clumsy or unsteady, tired, shaky or confused
while taking this medicine.
3. How to take Valganciclovir Mylan
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure. You
have to be careful when handling your tablets.
If you accidentally touch damaged tablets, wash
your hands thoroughly with soap and water. If
any powder from the tablets gets in your eyes,
rinse your eyes with sterile water or clean water
if you do not have sterile water.
Do not take more tablets than prescribed by
your doctor to avoid overdose.
Adults:
Prevention of CMV disease in transplant
patients
You should start to take this medicine within
10 days of your transplant. The recommended
dose is two tablets taken ONCE daily. You should
continue with this dose for up to 100 days
following your transplant. If you have received a
kidney transplant, your doctor may advise you
to take the tablets for 200 days.
Treatment of active CMV retinitis in AIDS
patients (called induction treatment)
The recommended dose is two tablets taken
TWICE a day for 21 days (three weeks). Do not
take this dose for more than 21 days unless your
doctor tells you to, as this may increase your risk
of possible side effects.
Longer term treatment to prevent recurrence
of active inflammation in AIDS patients with
CMV retinitis (called maintenance treatment)
The recommended dose is two tablets taken
ONCE daily. You should try to take the tablets at
the same time each day. Your doctor will advise
you how long you should continue to take
Valganciclovir Mylan. If your retinitis worsens
while you are on this dose, your doctor may
tell you to repeat the induction treatment (as
above) or may decide to give you a different
medicine to treat the CMV infection.
Older people
Valganciclovir Mylan has not been studied in
older people.
Patients with kidney problems
If your kidneys are not working properly, your
doctor may instruct you to take fewer tablets
each day or only to take your tablets on certain
days each week. It is very important that you
only take the number of tablets prescribed by
your doctor.
Patients with liver problems
This medicine is not recommended for use in
patients with liver problems.
Use in children and adolescents
This medicine is not recommended for use in
children.
Method of administration
• Valganciclovir Mylan should, whenever
possible, be taken with food. If you are unable
to eat for any reason, you should still take
your dose of Valganciclovir Mylan as usual.
• Swallow the tablet whole. Do not crush or
break the tablets.
If you take more Valganciclovir Mylan than
you should
Contact your doctor or hospital immediately
if you have taken, or think that you have taken,
more tablets than you should. Taking too
many tablets can cause serious side effects,
particularly affecting your blood, liver or
kidneys. Other side effects may include stomach
pain, being sick, diarrhoea, fits and shaking. You
may need hospital treatment.
000000
316235

Date: 17 Jun 2014
Description Valganciclovir 450mg 60
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 316235

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Client Market UK

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If you forget to take Valganciclovir Mylan
If you forget to take your tablets take the missed
dose as soon as you remember and take the
next dose at the usual time. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Valganciclovir Mylan
Do not stop taking your medicine unless your
doctor tells you to.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Valganciclovir Mylan and contact
your doctor or go to your nearest hospital
emergency department immediately if you
think you may have any of the following side
effects:
Very common (may affect more than 1 in
10 people):
• low white blood cell counts (severe
neutropenia) where you may notice frequent
infections, such as fever, chills, sore throat or
mouth ulcers.
Common (may affect up to 1 in 10 people):
• a reduction in the number of leucocytes
(blood cells that fight infection) in the blood,
a reduction in the number of platelets in
the blood - which can cause bruising and
bleeding, a reduction in the number of
several types of blood cells at the same
time and severe anaemia, a reduction in the
number of red blood cells, you may feel weak,
fatigued or short of breath. These may be
seen in blood tests and may be caused due to
decrease in production of blood cells by the
bone marrow (bone marrow failure)
• abnormal functioning of the liver or a rise in
some liver enzymes, which will only be seen
during blood tests
• reduced functioning of the kidneys (which
may include signs like swollen ankles, feet
or hands due to water retention, increased
need to urinate, muscle cramps, high blood
pressure)
• fits (convulsions)
• swelling within the eye (oedema), separation
of the back of the eye (detached retina)
• infections caused by bacteria or viruses in
the blood (sepsis) – which may cause high
fever, chills, headache, confusion and rapid
breathing
• inflammation of cellular tissue (cellulitis),
inflammation or infection of the kidneys or
bladder (which may include signs such as
pain or discomfort when urinating, blood
in urine, pain in your abdomen, back pain,
needing to urinate more often during the day
or night).
Uncommon (may affect up to 1 in 100 people):
• kidney failure; kidney disease with little
or no urine, drowsiness, nausea, vomiting,
breathlessness
• severe allergic reaction (anaphylactic shock)
with a raised, itchy skin rash (hives), sudden
swelling of the throat, face, lips and mouth
which may cause difficulty swallowing or
breathing, sudden swelling of the hands, feet
or ankles
• deafness
• inflammation of the pancreas (pancreatitis):
where you may notice severe upper stomach
pain and back, often with nausea and
vomiting.
These are serious side effects. You may need
medical attention.
Other side effects that have occurred during
treatment with valganciclovir or ganciclovir
are given below:
Very common (may affect more than 1 in
10 people):
• a reduction in the pigment in the blood that
carries oxygen (anaemia) - which can cause
tiredness and breathlessness when you
exercise
• feeling short of breath or having trouble
breathing (dyspnoea)
• diarrhoea.
Common (may affect up to 1 in 10 people):
• headache, difficulty sleeping (insomnia),
strange tastes (dysgeusia), becoming less
sensitive to touch (hypoaesthesia), prickly or
tingling skin (paraesthesia), loss of feeling in
the hands or feet (peripheral neuropathy),
dizziness
• eye pain, seeing floaters
• earache
• coughing
• feeling and being sick, stomach ache,
constipation, wind, indigestion (dyspepsia),
difficulty swallowing (dysphagia)
• inflamed skin (dermatitis), itching (pruritus),
sweating at night
• back pain, pain in the muscles (myalgia) or
joints (arthralgia), stiff muscles (rigor), muscle
cramps
• fungal infection in the mouth (oral
candidiasis)
• your kidneys may not work as well and your

