PAGE 4: AFTER FOLDING REAR FACE (OUTSIDE OF REEL AFTER FOLDING AND TACKING)

FOLD

LINE. PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING)

•    feeling anxious

•    sleeping problems

Uncommon (may affect up to 1 in 100 people):

•    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 (may affect up to 1 in 1,000 people):

•    muscle twitching or contractions (myoclonus)

•    aggression

•    inflammation of the pancreas

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

•    Erythema multiforme, a skin disease characterised by itchy pink-red blotches starting on your feet and hands

•    blisters full of fluid (dermatitis bullous)

•    abnormal sensations in the mouth (oral paraesthesia)

•    swelling in the mouth (mouth oedema)

•    swelling throughout the body (generalized oedema)

•    localized swelling

•    hyponatraemia

•    inappropriate antidiuretic hormone secretion

•    difficulty passing urine

•    distorted speech (dysarthria)

•    increased salivation

•    sleepwalking

•    increase in certain enzyme levels in the body

•    muscle pain, tenderness, weakness and swelling of the affected muscles (rhabdomyolysis)

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 or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects 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.

©Contents of the pack and other information

What Mirtazapine contains

Film coated tablets

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

• The other ingredients present in the 15 mg, 30 mg and 45 mg of Mirtazapine tablets are lactose monohydrate, maize starch, povidone K-30, anhydrous colloidal silica, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, macrogol 6000, 15 mg: yellow iron oxide (E 172) and 45 mg: yellow iron oxide (E 172) and red iron oxide (E172).

What Mirtazapine looks like and contents of the pack

• The 15 mg tablets are yellow, round tablets. One side of the tablet has a scoreline with the marking "9" on one side of the score line and the number "3" on the other. The other side of the tablet is marked with the number "7206".The tablet can be divided into equal doses.

• The 30 mg tablets are reddish brown, round tablets. One side of the tablet has a scoreline with the marking "9" on one side of the scoreline and the number "3" on the other. The other side of the tablet is marked with the number "7207".The tablet can be divided into equal doses.

• The 45 mg tablets are white to off-white, round tablets, debossed with the number "93" on one side of the tablet and debossed with the number "7208" on the other side.

• The 15 mg tablets are available in pack sizes of 14, 20, 28, 30, 50, 56, 60, 70 and 100 tablets.

• The 30 mg tablets are available in pack sizes of 14, 20, 28, 30, 50, 60, 100 and 200 (2 x 100) tablets.

• The 45 mg tablets are available in pack sizes of 20, 28, 30, 50, 60, 100 and 200 tablets.

• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder and company responsible for manufacture is: TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised in: March 2015.

PL 00289/0438 PL 00289/0439 PL 00289/0440

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 packaging 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

88365-D 323 x 320

Mirtazapine 15,

30 and 45 mg Tablets

Mirtazapine

Package leaflet: Information for the user

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 symptoms 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.

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.    Content of the pack and other information

OWhat 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 in adults.

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 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).

Warnings and precautions

Talk to your doctor or pharmacist before taking Mirtazapine

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

What i

in this leaflet:

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/over-activity 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 ;

-    certain kinds of heart conditions that may change your heart rhythm, a recent heart attack, heart failure, or take certain medicines that may affect the heart's rhythm.

•    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.

Children and adolescents

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 increased risk of side effects such as suicide 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.

Peel Here To Open

Ni

Pharma code 318 (00111111)

Top of page cut-off to middle of registration mark = 44 mm    pj_rst bar is 105mm from top edge

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 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. The symptoms of a possible overdose may include 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.

If you forget to take Mirtazapine

If you are supposed to take your dose once a day

•    Do not take double dose to make up for a forgotten 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 medicine, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

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

If you experience any of the following serious side effects, stop taking mirtazapine and tell your doctor immediately.

Uncommon (may affect up to 1 in 100 people):

•    feeling elated or emotionally 'high' (mania)

Rare (may affect up to 1 in 1,000 people):

•    yellow colouring of the eyes or skin; this may suggest disturbance in liver function (jaundice)

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

•    signs of infection such as sudden unexplainable high fever, sore throat and mouth ulcers (agranulocytosis). 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 anaemia), a shortage of blood platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia).

•    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, unconsciousness and increased salivation. In very rare cases these can be signs of serotonin syndrome.

•    thoughts of harming or killing yourself.

•    severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Other possible side effects with mirtazapine are:

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)

•    swelling (typically in ankles or feet) caused by fluid retention (oedema)

•    tiredness

•    vivid dreams

•    confusion