Document: Levetiracetam Ranbaxy film-coated tablets ENG PL change

• Levetiracetam Ranbaxy film-coated tablet PL
• Levetiracetam Ranbaxy film-coated tablets ENG PL

---

Package Leaflet: Information for the patient

Levetiracetam Ranbaxy 250 mg film-coated tablets

Levetiracetam Ranbaxy 500 mg film-coated tablets

Levetiracetam Ranbaxy 750 mg film-coated tablets

Levetiracetam Ranbaxy 1000 mg film-coated tablets

Levetiracetam

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 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 Ranbaxy is and what it is used for

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

3. How to take Levetiracetam Ranbaxy

4. Possible side effects

5. How to store Levetiracetam Ranbaxy

6. Contents of the pack and other information.

1. What Levetiracetam Ranbaxy is and what it is used for

Levetiracetam Ranbaxy is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Ranbaxy 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 Levetiracetam Ranbaxy

Do not take Levetiracetam Ranbaxy

Warnings and Precautions

Talk to your doctor before taking Levetiracetam Ranbaxy

decide if your dose should be adjusted.

• if you notice any slowdown 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.

Other medicines and Levetiracetam Ranbaxy

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

Levetiracetam Ranbaxy with food, drink and alcohol

You may take Levetiracetam Ranbaxy with or without food. As a safety precaution, do not take Levetiracetam Ranbaxy 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.

Levetiracetam Ranbaxy should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. 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 Ranbaxy may impair your ability to drive or operate any tools or machinery, as levetiracetam 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 Ranbaxy

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

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

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

Monotherapy

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

General dose: between 1000 mg and 3,000 mg each day.

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

Example: if your daily dose is 2,000 mg, you must take 1 tablet of 1000 mg in the morning and 1 tablet of 1000 mg in the evening.

Add-on therapy

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

General dose: between 1,000 mg and 3,000 mg each day.

Example: if your daily dose is 2,000 mg, you must take 1 tablet of 1000 mg in the morning and 1 tablet of 1000 mg in the evening.

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 according to the age, weight and dose.

An oral solution is a presentation more appropriate to infants and children under the age of 6 years.

General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.

Example: a general dose of 20 mg per kg bodyweight each day, you must give your 25 kg child 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening.

Dose in infants (1 month to less than 6 months)

An oral solution is a presentation more appropriate to infants.

Method of administration

Swallow Levetiracetam Ranbaxy tablets with a sufficient quantity of liquid (e.g. a glass of water).

Duration of treatment

• Levetiracetam Ranbaxy is used as a chronic treatment. You should continue Levetiracetam Ranbaxy 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 treatment with Levetiracetam Ranbaxy he/she will instruct you about the gradual withdrawal of Levetiracetam Ranbaxy.

If you take more Levetiracetam Ranbaxy than you should

The possible side effects of an overdose of levetiracetam tablets are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing 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 Ranbaxy

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

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

If you stop taking Levetiracetam Ranbaxy

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

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.

Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the 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 1000

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

• weight decrease, weight increase;

• suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, 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;

• 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 number of all blood cell types;severe hypersensitivity reactions (DRESS);

• decreased blood sodium concentration

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

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

• pancreatitis;

• hepatic 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), 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).

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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

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

Do not take Levetiracetam Ranbaxy after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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

What Levetiracetam Ranbaxy contain

The active substance is levetiracetam.

250mg

Each tablet contains 250mg levetiracetam.

The other ingredients are: Maize starch, Povidone, Microcrystalline cellulose, Silica colloidal anhydrous, Crospovidone, Talc, Magnesium stearate, Opadry blue (Hypromellose, Titanium dioxide (E171), Macrogol, Talc, Indigo carmine aluminium lake (E132)).

500mg

Each tablet contains 500mg levetiracetam.

The other ingredients are: Maize starch, Povidone, Microcrystalline cellulose, Silica colloidal anhydrous, Crospovidone, Talc, Magnesium stearate, Opadry yellow (Hypromellose, Titanium dioxide (E171), Macrogol, Talc, Iron oxide yellow (E172), Indigo carmine aluminium lake (E132)).

750mg

Each tablet contains 750mg levetiracetam.

The other ingredients are: Maize starch, Povidone, Cellulose microcystalline, Silica colloidal anhydrous, Crospovidone, Talc, Magnesium stearate, Opadry pink (Hypromellose, Titanium dioxide (E171), Macrogol, Talc, Iron oxide red (E172), Indigo carmine aluminium lake (E132)).

1000mg

Each tablet contains 1000mg levetiracetam.

The other ingredients are: Maize starch, Povidone, Cellulose microcrystalline, Silica colloidal anhydrous, Crospovidone, Talc, Magnesium stearate, Opadry white (Hypromellose, Titanium dioxide (E 171), Macrogol, Talc).

What Levetiracetam Ranbaxy tablets look like and contents of the pack

250mg

Blue coloured, oval shaped, 15x7mm, film-coated tablet, debossed with “RB” and “18” on either side of the score line on one side and plain on the other side.The tablets can be divided into equal halves.

500mg

Yellow coloured, oval shaped, 18.5X9mm, film-coated, debossed with “RB” and “19” on either side of the score line on one side and plain on the other side. The tablets can be divided into equal halves.

750mg

Pink coloured, oval shaped, 20.5x10mm, film-coated tablets debossed with “RB” and “20” on either side of the score line on one side and plain on the other side. The tablets can be divided into equal halves.

1000mg

White coloured, oval shaped, 19.1x10.2mm, film-coated tablets debossed with “LT” and “4” on either side of the score line on one side and plain on the other side. The tablets can be divided into equal halves.

Levetiracetam Ranbaxy film-coated tablets are supplied in blister packs. The pack sizes for each strength are as given below:

250mg: 10/20/30/50/60/100/120/200 tablets

500mg: 10/20/30/50/60/100/120/200 tablets

750mg: 10/20/30/50/60/100/120/200 tablets

1000mg: 30/50/60/100/200 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

<To be completed nationally>

Manufacturer:

Ranbaxy Ireland Limited, Spafield, Cork Road, Cashel, Co-Tipperary, Republic of Ireland

Terapia S.A., 124 Fabricii Street, 400 632 Cluj Napoca, Romania

Basics GmbH, Hemmelrather Weg 201, D-51377 Leverkusen, Germany

This medicinal product is authorized in the Member States of the EEA under the following names>

Germany: Levetiracetam Basics 250mg, 500mg, 750mg, 1000mg Film-coated Tablets

Greece: Levetiracetam Galenica 250mg, 500mg, 1000mg Film-coated Tablets

Spain: Levetiracetam Ranbaxy 500mg, 1000mg Film-coated Tablets

France: Levetiracetam Ranbaxy 250mg, 500mg, 1000mg Film-coated Tablets

Romania: Levetiracetam Terapia 250mg, 500mg, 1000mg Film-coated Tablets

Sweden: Levetiracetam Ranbaxy 250mg, 500mg, 750mg, 1000mg Film-coated Tablets

This leaflet was last revised in March2014