blood creatinine (a waste product) levels may
be higher as a result
• decreased appetite, weight loss
• tiredness, fever, chills, pain, chest pain,
unusual weakness (asthenia), generally
feeling unwell (malaise)
• depression, feeling anxious, confused, having
unusual thoughts.
Uncommon (may affect up to 1 in 100 people):
• changes to the normal heart beat
(arrhythmia)
• low blood pressure (hypotension), which can
cause you to feel light headed or faint
• shaking or trembling (tremor)
• red, swollen eyes (conjunctivitis), abnormal
vision
• swollen stomach, mouth ulcers
• hair loss (alopecia), itchy rash or swellings
(urticaria), dry skin
• blood in the urine (haematuria)
• a rise in the liver enzyme called alanine
aminotransferase (which will only be seen
during blood tests)
• infertility in men
• having unusual changes in mood and
behaviour, losing contact with reality such as
hearing voices or seeing things that are not
there, feeling agitated.
Additional side effects in children and
adolescents
Very common (may affect more than 1 in
10 children):
• a reduction in the number of white blood
cells in the blood (neutropenia) - which will
make you more likely to get infections, a
reduction in the pigment in the blood that
carries oxygen (anaemia) - which can cause
tiredness and breathlessness when you
exercise
• high blood pressure (hypertension)
• upper respiratory tract infection (which
include signs such as blocked or runny nose,
sneezing, fever)
• diarrhoea, feeling and being sick,
constipation
• fever, transplant rejection
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the
Yellow Card Scheme, website: www.mhra.gov.
uk/yellowcard. By reporting side effects you can
help provide more information on the safety of
this medicine.
5. How to store Valganciclovir Mylan
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date,
which is stated on the label and carton after
'EXP'. The expiry date refers to the last day of
that month. After opening, use within 3 months.
This medicine does not require any special
storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help protect
the environment.
6. Contents of the pack and other information
What Valganciclovir Mylan contains
The active substance is valganciclovir. Each
tablet contains 450 mg valganciclovir (as
valganciclovir hydrochloride).
The other ingredients (excipients) are: Tablet
core - cellulose, microcrystalline; crospovidone
and stearic acid. Film-coat - hypromellose;
titanium dioxide (E171); macrogol; iron oxide
red (E172) and polysorbate.
What Valganciclovir Mylan looks like and
contents of the pack
Valganciclovir Mylan are pink film-coated, oval,
biconvex, bevelled edge tablets marked with 'M'
on one side of the tablet and 'V45' on the other
side.
Valganciclovir Mylan are packed in bottles
containing 60 film-coated tablets.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1.
Hungary
Generics [UK] Limited
Station Close
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom
This leaflet was last revised in MM/YYYY

000000
316235

Date: 17 Jun 2014
Description Valganciclovir 450mg 60
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 316235

SAP No. N/A

Superceded Affiliate Item Code N/A
TrackWise PR No. N/A
MA No. TBC

Vendor Job No. 218093
Proof No. 3
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

No. of colours
Colours

1
Black

Time: 14:17
Page Count
PMS
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2
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Non-Print
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Dimensions 170 x 480mm

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• epileptic attack (convulsions)
• a combination of symptoms such as inexplicable
fever, sweating, increased heart rate, diarrhoea,
(uncontrollable) muscle contractions, shivering,
overactive reflexes, restlessness, mood
changes, unconsciousness and increased
salivation. In very rare cases these can be signs
of serotonin syndrome.
• thoughts of harming or killing yourself
• severe skin reactions (Stevens-Johnson
Syndrome, toxic epidermal necrolysis)
Other possible side effects with mirtazapine
are:
Very common (may affect more than 1 in
10 people):
• increase in appetite and weight gain
• drowsiness or sleepiness
• headache
• dry mouth
Common (may affect up to 1 in 10 people):
• lethargy
• dizziness
• shakiness or tremor
• nausea
• diarrhoea
• vomiting
• constipation
• rash or skin eruptions (exanthema)
• pain in your joints (arthralgia) or muscles
(myalgia)
• back pain
• feeling dizzy or faint when you stand up
suddenly (orthostatic hypotension)
• swelling (typically in ankles or feet) caused
by fluid retention (oedema)
• tiredness
• vivid dreams
• confusion
• feeling anxious
• sleeping problems
Uncommon (may affect up to 1 in 100 people):
• abnormal sensation in the skin e.g. burning,
stinging, tickling or tingling (paraesthesia)
• restless legs
• fainting (syncope)
• sensations of numbness in the mouth (oral
hypoaesthesia)
• low blood pressure
• nightmares
• feeling agitated
• hallucinations
• urge to move
Rare (may affect up to 1 in 1,000 people):
• muscle twitching or contractions (myoclonus)
• aggression
• abdominal pain and nausea; this may suggest
inflammation of the pancreas (pancreatitis)
Not known (frequency cannot be estimated
from the available data):
• abnormal sensations in the mouth (oral
paraesthesia)
• swelling in the mouth (mouth oedema)
• swelling throughout the body (generalized
oedema)
• localized swelling
• hyponatraemia
• inappropriate anti-diuretic hormone secretion
• severe skin reactions (dermatitis bullous,
erythema multiforme,)
• sleep walking (somnambulism)
• speech disorder
Additional side effects in children and
adolescents
In children under 18 years the following adverse
events were observed commonly in clinical trials:
significant weight gain, hives and increased blood
triglycerides.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE ZISPIN SOLTAB









