Levetiracetam Actavis: detailed information

Patient Information Leaflet

Levetiracetam Actavis 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets, 1000 mg film-coated tablets

levetiracetam
Read this leaflet carefully before you or your child starts taking this
medicine because it contains important information for you

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levetiracetam Actavis is and what it is used for
What you need to know before taking Levetiracetam Actavis
How to take Levetiracetam Actavis
Possible side effects
How to store Levetiracetam Actavis
Contents of the pack and other information

1. What is Levetiracetam Actavis and what is it used for?

Levetiracetam is an antiepileptic medicine (a medicine used to treat epileptic seizures).
Levetiracetam Actavis is used:

as monotherapy in adult and adolescent patients aged 16 years and older with newly diagnosed epilepsy,
to treat a certain form of epilepsy. Epilepsy is a condition in which patients experience
recurrent attacks (seizures). Levetiracetam is used for the type of epilepsy in which the seizure
initially affects only one part of the brain but may subsequently spread to broader areas on both
sides of the brain (partial-onset seizures with or without secondary generalization).
Your doctor has prescribed Levetiracetam to help reduce the number of seizures you experience.
as add-on therapy to other antiepileptic medicines to treat:
- partial-onset seizures, with or without secondary generalization, in adults, adolescents, children, and infants from 1 month of age
- myoclonic seizures (brief, shock-like jerks of a muscle or muscle group) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy
- primary generalized tonic-clonic seizures (grand mal seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic cause).

2. What you need to know before taking Levetiracetam Actavis

Do not take Levetiracetam Actavis
If you are allergic to levetiracetam, pyrrolidone derivatives, or any of the other ingredients
of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking Levetiracetam Actavis if you have kidney problems; follow your doctor's instructions. Your doctor may decide whether your dose needs to be adjusted.

If you notice slowed growth or unexpected onset of puberty in a child, contact your doctor.

A small number of people taking antiepileptic medicines such as Levetiracetam Actavis have had suicidal thoughts or thoughts about harming themselves. If you experience symptoms of depression and/or have suicidal thoughts, contact your doctor.

If you or a family member has a heart rhythm disorder (visible on electrocardiogram), or if you have a disease and/or are taking medicines that may cause irregular heartbeats or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last longer than a few days:

Unusual thoughts, feeling irritable, or more aggressive reactions than usual, or if you or your family and friends notice significant changes in mood or behaviour.
Worsening of epilepsy: Seizures may rarely worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. In a very rare early-onset form of epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types and loss of developmental skills, you may notice that seizures persist or worsen during treatment.

If you develop any of these new symptoms while taking Levetiracetam Actavis, consult a doctor as soon as possible.

Children and adolescents
Levetiracetam Actavis as monotherapy (used alone) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Actavis
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take macrogol (a medicine used as a laxative) within one hour before or one hour after taking levetiracetam, as it may cause a loss of effectiveness of levetiracetam.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary.

Do not stop your treatment without discussing it with your doctor.
A risk of birth defects in the unborn child cannot be completely ruled out.
Breastfeeding is not recommended during treatment.

Driving and using machines
Levetiracetam Actavis may reduce your ability to drive vehicles or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. You must not drive or use machinery until you have determined that your ability to perform these activities is not impaired.

Levetiracetam Actavis 750 mg tablets contain sunset yellow (E110)
Sunset yellow (E110) may cause allergic reactions.

3. How to take Levetiracetam Actavis

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Take the number of tablets as instructed by your doctor.
Levetiracetam Actavis should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Adjunctive and monotherapy treatment (from 16 years of age)

Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more: Recommended dose: between 1000 mg and 3000 mg per day. When you first start taking Levetiracetam Actavis, your doctor will prescribe a lower starting dose for 2 weeks before increasing to your lowest daily dose. Example: if your daily dose is to be 1000 mg, your initial reduced dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased to reach 1000 mg per day after 2 weeks.
Adolescents (12 to 17 years) weighing less than 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Actavis based on body weight and required dose.

Dose for infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on age,
weight, and required dose.
The oral solution is the most suitable formulation for infants and children under 6 years of age, for
children and adolescents (6 to 17 years) weighing less than 50 kg, and when tablets do not allow for
accurate dosing.

Method of administration:
Swallow Levetiracetam Actavis tablets with a sufficient amount of liquid (e.g. a glass of water). You may take Levetiracetam Actavis with or without food. After oral administration, you may experience a bitter taste of levetiracetam.

Duration of treatment:

Levetiracetam Actavis is used as a chronic treatment. Treatment with Levetiracetam Actavis should continue for as long as prescribed by your doctor.
Do not stop treatment without consulting your doctor, as this could increase the frequency of seizures.

If you take more Levetiracetam Actavis than you should:
Possible adverse effects of an overdose of Levetiracetam Actavis include drowsiness, agitation, aggression, decreased attention, respiratory depression, and coma.
Contact your doctor if you have taken more tablets than prescribed. Your doctor will determine the most appropriate treatment for overdose.

