Levetiracetam Rudipharm 1000mg – 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:

  • 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

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 slowdown 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. In a very rare form of early-onset epilepsy (epilepsy

  associated with SCN8A mutations) that causes multiple types of seizures and loss of skills you may notice that the seizures remain present or are becoming worse during your treatment. 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 or 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 reduction of its effect. Pregnancy and breast-feeding

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. 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.

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.

Adjunctive Therapy and Monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:

Recommended dose: between 1,000 mg and 3,000 mg each day.

When you will first start taking Levetiracetam, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest daily dose.

Example: if your daily dose is intended to be 1,000 mg, your reduced starting dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually incremented to reach 1,000 mg daily after 2 weeks.

Adolescents (12 to 17 years) weighing 50 kg or less:

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

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

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

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 adolescents (from 6 to 17 years) weighing less than 50kg 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 Levetiracetam 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.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (sleepiness), headache.

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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.

Very rare: may affect up to 1 in 10,000 people

• repeated unwanted thoughts or sensations or the

  urge to do something over and over again (Obsessive Compulsive Disorder);

Evidence also suggests a possible predisposition of the Japanese population to neuroleptic malignant syndrome (NMS).

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: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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 stated on the cardboard box and blister after EXP: The expiry date refers to the last day of the month.

This medicinal product 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. Levetiracetam Rudipharm 250mg Film-coated Tablets: Each tablet contains 250 mg of levetiracetam. Levetiracetam Rudipharm 500mg Film-coated Tablets: Each tablet contains 500 mg of levetiracetam. Levetiracetam Rudipharm 750mg Film-coated Tablets: Each tablet contains 750 mg of levetiracetam. Levetiracetam Rudipharm 1000mg Film-coated Tablets: Each tablet contains 1000 mg of levetiracetam. The core ingredients are: maize starch, croscarmellose sodium, povidone, colloidal anhydrous silica, talc, magnesium stearate.

The coating ingredients are: polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol, talc, indigo carmine (250mg), iron oxide yellow (500mg & 750mg), iron oxide red (750mg).

What Levetiracetam looks like and contents of the pack

Levetiracetam Tablets 250 mg are blue coloured, oblong shaped, scored film coated tablets debossed with ‘H’ on one side and ‘87’ on other side. Levetiracetam Tablets 500 mg and yellow coloured, oblong shaped, scored, film coated tablets debossed with “H’ on one side and ‘88’ on other side. Levetiracetam Tablets 750 mg are beige to light orange coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘90’ on other side. Levetiracetam Tablets 1000 mg are white coloured oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘91’ on other side. Levetiracetam Rudipharm film-coated tablets are available in Alu-PVC blister packs of 20, 30, 50, 60, 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Rudipharm Limited

Unit 6, Salbrook Road Industrial Estate

Salbrook Road, Redhill, Surrey,

RH1 5GJ, United Kingdom

Manufacturer:

Mobius Laboratories Limited

Unit 7, Bourne End Mills, Upper Bourne End Lane Hemel Hempstead, Hertfordshire, HP1 2UJ, United Kingdom

To listen to or request a copy of this leaflet in Braille, large print or audio please call, 01293827819 (UK only)

Please be ready to give the following information:

Product name Reference number Levetiracetam PL 49565/0133 Rudipharm 250mg

Film-coated Tablets

Levetiracetam PL 49565/0134 Rudipharm 500mg

Film-coated Tablets

Levetiracetam PL 49565/0135 Rudipharm 750mg

Film-coated Tablets

Levetiracetam PL 49565/0136 Rudipharm 1000mg

Film-coated Tablets

This leaflet was last revised in July 2024. Levetiracetam Tablet SL - PIL

Normal Text: 10pt (Regular)