MIRTAZAPINE 15 MG FILM-COATED TABLETS

Active substance: MIRTAZAPINE

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• 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)
Stop taking Mirtazapine and tell your doctor straight away.
• muscle twitching or contractions (myoclonus)
• aggression
• pancreatitis which can casus a severe dull pain around the top of your stomach which may
move along your back sometimes with feeling and being sick, diarrhea, loss of appetite,
high temperature and tenderness of the abdomen (stomach)
Not known:
• signs of infection such as sudden unexplainable high fever, sore throat and mouth ulcers
(agranulocytosis)
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)
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.
Stop taking Mirtazapine and tell your doctor straight away.
• thoughts of harming or killing yourself
Contact your doctor or go to a hospital straight away.
• abnormal sensations in the mouth (oral paraesthesia)
• difficulty speaking clearly
• swelling in the mouth (mouth oedema) or elsewhere in your body (local and general
oedema)
• an increase in saliva production
• sleep walking
• hyponatraemia
• inappropriate anti-diuretic hormone secretion
• Severe reactions to this medicine include rash, blisters or peeling skin which keep getting
worse. Stop taking Mirtazapine and tell your doctor straight away.
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 tablets
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Store in the original package.
Do not use Mirtazapine tablets after the expiry date, which is stated on the carton. The expiry
date refers to the last day of that month.
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 tablets contain
The active ingredient is Mirtazapine. Each film coated tablet contains 15, 30 or 45 mg
Mirtazapine.
- The other ingredients are lactose monohydrate, maize starch, hydroxypropyl cellulose, low
substituted hydroxypropyl cellulose, magnesium stearate (E470b), silica colloidal
anhydrous, hypromellose (E464) and titanium dioxide (E 171).
The 15 mg tablets also contain yellow iron oxide (E 172).
The 30 mg tablets also contain yellow iron oxide (E172), red iron oxide (E172) and black
iron oxide (E172).
What Mirtazapine tablets look like and contents of the pack
Mirtazapine 15 mg tablets are yellow, biconvex, capsule shaped film coated tablets with score
line on one side and 15 debossed on other side.
Mirtazapine 30 mg tablets are reddish brown, biconvex, capsule shaped film coated tablets
with score line on one side and 30 debossed on other side.
Mirtazapine 45 mg tablets are white, biconvex, capsule shaped film coated tablets plain on
one side and 45 debossed on other side.
Mirtazapine 15, 30 and 45 mg tablets are available in PVC coated PVdC blister packs of 10/14/
28/30/40/50/56/60/70/84/90/100/200/250/500 tablets. Not all packs may be marketed.
15mg: PL No.: 21880/0053
30mg: PL No.: 21880/0054
45mg: PL No.: 21880/0055
This leaflet was last revised in 04/2013
MA Holder:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail : info@medreich.co.uk

Pantone
Red 032 C

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirtazapine 15, 30 & 45 mg tablets

(Mirtazapine)
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 gets 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 tablet is and what it is used for
2) Before you take Mirtazapine tablets
3) How to take Mirtazapine tablets
4) Possible side effects
5) How to store Mirtazapine tablets
6) Further information
1) What Mirtazapine tablets are and what they are used for
Mirtazapine is one of a group of medicines called antidepressants.
Mirtazapine tablets are used to treat depressive illness.
2) Before you take Mirtazapine tablets
Do not take Mirtazapine tablets
• if you are allergic (hypersensitive) to Mirtazapine or any of the other ingredients of Mirtazapine
tablets. 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).
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
efficiency 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 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 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. 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
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 tablets 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 tablets with or without food.
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine.
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 are taking Mirtazapine tablets and you become pregnant or you plan to get pregnant,
ask your doctor whether you may continue taking Mirtazapine tablets. If you use Mirtazapine
tablets 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 tablets.
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.
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.
Important information about some of the ingredients of Mirtazapine tablets
Mirtazapine film-coated tablet contains lactose. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3) How to take Mirtazapine tablets
Always take Mirtazapine tablets 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 tablets
Take Mirtazapine tablets at the same time each day.
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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.
Take your tablets orally. Swallow your prescribed dose of Mirtazapine tablets without chewing,
with some water or juice.
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.
If you take more Mirtazapine tablets than you should
If you or someone else have 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.
If you forget to take Mirtazapine tablets
If you are supposed to take your dose once a day
• If you have forgotten to take your dose of Mirtazapine tablets, 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 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, Mirtazapine tablets 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)
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)

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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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