LEVETIRACETAM RELONCHEM 250 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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:

o partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age

o 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

o 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.
• 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, see a doctor as soon as possible.

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, 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 results in a loss 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. The risk of birth defects for your unborn child cannot be completely excluded.

Breast-feeding 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 Sodium

This medicine contains less than 1 mmol sodium (23 mg) per 1 tablet, 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.

Take the number of tablets following your doctor's instruc­tions.

Levetiracetam must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 1000 mg and 3,000 mg each day.

When you will first start taking Levetiracetam, your doctor will prescribe you a lower dose (500 mg each day) during 2 weeks before giving you the lowest general dose of 1000 mg.

Example: if your daily dose is 1000 mg, your reducing starting dose is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more :

General dose: between 1000 mg and 3,000 mg each day.

Example: if your daily dose is 1,000 mg, you must take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam according to the age, weight and dose.

A levetiracetam 100 mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50 kg and when tablets don't allow accurate dosage.

Method of administration

Swallow Levetiracetam tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take Levetiracetam with or without food.

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

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 tablets 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 tablet.

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: Uncommon: (may affect up to 1 in 100 people)

• suicide attempt and suicidal ideation.

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

• signs of serious mental changes or if someone around you notices signs of confusion, 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
• weakness, feel light-headed or dizzy or have difficulty in 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)
• pancreatitis
• liver failure, hepatitis
• rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non Japanese patients.

The most frequently reported side effects are 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 user 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;
• mental disorder, abnormal behaviour, hallucination, anger, panic attack, emotional instability/ mood swings, agitation;
• 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;
• decreased blood sodium concentration;
• suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
• limp or difficulty in walking;
• delirium;
• encephalopathy (see sub-section ‚Tell your doctor immediately‘ for a detailed description of symptoms);
• seizures may become worse or happen more often;
• change of the heart rhythm (Electrocardi­ogram);
• sudden decrease in kidney function.

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 carton box and 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 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

The active substance is called levetiracetam. Each tablet contains 250 mg of levetiracetam.

The other ingredients are:

Tablet core: Croscarmellose sodium, Maize starch, Povidone K-30, Silica colloidal anhydrous, Magnesium stearate.

Film-coating: Hypromellose 6cP (E464), Titanium dioxide (E171), Macrogol 400, Indigo Carmine Aluminium Lake (E132).

What Levetiracetam looks like and contents of the pack

Levetiracetam Relonchem 250 mg film-coated tablets are light blue, capsule shaped, biconvex, length: 12.9 mm to 13.3 mm, width: 5.9 mm to 6.3 mm and thickness: 4.2 mm to 4.8 mm, film-coated tablets plain on both sides.

Aluminium/PVC/PE/PV­DC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK.

Date leaflet last revised in: April 2021.

Product licence number : PL 20395/0278.