Levetiracetam Actavis Group

Do not take it if

From the package leaflet in EMA’s product information, p. 37.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 Actavis Group must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
• Take the oral solution following your doctor’s instructions.
• Monotherapy (from 16 years of age)
• Adults (≥18 years) and adolescents from 16 years of age:
• Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years and above.
• Recommended dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500 mg) and 15 ml (1500 mg).
• When you will first start taking Levetiracetam Actavis Group, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest daily dose.
• Add-on therapy Dose in adults and adolescents (12 to 17 years):
• Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.
• Recommended dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500 mg) and 15 ml (1500 mg).
• Dose in children 6 months and older:
• Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.
• For children 6 months to 4 years, measure the appropriate dosage using the 3 ml syringe included in the package.
• For children above 4 years, measure the appropriate dosage using the 10 ml syringe included in the package.
• Recommended dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10 mg) and 0.3 ml (30 mg), per kg bodyweight of the child. (see table below for dose examples).
• Dose in children 6 months and older:
• Weight Starting dose: 0.1 ml/kg twice daily Maximum dose: 0.3 ml/kg twice daily 6 kg 0.6 ml twice daily 1.8 ml twice daily 8 kg 0.8 ml twice daily 2.4 ml twice daily 10 kg 1 ml twice daily 3 ml twice daily 15 kg 1.5 ml twice daily 4.5 ml twice daily 20 kg 2 ml twice daily 6 ml twice daily 25 kg 2.5 ml twice daily 7.5 ml twice daily From 50 kg 5 ml twice daily 15 ml twice daily Dose in infants (1 month to less than 6 months):
• For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.
• Recommended dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7 mg) and 0.21 ml (21 mg), per kg bodyweight of the infant. (see table below for dose examples).
• Dose in infants (1 month to less than 6 months):
• Weight Starting dose: 0.07 ml/kg twice daily Maximum dose: 0.21 ml/kg twice daily 4 kg 0.3 ml twice daily 0.85 ml twice daily 5 kg 0.35 ml twice daily 1.05 ml twice daily 6 kg 0.45 ml twice daily 1.25 ml twice daily 7 kg 0.5 ml twice daily 1.5 ml twice daily Method of administration:
• After measuring the correct dose with an appropriate syringe, Levetiracetam Actavis Group oral solution may be diluted in a glass of water or baby’s bottle. You may take Levetiracetam Actavis Group with or without food. After oral administration the bitter taste of levetiracetam may be experienced.
• Instruction for use:
• Instruction for use for 10 ml syringes Open the bottle. Before starting the measuring procedure make sure that the transparent dosing body of the syringe as well as the white plunger are in the bottom most position. To measure the dosing quantity, use one hand to hold the dosing body and the other hand to pull up the plunger until you reach the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (Figure 1).
• Pull the syringe by the dosing body out of the bottle (Figure 2).
• Empty the contents of the syringe in a glass of water by pushing down the plunger. Be sure to drink the whole contents of the glass. The contents of the syringe can also be given directly from the syringe into the mouth or emptied onto a spoon (Figure 3).
• Wash the syringe with water after use and close the bottle with the plastic screw cap (Figure 4).
• Instruction for use for 1 ml and 3 ml syringes with an adaptor Open the bottle and push the syringe adaptor firmly into the bottle neck (Figure 1).
• Take the syringe and pull back the plunger a little way (Figure 2).
• Push the tip of the syringe into the adaptor opening. Push the plunger down slowly to introduce air inside the bottle (Figure 3).
• Turn the bottle upside down with the syringe still in place (Figure 4).
• Pull the plunger down and fill the syringe with a quantity of solution slightly beyond the prescribed dose (Figure 5).
• If any bubbles appear in the syringe keep the bottle upside down and slightly push in the plunger and pull it back again. Repeat until there are no bubbles in the syringe (Figure 6).
• Push the plunger in slowly to the graduation mark corresponding to the quantity in milliliters (ml)
• prescribed by your doctor (Figure 7).
• Turn the bottle the right way up and remove the syringe (Figure 8).
• For young children gently put the tip of the syringe into the child´s mouth to the inside of the cheek.
• Push the plunger in slowly and allow the child to swallow the content of the syringe. The content of the syringe can also be emptied in a glass of water or baby´s bottle. Be sure to drink the whole contents of the glass (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. You should continue Levetiracetam Actavis Group 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 you take more Levetiracetam Actavis Group than you should The possible side effects of an overdose of Levetiracetam Actavis Group are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
• Contact your doctor if you took more Levetiracetam Actavis Group than you should. Your doctor will establish the best possible treatment of overdose.
• If you forget to take Levetiracetam Actavis Group Contact your doctor if you have missed one or more doses.
• Do not take a double dose to make up for a forgotten dose.
• If you stop taking Levetiracetam Actavis Group If stopping treatment, Levetiracetam Actavis Group should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam Actavis Group treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Actavis Group.
• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 39–44.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 37–38.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 38.

Other medicines

From the package leaflet in EMA’s product information, p. 38.

Driving and using machines

• Levetiracetam Actavis Group 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.
• Levetiracetam Actavis Group contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, maltitol, propylene glycol and sodium.
• Levetiracetam Actavis Group oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
• Levetiracetam Actavis Group oral solution also contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• Levetiracetam Actavis Group oral solution contains propylene glycol (E1520). If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
• This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium- free’.

From the package leaflet in EMA’s product information, p. 38–39.

Side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Tell your doctor immediately, or go to your nearest emergency department, if you experience:
• weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction;
• swelling of the face, lips, tongue and throat (Quincke’s oedema);
• flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia), enlarged lymph nodes and the involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]);
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function;
• a skin rash which may form blisters and look 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);
• a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.
• The most frequently reported adverse reactions were 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.
• Very common: may affect more than 1 in 10 people
• nasopharyngitis;
• somnolence (sleepiness), headache.
• Common: may affect up to 1 in 10 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, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).
• Uncommon: may affect up to 1 in 100 people
• 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;
• elevated/abnormal values in a liver function test;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.
• Rare: may affect up to 1 in 1000 people
• infection;
• decreased number of all blood cell types;
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);
• decreased blood sodium concentration;
• suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
• delirium;
• encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms);
• seizures may become worse or happen more often;
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
• change of the heart rhythm (Electrocardiogram);
• pancreatitis;
• liver failure, hepatitis;
• sudden decrease in kidney function;
• 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);
• rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients;
• limp or difficulty walking;
• combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome).
• Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
• Very rare: may affect up to 1 in 10000 people
• repeated unwanted thoughts or sensations or the urge to do something over and over again (Obsessive Compulsive Disorder).
• 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.

From the package leaflet in EMA’s product information, p. 44–46.

How to store it

• 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 cardboard box and bottle after EXP:.
• The expiry date refers to the last day of that month.
• Do not use after 7 months of first opening the bottle.
• 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.

From the package leaflet in EMA’s product information, p. 46.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

• The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerin, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grape flavour (contains propylene glycol), purified water.
• What Levetiracetam Actavis Group looks like and contents of the pack

From the package leaflet in EMA’s product information, p. 46.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

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