Levetiracetam Actavis Group

Package leaflet: Information for the patient

Levetiracetam Actavis Group 100 mg/mL oral solution

levetiracetam
Read this entire 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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Levetiracetam Actavis Group is and what it is used for
2. What you need to know before taking Levetiracetam Actavis Group
3. How to take Levetiracetam Actavis Group
4. Possible side effects
5. How to store Levetiracetam Actavis Group
6. Contents of the pack and other information

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

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

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients experience repeated seizures. Levetiracetam is used for the type of epilepsy in which the seizure starts in 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 reduce the number of seizures.
• 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 muscle jerks of a muscle or group of muscles) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy;
  • primary generalized tonic-clonic seizures in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you should know before taking Levetiracetam Actavis Group

Do not take Levetiracetam Actavis Group
if you are allergic to levetiracetam, pyrrolidone derivatives, or any of the excipients of this
medicinal product (listed in section 6.6).

Warnings and precautions
Talk to your doctor before taking Levetiracetam Actavis Group
if you have kidney problems, follow your doctor's instructions. Your doctor may decide whether the
dose needs to be adjusted.
If you observe slowed growth or unexpected development of puberty in the child, contact your doctor.
A limited number of people treated with antiepileptic medicines such as Levetiracetam Actavis
Group have experienced self-harming thoughts or suicidal ideation. If you experience any symptoms of
depression and/or suicidal thoughts, contact your doctor.
If you or a family member has a cardiac arrhythmia (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, your family, or friends notice the onset of 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 form of early-onset epilepsy (epilepsy associated with SCN8A mutations), which causes multiple types of seizures and loss of abilities, you may notice that seizures persist or worsen during treatment.

If you develop any of these new symptoms while being treated with Levetiracetam Actavis
Group, consult a doctor as soon as possible.

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

Other medicines and Levetiracetam Actavis Group
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 loss of effect of the latter.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, talk to
your doctor 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 for the unborn
child cannot be completely ruled out.
Breastfeeding is not recommended during treatment.

Driving and using machines
Levetiracetam Actavis Group may reduce your ability to drive or operate tools or machinery, as
Levetiracetam Actavis Group 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 are certain that your ability to
perform these activities is not impaired.

Levetiracetam Actavis Group contains methyl parahydroxybenzoate, propyl parahydroxybenzoate,
maltitol, propylene glycol, and sodium.
Levetiracetam Actavis Group oral solution contains methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).
Levetiracetam Actavis Group oral solution also contains maltitol. If your doctor has told you that you
have an intolerance to certain sugars, contact your doctor before taking this medicine.
Levetiracetam Actavis Group oral solution contains propylene glycol (E1520). If the child is less than
4 weeks old, talk to your doctor or pharmacist before administering this medicine, especially if the
child is taking other medicines containing propylene glycol or alcohol.
This medicine contains less than 1 mmol (23 mg) of sodium per mL, i.e. it is essentially 'sodium-free'.

3. How to take Levetiracetam Actavis Group

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor.
Levetiracetam Actavis Group should be taken twice daily, once in the morning and once in the
evening, approximately at the same time each day.
Take the oral solution according to your doctor's instructions.

Monotherapy (from 16 years of age)
Adults (≥18 years) and adolescents from 16 years of age:
Measure the appropriate dose using the 10 mL syringe provided in the package, for patients from 4 years of age.
Recommended dose: Levetiracetam Actavis Group is taken twice daily in two equally divided doses, each ranging between 5 mL (500 mg) and 15 mL (1,500 mg).
When you first start taking Levetiracetam Actavis Group, your doctor will prescribe a lower starting dose for 2 weeks before increasing to the lowest daily dose.

Adjunctive therapy
Dose for adults and adolescents (from 12 to 17 years of age):
Measure the appropriate dose using the 10 mL syringe provided in the package, for patients from 4 years of age.
Recommended dose: Levetiracetam Actavis Group is taken twice daily in two equally divided doses, each ranging between 5 mL (500 mg) and 15 mL (1,500 mg).

Dose for children from 6 months of age
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Actavis Group depending on the child's age, weight, and required dose.
For children from 6 months to 4 years of age: measure the appropriate dose using the 3 mL syringe provided in the package.
For children above 4 years of age: measure the appropriate dose using the 10 mL syringe provided in the package.
Recommended dose: Levetiracetam Actavis Group is taken twice daily in two equally divided doses, each ranging between 0.1 mL (10 mg) and 0.3 mL (300 mg) per kg of the child's body weight (see the following table for dose examples).

Dose for children from 6 months of age

Dosage for infants (from 1 month up to less than 6 months):
For infants from 1 month up to less than 6 months: measure the appropriate dose using the 1 mL syringe provided in the package.
Recommended dose: Levetiracetam Actavis Group is taken twice daily in two equally divided doses, each ranging between 0.07 mL (7 mg) and 0.21 mL (21 mg) per kg of the infant's body weight (see the following table for examples of dosing).
Dosage for infants (from 1 month up to less than 6 months):

Administration method:
After measuring the correct dose with an appropriate syringe, Levetiracetam Actavis Group oral solution may be diluted in a glass of water or in a feeding bottle. You may take Levetiracetam Actavis Group with or without food. After oral administration, you may perceive the bitter taste of levetiracetam.