Keep out of the sight and reach of children.
Store in the original package to protect from
light and moisture.
Do not store above 30°C
Do not take this medicine after the expiry date
shown on the carton label.
If your doctor tells you to stop taking this
medicine, take any remaining medicine back to
the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine become discoloured or show
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Zispin SolTab contains
Each Tablet contains 15mg mirtazapine. Zispin
SolTab also contains the following inactive
ingredients: sugar spheres (sucrose),
hypromellose, povidone K30, magnesium stearate,
basic butylated methacrylate copolymer,
aspartame E951, anhydrous citric acid,
crospovidone (type A), mannitol E421,
microcrystalline cellulose, orange flavour
(SN027512) and sodium hydrogen carbonate.
What Zispin SolTab looks like and contents of
the pack
Zispin SolTab 15mg tablets are round, white,
standard bevelled-edge tablets marked with the
code TZ/1 on one side and plain on the other side.
Zispin SolTab comes in blister packs of 30 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by N.V. Organon,
Kloosterstraat 6, P.O box 20, 5340 BH Oss, The
Netherlands and is procured from within the EU
and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1311

Zispin, Remergon and SolTab are registered
trademarks of N.V. Organon.
Leaflet revision date: 17/08/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

®

PATIENT INFORMATION LEAFLET

Ref: 1311/170815/1/F

®

(mirtazapine)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
Your medicine is called Zispin SolTab 15mg
Orodispersible Tablets, but will be referred to as
Zispin SolTab throughout
What is in this leaflet:
1. What Zispin SolTab is and what it is used for
2. What you need to know before you take Zispin
SolTab
3. How to take Zispin SolTab
4. Possible side effects
5. How to store Zispin SolTab
6. Contents of the pack and other information
1. WHAT ZISPIN SOLTAB IS AND WHAT IT IS
USED FOR
Zispin SolTab is one of a group of medicines
called antidepressants.
Zispin SolTab is used to treat depressive illness in
adults.
Zispin SolTab will take 1 to 2 weeks before it starts
working. After 2 to 4 weeks you may start feeling
better. You must talk to your doctor if you do not
feel better or if you feel worse after 2 to 4 weeks.
More information is in section 3 heading “When
can you expect to start feeling better”.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ZISPIN SOLTAB
Do not take Zispin SolTab
• if you are allergic to mirtazapine or any of the
other ingredients of this medicine (listed in
section 6). If so, you must talk to your doctor as
soon as you can before taking Zispin SolTab.
• if you are taking or have recently taken
(within the last two weeks) medicines called
monoamine oxidase inhibitors (MAO-Is).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Zispin SolTab.
Children and adolescents
Zispin SolTab should normally not be used for
children and adolescents under 18 years because
efficacy was not demonstrated. Also, you should
know that patients under 18 have an increased
risk of side-effects such as suicide attempt,
suicidal thoughts and hostility (predominantly
aggression, oppositional behaviour and anger)
when they take this class of medicines. Despite
this, your doctor may prescribe Zispin SolTab for
patients under 18 because he/she decides that
this is in their best interests. If your doctor has
prescribed Zispin SolTab for a patient under 18
and you want to discuss this, please go back to
your doctor. You should inform your doctor if any
of the symptoms listed above develop or worsen
when patients under 18 are taking Zispin SolTab.
Also, the long-term safety effects concerning
growth, maturation and cognitive and behavioural
development of Zispin SolTab in this age group
have not yet been demonstrated.

In addition, significant weight gain has been
observed in this age category more often when
treated with Zispin SolTab compared with adults.
Thoughts of suicide and worsening of your
depression
If you are depressed you can sometimes have
thoughts of harming or killing yourself. These
may be increased when first starting
antidepressants, since these medicines all take
time to work, usually about two weeks but
sometimes longer.
You may be more likely to think like this:
• if you have previously had thoughts about
killing or harming yourself.
• if you are a young adult. Information from
clinical trials has shown an increased risk of
suicidal behaviour in adults aged less than 25
years with psychiatric conditions who were
treated with an antidepressant.
➜ If you have thoughts of harming or killing
yourself at any time, contact your doctor or go
to a hospital straight away.
You may find it helpful to tell a relative or
close friend that you are depressed, and ask
them to read this leaflet. You might ask them to
tell you if they think your depression is getting
worse, or if they are worried about changes in
your behaviour.
Also take special care with Zispin SolTab
• if you have, or have ever had one of the
following conditions.
➜ Tell your doctor about these conditions
before taking Zispin SolTab, if not done
previously.
• seizures (epilepsy). If you develop seizures
or your seizures become more frequent, stop
taking Zispin SolTab and contact your doctor
immediately;
• liver disease, including jaundice. If jaundice
occurs, stop taking Zispin SolTab and contact
your doctor immediately;
• kidney disease;
• heart disease, or low blood pressure;
• schizophrenia. If psychotic symptoms, such
as paranoid thoughts become more frequent
or severe, contact your doctor straightaway;
• manic depression (alternating periods of
feeling elated/overactivity and depressed
mood). If you start feeling elated or
over-excited, stop taking Zispin SolTab and
contact your doctor immediately;
• diabetes (you may need to adjust your dose
of insulin or other antidiabetic medicines);
• eye disease, such as increased pressure in
the eye (glaucoma);
• difficulty in passing water (urinating), which
might be caused by an enlarged prostate.
• certain kinds of heart conditions that may
change your heart rhythm, a recent heart
attack, heart failure, or take certain medicines
that may affect the heart’s rhythm.
• if you develop signs of infection such as
inexplicable high fever, sore throat and mouth
ulcers.
➜ Stop taking Zispin SolTab and consult your
doctor immediately for a blood test.
In rare cases these symptoms can be signs of
disturbances in blood cell production in the bone
marrow. While rare, these symptoms most
commonly appear after 4-6 weeks of treatment.
• if you are an elderly person. You could be
more sensitive to the side-effects of
antidepressants.

