DRETACEN 250 mg, filmomhulde tabletten

DRETACEN are an antiepileptic medicine (a medicine used to treat seizures in epilepsy). This medicine 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 : o partial onset seizures with or without generalisation in adults, adolescents, children and infants from 1 month age. o myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy. o primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

Do NOT take DRETACEN:

• if you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of DRETACENthis medicine (listed in Section 6).

Warnings and precautions

Talk to your doctor before taking DRETACEN if you:

• have kidney problems, follow your doctor’s instructions, your dose may need to be adjusted.
• notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
• notice an increase in seizure severity (e.g. increased number), please contact your doctor.
• have any symptoms of depression and / or suicidal ideation, please contact your doctor. A small number of people being treated with antiepileptics such as DRETACEN have had thoughts of harming or killing themselves.

Other medicines and DRETACEN

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

DRETACEN with food, drink and alcohol

You can take DRETACEN with or without food. As a safety precaution, do not take DRETACEN 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. DRETACEN should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown. This medicine 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

DRETACEN may impair your ability to drive or operate any tools or machinery, as it 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.

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

DRETACEN 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 (<For 250mg> 4 tablets <For 500mg> 2 tablets) and 3,000 mg (<For 250mg> 12 tablets <For 500mg> 6 tablets) each day.

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

<For 250mg>

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

<For 500mg>

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

<For 750mg>

Example: if your daily dose is 3,000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.

<For 1000mg>

Example: if your daily dose is 2,000 mg, you must take 1 tablet in the morning and 1 tablet 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 (<For 250mg> 4 tablets <For 500mg> 2 tablets) and 3,000 mg (<For 250mg> 12 tablets <For 500mg> 6 tablets) each day.

<For 250mg>

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

<For 500mg>

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

<For 750mg>

Example: if your daily dose is 1,500 mg, you must take 1 tablet in the morning and 1 tablet in the evening.

<For 1000mg>

Example: if your daily dose is 2,000 mg, you must take 1 tablet in the morning and 1 tablet 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 of levetiracetam according to the age, weight and dose.

Levetiracetam 100 mg/ml 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.

<For 250mg>

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

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

DRETACEN 100 mg/ml oral solution is a presentation more appropriate to infants.

Method of administration:

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

Duration of treatment:

• DRETACEN is used as a chronic treatment. You should continue the 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. If your doctor decides to stop your treatment, he/she will instruct you to gradually withdraw the treatment.

If you take more DRETACEN than you should

The possible side effects of an overdose of DRETACEN 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 DRETACEN

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 DRETACEN

If you are stopping treatment, as with other antiepileptic medicines, DRETACEN should be discontinued gradually to avoid an increase in seizures.

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

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

Some side effects such as 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;
• 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).

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. How to store DRETACEN

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 the month. The shelf life after first opening of the bottle is 100 days.

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.

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

What DRETACEN contains

The active substance is called levetiracetam.

The other ingredients are:

Tablet core: povidone K25, cellulose microcrystalline, croscarmellose sodium, crospovidone (type A), silica colloidal anhydrous, talc, magnesium stearate.

<For 250mg>

Film-coating: hypromellose, hydroxypropylcellulose, macrogol type 6000, titanium dioxide (E171), talc, indigo carmine (E132).

<For 500mg>

Film-coating: hypromellose, hydroxypropylcellulose, macrogol type 6000, titanium dioxide (E171), talc, iron oxide yellow (E 172).

<For 750mg>

Film-coating: hypromellose, hydroxypropylcellulose, macrogol type 6000, titanium dioxide (E171), talc, iron oxide Red (E 172), iron oxide yellow (E 172).

<For 1000mg>

Film-coating: hypromellose, hydroxypropylcellulose, macrogol type 6000, titanium dioxide (E171), talc.

