MIRTAZAPINE 15MG TABLETS

Active substance: MIRTAZAPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Mirtazapine 15mg film-coated tablets
Mirtazapine 30mg film-coated tablets
Mirtazapine 45mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
- If any of the side-effects get serious, or if you notice any side-effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Mirtazapine is and what it is used for
2. Before you take Mirtazapine
3. How to take Mirtazapine
4. Possible side-effects
5. How to store Mirtazapine
6. Further information
1. WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR
The name of your medicine is Mirtazapine 15, 30 or 45mg film-coated tablets
(referred to as Mirtazapine throughout this leaflet).
Mirtazapine is one of a group of medicines called antidepressants.
Mirtazapine is used to treat depressive illness.
2. BEFORE YOU TAKE MIRTAZAPINE
Do not take Mirtazapine:
• if you are allergic (hypersensitive) to mirtazapine or any of the other ingredients
of Mirtazapine. If so, you must talk to your doctor as soon as you can before
taking Mirtazapine.
• if you are taking or have recently taken (within the last two weeks) medicines
called monoamine oxidase inhibitors (MAO-Is).
Take special care with Mirtazapine
Use in 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 (predominantly 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 your 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 than 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 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). If you develop seizures or your seizures become more
frequent, stop taking Mirtazapine and contact your doctor immediately;
− liver disease, including jaundice. If jaundice occurs, stop taking Mirtazapine
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 straight away;
− manic depression (alternating periods of feeling elated/overactivity and
depressed mood). If you start feeling elated or over-excited, stop taking
Mirtazapine 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.





if you develop signs of infection such as inexplicable high fever, sore throat and
mouth ulcers. → Stop taking Mirtazapine 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.

Taking other medicines
Tell your doctor or pharmacist if you are taking (or plan to take) any of the medicines
in the following list.
Please also tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
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).
Take care when taking Mirtazapine 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) and St. Johns 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 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 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;
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 HIVprotease inhibitors).
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.
• medicines for epilepsy such as carbamazepine and phenytoin;
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 the dose of Mirtazapine again.
• medicines to prevent blood clotting such as warfarin.
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.
Taking Mirtazapine with food and drink
You may get drowsy if you drink alcohol while you are taking Mirtazapine.
You are advised not to drink any alcohol.
You can take Mirtazapine with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
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.

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.
Ask your doctor whether you can breast-feed, while taking 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.
Important information about some of the ingredients of Mirtazapine
Mirtazapine tablets contain 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.
Mirtazapine 15 mg contains the colouring agent sunset yellow which may cause
allergic reactions.
3. HOW TO TAKE MIRTAZAPINE
Always take Mirtazapine 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
The usual 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.
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.
Take your tablets orally. Swallow your prescribed dose of Mirtazapine without
chewing, with some water or juice.
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.
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 and increased heart rate.
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.

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 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, 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 product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Mirtazapine can cause side effects, although not everybody gets
these side effects. Some side effects are more likely to occur than others. The
possible side effects of Mirtazapine are listed below and can be divided as:

Very common: affects more than 1 user in 10

Common: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1,000

Rare: affects 1 to 10 users in 10,000

Very rare: affects less than 1 user in 10,000

Not known: cannot be estimated from the available data
Very common:

increase in appetite and weight gain

drowsiness or sleepiness

headache

dry mouth
Common:

lethargy

dizziness

shakiness or tremor

nausea

diarrhoea

vomiting

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

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

feeling elated or emotionally ‘high’ (mania)
o 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

hallucinations

urge to move
Rare:

yellow colouring of eyes or skin; this may suggest disturbance in liver function
(jaundice)
o Stop taking Mirtazapine and tell your doctor straight away.

muscle twitching or contractions (myoclonus)
Not known:

signs of infection such as sudden unexplainable high fever, sore throat and
mouth ulcers (agranulocytosis)
o Stop taking Mirtazapine and contact your doctor straight away for a
blood test.
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).

epileptic attack (convulsions)
o Stop taking Mirtazapine and tell your doctor straight away.

a combination of symptoms such as inexplicable 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.
o Stop taking Mirtazapine and tell your doctor straight away.

thoughts of harming or killing yourself
o Contact your doctor or go to a hospital straight away.

abnormal sensations in the mouth (oral paraesthesia)

swelling in the mouth (mouth oedema)

hyponatraemia

inappropriate anti-diuretic hormone secretion
Sunset yellow may cause allergic reactions.

If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE MIRTAZAPINE
Keep out of the reach and sight of children.
Do not use Mirtazapine after the expiry date which is stated on the carton and the
blister or bottle. The expiry date refers to the last day of that month.
Store in the original package in order to protect the product from light.
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 to protect the environment.
6. FURTHER INFORMATION
What Mirtazapine contains
The active substance of 15mg, 30mg or 45mg tablets is mirtazapine.
Mirtazapine 15 mg film-coated tablets contain 15 mg mirtazapine per film-coated
tablet.
Mirtazapine 30 mg film-coated tablets contain 30 mg mirtazapine per film-coated
tablet.
Mirtazapine 45 mg film-coated tablets contain 45 mg mirtazapine per film-coated
tablet.
15 mg/30 mg: The tablet can be divided into equal halves.
The other ingredients are: lactose monohydrate, maize starch, hydroxypropyl
cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose,
titanium dioxide (E171) and macrogol 8000.
The 15mg tablets also contain: iron oxide yellow (E172), quinoline yellow (E104) and
sunset yellow FCF (E110).
The 30mg tablets also contain: iron oxide red (E172), iron oxide yellow (E172) and
iron oxide black (E172).
What Mirtazapine looks like and contents of the pack
Mirtazapine are film-coated tablets.
Mirtazapine 15mg Tablets are oblong, biconvex, yellow, film-coated tablets and
scored on one side.
Mirtazapine 30mg Tablets are oblong, biconvex, beige, film-coated tablets and
scored on one side.
Mirtazapine 45mg Tablets are circular, biconvex, white, film-coated tablets.
Mirtazapine is available in blister packs of 15 mg, 30 mg and 45 mg: 10, 14, 20, 28,
30, 40, 48, 50, 60, 90, 98, 100, 110, 150, 200, 250, 300, 350, 500, 1000 tablets,
although not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Genus Pharmaceuticals, Park View House, 65 London Road, Newbury, Berkshire
RG14 1JN, UK.

Manufacturer
Genus Pharmaceuticals, Park View House, 65 London Road, Newbury, Berkshire
RG14 1JN, UK.
Stada Arzneimittel AG, Stadastrasse 2-18, D-61118 Bad Vilbel, Germany.
Comino Pharm S.L, Fructuós Gelabert 6-8, Sant Joan Despí 08970, Barcelona,
Spain.
This leaflet was last approved in November 2011

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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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