Other medicines and Zispin SolTab
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Do not take Zispin SolTab in combination with:
• monoamine oxidase inhibitors (MAO
inhibitors). Also, do not take Zispin SolTab
during the two weeks after you have stopped
taking MAO inhibitors. If you stop taking Zispin
SolTab, do not take MAO inhibitors during the
next two weeks either.
Examples of MAO inhibitors are moclobemide,
tranylcypromine (both are antidepressants)
and selegiline (used for Parkinson’s disease).
Take care when taking Zispin SolTab in
combination with:
• antidepressants such as SSRIs, venlafaxine
and L-tryptophan, or triptans (used to treat
migraine), tramadol (a pain-killer), linezolid (an
antibiotic), lithium (used to treat some
psychiatric conditions), methylene blue (used
to treat high levels of methemoglobin in the
blood) and St. John’s Wort - Hypericum
perforatum preparations (a herbal remedy for
depression). In very rare cases Zispin SolTab
alone or the combination of Zispin SolTab with
these medicines, can lead to a so-called
serotonin syndrome. Some of the symptoms of
this syndrome are: inexplicable fever, sweating,
increased heart rate, diarrhoea, (uncontrollable)
muscle contractions, shivering, overactive
reflexes, restlessness, mood changes, and
unconsciousness. If you get a combination of
these symptoms, talk to your doctor
immediately.
• the antidepressant nefazodone. It can
increase the amount of Zispin SolTab in your
blood. Inform your doctor if you are using this
medicine. It might be needed to lower the
dose of Zispin SolTab, or when use of
nefazodone is stopped, to increase the dose
of Zispin SolTab again.
• medicines for anxiety or insomnia such as
benzodiazepines;
medicines for schizophrenia such as
olanzapine;
medicines for allergies such as cetirizine;
medicines for severe pain such as morphine.
In combination with these medicines Zispin
SolTab can increase the drowsiness caused by
these medicines.
• medicines for infections; medicines for
bacterial infections (such as erythromycin);
medicines for fungal infections (such as
ketoconazole) and medicines for HIV/AIDS
(such as HIV-protease inhibitors) and drugs for
stomach ulcers (such as cimetidine).
In combination with Zispin SolTab these
medicines can increase the amount of Zispin
SolTab in your blood. Inform your doctor if you
are using these medicines. It might be needed
to lower the dose of Zispin SolTab, or when
these medicines are stopped, to increase the
dose of Zispin SolTab again
• medicines for epilepsy such as
carbamazepine and phenytoin;
medicines for tuberculosis such as
rifampicin.
In combination with Zispin SolTab these
medicines can reduce the amount of Zispin
SolTab in your blood. Inform your doctor if you
are using these medicines. It might be needed
to increase the dose of Zispin SolTab, or when
these medicines are stopped to lower the dose
of Zispin SolTab again.
• medicines to prevent blood clotting such as
warfarin.
Zispin SolTab can increase the effects of
warfarin on the blood. Inform your doctor if you
are using this medicine. In case of combination
it is advised that a doctor monitors your blood
carefully.



medicines that may affect the heart’s rhythm
such as certain antibiotics and some
anti-psychotics.

Zispin SolTab with food and alcohol
You may get drowsy if you drink alcohol while
you are taking Zispin SolTab.
You are advised not to drink any alcohol.
You can take Zispin SolTab with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
Limited experience with Zispin SolTab
administration to pregnant women does not
indicate an increased risk. However, caution
should be exercised when used during pregnancy.
If you use Zispin SolTab until, or shortly before
birth, your baby should be supervised for
possible adverse effects.
When taken during pregnancy, similar drugs
(SSRIs) may increase the risk of a serious
condition in babies, called persistent pulmonary
hypertension of the newborn (PPHN), making the
baby breathe faster and appear bluish. These
symptoms usually begin during the first 24 hours
after the baby is born. If this happens to your baby
you should contact your midwife and/or doctor
immediately.
Driving and using machines
Zispin SolTab can affect your concentration
or alertness. Make sure these abilities are not
affected before you drive or operate machinery.
If your doctor has prescribed Zispin SolTab
for a patient under 18 years make sure the
concentration and alertness is not affected
before participation in traffic (e.g. on bicycle).

Take the orodispersible tablet as follows
Take your tablets orally.
1. Do not crush the orodispersible tablet
In order to prevent crushing the orodispersible
tablet, do not push against the tablet pocket
(Figure A).

Fig. A.
2. Tear off one tablet pocket
Each blister contains six tablet pockets, which are
separated by perforations. Tear off one tablet
pocket along the dotted lines (Figure 1).

Fig. 1.
3. Peel off the lid
Carefully peel off the lidding foil, starting in the
corner indicated by the arrow (Figures 2 and 3).

Fig. 2.

