Document: leaflet MAH BRAND_PL 29831-0620 change

• leaflet MAH BRAND_PL 29831-0620
• leaflet MAH GENERIC_PL 29831-0620

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PACKAGE LEAFLET: INFORMATION FOR THE USER MEVLUXA 100 mg/ml ORAL SOLUTION levetiracetam

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 signs of illness are the same as yours.

-    If you get any side effect please tell your doctor or pharmacist. This includes possible side effects not listed in this leaflet. See section 4

What is in this leaflet:

1.    What Mevluxa is and what it is used for

2.    What you need to know before you take Mevluxa

3.    How to take Mevluxa

4.    Possible side effects

5.    How to store Mevluxa

6.    Contents of the pack and other information

1. WHAT MEVLUXA IS AND WHAT IT IS USED FOR

Mevluxa 100 mg/ml Oral Solution contains the active ingredient levetiracetam, which is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Mevluxa is used:

•    on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalisation.

•    as an add-on to other antiepileptic medicines to treat:

■    partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age

■    myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy

■    primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEVLUXA

Do not take Mevluxa

•    If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Mevluxa

•    If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted.

•    If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.

•    If you notice an increase in seizure severity (e.g. increased number), please contact your doctor.

•    A small number of people being treated with anti-epileptics such as Mevluxa have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Other medicines and Mevluxa:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Mevluxa with food and drink:

You may take Mevluxa with or without food. As a safety precaution, do not take Mevluxa with alcohol.

Pregnancy and breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or if you think you may be pregnant, please inform your doctor.

Mevluxa should not be used during pregnancy unless clearly necessary. A risk of birth defects to your unborn child cannot be completely excluded. Mevluxa has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.

Breast-feeding is not recommended during treatment.

Driving and using machines:

Mevluxa may impair your ability to drive or operate any tools or machinery, as Mevluxa may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Mevluxa contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and maltitol. Mevluxa includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate

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(E216) which may cause allergic reactions (possibly delayed).

Mevluxa also contains maltitol. 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 MEVLUXA

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

Mevluxa must be taken twice a day, once in the morning and once in the evening, at about the same time each day. Take the oral solution following your doctor’s instructions.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day.

When you first start taking Mevluxa, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:

General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day.

Dose in infants (6 to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Mevluxa according to the age, weight and dose.

General dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) per kg bodyweight each day, divided in 2 intakes per day. The exact quantity of oral solution formulation should be delivered using the syringe provided in the cardboard box.

Method of administration:

Mevluxa may be diluted in a glass of water or baby’s bottle. Instructions for use:

•    Open the bottle: press the cap and turn it anticlockwise

•    Separate the adaptor from the syringe. Insert the adaptor into the bottle neck. Ensure it is well fixed.

•    Take the syringe and put it in the adaptor opening.

Turn the bottle upside down

•    Fill the syringe with a small amount of solution by pulling the piston down, then push the piston upward in order to remove any possible bubble. Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor.

Turn the bottle the right way up. Remove the syringe from the adaptor.

•    Empty the contents of the syringe in a glass of water or baby’s bottle by pushing the piston to the bottom of the syringe.

•    Drink the whole contents of the glass/baby’s bottle.

•    Close the bottle with the plastic screw cap.

•    Wash the syringe with water only.    107008/1

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Duration of treatment:

•    Mevluxa is used as a chronic treatment. You should continue Mevluxa treatment for as long as your doctor has told you.

•    Do not stop your treatment without your doctor’s advice as this could increase your seizures.

Should your doctor decide to stop your Mevluxa treatment, he/she will instruct you about the gradual withdrawal of Mevluxa.

If you take more Mevluxa than you should:

The possible side effects of an overdose of Mevluxa are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma. Contact your doctor if you took more Mevluxa than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Mevluxa:

Contact your doctor if you have missed one or more doses. Do not take a double dose to make up for a forgotten dose.

If you stop taking Mevluxa:

If stopping treatment, as with other antiepileptic medicines, Mevluxa should be discontinued gradually to avoid an increase of seizures.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Please stop taking, and talk to your doctor immediately or go to a hospital straight away if you experience any of the following serious side effects (occurring rarely):

•    severe skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);

•    uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);

•    severe hypersensitivity reactions (DRESS);

•    hepatic failure (signs and symptoms may include yellowing of the skin and eyeballs (jaundice), pain or swelling of the abdomen, nausea, vomiting, a general feeling of illness (malaise), disorientation or confusion or tiredness);

Please talk to your doctor immediately if you experience any of the following rare, but serious side effects:

•    suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate), suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, emotional instability/mood swings, agitation;

•    decreased number of all blood cell types (most common symptom of which is tiredness (fatigue))

•    pancreatitis (signs and symptoms include abdominal and /or back pain and/or swelling, nausea, vomiting, fever and an increased heart rate),;

•    hepatitis (signs and symptoms include loss of appetite, tiredness (fatigue), mild fever, muscle or joint pains, nausea, vomiting, and abdominal pain).

Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of treatment or at dose increase. These effects should however decrease over time.

Very common: (may affect more than 1 user in 10)

•    nasopharyngitis;

•    somnolence (sleepiness), headache.

Common: (may affect 1 to 10 users in 100)

•    anorexia (loss of appetite);

•    depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

•    convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy, tremor (involuntary trembling);

•    vertigo (sensation of rotation);

•    cough;

•    abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;

•    rash;

•    asthenia/fatigue (tiredness).

Uncommon: (may affect 1 to 10 users in 1,000)

•    decreased number of blood platelets, decreased number of white blood cells;

•    weight decrease, weight increase;

•    amnesia (loss of memory), memory impairment (forgetfulness),

abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);

•    diplopia (double vision), vision blurred;

•    liver function test abnormal;

•    hair loss, eczema, pruritus;

•    muscle weakness, myalgia (muscle pain);

•    injury.

Rare: (may affect 1 to 10 users in 10,000)

•    infection;

•    decreased blood sodium concentration.

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 the leaflet. You can also report side effects directly via the national reporting systems listed below:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard.

Ireland:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie

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

5. HOW TO STORE MEVLUXA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and bottle after EXP:.

The expiry date refers to the last day of the month. Do not use after 1 month of first opening the bottle. Store below 25°C. Due to sensitivity to light, store in the original container. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mevluxa contains

The active substance is called levetiracetam. Each 1 ml contains 100 mg of levetiracetam.

The other ingredients are: Sodium citrate, Citric acid, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Ammonium glycyrrhizate, Glycerol (E422), Maltitol (E965), Acesulfame potassium (E950), Grape flavour, Purified water.

What Mevluxa looks like and contents of the pack

Mevluxa 100 mg/ml Oral Solution is a clear liquid.

The 300 ml glass bottle of Mevluxa (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml) and an adaptor for the syringe.

The 150 ml glass bottle of Mevluxa (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3 ml syringe (graduated every 0.1 ml) and an adaptor for the syringe.

The 150 ml glass bottle of Mevluxa (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml syringe (graduated every 0.05 ml) and an adaptor for the syringe.

Marketing Authorisation Holder: Wockhardt UK Ltd,

Ash Road North, Wrexham, LL13 9UF

Manufacturer: Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

PA Number: 1339/56/1 PL Number: 29831/0620

Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only). Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People For the Republic of Ireland please call: + 353 52 36253.

This leaflet was last updated on 08/2014

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