Levetiracetam Actavis Group - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package Leaflet: Information for the patient

Levetiracetam Actavis Group 100 mg/ml oral solution Levetiracetam

Read all of this leaflet carefully before you or your child 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 Actavis Group is and what it is used for

• 2. What you need to know before you take 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 seizures in epilepsy).

Levetiracetam Actavis Group is used:

• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.
• 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 (short, shock-like jerks of a muscle or group of muscles) in adults

and adolescents from 12 years of age with juvenile myoclonic epilepsy

• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you take Levetiracetam Actavis Group

Do not take Levetiracetam Actavis Group

• 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 Group

• If you suffer from kidney problems, follow your doctor’s instruc­tions. He/she may decide if your dose should be adjusted.
• If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
• A small number of people being treated with anti-epileptics such as levetiracetam have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
• If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances.

Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:

• Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.
• Aggravation of epilepsy

Your seizures may rarely become worse or happen more often, mainly during the first month after the start of the treatment or increase of the dose. If you experience any of these new symptoms while taking Levetiracetam Actavis Group, see a doctor as soon as possible.

Children and adolescents

Levetiracetam Actavis Group is not indicated in children and adolescents below 16 years on its own (monotherapy).

Other medicines and Levetiracetam Actavis Group

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

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may result in a reduction of its effect.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.

You should not stop your treatment without discussing this with your doctor.A risk of birth defects for your unborn child cannot be completely excluded.

Breast-feeding is not recommended during treatment.

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’.

3. How to take Levetiracetam Actavis Group

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.

General 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 (1,500 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 general 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.

General 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 (1,500 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.

General 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.

General 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

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).

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.

4. Possible 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) and enlarged lymph nodes (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 1,000 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.

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 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.

6. Contents of the pack 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 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

Levetiracetam Actavis Group 100 mg/ml oral solution is a clear, faint yellowish-brown solution.

The 300 ml glass bottle of Levetiracetam Actavis Group (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml).

The 300 ml glass bottle of Levetiracetam Actavis Group (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.

The 300 ml glass bottle of Levetiracetam Actavis Group (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) and an adaptor for the syringe.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76–78

220 Hafnarfjordur

Iceland

Manufacturer

Balkanpharma-Troyan AD

1 Krayrechna Str,

Troyan 5600

Bulgaria

This leaflet was last revised in {month/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

/.

48