Zispin SolTab orodispersible tablets contain
sugar spheres, containing sucrose
Zispin SolTab orodispersible tablets contain
sugar spheres, containing sucrose. If you
have been told by your doctor that you have
an intolerance for some sugars, contact your
doctor before taking this medicinal product.
Zispin Soltab orodispersible tablets contain
aspartame, a source of phenylalanine.
Zispin SolTab orodispersible tablets contain
aspartame, a source of phenylalanine. May be
harmful for people with phenylketonuria.

Fig. 3.
4. Take out the orodispersible tablet
Take out the orodispersible tablet with dry hands
and place it on the tongue. (Figure 4).

If you are supposed to take your dose twice a day
• if you have forgotten to take your morning dose,
simply take it together with your evening dose.
• if you have forgotten to take your evening dose,
do not take it with the next morning dose; just
skip it and continue with your normal morning
and evening doses.
• if you have forgotten to take both doses, do
not attempt to make up for the missed doses.
Skip both doses and continue the next day
with your normal morning and evening doses.
If you stop taking Zispin SolTab
➜ Only stop taking Zispin SolTab in consultation
with your doctor.
If you stop too early, your depression might
come back. Once you are feeling better, talk to
your doctor. Your doctor will decide when
treatment can be stopped.
Do not suddenly stop taking Zispin SolTab, even
when your depression has lifted. If you suddenly
stop taking Zispin SolTab you may feel sick, dizzy,
agitated or anxious, and have headaches. These
symptoms can be avoided by stopping gradually.
Your doctor will tell you how to decrease the dose
gradually.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets them.
If you experience any of the following serious
side effects, stop taking mirtazapine and tell
your doctor immediately.

Always take Zispin SolTab exactly as your doctor
or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.

When to take Zispin SolTab
➜ Take Zispin SolTab at the same time each day.
It is best to take Zispin SolTab as a single dose
before you go to bed. However your doctor may
suggest to split your dose of Zispin SolTab –
once in the morning and once at night-time
before you go to bed. The higher dose should
be taken before you go to bed.

If you forget to take Zispin SolTab
If you are supposed to take your dose once
a day
• Do not take a double dose to make up for
a forgotten dose. Take your next dose at
the normal time.

If you have any further questions on the use of
this product, ask your doctor or pharmacist.

3. HOW TO TAKE ZISPIN SOLTAB

How much to take
The recommended starting dose is 15 or 30 mg
every day. Your doctor may advise you to
increase your dose after a few days to the amount
that is best for you (between 15 and 45 mg per
day). The dose is usually the same for all ages.
However, if you are an elderly person or if you
have renal or liver disease, your doctor may
adapt the dose.

If you take more Zispin SolTab than
you should
➜ If you or someone else has taken too much
Zispin SolTab, call a doctor straight away.
The most likely signs of an overdose of Zispin
SolTab (without other medicines or alcohol) are
drowsiness, disorientation and increased
heart rate. The symptoms of a possible overdose
may include changes to your heart rhythm (fast,
irregular heartbeat) and/or fainting which could be
symptoms of a life-threatening condition known as
Torsade de Pointes.

Uncommon (may affect up to 1 in 100 people):
• feeling elated or emotionally ‘high’ (mania)
Fig. 4.
It will rapidly disintegrate and can be swallowed
without water.
When can you expect to start feeling better
Usually Zispin SolTab will start working after 1 to
2 weeks and after 2 to 4 weeks you may start to
feel better.
It is important that, during the first few weeks of
the treatment, you talk with your doctor about
the effects of Zispin SolTab:
➜ 2 to 4 weeks after you have started taking
Zispin SolTab, talk to your doctor about how
this medicine has affected you.
If you still don’t feel better, your doctor may
prescribe a higher dose. In that case, talk to
your doctor again after another 2 to 4 weeks.
Usually you will need to take Zispin SolTab
until your symptoms of depression have
disappeared for 4 to 6 months.

Rare (may affect up to 1 in 1,000 people):
• yellow colouring of eyes or skin; this may
suggest disturbance in liver function (jaundice)
Not known (frequency cannot be estimated
from the available data):
• signs of infection such as sudden unexplainable
high fever, sore throat and mouth ulcers
(agranulocytosis). In rare cases mirtazapine can
cause disturbances in the production of blood
cells (bone marrow depression). Some people
become less resistant to infection because
mirtazapine can cause a temporary shortage of
white blood cells (granulocytopenia). In rare
cases mirtazapine can also cause a shortage of
red and white blood cells, as well as blood
platelets (aplastic anemia), a shortage of blood
platelets (thrombocytopenia) or an increase in
the number of white blood cells (eosinophilia).

