Levetiracetam Tarbis 100 mg/ml oral solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Levetiracetam Tarbis 100 mg/ml oral solution EFG

Levetiracetam

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Contents of this leaflet:

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

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

Levetiracetam Tarbis 100 mg/ml oral solution is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Tarbis is used:

• as monotherapy (without the need for another antiepileptic medicine) in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat partial-onset seizures with or without secondary generalization.

• in combination with other antiepileptic medicines to treat:

  • partial-onset seizures with or without secondary generalization in adults, adolescents, children, and infants from 1 month of age.
  • myoclonic seizures in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy.
  • primary generalized tonic-clonic seizures in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy.

2. What you need to know before starting to take Levetiracetam Tarbis

Do not take Levetiracetam Tarbis

• If you are allergic (hypersensitive) to levetiracetam or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levetiracetam Tarbis.

• If you have kidney problems, follow your doctor's instructions, as they will decide whether your dose needs to be adjusted.
• If you notice any slowing in your child's growth or unexpected development of puberty, contact your doctor.
• If you notice an increase in the severity of seizures (e.g., increased frequency), contact your doctor.
• A small number of people taking antiepileptic medicines such as levetiracetam have had thoughts of harming themselves or of suicide. If you experience symptoms of depression and/or suicidal thoughts, contact your doctor.

Taking Levetiracetam Tarbis with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Taking Levetiracetam Tarbis with food, drinks, and alcohol

You may take Levetiracetam Tarbis with or without food. As a precaution, do not take Levetiracetam Tarbis with alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Levetiracetam Tarbis should not be used during pregnancy unless strictly necessary. The potential risk to the baby during pregnancy is unknown. Animal studies have shown adverse effects of levetiracetam on reproduction at doses higher than those required to control seizures. Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam Tarbis may affect your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or when the dose is increased. You should not drive or use machinery until you are certain that your ability to perform these activities is not impaired.

Levetiracetam Tarbis contains methylparahydroxybenzoate (E218), propylparahydroxybenzoate, and maltitol.

It may cause allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216).

This medicine contains maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Levetiracetam Tarbis

Follow exactly the instructions for administering Levetiracetam Tarbis provided by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Levetiracetam Tarbis is twice daily, once in the morning and once in the evening, approximately at the same time each day.

Take the oral solution according to your doctor's instructions.

Monotherapy

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

Measure the appropriate dose using the 10 ml syringe supplied in the package for patients aged 4 years and older.

General dose: Levetiracetam Tarbis is taken twice daily, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

When you start taking Levetiracetam Tarbis, your doctor will prescribe a lower dose for two weeks before administering the lowest general dose.

Concomitant therapy

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

Measure the appropriate dose using the 10 ml syringe supplied in the package for patients aged 4 years and older.

General dose: Levetiracetam Tarbis is taken twice daily, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

Dosage in children from 6 months of age onwards:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Tarbis based on the child's age, weight, and required dose.

For children aged 6 months to 4 years, measure the appropriate dose using the 3 ml syringe supplied in the package.

For children older than 4 years, measure the appropriate dose using the 10 ml syringe supplied in the package.

General dose: Levetiracetam Tarbis is taken twice daily, divided into two equal doses, each ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kg of the child's body weight (see dosing examples in the table below).

Dosage in children from 6 months of age onwards:

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

For infants from 1 month to less than 6 months, measure the appropriate dose using the 1 ml syringe provided in the package.

General dose: Levetiracetam Tarbis is taken twice daily, divided into two equal doses, each ranging from 0.07 ml (7 mg) to 0.21 ml (21 mg) per kg of the infant's body weight (see dosage examples in the table below).

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

Administration method:

After measuring the correct dose with an appropriate syringe, Levetiracetam Tarbis may be taken by diluting the oral solution in a glass of water or in a baby bottle.

Instructions for correct administration:

• Open the bottle: press down on the cap and unscrew counterclockwise (figure 1).

• Insert the syringe adapter into the neck of the bottle (figure 2). Make sure it is securely in place.

• Take the syringe and insert it into the opening of the adapter (figure 2).

• Turn the bottle upside down (figure 3).

