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PACKAGE LEAFLET: INFORMATION FORTHE USER

Mirtazapine 15mg, 30mg and 45mg FUm-coated 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 haveanyfurtherquestions.askyourdoctororpharmacist.

•    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 Film-coated Tablets

3.    How to take Mirtazapine Film-coated Tablets

4.    Possible side effects

5.    How to store Mirtazapine Film-coated 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 Tablets are used to treat depressive illness.

2. BEFORE YOU TAKE MIRTAZAPINE FILM-COATED 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-ls).

Take special care with Mirtazapine Tablets:

Use in children and adolescents under 18 years of age

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 backtoyourdoctor.

You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Mirtazapine Tablets. The long term safety effects related to growth and development 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 Tablets 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 straightaway.

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 Tablets

•    if you have, or have ever had one of the following conditions.

•    Tell your doctor about these conditions before taking Mirtazapine Tablets, ifnotdone previously

•    seizures (epilepsy). If you develop seizures oryour 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 yourdoctor immediately;

•    kidney disease;

•    heart disease, or low blood pressure;

•    schizophrenia. If psychotic symptoms, such as paranoid thoughts become more frequent or severe, contactyourdoctorstraight away;

•    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.

•    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.

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 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 Mirtazapine Tablets, 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 ortriptans (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 Tablets alone or the combination of Mirtazapine Tablets 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 necessary to lower the dose of Mirtazapine Tablets, orwhen 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 Mirtazapine Tablets 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). In combination with Mirtazapine Tablets these medicines can increase the amount of mirtazapine in your blood. Inform your doctor if you are using these medicines. It might be necessary 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;

•    medicinesfortuberculosis such as rifampicin.

In combination with Mirtazapine Tablets these medicines can reduce the amount of mirtazapine in your blood. Inform your doctor if you are using these medicines. It might be necessary 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 ofwarfarin on the blood. Inform yourdoctor if you are using this medicine. In case of combination it is advised that a doctor monitors your blood carefully.

•    medicines for heartburn and peptic ulcer such as cimetidine.

Taking Mirtazapine Tablets with food and drink

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

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.

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

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 Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Mirtazapine 15mg tablets also contain sunset yellow FCF (E-110) which can cause allergic reactions including asthma.

3. HOW TO TAKE MIRTAZAPINE FILM-COATED TABLETS

Always take mirtazapine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Howmuchtotake

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 prescribe a lower dose.

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 you 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 waterorjuice.

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 MirtazapineTablets, 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 togetherwithyourevening 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.

Ifyou stop too early, yourdepression 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, askyourdoctor or pharmacist.

Common (affects 1 to 10 users in 100):

•    lethargy

•    dizziness

•    shakiness or tremor

•    nausea

•    diarrhoea

•    vomiting

•    rash or skin eruptions (exanthema)

•    pain in yourjoints (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 (affects 1 to 10 users in 1,000):

•    abnormal sensation in the skin e.g. burning, stinging, tickling ortingling (paraesthesia)

•    restless legs

•    fainting (syncope)

•    sensations of numbness in the mouth (oral hypoaesthesia)

•    low blood pressure

•    nightmares

•    feeling agitated

•    hallucinations

•    urge to move.

Rare (affects 1 to 10 users in 10,000):

•    muscle twitching or contractions (myoclonus)

•    aggression.

Not known (cannot be estimated from the available data):

•    abnormal sensations in the mouth (oral paraesthesia)

•    difficulty in speaking

•    swelling in the mouth (mouth oedema)

•    increased salivation

•    hyponatraemia (low levels of sodium in the blood)

•    inappropriate anti-diuretic hormone secretion (symptoms such as nausea orvomiting, cramps or tremors, depressed mood, memory impairment, irritability, personality changes such as combativeness, confusion and hallucinations, seizures, stupor or coma).

•    sleepwalking.

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 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 FILM-COATED TABLETS

Keep out of the sight and reach of children.

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

Store in the original package. Keep the blister in the outer carton.

Medicines should not be disposed ofvia wastewateror household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

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

Some side effects are more likely to occur than others. The possible side effects of Mirtazapine Tablets are listed below and can be divided as:

Tell your doctor and stop taking mirtazapine immediately ifyou notice any of the following side effects:

•    Signs of infection such as fever, sore throat, mouth ulcers. These are symptoms of agranulocytosis in which a reduction in the number of white blood cells results in a lower resistance to infection. Other changes to your normal red and white blood cell levels may occur. Ifyou have these symptoms you should tell your doctor who will probably give you a blood test.

•    Feeling elated oremotionally'high' (mania).

•    Yellowing of your skin / eyes (signs of jaundice), this may suggest a disturbance in liverfunction.

•    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. In very rare cases these can be signs of serotonin syndrome.

•    sever blistering of the skin/and or mucous membranes of lips, mouth, eyes, nasal passages or genital area, skin eruption. If you develop any of these symptoms, contactyourdoctor straight away.

If you have any thoughts of suicide or harming yourself whilst taking this medicine, you should contact your doctor immediately (see also Section 2 -Before you take).

Very common (affects more than 1 user in 10):

•    increase in appetite and weight gain

•    drowsiness orsleepiness

•    headache

•    dry mouth.

What Mirtazapine Tablets contain:

•    The active substance is mirtazapine. Each film-coated tablet contains 15mg, 30mg or 45mg of mirtazapine.

•    The other ingredients are lactose monohydrate, maize starch, hydroxypropylcellulose, silica colloidal anhydrous, magnesium stearate, hypromellose, macrogol 8000 and titanium dioxide (E171). The 15mg tablet also contains quinoline yellow (E104), sunset yellow FCF (E110) and yellow iron oxide (E172). The 30mg tablet also contains yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).

What Mirtazapine Tablets look like and contents of the pack:

Your medicine is in the form of film-coated tablets.

•    The 15mg tablets are yellow, oblong, biconvex tablets with a score line on one side.

•    The 30mg tablets are beige, oblong, biconvex tablets with a score line on one side.

•    The45mg tablets are white, round, biconvex tablets.

Mirtazapine Tablets are available in blisters of:

15mg: 14,28,30,56,60,70,90 and 100 tablets.

30mg: 14, 20, 28, 30, 50, 56, 60, 70, 90,100, 200 and 500 tablets

45mg: 14, 20, 28, 30, 50, 56, 70, 100, 200 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder & Manufacturer:

Relonchem Limited

Cheshire House, Gorsey Lane, Widnes, Cheshire,

WA8 0RP, UK

This leaflet was last revised in July 2014.