Ref: 1311/170815/1/B

• epileptic attack (convulsions)
• a combination of symptoms such as inexplicable
fever, sweating, increased heart rate, diarrhoea,
(uncontrollable) muscle contractions, shivering,
overactive reflexes, restlessness, mood
changes, unconsciousness and increased
salivation. In very rare cases these can be signs
of serotonin syndrome.
• thoughts of harming or killing yourself
• severe skin reactions (Stevens-Johnson
Syndrome, toxic epidermal necrolysis)
Other possible side effects with mirtazapine
are:
Very common (may affect more than 1 in
10 people):
• increase in appetite and weight gain
• drowsiness or sleepiness
• headache
• dry mouth
Common (may affect up to 1 in 10 people):
• lethargy
• dizziness
• shakiness or tremor
• nausea
• diarrhoea
• vomiting
• constipation
• rash or skin eruptions (exanthema)
• pain in your joints (arthralgia) or muscles
(myalgia)
• back pain
• feeling dizzy or faint when you stand up
suddenly (orthostatic hypotension)
• swelling (typically in ankles or feet) caused
by fluid retention (oedema)
• tiredness
• vivid dreams
• confusion
• feeling anxious
• sleeping problems
Uncommon (may affect up to 1 in 100 people):
• abnormal sensation in the skin e.g. burning,
stinging, tickling or tingling (paraesthesia)
• restless legs
• fainting (syncope)
• sensations of numbness in the mouth (oral
hypoaesthesia)
• low blood pressure
• nightmares
• feeling agitated
• hallucinations
• urge to move
Rare (may affect up to 1 in 1,000 people):
• muscle twitching or contractions (myoclonus)
• aggression
• abdominal pain and nausea; this may suggest
inflammation of the pancreas (pancreatitis)
Not known (frequency cannot be estimated
from the available data):
• abnormal sensations in the mouth (oral
paraesthesia)
• swelling in the mouth (mouth oedema)
• swelling throughout the body (generalized
oedema)
• localized swelling
• hyponatraemia
• inappropriate anti-diuretic hormone secretion
• severe skin reactions (dermatitis bullous,
erythema multiforme,)
• sleep walking (somnambulism)
• speech disorder
Additional side effects in children and
adolescents
In children under 18 years the following adverse
events were observed commonly in clinical trials:
significant weight gain, hives and increased blood
triglycerides.

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE MIRTAZAPINE TABLETS









Keep out of the sight and reach of children.
Store in the original package to protect from
light and moisture.
Do not store above 30°C
Do not take this medicine after the expiry date
shown on the carton label.
If your doctor tells you to stop taking this
medicine, take any remaining medicine back to
the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine become discoloured or show
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Mirtazapine tablets contains Each Tablet
contains 15mg mirtazapine. Mirtazapine tablets
also contains the following inactive ingredients:
sugar spheres (sucrose), hypromellose, povidone
K30, magnesium stearate, basic butylated
methacrylate copolymer,
aspartame E951, anhydrous citric acid,
crospovidone (type A), mannitol E421,
microcrystalline cellulose, orange flavour
(SN027512) and sodium hydrogen carbonate.
What Mirtazapine tablets looks like and
contents of the pack
Mirtazapine tablets 15mg tablets are round, white,
standard bevelled-edge tablets marked with the
code TZ/1 on one side and plain on the other side.
Mirtazapine tablets comes in blister packs of
30 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by N.V. Organon,
Kloosterstraat 6, P.O box 20, 5340 BH Oss, The
Netherlands and is procured from within the EU
and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1311

Leaflet revision date: 17/08/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Ref: 1311/170815/1/F

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

In addition, significant weight gain has been
observed in this age category more often when
treated with Mirtazapine tablets compared with
adults.

Your medicine is called Mirtazapine 15mg
Orodispersible Tablets, but will be referred to as
Mirtazapine tablets throughout

You may be more likely to think like this:
• if you have previously had thoughts about
killing or harming yourself.
• if you are a young adult. Information from
clinical trials has shown an increased risk of
suicidal behaviour in adults aged less than 25
years with psychiatric conditions who were
treated with an antidepressant.
➜ If you have thoughts of harming or killing
yourself at any time, contact your doctor or go
to a hospital straight away.
You may find it helpful to tell a relative or
close friend that you are depressed, and ask
them to read this leaflet. You might ask them to
tell you if they think your depression is getting
worse, or if they are worried about changes in
your behaviour.

What is in this leaflet:
1. What Mirtazapine tablets is and what it is used
for
2. What you need to know before you take
Mirtazapine tablets
3. How to take Mirtazapine tablets
4. Possible side effects
5. How to store Mirtazapine tablets
6. Contents of the pack and other information
1. WHAT MIRTAZAPINE TABLETS IS AND
WHAT IT IS USED FOR
Mirtazapine tablets is one of a group of medicines
called antidepressants.
Mirtazapine tablets is used to treat depressive
illness in adults.
Mirtazapine tablets will take 1 to 2 weeks before it
starts working. After 2 to 4 weeks you may start
feeling better. You must talk to your doctor if you
do not feel better or if you feel worse after 2 to 4
weeks. More information is in section 3 heading
“When can you expect to start feeling better”.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE MIRTAZAPINE TABLETS
Do not take Mirtazapine tablets
• if you are allergic to mirtazapine or any of the
other ingredients of this medicine (listed in
section 6). If so, you must talk to your doctor as
soon as you can before taking Mirtazapine
tablets.
• if you are taking or have recently taken
(within the last two weeks) medicines called
monoamine oxidase inhibitors (MAO-Is).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Mirtazapine tablets.
Children and adolescents
Mirtazapine tablets should normally not be used
for children and adolescents under 18 years
because efficacy was not demonstrated. Also,
you should know that patients under 18 have an
increased risk of side-effects such as suicide
attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional behaviour
and anger) when they take this class of medicines.
Despite this, your doctor may prescribe
Mirtazapine tablets for patients under 18 because
he/she decides that this is in their best interests.
If your doctor has prescribed Mirtazapine tablets
for a patient under 18 and you want to discuss
this, please go back to your doctor. You should
inform your doctor if any of the symptoms listed
above develop or worsen when patients under
18 are taking Mirtazapine tablets.
Also, the long-term safety effects concerning
growth, maturation and cognitive and behavioural
development of Mirtazapine tablets in this age
group have not yet been demonstrated.

Thoughts of suicide and worsening of your
depression
If you are depressed you can sometimes have
thoughts of harming or killing yourself. These
may be increased when first starting
antidepressants, since these medicines all take
time to work, usually about two weeks but
sometimes longer.