Instructions for use:
Instructions for use for the 10 mL syringe

Open the bottle. Before starting the measuring procedure, ensure that the transparent barrel of the syringe and the white plunger are in the lowest possible position. To measure the required dose, use one hand to hold the syringe barrel steady and the other hand to pull the plunger up to the graduation mark corresponding to the amount in millilitres (mL) prescribed by your doctor (Figure 1).

Remove the syringe from the bottle (Figure 2).

Empty the syringe contents into a glass of water by pressing the plunger fully down. Drink the entire contents of the glass. The contents of the syringe may also be administered directly into the mouth from the syringe or emptied into a spoon (Figure 3).

Wash the syringe with water after use and close the bottle with the plastic screw cap (Figure 4).

Instructions for use with 1 mL and 3 mL syringes with adapter

Open the bottle and firmly insert the syringe adapter onto the neck of the bottle (Figure 1).

Take the syringe and gently pull back the plunger (Figure 2).

Push the tip of the syringe into the opening of the adapter. Gently push the plunger down to introduce air into the bottle (Figure 3).

Invert the bottle while keeping the syringe in place (Figure 4).

Pull the plunger down and fill the syringe with an amount of solution slightly exceeding the prescribed dose (Figure 5).

If air bubbles appear, keep the bottle inverted, gently push the plunger and pull it back again. Repeat this process until no bubbles remain in the syringe (Figure 6).

Gently push the plunger down to the graduation mark corresponding to the amount in millilitres (mL) prescribed by your doctor (Figure 7).

Return the bottle to its upright position and remove the syringe (Figure 8).

For small children, gently place the tip of the syringe into the child’s mouth, inside the cheek. Slowly push the plunger and allow the child to swallow the contents of the syringe. The syringe contents may also be emptied into a glass of water or feeding bottle. Make sure the entire contents of the glass are consumed (Figure 9).

Wash the syringe with water after use and close the bottle with the plastic screw cap (Figure 10).

Duration of treatment:
Levetiracetam Actavis Group is used as a chronic treatment. Treatment with Levetiracetam Actavis Group should continue 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 Group than you should:
Possible adverse effects of an overdose of Levetiracetam Actavis Group include drowsiness, agitation, aggression, decreased attention, respiratory depression, and coma.
Contact your doctor if you have taken more Levetiracetam Actavis Group than you should. Your doctor will determine the most appropriate treatment for the overdose.

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

If you stop taking Levetiracetam Actavis Group:
If treatment needs to be discontinued, Levetiracetam Actavis Group should be stopped gradually to avoid an increase in seizures. If your doctor decides to discontinue treatment with Levetiracetam Actavis Group, they will provide you with instructions for the gradual withdrawal of Levetiracetam Actavis Group.

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 have difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue, or throat (angioedema, Quincke's edema)
• 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 appear as blister-like lesions resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form of skin rash causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental disturbances, or if someone around you notices confusion, drowsiness, amnesia (memory loss), impaired memory (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 unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (spinning sensation);
• 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 attacks, 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 significant allergic reaction], angioedema [swelling of face, lips, tongue, and throat]);
• decreased concentration of sodium in the blood;
• suicide, personality disorder (behavioural problems), thought disorder (slowed 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);
• change in heart rhythm (electrocardiogram abnormalities);
• pancreatitis;
• liver failure, hepatitis;
• sudden decrease in kidney function;
• skin rash that may appear as blister-like lesions resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form with skin peeling affecting more than 30% of body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. 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, and reduced level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). 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 urges to perform actions repeatedly (obsessive-compulsive disorder).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Group

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 more than 7 months after first opening the bottle.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Levetiracetam Actavis Group contains
The active substance is called levetiracetam. Each mL contains 100 mg of levetiracetam.
The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216), ammonium glycyrrhizinate, glycerin, glycerol (E422), maltitol
liquid (E965), acesulfame potassium (E950), grape flavour (contains propylene glycol), purified water.

Description of the appearance of Levetiracetam Actavis Group and contents of the pack
Levetiracetam Actavis Group 100 mg/mL is a clear solution, brown to slightly yellowish in colour.
The 300 mL glass bottle of Levetiracetam Actavis Group (for children from 4 years of age onwards, adolescents and adults) is packaged in a carton containing a 10 mL graduated syringe (graduated every 0.25 mL).
The 300 mL glass bottle of Levetiracetam Actavis Group (for infants from 6 months of age and children from 2 to 4 years of age) is packaged in a carton containing a 3 mL graduated syringe (graduated every 0.1 mL) and a syringe adapter.
The 300 mL glass bottle of Levetiracetam Actavis Group (for infants and young children from 6 months up to 4 years of age) is packaged in a carton containing a 1 mL graduated syringe (graduated every 0.05 mL) and a syringe adapter.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
Balkanpharma-Troyan AD
1 Krayrechna Str,
Troyan 5600
Bulgaria

For further information about this medicinal product, please contact the local representative of the Marketing Authorization 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

This Patient Information Leaflet was last revised in {MM/YYYY}.

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