LEVETIRACETAM SANDOZ 100 MG / ML ORAL SOLUTION - patient leaflet, side effects, dosage

Levetiracetam 100 mg/ml oral solution

levetiracetam

Read all of this leaflet carefully before you 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.

• 1. What Levetiracetam is and what it is used for

• 2. What you need to know before you take Levetiracetam

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• 3. How to take Levetiracetam

• 4. Possible side effects

• 5. How to store Levetiracetam

• 6. Contents of the pack and other information

1. what levetiracetam is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam 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

Do not take Levetiracetam

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

• 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.

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.

Children and adolescents

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

Other medicines and Levetiracetam

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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. Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam 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 contains methyl parahydroxyben­zoate, maltitol, benzyl alcohol and sodium

This medicine contains methyl parahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed).

This medicine 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.

This medicine contains 1.6 microgram benzyl alcohol in each ml. Benzyl alcohol may cause allergic reactions.

Ask your doctor or pharmacist for advice if you are pregnant, breast-feeding or have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist. Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor. This is because benzyl alcohol has been linked with the risk of severe side effects including breathing problems in young children. This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

3. how to take levetiracetam

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 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.

When measuring the dose of Levetiracetam oral solution, only use the dosing syringe included in the package.

Once the bottle is empty, the syringe should be thrown away and not kept.

Monotherapy

Dose in adults and adolescents

(from 16 years of age):

Measure the appropriate dose using the 10 ml syringe included in the package for patients 4 years and above.

General dose: Levetiracetam is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1500mg).

When you will first start taking Levetiracetam, 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 dose using the 10 ml syringe included in the package for patients of 4 years and above.

General dose: Levetiracetam is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1500mg)

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 dose using the 3 ml syringe included in the package.

For children above 4 years , measure the appropriate dose using the 10 ml syringe included in the package.

General dose: Levetiracetam is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10mg) and 0.3 ml (30mg), per kg bodyweight of the child (see table below for dose examples).

Dose in children 6 months and older:

Dose in infants (1 month to less than 6 months): For infants 1 month to less than 6 months , measure the appropriate dose using the 1 ml syringe included in the package.

General dose: Levetiracetam is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7mg) and 0.21 ml (21mg), per kg bodyweight of the infant (see table below for dose examples).

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

Method of administration:

After measuring the correct dose with an appropriate syringe, Levetiracetam may be diluted in a glass of water or baby’s bottle.

You may take Levetiracetam with or without food.

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After oral administration the bitter taste of levetiracetam may be experienced.

Instructions for use:

• Open the bottle : press the cap and turn it anticlockwise (figure 1)
• Separate the adaptor from the syringe (figure 2) Insert the adaptor into the bottle neck. Ensure it is well fixed.
• Take the syringe and put it in the adaptor opening. Turn the bottle upside down (figure 3)
• Fill the syringe with a small amount of solution by pulling the piston down (figure 4 a), then push the piston upward in order to remove any possible bubble (figure 4 b) Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 4 c).
• Turn the bottle the right way up. Remove the syringe from the adaptor.
• Empty the contents of the syringe in a glass of water or baby’s bottle by pushing the piston to the bottom of the syringe (figure 5).
• Drink the whole contents of the glass/baby’s bot­tle.
• Close the bottle with the plastic screw cap.
• Wash the syringe with water (figure 6)

Duration of treatment:

• Levetiracetam is used as a chronic treatment. You should continue Levetiracetam 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 than you should The possible side effects of an overdose of Levetiracetam are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma. Contact your doctor if you took more than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Levetiracetam

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

If stopping treatment, Levetiracetam should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam. 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.

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), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion)

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, hallucination, anger, panic attack, emotional instability/mood swings, agitation;
• 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;
• decreased blood sodium concentration;
• suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
• delirium;
• uncontrollable muscle spasms affecting the head, torso and limbs, hyperkinesia (hyperactivity);
• pancreatitis;
• liver failure, hepatitis;
• limp or difficulty walking
• rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to nonJapanese patients.

5. how to store levetiracetam

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 bottle and carton after “EXP”. The expiry date refers to the last day of that month.

Do not use after 7 months of first opening the bottle.

Store in the original container in order to protect from light.

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 contains

y The active substance is levetiracetam.

Each ml contains 100 mg of levetiracetam. y The other ingredients are sodium citrate

(for pH adjustment); citric acid (for pH adjustment); methyl parahydroxybenzoate (E 218); glycerol (E 422); acesulfame potassium (E 950); maltitol liquid (E 965); raspberry flavour (contains benzyl alcohol); purified water.

What Levetiracetam looks like and the contents of the pack

Levetiracetam is a clear liquid.

The 300 ml glass bottle of Levetiracetam (for children aged 4 years and above, adolescents and adults) is packed in a carton containing a graduated oral syringe of 10 ml graduated per 0.25 ml and an adaptor for the syringe.

The 150 ml glass bottle of Levetiracetam (for infants aged 6 months and above and children aged 2 to 4 years) is packed in a carton containing a graduated oral syringe of 3 ml graduated per 0.1 ml and an adaptor for the syringe.

The 150 ml glass bottle of Levetiracetam (for infants aged 1 month to less than 6 months) is packed in a carton box containing a graduated oral syringe of 1 ml graduated per 0.05 ml and an adaptor for the syringe.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Limited,Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK Manufacturer(s):

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, Limassol, 3056, Cyprus Or Lek Phamaceuticals d.d. Verovskova 57, 1526 Ljubljana, Slovenia Or S.C. Sandoz S.R.L, 7A Livezeni Street, 540472 Targu Mures, Romania Or Lek S.A. Ul. Domaniewska 50 C, 02–672 Warszawa, Poland Or Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben, Germany Or Lek Phamaceuticals d.d. Trimlini 2d, 9220 Lendava, Slovenia

This leaflet was last revised in 04/2020

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