Also take special care with Mirtazapine tablets
• if you have, or have ever had one of the
following conditions.
➜ Tell your doctor about these conditions
before taking Mirtazapine tablets, if not done
previously.
• seizures (epilepsy). If you develop seizures
or your seizures become more frequent, stop
taking Mirtazapine tablets and contact your
doctor immediately;
• liver disease, including jaundice. If jaundice
occurs, stop taking Mirtazapine tablets and
contact your doctor immediately;
• kidney disease;
• heart disease, or low blood pressure;
• schizophrenia. If psychotic symptoms, such
as paranoid thoughts become more frequent
or severe, contact your doctor straightaway;
• manic depression (alternating periods of
feeling elated/overactivity and depressed
mood). If you start feeling elated or
over-excited, stop taking Mirtazapine tablets
and contact your doctor immediately;
• diabetes (you may need to adjust your dose
of insulin or other antidiabetic medicines);
• eye disease, such as increased pressure in
the eye (glaucoma);
• difficulty in passing water (urinating), which
might be caused by an enlarged prostate.
• certain kinds of heart conditions that may
change your heart rhythm, a recent heart
attack, heart failure, or take certain medicines
that may affect the heart’s rhythm.
• if you develop signs of infection such as
inexplicable high fever, sore throat and mouth
ulcers.
➜ Stop taking Mirtazapine tablets and consult
your doctor immediately for a blood test. In
rare cases these symptoms can be signs of
disturbances in blood cell production in the bone
marrow. While rare, these symptoms most
commonly appear after 4-6 weeks of treatment.
• if you are an elderly person. You could be
more sensitive to the side-effects of
antidepressants.

Other medicines and Mirtazapine tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Do not take Mirtazapine tablets in combination
with:
• monoamine oxidase inhibitors (MAO
inhibitors). Also, do not take Mirtazapine tablets
during the two weeks after you have stopped
taking MAO inhibitors. If you stop taking Zispin
SolTab, do not take MAO inhibitors during the
next two weeks either.
Examples of MAO inhibitors are moclobemide,
tranylcypromine (both are antidepressants)
and selegiline (used for Parkinson’s disease).
Take care when taking Mirtazapine tablets in
combination with:
• antidepressants such as SSRIs, venlafaxine
and L-tryptophan, or triptans (used to treat
migraine), tramadol (a pain-killer), linezolid
(an antibiotic), lithium (used to treat some
psychiatric conditions), methylene blue (used
to treat high levels of methemoglobin in the
blood) and St. John’s Wort - Hypericum
perforatum preparations (a herbal remedy for
depression). In very rare cases Mirtazapine
tablets alone or the combination of Mirtazapine
tablets with these medicines, can lead to a socalled serotonin syndrome. Some of the
symptoms of this syndrome are: inexplicable
fever, sweating, increased heart rate, diarrhoea,
(uncontrollable) muscle contractions, shivering,
overactive reflexes, restlessness, mood
changes, and unconsciousness. If you get a
combination of these symptoms, talk to your
doctor immediately.
• the antidepressant nefazodone. It can
increase the amount of Mirtazapine tablets in
your blood. Inform your doctor if you are using
this medicine. It might be needed to lower the
dose of Mirtazapine tablets, or when use of
nefazodone is stopped, to increase the dose
of Mirtazapine tablets again.
• medicines for anxiety or insomnia such as
benzodiazepines;
• medicines for schizophrenia such as
olanzapine;
medicines for allergies such as cetirizine;
medicines for severe pain such as morphine.
In combination with these medicines Zispin
SolTab can increase the drowsiness caused by
these medicines.
• medicines for infections; medicines for
bacterial infections (such as erythromycin);
medicines for fungal infections (such as
ketoconazole) and medicines for HIV/AIDS
(such as HIV-protease inhibitors) and drugs for
stomach ulcers (such as cimetidine).
In combination with Mirtazapine tablets these
medicines can increase the amount of Zispin
SolTab in your blood. Inform your doctor if you
are using these medicines. It might be needed
to lower the dose of Mirtazapine tablets, or
when these medicines are stopped, to increase
the dose of Mirtazapine tablets again
• medicines for epilepsy such as
carbamazepine and phenytoin;
medicines for tuberculosis such as rifampicin.
In combination with Mirtazapine tablets these
medicines can reduce the amount of Zispin
SolTab in your blood. Inform your doctor if you
are using these medicines. It might be needed
to increase the dose of Mirtazapine tablets, or
when these medicines are stopped to lower the
dose of Mirtazapine tablets again.
• medicines to prevent blood clotting such as
warfarin.
Mirtazapine tablets can increase the effects of
warfarin on the blood. Inform your doctor if you
are using this medicine. In case of combination
it is advised that a doctor monitors your blood
carefully.



medicines that may affect the heart’s rhythm
such as certain antibiotics and some
anti-psychotics.

Mirtazapine tablets with food and alcohol
You may get drowsy if you drink alcohol while
you are taking Mirtazapine tablets.
You are advised not to drink any alcohol.
You can take Mirtazapine tablets with or without
food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
Limited experience with Mirtazapine tablets
administration to pregnant women does not
indicate an increased risk. However, caution
should be exercised when used during pregnancy.
If you use Mirtazapine tablets until, or shortly
before birth, your baby should be supervised for
possible adverse effects.
When taken during pregnancy, similar drugs
(SSRIs) may increase the risk of a serious
condition in babies, called persistent pulmonary
hypertension of the newborn (PPHN), making the
baby breathe faster and appear bluish. These
symptoms usually begin during the first 24 hours
after the baby is born. If this happens to your baby
you should contact your midwife and/or doctor
immediately.
Driving and using machines
Mirtazapine tablets can affect your concentration
or alertness. Make sure these abilities are not
affected before you drive or operate machinery.
If your doctor has prescribed Mirtazapine tablets
for a patient under 18 years make sure the
concentration and alertness is not affected
before participation in traffic (e.g. on bicycle).
Mirtazapine tablets orodispersible tablets
contain sugar spheres, containing sucrose
Mirtazapine tablets orodispersible tablets contain
sugar spheres, containing sucrose. If you
have been told by your doctor that you have
an intolerance for some sugars, contact your
doctor before taking this medicinal product.
Mirtazapine tablets orodispersible tablets
contain aspartame, a source of phenylalanine.
Mirtazapine tablets orodispersible tablets contain
aspartame, a source of phenylalanine. May be
harmful for people with phenylketonuria.

Take the orodispersible tablet as follows
Take your tablets orally.
1. Do not crush the orodispersible tablet
In order to prevent crushing the orodispersible
tablet, do not push against the tablet pocket
(Figure A).

Fig. A.
2. Tear off one tablet pocket
Each blister contains six tablet pockets, which are
separated by perforations. Tear off one tablet
pocket along the dotted lines (Figure 1).

Fig. 1.
3. Peel off the lid
Carefully peel off the lidding foil, starting in the
corner indicated by the arrow (Figures 2 and 3).

Fig. 2.

Fig. 3.
4. Take out the orodispersible tablet
Take out the orodispersible tablet with dry hands
and place it on the tongue. (Figure 4).

3. HOW TO TAKE MIRTAZAPINE TABLETS

Fig. 4.

When to take Mirtazapine tablets
➜ Take Mirtazapine tablets at the same time each
day.
It is best to take Mirtazapine tablets as a single
dose before you go to bed. However your doctor
may suggest to split your dose of Mirtazapine
tablets – once in the morning and once at
night-time before you go to bed. The higher dose
should be taken before you go to bed.

If you forget to take Mirtazapine tablets
If you are supposed to take your dose once
a day
• Do not take a double dose to make up for
a forgotten dose. Take your next dose at
the normal time.
If you are supposed to take your dose twice a day
• if you have forgotten to take your morning dose,
simply take it together with your evening dose.
• if you have forgotten to take your evening dose,
do not take it with the next morning dose; just
skip it and continue with your normal morning
and evening doses.
• if you have forgotten to take both doses, do
not attempt to make up for the missed doses.
Skip both doses and continue the next day
with your normal morning and evening doses.
If you stop taking Mirtazapine tablets
➜ Only stop taking Mirtazapine tablets in
consultation with your doctor.
If you stop too early, your depression might
come back. Once you are feeling better, talk to
your doctor. Your doctor will decide when
treatment can be stopped.
Do not suddenly stop taking Mirtazapine tablets,
even when your depression has lifted. If you
suddenly stop taking Mirtazapine tablets you may
feel sick, dizzy, agitated or anxious, and have
headaches. These symptoms can be avoided by
stopping gradually. Your doctor will tell you how to
decrease the dose gradually.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets them.
If you experience any of the following serious
side effects, stop taking mirtazapine and tell
your doctor immediately.

Always take Mirtazapine tablets exactly as your
doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
How much to take
The recommended starting dose is 15 or 30 mg
every day. Your doctor may advise you to
increase your dose after a few days to the amount
that is best for you (between 15 and 45 mg per
day). The dose is usually the same for all ages.
However, if you are an elderly person or if you
have renal or liver disease, your doctor may
adapt the dose.

If you take more Mirtazapine tablets than
you should
➜ If you or someone else has taken too much
Mirtazapine tablets, call a doctor straight away.
The most likely signs of an overdose of
Mirtazapine tablets (without other medicines or
alcohol) are drowsiness, disorientation and
increased heart rate. The symptoms of a
possible overdose may include changes to your
heart rhythm (fast, irregular heartbeat) and/or
fainting which could be symptoms of a
life-threatening condition known as Torsade de
Pointes.

It will rapidly disintegrate and can be swallowed
without water.
When can you expect to start feeling better
Usually Mirtazapine tablets will start working after
1 to 2 weeks and after 2 to 4 weeks you may start
to feel better.
It is important that, during the first few weeks of
the treatment, you talk with your doctor about
the effects of Mirtazapine tablets:
➜ 2 to 4 weeks after you have started taking
Mirtazapine tablets, talk to your doctor about
how this medicine has affected you.
If you still don’t feel better, your doctor may
prescribe a higher dose. In that case, talk to
your doctor again after another 2 to 4 weeks.
Usually you will need to take Mirtazapine tablets
until your symptoms of depression have
disappeared for 4 to 6 months.

Uncommon (may affect up to 1 in 100 people):
• feeling elated or emotionally ‘high’ (mania)
Rare (may affect up to 1 in 1,000 people):
• yellow colouring of eyes or skin; this may
suggest disturbance in liver function (jaundice)
Not known (frequency cannot be estimated
from the available data):
• signs of infection such as sudden unexplainable
high fever, sore throat and mouth ulcers
(agranulocytosis). In rare cases mirtazapine can
cause disturbances in the production of blood
cells (bone marrow depression). Some people
become less resistant to infection because
mirtazapine can cause a temporary shortage of
white blood cells (granulocytopenia). In rare
cases mirtazapine can also cause a shortage of
red and white blood cells, as well as blood
platelets (aplastic anemia), a shortage of blood
platelets (thrombocytopenia) or an increase in
the number of white blood cells (eosinophilia).
Ref: 1311/170815/1/B

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