Levetiracetam Rudipharm 100 mg/ml oral solution – patient leaflet, side effects, dosage

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

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

Levetiracetam Rudipharm 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 Rudipharm 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). Leveti-racetam Rudipharm 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 Rudipharm

Do not take Levetiracetam Rudipharm

• 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 Rudipharm

• 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 Rudi-

  pharm 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 electrocar-

  diogram), or if you have a disease and/or take a treatment that make(s) you prone to heart-beat 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 Rudipharm is not indicated in children and adolescents below 16 years on its

  own (monotherapy)

Other medicines and Levetiracetam Rudipharm

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 Rudipharm 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 recom-mended during treatment.

Driving and using machines

Levetiracetam Rudipharm 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 Rudipharm contains methyl parahydroxybenzoate, propyl parahydroxy-benzoate and maltitol

Levetiracetam Rudipharm oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). Levetiracetam Rudipharm oral solution 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 medicinal product.

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

3. How to take Levetiracetam Rudipharm

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 Rudipharm 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.

Monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (from 16 years of age):

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

Recommended dose: Levetiracetam Rudipharm is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1,500mg).

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.

Dose in children 6 months and older:

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

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.

Recommended dose: Levetiracetam Rudipharm 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).

Method of administration:

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

Instructions on how to use the syringe:

• Open the bottle: press the cap and turn it anticlockwise (figure 1)
• Take off the adaptor from the oral syringe (figure 2).
• Put the adaptor into the top of the bottle (figure 3). Make sure it is fixed well in place. You do not need to remove the adaptor after use.
• Put the oral syringe into
• the adaptor opening (figure 4).
• Turn the bottle upside down (figure 5).
• Hold the bottle upside down in one hand and use the other hand to fill the oral syringe.
• Pull the plunger down to fill the oral syringe with a small amount of solution (figure 5A).
• Then push the plunger up to remove any possible air bubbles (figure 5B).
• Pull the plunger down to the millilitre (ml) dose marker on the oral syringe prescribed by your doctor (figure 5C). The plunger may rise back up the barrel on the first dosage. There-fore, ensure that the plunger is kept in position until the dosing syringe is disconnected from the bottle.

• Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure

  6B).

Add-on therapy

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.

Recommended dose: Levetiracetam Rudipharm is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1,500mg).

Dose in children 6 months and older:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Rudi-pharm 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.

Recommended dose: Levetiracetam Rudipharm 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).

Back Side Page

• 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 7).

• Drink the whole contents of the glass/baby’s bottle.
• Close the bottle with the plastic screw cap (you do not need to remove the adaptor).

• To clean the syringe, rinse with cold water only, moving the plunger several times up and

  down to take up and expel the water, without separating the two components (figure 8).

• Keep the bottle, the oral syringe and the leaflet in the carton.

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 estab-lish 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 tempera-

  ture, 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 surround-

  ed 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 (sleepi-ness), 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 coordina-

  tion/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 surround-ed 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-Jap-anese patients.
  • limp or difficulty walking.

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

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).

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 informa-tion on the safety of this medicine.

5. How to store Levetiracetam Rudipharm

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 bottle after EXP: The expiry date refers to the last day of the month.

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

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 Rudipharm contains

The active substance is called levetiracetam. Each ml contains 100 mg of levetiracetam.

The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzo-ate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grape flavour, purified water.

What Levetiracetam Rudipharm looks like and contents of the pack

Levetiracetam Rudipharm 100 mg/mL Oral Solution 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 cardboard box containing a 10 mL oral syringe (graduated every 0.25 mL) and an adaptor for the syringe.

The 200 mL glass bottle which contains 150 mL of Levetiracetam oral solution (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3 mL oral syringe (graduated every 0.1 mL) and an adaptor for the syringe.

The 200 mL glass bottle which contains 150 mL of Levetiracetam oral solution (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 mL oral syringe (graduated every 0.05 mL) and an adaptor for the syringe.

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:

Rudipharm Limited

Oak House, Reeds Crescent,

Watford, WD24 4QP, UK

POM

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 Rudipharm 100mg/ml PL 49565/106 Oral Solution

This leaflet was last revised in January 2026.

Levetiracetam Rudipharm 100mg-ml Oral Solution - PIL

Levetiracetam Rudipharm

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