If you forget to take Levetiracetam Actavis:
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for a missed tablet.

If you stop taking Levetiracetam Actavis:
If treatment needs to be discontinued, Levetiracetam Actavis should be gradually withdrawn to avoid an increase in seizure frequency. If your doctor decides to stop treatment with Levetiracetam Actavis, they will provide you with instructions on how to gradually discontinue the medication.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

weakness, feeling faint or dizzy, or if you have difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
swelling of the face, lips, tongue, and throat (Quincke's oedema)
flu-like symptoms and rash on the face followed by widespread rash with high fever, increased liver enzyme levels observed in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms])
symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may indicate sudden decrease in kidney function
a skin rash that may present as blisters appearing like small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
a widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
a more severe form of skin rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
signs of severe mental disturbances or if someone around you notices signs of confusion, drowsiness, amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour, or other neurological signs, including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

The most frequently reported side effects are: nasopharyngitis, drowsiness, headache,
fatigue, and dizziness.
At the beginning of treatment or when the dose is increased, side effects such as drowsiness, fatigue, and dizziness may be more common. However, these effects should decrease over time.
Very common: may affect more than 1 in 10 people

nasopharyngitis;
drowsiness, headache;

Common: may affect up to 1 in 10 people

anorexia (loss of appetite);
depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
seizure, balance disorder, dizziness (sensation of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
vertigo (sensation of spinning);
cough;
abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
rash;
asthenia/fatigue (feeling weak).

Uncommon: may affect up to 1 in 100 people

decreased number of platelets in the blood, decreased number of white blood cells in the blood;
weight loss, weight gain;
suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional lability/mood changes, agitation;
amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), attention disturbance (loss of concentration);
diplopia (double vision), blurred vision;
elevated or abnormal liver function test results;
hair loss, eczema, pruritus (itching);
muscle weakness, myalgia (muscle pain);
trauma;

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

infection;
decreased number of all types of blood cells;
severe allergic reactions (DRESS, anaphylactic reaction [severe and serious allergic reaction], Quincke's oedema [swelling of face, lips, tongue, and throat]);
decreased concentration of sodium in the blood;
suicide, personality disorder (behavioural problems), thought disturbance (slowness of thinking, inability to concentrate);
delirium;
encephalopathy (see the subsection "Contact your doctor immediately" for a detailed description of symptoms);
seizures may worsen or occur more frequently;
uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
alteration of heart rhythm (electrocardiogram);
pancreatitis;
liver failure, hepatitis;
sudden decrease in kidney function;
skin rash that may present as blisters appearing like small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
limping or difficulty walking;
combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 people

repetitive unwanted thoughts or sensations or the urge to repeat an action (obsessive-compulsive disorder).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam Actavis

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 carton after Exp.: and on the
blister after EXP:.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levetiracetam Actavis contains
The active substance is called levetiracetam.
One film-coated tablet contains 250 mg of levetiracetam.
One film-coated tablet contains 500 mg of levetiracetam.
One film-coated tablet contains 750 mg of levetiracetam.
One film-coated tablet contains 1000 mg of levetiracetam.

The other components are:
Crospovidone, povidone, anhydrous colloidal silica, magnesium stearate, partially hydrolysed polyvinyl alcohol, macrogol 4000, talc, titanium dioxide (E171), colourants*.

* The colourants are:
250 mg tablets: indigo carmine (E132)
500 mg tablets: yellow iron oxide (E172), indigo carmine (E132)
750 mg tablets: indigo carmine (E132), sunset yellow (E110), red iron oxide (E172)

Description of the appearance of Levetiracetam Actavis and pack sizes
Levetiracetam Actavis 250 mg film-coated tablets are blue, oval-shaped, 13.6 x 6.4 mm in size, engraved with an "L" on one side and "250" on the other.
Levetiracetam Actavis 500 mg film-coated tablets are yellow, oval-shaped, 17.1 x 8.1 mm in size, engraved with an "L" on one side and "500" on the other.
Levetiracetam Actavis 750 mg film-coated tablets are orange, oval-shaped, 19.0 x 9.3 mm in size, engraved with an "L" on one side and "750" on the other.
Levetiracetam Actavis 1000 mg film-coated tablets are white, oval-shaped, 19.0 x 10.0 mm in size, engraved with an "L" on one side and "1000" on the other.

Pack sizes:
Blister packs: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Unit dose divisible blister: 60 x 1 film-coated tablets (available only for 250 mg, 500 mg and 1000 mg tablets).
Bottles: 30, 100 and 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Marketing Authorisation Holder:
Actavis Group PTC ehf.
Dalshraun 1, 220 Hafnarfjörður, Iceland

Manufacturer
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków, Poland
Tjoapack Netherlands B.V.
Nieuwe Donk 9, ETTEN-LEUR, 4879AC, The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
Specifar A.B.E.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
Specifar A.B.E.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu