PATIENT INFORMATION LEAFLET

MIRTAZAPINE 30mg TABLETS

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 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 signs of illness 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.

IN THIS LEAFLET

1.    What Mirtazapine Tablets is and what it is used for

2.    What you need to know before you take Mirtazapine Tablets

3.    How to take Mirtazapine Tablets

4.    Possible side effects

5.    How to store Mirtazapine Tablets

6.    Contents of the pack and other information

WHAT MIRTAZAPINE TABLETS IS AND . WHAT IT IS USED FOR

Mirtazapine 30mg Tablets contain the active substance, mirtazapine.

Mirtazapine is one of a group of medicines called antidepressants. Depression is linked to a shortage of substances which carry messages in the brain (including serotonin and noradrenaline). Mirtazapine helps to relieve the shortage of these ‘brain messages'. Common signs of depression include feelings of worthlessness or deep sadness; difficulty with everyday tasks; sleeping too much or not being able to sleep; feeling anxious; and changes in appetite.

It may take 2 to 4 weeks before you start to feel better and sleep better. It is important to take your medicine every day and not to stop taking it unless your doctor tells you to. If you do, your symptoms may come back.

WHAT YOU NEED TO KNOW BEFORE . YOU TAKE MIRTAZAPINE TABLETS

DO NOT TAKE Mirtazapine 30mg Tablets:

• if you are allergic to mirtazapine or any of the other ingredients of Mirtazapine 30mg Tablets

•    if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs)

Warnings and precautions Children and adolescents

Mirtazapine 30mg Tablets should normally not be used for children and adolescents under 18 years because efficacy was not demonstrated. Patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional (defiant) behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Mirtazapine 30mg Tablets for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Mirtazapine 30mg Tablets 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 30mg Tablets. The long-term safety effects concerning growth, maturation and cognitive and behavioural development of Mirtazapine 30mg Tablets 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 or anxiety disorder

If you are depressed and/or have anxiety disorders 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 or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Take special care with Mirtazapine 30mg Tablets and tell your doctor if you have or have had:

•    epilepsy (seizures or fits)

•    liver disease (including jaundice)

•    kidney disease

•    heart disease

•    low blood pressure

•    difficulty in passing water (urinating), which may be caused by an enlarged prostate

•    an eye disorder called glaucoma or increased pressure in the eye

•    diabetes

•    psychiatric disorders such as schizophrenia or manic depression, delirium or senile dementia

•    an intolerance to some sugars, as this medicine contains lactose

Other medicines and Mirtazapine 30mg Tablets

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 30mg Tablets if you are taking:

•    other antidepressants known as Monoamine Oxidase Inhibitors (MAOIs) e.g. moclobemide, tranylcypromine and selegiline. Do not take Mirtazapine 30mg Tablets during the two weeks after you have stopped taking MAOIs. Do not take MAOIs until at least 2 weeks after stopping Mirtazapine 30mg Tablets.

Take care when taking Mirtazapine 30mg Tablets with any of the following medicines:

•    erythromycin, used to treat bacterial infections

•    certain medicines to treat fungal infections, e.g. ketoconazole

•    linezolid, used to treat pneumonia

•    rifampicin, used to treat tuberculosis

•    medicines for treating HIV/AIDS (e.g. HIV-protease inhibitors)

•    certain antidepressants, e.g. venlafaxine, L-Tryptophan, lithium and St John's wort (can lead to the development of serotonin syndrome and should be used with caution)

•    nefazodone, an antidepressant

•    medicines for schizophrenia (antipsychotics) e.g. olanzapine

•    medicines for treating anxiety or insomnia e.g. benzodiazepines

•    medicines for treating epilepsy (e.g. carbamazepine and phenytoin)

•    triptans, used to treat severe headache

•    tramadol, a painkiller

•    medicines for severe pain, e.g. morphine

•    medicines to treat allergies (antihistamines) e.g. cetirizine

•    cimetidine, a medicine used for the treatment of indigestion or stomach ulcers

•    medicines to prevent blood clotting e.g. warfarin

Mirtazapine 30mg Tablets with food and drink

You may get drowsy if you drink alcohol while you are taking this medicine. It is therefore advisable to avoid drinking any alcohol. You can take Mirtazapine 30mg 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 use Mirtazapine 30mg Tablets until, or shortly before birth, your baby should be supervised for possible adverse effects. Make sure your midwife and/or doctor know you are on Mirtazapine 30mg 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.

