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MIRTAZAPINE 30MG FILM COATED TABLETS

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Mirtazapine 30mg Tablets
(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.
What is in this leaflet
1. What Mirtazapine is and what it is used for
2. What you need to know before you take Mirtazapine
3. How to take Mirtazapine
4. Possible side effects
5. How to store Mirtazapine
6. Contents of the pack and other information

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 illnesses.

2. What you need to know before you take Mirtazapine
Do not take Mirtazapine:
• 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 (MAOIs).
Warnings and precautions
Children and adolescents under 18 years of age
Mirtazapine should normally not be used for children and
adolescents under 18 years because efficacy has not been
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
medicines. 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 this 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.

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Talk to your doctor or pharmacist before taking Mirtazapine if
you have, or have ever had one of the following conditions.
Tell your doctor about these conditions before taking
Mirtazapine, if not done previously
• seizures (epilepsy)
• liver disease, including jaundice
• kidney disease
• heart disease or 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.
During treatment
• if you develop signs of infection such as inexplicable high fever,
sore throat and mouth ulcers. 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 older person. You could be more sensitive to the
side effects of antidepressants.
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 an MAO inhibitor. 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).
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 e.g. sumatriptan (used to treat
migraine), 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: 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 signs, talk
to your doctor immediately.
• the antidepressant nefazodone. It can increase the amount
of Mirtazapine in your blood. Inform your doctor if you are
using this medicine. It might be needed to lower the dose of
Mirtazapine, or when use of nefazodone is stopped, to increase
the dose of Mirtazapine again.
• 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.
• 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 e.g. ritonavir, nelfinavir).
• cimetidine, medicine for stomach ulcers. 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.
• carbamazepine and phenytoin, medicines for epilepsy.
• medicines for tuberculosis such as rifampicin. 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
your dose of Mirtazapine again.
• warfarin, medicines 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.
• medicines that may affect the heart's rhythm such as certain
antibiotics and some anti-psychotics.
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
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.
Pregnancy
Limited experience with mirtazapine administration to pregnant
women does not indicate an increased risk. However, caution
should be exercised when used during pregnancy.
If you use Mirtazapine until, or shortly before birth, your baby
should be monitored for possible adverse effects.
Make sure your midwife and/or doctor knows you are on
Mirtazapine. 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.
Breast-feeding
Mirtazapine passes into breast milk in small amounts. There is
a potential risk of an effect on the baby. Therefore, you should
discuss the matter with your doctor, and he/she will decide
whether you should stop breast-feeding or stop the therapy
with Mirtazapine.
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 lactose.
If you have been told by your doctor that you have an
intolerance for some sugars, contact your doctor before taking
this medicinal product.

3. How to take Mirtazapine
Always take this medicine exactly as your doctor or pharmacist
tells you to. You should check with your doctor or pharmacist if
you are not sure.
How much to take
Adults:
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 recommended dose is usually the same for all ages.
However, if you are an older person or if you have kidney or liver
disease, your doctor may change the dose.
The score line is only there to help you break the tablet if you
have difficulty swallowing it whole.
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”).

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Package Leaflet: Information for the patient

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 you 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.
Swallow your tablets without chewing, with some water or juice.

• swelling (typically in ankles or feet) caused by fluid retention
(oedema)
• tiredness
• vivid dreams
• confusion
• feeling anxious
• sleeping problems

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.

Uncommon (may affect up to 1 in 100 people)
• feeling elated or emotionally 'high' (mania)
Stop taking Mirtazapine and tell your doctor straight away.
• 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

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.
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.
In some cases the side effect is not caused by the medicine but is
a sign of your illness.
If any of the following happen, stop taking Mirtazapine and
tell your doctor immediately or go to your nearest hospital
emergency department:
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.
• yellowing of your skin or eyes; this may suggest disturbance in
liver function (jaundice).
Not known (cannot be estimated from the available data)
• serious allergic reactions such as rash, itching or hives on the
skin, swelling of the face, lips, tongue or other parts of the
body, shortness of breath, wheezing or trouble breathing.
• 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). Mirtazapine can also cause a
shortage of red and white blood cells which may cause pale skin,
feeling tired and breathless and having dark urine, blood platelets
(aplastic anaemia), a shortage of blood platelets with signs of
bleeding or bruising more easily than normal (thrombocytopenia)
or an increase in the number of white blood cells (eosinophilia).
• 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.
• thoughts of harming or killing yourself (see section 2 “Thoughts
of suicide and worsening of your depression”).
• 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 and unconsciousness. These can be signs of
serotonin syndrome.
• signs of severe skin reaction or disease which may include
rash, red skin, fever, sore throat, and fatigue, which may be
followed by ulcers, peeling of the skin and other lesions,
usually around the mouth and lips (Stevens-Johnson
syndrome, toxic epidermal necrolysis, dermatitis bullous or
erythema multiforme).
• 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.

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 (cannot be estimated from the available data)
• abnormal sensations in the mouth (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
• difficulty speaking
• increased salivation
• sleepwalking
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, pharmacist or
nurse. 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.
Do not use this medicine after the expiry date which is stated on
the carton or container after 'EXP'. The expiry date refers to the
last day of that month.
Store in the original package.
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 further information
What Mirtazapine contains
The active substance is mirtazapine. Each tablet contains 30 mg
of mirtazapine.
The other ingredients are anhydrous lactose (see
section 2 “Mirtazapine contains lactose”), maize starch,
colloidal anhydrous silica, hydroxypropyl cellulose low
substituted and magnesium stearate. The coating includes
titanium dioxide (E171), macrogol 4000, lactose monohydrate
(see section 2 “Mirtazapine contains lactose”), red iron oxide
(E172), yellow iron oxide (E172), black iron oxide (E172) and
hypromellose.
What Mirtazapine looks like and contents of the pack
Your medicine comes as a round film-coated tablet.
The tablets are buff-coloured, marked 'MR|30' on one side and 'G'
on the other.
Mirtazapine is available in blisters packs of 10, 14, 20, 28, 30, 50,
100, 250 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.

Other possible side effects
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)

This leaflet was last revised in
April 2016

849644

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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