Package Leaflet: Information for the patient

Levetiracetam Rivopharm 1000 mg film-coated tablets

Levetiracetam

Read all of this leaflet carefully before you or your child 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 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.

What is in this leaflet:

1.    What Levetiracetam tablets are and what they are used for

2.    What you need to know before you take Levetiracetam tablets

3.    How to take Levetiracetam tablets

4.    Possible side effects

5.    How to store Levetiracetam tablets

6.    Contents of the pack and other information

1.    What Levetiracetam tablets are and what they are used for

Levetiracetam tablets (as they will be called in the rest of this leaflet) contain 1000 mg of Levetiracetam in a film coated tablet.

Levetiracetam tablets are used in the treatment of epilepsy. They may be used:

•    on their own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by doctor to reduce the number of fits

■    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 (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy

-    primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2.    What you need to know before you take Levetiracetam tablets

Do not take Levetiracetam

•    If you are allergic to levetiracetam, pyrrolidone derivates or any of the other ingredients of this medicine (listed in Section 6).

Warnings and precautions

Talk to your doctor before taking Levetiracetam tablets

•    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.

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

Children and adolescents

•    Levetiracetam tablets are not indicated in children and adolescents below 16 years on its own (monotherapy).

Other medicines and Levetiracetam tablets

Tell vour doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a loss of its effect.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Levetiracetam tablets should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown. Levetiracetam 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

Levetiracetam tablets may impair your ability to drive or operate any tools or machinery, as they 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.

3.    How to take Levetiracetam tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take the number of tablets following your doctor's instructions.

Levetiracetam tablets must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Monotherapy

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

General dose: between 1000 mg and 3000 mg each day.

When you will first start taking Levetiracetam tablets , your doctor will prescribe you a lower dose (500 mg each day) during 2 weeks before giving you the lowest general dose of 1000mg.

Add-on therapy

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

General dose: between 1000 mg and 3000 mg each day.

Example: if your daily dose is 1000 mg, you might take 2 tablets of250 mg in the morning and 2 tablets of 250 mg in the evening.

Dose in infants (1 month 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 levetiracetam according to the age, weight and dose.

An oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50 kg and when tablets don’t allow accurate dosage

Method of administration

Swallow Levetiracetam tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take Levetiracetam tablets with or without food.

Duration of treatment

•    Levetiracetam tablets are used as a chronic treatment. You should continue Levetiracetam tablets treatment for as long as your doctor has told you.

■    Do not stop vour treatment without vour doctor’s advice as this could increase vour seizures.

If you take more Levetiracetam tablets than you should

The possible side effects of an overdose of Levetiracetam tablets are sleepiness, agitation, aggression, decrease of alertness, breathing difficulties and coma.

Contact your doctor if you took more tablets than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Levetiracetam tablets:

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for a forgotten tablet.

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If you stop taking Levetiracetam tablets:

If stopping treatment, Levetiracetam tablets should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam tablets treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam tablets.

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

4.    Possible side effects

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

The most frequent reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Contact your doctor immediately if you notice one of the following symptoms:

•    Thoughts of harming or killing yourself

•    Persistant stomach discomfort or pain, feeling sick and being sick which could indicate a serious problem in the pancreas (inflammation of the pancreas)

•    Itching, yellow skin or eyes, dark urine, tendency to bleed, flu-like symptoms, thought disturbances or sleeplessness, which are symptoms of inflammation of the liver and which could lead to life-threatening liver failure (including fatal cases)

•    Severe skin reactions that may be life-threatening including extensive blistering and peeling of the 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)

•    Severe hypersensitivity reactions (DRESS), characterized by rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cells (eosinophilia) and enlarged lymph nodes

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

•    nasopharyngitis (inflammation of the nose and throat area)

•    somnolence (sleepiness), headache

Common (affects 1 to 10 users in 100 people):

•    anorexia (loss of appetite)

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

•    convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling)

•    vertigo (sensation of rotation)

•    cough

•    abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea

•    rash

•    asthenia/fatigue (tiredness)

Uncommon (affects 1 to 10 users in 1,000 people):

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

•    weight decrease, weight increase

•    suicide attempt and suicidal ideation, mental disorder, abnormalbehaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation

•    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

•    elevated/abnormal values in a liver function test

•    hair loss, eczema, pruritus (itching)

■    muscle weakness, myalgia (muscle pain)

•    injury

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

■    infection

•    decreased number of blood cell types

•    severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling on the face, lips tongue and throat])

•    decreased blood sodium concentration

•    suicide, personality disorders (behavioural problems), thinking abnormally (slow thinking, unable to concentrate)

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

•    liverc failure, hepatitis

•    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)

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. 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 Levetiracetam tablets

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

Do not use this medicine after the expiry date stated on the carton box and blister after EXP:. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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.

6.    Contents of the pack and other information

What Levetiracetam tablets contain

The active substance is called levetiracetam.

Each tablet contains 1000 mg of levetiracetam.

The other ingredients are:

Tablet core: Maize starch, Colloidal anhydrous silica, Magnesium stearate, Talc, Povidone K 30.

Film-coating: Opadry 85F18422: Macrogol 3350, Polyvinyl alcohol, Titanium dioxide (E171), Talc.

Levetiracetam tablets are packed in blisters in cardboard boxes.

Each blister contains 10 tablets.

What Levetiracetam tablets look like and contents of the pack

Levetiracetam 1000 mg film-coated tablets are white, oblong, scored and marked with the code “1000” on the same side.

The tablet can be divided into equal halves.

The cardboard boxes contain 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 100 (10x10) and 200 (20x10) film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder:

Rivopharm UK Ltd.

30th Floor, 40 Bank Street Canary Wharf London E14 5NR, UK

Manufacturers:

Laboratoires BTT Zl de Krafft,

67150 Erstein,

France

Rivopharm UK Ltd.

30^th Floor, 40 Bank Street Canary Wharf London E14 5NR, UK

This leaflet was last revised in 07/2016

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