DRETACEN 250 mg is packaged in OPA/Al/PVC - Al blisters placed into cardboard boxes containing 10, 20,30,50,60,100 and 200 film-coated tablets or HDPE bottles with polypropylene screw cap and silicagel capsule placed into cardboard boxes containing 50 and 100 film-coated tablets.

Not all pack sizes may be marketed.

DRETACEN 500 mg is packaged in OPA/Al/PVC - Al blisters placed into cardboard boxes containing 10 ,20, 30, 50, 60, 100, 120 and 200film-coated tablets or HDPE bottles with polypropylene screw cap and silicagel capsule placed into cardboard boxes containing 50 and 100 film-coated tablets.

Not all pack sizes may be marketed.

DRETACEN 750 mg is packaged in OPA/Al/PVC - Al blisters placed into cardboard boxes containing 10, 30, 50, 60, 100 film-coated tablets or HDPE bottles with polypropylene screw cap and silicagel capsule placed into cardboard boxes containing 50 and 100 film-coated tablets.

Not all pack sizes may be marketed.

DRETACEN 1000 mg is packaged in OPA/Al/PVC - Al blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100 and 200 film-coated tablets or HDPE bottles with polypropylene screw cap and silicagel capsule placed into cardboard boxes containing 50 and 100 film-coated tablets. Not all pack sizes may be marketed.

DRETACEN 250 mg film-coated tablets:

Each film-coated tablet contains 250 mg levetiracetam.

DRETACEN 500 mg film-coated tablets:

Each film-coated tablet contains 500 mg levetiracetam.

DRETACEN 750 mg film-coated tablets:

Each film-coated tablet contains 750 mg levetiracetam.

DRETACEN 1000 mg film-coated tablets:

Each film-coated tablet contains 1000 mg levetiracetam.

What DRETACEN looks like and contents of the pack

DRETACEN 250 mg film-coated tablets:

Light blue, oval, biconvex film-coated tablets, scored on both sides, debossed with LVT / 250 on one side.

The tablet can be divided into equal halves.

DRETACEN 500 mg film-coated tablets:

Yellow, oval, biconvex film-coated tablets, scored on both sides, debossed with LVT / 500 on one side.

The tablet can be divided into equal halves.

DRETACEN 750 mg film-coated tablets:

Apricot color, oval, biconvex film-coated tablets, scored on both sides, debossed with LVT / 750 on one side.

The tablet can be divided into equal halves.

DRETACEN 1000 mg film-coated tablets:

White, oval, biconvex film-coated tablets, scored on both sides, debossed with LVT / 1000 on one side.

The tablet can be divided into equal halves.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz B.V.

Veluwezoom 22

Almere

Nederland

Manufacturer

Lek Pharmaceuticals d.d. Verovškova 57

1526 Ljubljana Slovenië

LEK S.A.

ul. Domaniewska 50 C 02-672 Warschau Polen

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Duitsland

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Roemenië

MA-numbers:

RVG 108561

RVG 108563

RVG 108564

RVG 108565

This medicinal product is authorised in the Member States of the EEA under the following names:

RMS	DRETACEN 250 mg, filmomhulde tabletten
NL	DRETACEN 500 mg, filmomhulde tabletten
	DRETACEN 750 mg, filmomhulde tabletten
	DRETACEN 1000 mg, filmomhulde tabletten
BG	DRETACEN
CZ	DRETACEN 250 mg
	DRETACEN 500 mg
	DRETACEN 1000 mg
LT	DRETACEN 250 mg plėvele dengtos tabletės
	DRETACEN 500 mg plėvele dengtos tabletės
	DRETACEN 750 mg plėvele dengtos tabletės
	DRETACEN 1000 mg plėvele dengtos tablets
PL	DRETACEN
RO	DRETACEN 250 mg, comprimate filmate
	DRETACEN 500 mg, comprimate filmate
	DRETACEN 750 mg, comprimate filmate
	DRETACEN 1000 mg, comprimate filmate

This leaflet was last approved in November 2012.