Levetiracetam Brillpharma 100mg/ml Oral solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you. Do not pass it onto 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet (See section 4).

1. What Levetiracetam Brillpharma is and what it is used for
2. What you need to know before you take Levetiracetam Brillpharma
3. How to take Levetiracetam Brillpharma
4. Possible side effects
5. How to store Levetiracetam Brillpharma
6. Contents of the pack and other information

• if you are allergic (hypersensitive) to Levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (see section 6).

Talk to your doctor, pharmacist or nurse before taking Levetiracetam Brillpharma:

• if you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
• if you suffer from kidney problems, follow your doctor’s instructions. Doctor may decide if your dose should be adjusted.
• 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 the treatment. If you experience any of these new symptoms while taking levetiracetam, see a doctor as soon as possible.

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

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 reduction of its effect.

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.

Levetiracetam Brillpharma may make you feel sleepy, which may affect your ability to drive or operate any tools or machinery. This is more likely at the beginning of your 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.

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).

If you have been told by your doctor that you have an intolerance to some sugars (such as liquid maltitol (E965)), contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per dose (0.3 ml to 15 ml), that is to say essentially ‘sodium free’.

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

General dose: Levetiracetam Brillpharma 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.

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 Brillpharma 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 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 Brillpharma 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:

Starting dose: 0.1 ml/kg twice daily

Maximum dose: 0.3 ml/kg twice daily

Weight: 6 kg

Starting dose: 0.6 ml twice daily

Maximum dose: 1.8 ml twice daily

Weight: 8 kg

Starting dose: 0.8 ml twice daily

Maximum dose: 2.4 ml twice daily

Weight: 10 kg

Starting dose: 1 ml twice daily

Maximum dose: 3 ml twice daily

Weight: 15 kg

Starting dose: 1.5 ml twice daily

Maximum dose: 4.5 ml twice daily

Weight: 20 kg

Starting dose: 2 ml twice daily

Maximum dose: 6 ml twice daily

Weight: 25 kg

Starting dose: 2.5 ml twice daily

Maximum dose: 7.5 ml twice daily

Weight: 25 kg

Starting dose: 5 ml twice daily

Maximum dose: 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 Brillpharma 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)

Starting dose: 0.07 ml/kg twice daily

Maximum dose: 0.21 ml/kg twice daily

Weight: 4 kg

Starting dose: 0.3 ml twice daily

Maximum dose: 0.85 ml twice daily

Weight: 5 kg

Starting dose: 0.35 ml twice daily

Maximum dose: 1.05 ml twice daily

Weight: 6 kg

Starting dose: 0.45 ml twice daily

Maximum dose: 1.25 ml twice daily

Weight: 7 kg

Starting dose: 0.5 ml twice daily

Maximum dose: 1.5 ml twice daily

After measuring the correct dosage with an appropriate syringe, Levetiracetam Brillpharma may be diluted in a glass of water or baby’s bottle. You may take Levetiracetam with or without food. After oral administration the bitter taste of levetiracetam may be experienced.

• Open the bottle: press the cap and turn it anticlockwise

• Separate the adaptor from the syringe. 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.

• Fill the syringe with a small amount of oral solution by pulling the piston down, then push the piston upward in order to remove any possible bubble.
  Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor.

• 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.

• Drink the whole contents of the glass/baby’s bottle.
• Close the bottle with the plastic screw cap.
• Wash the syringe with water only.

• Levetiracetam Brillpharma is used as a chronic treatment. You should continue Levetiracetam Brillpharma 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.

The possible side effects of Levetiracetam Brillpharma overdose are agitation, aggression, sleepiness, decrease of alertness, inhibition of breathing and coma.

You should contact your doctor if you took more Levetiracetam Brillpharma than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take one or more doses then contact your doctor.

Do not take a double dose to make up for a forgotten dose.

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

• 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. Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment or at dose increase. These effects should however decrease over time.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Very common (may affect more than 1 in 10 people):

• somnolence (sleepiness), headache
• nasopharyngitis

Common (may affect up to 1 in 10 people):

• convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor, (involuntary trembling);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• vertigo (sensation of rotation);
• anorexia (loss of appetite);
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• cough;
• rash;
• asthenia/fatigue (tiredness).

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

• amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
• decreased number of blood platelets, decreased number of white blood cells;
• weight decrease, weight increase;
• diplopia (double vision), vision blurred;
• injury
• muscle weakness, myalgia (muscle pain);
• elevated/abnormal values in a liver function test;
• hair loss, eczema, pruritus;
• suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;

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
• combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome).
  Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.

Very rare: (may affect up to 1 in 10000 people)

repeated unwanted thoughts or sensations or the urge to do something over and over again (Obsessive Compulsive Disorder).

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.

The active substance is Levetiracetam. Each 1 ml of oral solution contains 100 mg of Levetiracetam.

The other ingredients are sodium citrate (E331), citric acid anhydrous (E330), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, acesulfame potassium (E950), glycerol (E422), liquid maltitol (E965), grape flavour, sucralose and purified water.

Levetiracetam Brillpharma is a clear, colourless to light yellow colour liquid.

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

The 150 ml glass bottle with a child resistant closure (for infants and young children aged from 6 months to less than 4 years) is packed in a carton containing a 3 ml oral syringe (graduated every 0.1ml) and an adaptor for the syringe.

The 150 ml glass bottle with a child resistant closure (for infants aged 1 month to less than 6 months) is packed in a carton containing a 1 ml oral syringe (graduated every 0.05ml) and an adaptor for the syringe.

Not all pack sizes may be marketed.

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