Document: leaflet MAH GENERIC_PL 20532-0165 change

• leaflet CONSILIENT HEALTH_PL 01656-0038
• leaflet MAH GENERIC_PL 00289-0876
• leaflet MAH GENERIC_PL 01656-0038
• leaflet MAH GENERIC_PL 20532-0165
• leaflet NICHE GENERICS_PL 01656-0038

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirtazapine 15 mg orodispersible tablets Mirtazapine 30 mg orodispersible tablets Mirtazapine 45 mg orodispersible tablets

(Mirtazapine)

Read all of this leaflet carefully before you start using 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 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 tablets

6.    Further 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 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 tablets. 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-ls).

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 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. 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 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.

a 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, a 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, a 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 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.

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 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.

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. 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 tablets

Mirtazapine tablets contains aspartame, a source of phenylalanine. May be harmful for people with phenylketonuria.

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 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).    _v

Fig. A.

2. Tear off one tablet pocket

Each strip 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).

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 mlrtazaplne 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 mlrtazaplne:

-► 2 to 4 weeks after you have started taking mlrtazaplne, 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.

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 devided as:

affects more than 1 user in 10

affects 1 to 10 users in 100

affects 1 to 10 users in 1,000

affects 1 to 10 users in 10,000

affects less than 1 user in 10,000

cannot be estimated from the available data

Very common:

•    increase in appetite and weight

•    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)

•    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) Stop taking mirtazapine and tell your doctor straight away.

•    muscle twitching or contractions (myoclonus)

•    aggression

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), difficulty with speaking,

-> 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)

•    swelling in the mouth (mouth oedema), increase in saliva secretion or watery mouth.

•    hyponatraemia

•    inappropriate anti-diuretic hormone secretion

•    sleepwalking

•    blisters of the skin (dermatitis bullous)

•    Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) called erythema multiforme

•    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)

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.

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

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose off medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Mirtazapine contains

•    The active substance is mirtazapine. Each orodispersible tablet contains 15 mg, 30 mg or 45 mg mirtazapine.

•    The other ingredients are crospovidone (type B), mannitol (E421), Cellulose, microcrystalline, aspartame (E951), silica colloidal anhydrous, magnesium stearate, strawberry guarana flavor [maltodextrin, propylene glycol, artificial flavours, acetic acid] and peppermint flavor [artificial flavours, corn starch].

What Mirtazapine look like and contents of the pack

Orodispersible tablet.

Mirtazapine 15 mo orodispersible tablets:

White, round orodispersible tablets debossed with “36”on one side and 'A' on the other side with an embossed circular edge.

Mirtazapine 30 mg orodispersible tablets:

White, round orodispersible tablets debossed with “37" on one side and 'A' on the other side with an embossed circular edge.

Mirtazapine 45 ma orodispersible tablets:

White, round orodispersible tablets debossed with “38” on one side and 'A' on the other side with an embossed circular edge.

Mirtazapine orodispersible tablets are available in Polyamide/ aluminium/ PVC/ paper/ polyster/ aluminum perforated unit dose blister packs of 6,18, 30,48, 90 and 96 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Aurobindo Pharma Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom Tel: ++ 44 20 8845 8811 Fax: ++ 44 20 8845 8795

Manufacturer

Milpharm Limited

Ares, Odyssey Business Park

West End Road

South Ruislip HA4 6QD

United Kingdom

or

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

This medicinal product is authorized in the Member States of the EEA under the following names:

Belgium:    Mirtazapine Apotex® 15 mg/ 30 mg/ 45 mg orodispergeerbare tabletten

Bulgaria:    Mirtazapine Aurobindo 15 mg/ 30 mg/ 45 mg TaSneTKM, flucneprupama ce

b ycraTa

Cyprus:    Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg Sioxia SiaonEipopEvo ctto

OTopa

Denmark:    Mirtazapin “Aurobindo”

Estonia:    Mirtazapin Aurobindo 15 mg/ 30 mg/ 45    mg suus dispergeeruvad    tabletid

Finland:    Mirtazapin Aurobindo 15 mg/ 30 mg/ 45    mg tabletti, suussa hajoava

France:    MIRTAZAPINE AUROBINDO 15 mg comprimes orodispersible

Germany:    Mirtazapin Aurobindo 15 mg/ 30 mg/ 45    mg Schmelztabletten

Greece:    mirtazaFer 15 mg/ 30 mg/ 45 mg Sioxia SiaanEipSpEvo oto OTdpa

Hungary:    Mirtazapine Aurobindo 15 mg/ 30 mg/ 45 mg szajban diszpergalodo

tabletta

Ireland:    Mirtazapine Aurobindo 15 mg/ 30 mg/ 45 mg orodispersible tablets

Italy:    MIRTAZAPINA DOC Generici 15 mg/ 30 mg/ 45 mg compresse

Latvia:

Lithuania:

Norway:

Netherlands:

Poland:

Portugal:

Romania:

Spain:

Sweden:

United Kingdom:

This leaflet was last approved in 11/2012.