• Fill the syringe with a small amount of solution by first pushing the plunger down (figure 4), then pulling it up to remove any possible air bubbles (figure 5), and finally pulling the plunger down to the graduation mark corresponding to the prescribed dose in millilitres (ml) as directed by your doctor (figure 6).
• Turn the bottle upright.
• Remove the syringe from the adapter.
• Empty the contents of the syringe into a glass of water or into a baby bottle by pushing the plunger down completely (figure 7).
• Drink all the contents of the glass.
• Close the bottle with the plastic screw cap.
• Wash the syringe with water (figure 8).

Duration of treatment:

• Levetiracetam Tarbis is used as a chronic treatment. You must continue treatment with Levetiracetam Tarbis for the length of time indicated by your doctor.
• Do not stop your treatment without your doctor's recommendation, as your seizures may increase. If your doctor decides to discontinue treatment with Levetiracetam Tarbis, they will provide you with instructions for gradually withdrawing the medication.

If you take more Levetiracetam Tarbis than you should:

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

Possible adverse effects of a Levetiracetam Tarbis overdose include somnolence, agitation, aggressiveness, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more oral solution than you should. Your doctor will determine the best treatment for the overdose.

If you forget to take Levetiracetam Tarbis:

Contact your doctor if you have missed one or more doses.

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

If you interrupt treatment with Levetiracetam Tarbis:

As with other antiepileptic medicines, discontinuation of treatment with Levetiracetam Tarbis should be done gradually to avoid an increase in seizures.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Levetiracetam Tarbis can cause adverse effects, although not everyone experiences them.

Some adverse effects such as drowsiness, weakness, and dizziness may be more common when treatment is started or when the dose is increased. However, these adverse effects should decrease over time.

Contact your doctor immediately or go to the nearest hospital emergency department if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction;
• swelling of the face, lips, tongue, or throat (angioedema);
• flu-like symptoms and rash on the face followed by a prolonged rash with high fever, elevated liver enzymes in blood tests, an increase in a type of white blood cells (eosinophilia), and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS));
• symptoms such as low urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as these may indicate sudden decrease in kidney function;
• a skin rash that may blister and may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme);
• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
• a more severe form causing skin peeling over 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 (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs, including involuntary or uncontrolled movements. These may be signs of encephalopathy.

The frequency of the possible adverse effects listed below is defined as follows:

Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect less than 1 in 1,000 people)
Frequency not known (cannot be estimated from available data)

Very common:

• nasopharyngitis;
• somnolence (drowsiness), headache.

Common:

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorder, dizziness (feeling of instability), lethargy, tremor (involuntary shaking);
• vertigo (spinning sensation);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion, burning, and acid reflux), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon:

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (lack of memory), abnormal coordination/ataxia (impaired movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal results in liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare:

• infection;
• decrease in all types of blood cells;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• uncontrollable muscle spasms affecting the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• skin rash, which may lead to blisters that may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• decreased concentration of sodium in blood;
• sudden decrease in kidney function;
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Levetiracetam Tarbis

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Do not use more than 7 months after opening the container.

Store in the original packaging to protect from light. Store in an upright position.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam Tarbis

• The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.
• The other components are: glycerol (E422), propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), ammonium glycyrrhizinate, citric acid monohydrate, sodium citrate dihydrate, potassium acesulfame, maltitol (E965), grapefruit flavouring, and purified water.

Appearance of the product and contents of the pack

Levetiracetam Tarbis 100 mg/ml oral solution is a clear, colourless liquid.

Levetiracetam Tarbis is packaged in 300 ml or 150 ml amber glass bottles contained in a cardboard carton:

150 ml amber glass bottle with a white child-resistant cap, accompanied by a 1 ml graduated oral dosing syringe and a syringe adapter. This presentation is suitable for infants from 1 month to less than 6 months of age.

150 ml amber glass bottle with a white child-resistant cap, accompanied by a 3 ml graduated oral dosing syringe and a syringe adapter. This presentation is suitable for infants and young children from 6 months to less than 4 years of age.

300 ml amber glass bottle with a white child-resistant cap, accompanied by a 10 ml graduated oral dosing syringe and a syringe adapter. This presentation is suitable for children from 4 years of age, adolescents and adults.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Bluepharma Indústria Farmacêutica, S.A.

Cimo de Fala – S. Martinho do Bispo

3045-016 Coimbra

Portugal

Date of the most recent revision of this leaflet: May 2017.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/