LEVETIRACETAM MILPHARM1000 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam Milpharm 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 onlyone side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizures 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 milpharm

Do not take Levetiracetam Milpharm:

• 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 or pharmacist before taking Levetiracetam Milpharm:

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

Children and adolescents

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

Other medicines and Levetiracetam Milpharm 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 loss of its effect.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist 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 Milpharm 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 Milpharm contains Sunset

Yellow FCF (E110):

Levetiracetam Milpharm 750 mg contains Sunset Yellow FCF (E110). It may cause allergic reactions.

3. how to take levetiracetam milpharm

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 Milpharm 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:

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

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

Example: if your daily dose is intended to be 1000 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 1000 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 Milpharm according to weight and dose.

Dose in infants (1 month to 23 months), 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 adolescent (from 6 to 17 years) weighing less than 50kg and when tablets don’t allow accurate dosage.

Method of administration:

Swallow Levetiracetam Milpharm tablets with a sufficient quantity of liquid (e.g. a glass of water).

You may take Levetiracetam Milpharm with or without food. After oral administration the bitter taste of levetiracetam may be experienced.

Duration of treatment:

• Levetiracetam Milpharm is used as a chronic treatment. You should continue Levetiracetam Milpharm treatment for as long as your doctor has told you.
• Do not stop your treatment without your doctor advice as this could increase your seizures.

If you take more Levetiracetam Milpharm than you should:

The possible side effects of an overdose of Levetiracetam Milpharm 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 Milpharm: 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 Milpharm:

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

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 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 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 nonJapanese patients.
• limp or difficulty walking

5. how to store levetiracetam milpharm

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 label, carton& bottle after EXP. The expiry date refers to the last day of that 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 Milpharm contains

The active substance is levetiracetam. Each film-coated tablet contains 250 mg/ 500 mg/ 750 mg/ 1000 mg levetiracetam.

The other ingredients are:

Tablet core: Maize starch, Silica colloidal anhydrous (E551), Povidone (K-30) (E1201), Talc (E553b), Magnesium stearate (E470b).

Film-coating:

250 mg: Hypromellose 3cp & 6cp (E464), titanium dioxide (E 171), macrogol 4000, indigo carmine aluminium lake (E132).

500 mg: Hypromellose 3cp & 6cp (E464), titanium Dioxide (E 171), macrogol 4000, iron oxide yellow (E172).

750 mg: Hypromellose 3cp & 6cp (E464), titanium Dioxide (E 171), macrogol 4000, indigo carmine aluminium lake (E132), sunset yellow aluminium lake (E110), iron oxide red. (E172)

1000 mg: Hypromellose 5 cp (E464), titanium dioxide (E 171), macrogol 400.

What Levetiracetam Milpharm looks like and contents of the pack

Film-coated tablet.

Levetiracetam Milpharm 250 mg film-coated tablets Blue oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘10’ on one side and plain on the other side. The tablet can be divided into equal doses.

Levetiracetam Milpharm 500 mg film-coated tablets Yellow oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘11’ on one side and plain on the other side. The tablet can be divided into equal doses.

Levetiracetam Milpharm 750 mg film-coated tablets Orange oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘12’ on one side and plain on the other side. The tablet can be divided into equal doses.

Levetiracetam Milpharm 1000 mg film-coated tablets

White modified oval shaped, biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘13’ on one side and plain on the other side. The tablet can be divided into equal doses.

Levetiracetam Milpharm film-coated tablets are packaged in blister pack or HDPE bottle.

Pack sizes:

Blister pack: 20, 30, 50, 60, 100, 200 and 500 film-coated tablets

Bottle pack: 30, 100, 200 and 500 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

Ares, Odyssey Business Park

West End Road

South Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

This leaflet was last revised in 06/2021.