Driving and using machines

Antidepressants can affect your concentration or judgement. When you first start taking Mirtazapine 30mg Tablets, make sure your abilities are not affected before you drive or operate machinery.

Mirtazapine 30mg 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 medicinal product.

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HOW TO TAKE MIRTAZAPINE TABLETS

The tablets should be swallowed whole without chewing and with plenty of fluid.

Dosage

Adults

The usual starting dose is 15mg or 30mg, taken preferably in the evening. Your doctor may advise you to increase your dose after a few days to the amount that may be best for you.

After 2 to 4 weeks, talk to your doctor about the effect the treatment has had.

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If you still don't feel well, your doctor may prescribe a higher dose. After another 2 to 4 weeks talk to your doctor again.

If you have the impression that the effect of Mirtazapine 30mg Tablets is too strong or too weak, talk to your doctor or pharmacist.

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)

Your doctor will probably advise you to take Mirtazapine 30mg Tablets as a single dose before you go to bed, as it may help you to sleep.

However, your doctor may suggest you split your dose - for example one tablet in the morning, and another in the evening before you go to bed.

Children

Mirtazapine 30mg Tablets are not recommended for use in children or adolescents (under the age of 18).

Elderly people

Mirtazapine 30mg Tablets can be taken by elderly patients, any dose changes will be done under the close supervision by your doctor.

People with kidney or liver problems

Patients with kidney or liver problems may be given a lower dose of this medicine.

If you take more of your medicine than you should

Call a doctor straight away or go immediately to the nearest casualty department, taking the remaining tablets with you. The most likely signs of overdose are drowsiness, disorientation and increased heart rate.

If you forget to take your medicine

Do not take a double dose to make up for a forgotten dose. Just skip that dose and take your next one at the normal time.

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

•    yellow colouring of 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 anemia), 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:

If you stop taking your medicine

Do not suddenly stop taking Mirtazapine 30mg Tablets even if your depression has lifted. If you stop suddenly, you may feel sick, anxious or agitated and have headaches. It is possible that some of your symptoms may come back.

Once you are feeling better, talk to your doctor who will tell you how to reduce the dose gradually. This will usually be about 4 to 6 months after you start feeling better.

. POSSIBLE SIDE EFFECTS

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

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

•    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

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

•    abdominal pain and nausea; this may suggest inflammation of the pancreas (pancreatitis)

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

•    abnormal sensations in the mouth (oral paraesthesia)

•    swelling in the mouth (mouth oedema)

•    swelling throughout the body (generalized oedema)

•    localized swelling

•    hyponatraemia

•    inappropriate anti-diuretic hormone secretion

•    severe skin reactions (dermatitis bullous, erythema multiforme)

•    sleep walking (somnambulism)

•    speech disorder

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 directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

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HOW TO STORE MIRTAZAPINE TABLETS

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 packaging. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

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

CONTENTS OF THE PACK AND OTHER . INFORMATION

What Mirtazapine 30mg Tablets contain

Each film-coated tablet contains 30mg of the active substance mirtazapine. The other ingredients are lactose monohydrate, pregelatinised maize starch, anhydrous colloidal silica, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

What Mirtazapine 30mg Tablets look like and contents of the pack

Mirtazapine 30mg Tablets are brownish, oval, biconvex, film-coated tablets, scored on both sides and marked with I on one side.

The tablets are supplied in blister packs of 28 film-coated tablets.

Marketing Authorisation Holder

Athlone Laboratories Limited, Ballymurray,

Co. Roscommon, Ireland.

Manufacturer responsible for batch release

Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

Distributor: Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

Product Licence Number: PL 06453/0061 This leaflet was revised in April 2014.

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