Summary of Product Characteristics:Information for the User

Levetiracetam Tarbis 100 mg/ml Oral Solution EFG

Levetiracetam

Please read this leaflet carefully before you start to take this medicine because it contains important information for you.

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

Levetiracetam Tarbis 100 mg/ml oral solution is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam Tarbis is used:

• alone (without the need for another antiepileptic medication) in adults and adolescents aged 16 years or olderor olderwith recently diagnosed epilepsy to treat partial onset seizures with or without secondary generalization.
• concurrently with other antiepileptic medications to treat:

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

Do not take Levetiracetam Tarbis

• If you are allergic (hypersensitive) to levetiracetam or to any of the other components of this medication (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, who will decide if you need to adjust your dosage.
• If you notice any decrease in your child's growth or an 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 medications such as levetiracetam have had thoughts of self-harm or suicide.If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Taking Levetiracetam Tarbis with other medications

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

Taking Levetiracetam Tarbis with food, drinks and alcohol

You can take Levetiracetam Tarbis with or without meals.As a precaution, do not take Levetiracetam Tarbis with alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Levetiracetam Tarbis should not be used during pregnancy unless strictly necessary.The possible risk to the baby during pregnancy is unknown.In animal studies, levetiracetam has shown unwanted effects on reproduction at doses higher than those you may need to control your seizures.It is not recommended to breastfeed naturally during treatment.

Driving and operating machinery

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

Levetiracetam Tarbis containsparahydroxybenzoic acid methyl ester (E218), parahydroxybenzoic acid propyl ester and maltitol.

It may cause allergic reactions (possibly delayed) becauseit containsparahydroxybenzoic acid methyl ester (E218) and parahydroxybenzoic acid propyl ester (E216).

This medication contains maltitol.If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for Levetiracetam Tarbis as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

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

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

Monotherapy

Dose in adults and adolescents (16 years of age and older):

Measure the appropriate dose using the 10 ml syringe included in the package for patients 4 years of age and older.

Dose in general:Levetiracetam Tarbis is taken twice a day, divided into two equal doses, each between 5 ml (500 mg) and 15 ml (1,500 mg).

When starting to take Levetiracetam Tarbis, your doctor will prescribe alower dosefor two weeks before administering the general lowest dose.

Concomitant therapy

Dose in adults and adolescents (12 to 17 years) with a weight of 50 kg or more:

Measure the appropriate dose using the 10 ml syringe included in the package for patients 4 years of age and older.

Dose in general:Levetiracetam Tarbis is taken twice a day, divided into two equal doses, each between 5 ml (500 mg) and 15 ml (1,500 mg).

Dose in children 6 months of age and older:

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

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

For children over 4 years, measure the appropriate dose using the 10 ml syringe included in the package.

Dose in general: Levetiracetam Tarbis is taken twice a day, divided into two equal doses, each between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kilogram of body weight of the child (see examples of doses in the table below).

Dose in children 6 months of age and older:

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

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

Dose in general: Levetiracetam Tarbis is taken twice a day, divided into two equal doses, each between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of body weight of the infant (see examples of doses in the table below).

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

Administration form:

After measuring the correct dose with an appropriate syringe, Levetiracetam Tarbis can be taken by dissolving the oral solution in a glass of wateror in a bottle.

Instructions for correct administration:

• Open the bottle:press the cap and unscrew in the opposite direction to the clock hands (figure 1).

• Insert the adapter of the syringe into the neck of the bottle (figure 2).Make sure it is well fixed.
• Take the syringe and insert it into the opening of the adapter (figure 2).

• Place the bottle upside down (figure 3).

• Fill the syringe with a small amount of solution, lowering the plunger (figure 4) and thenraising it to eliminate any possible bubble (figure 5), finally lower the plunger to the graduation mark that corresponds to the dose in milliliters (ml) prescribed by your doctor (figure 6).

• Place the bottle upright.
• Remove the syringe from the adapter.
• Empty the contents of the syringe into a glass of water or a bottle, lowering the plunger to the end(figure 7).

• Drink all the contents of the glass.
• Close the bottle with the plastic screw cap.
• Wash the syringe with water (figure 8).

Treatment duration:

• Levetiracetam Tarbis is used as a chronic treatment.Continue with the treatment with Levetiracetam Tarbis for the time indicated by your doctor.
• Do not stop your treatment without your doctor's recommendation, as it may increase your seizures. If your doctor decides to stop your treatment with Levetiracetam Tarbis, he/she will give you instructions for the gradual withdrawal of Levetiracetam Tarbis.

If you take more Levetiracetam Tarbis than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The possible adverse effects of an overdose of Levetiracetam Tarbis are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

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

If you forgot to take Levetiracetam Tarbis:

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

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Levetiracetam Tarbis:

Like with other antiepileptic medications, the discontinuation of treatment with Levetiracetam Tarbisshould be done gradually to avoid an increase in seizures.

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

Like all medications, Levetiracetam Tarbis may cause side effects, although not everyone will experience them.

Some side effects, such as drowsiness, weakness, and dizziness, may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Inform 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 severe allergic reaction (anaphylactic).

- swelling of the face, lips, tongue, or throat (Quincke's edema)

- symptoms of the flu and a rash on the face followed by a prolonged rash with high fever, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (medication hypersensitivity reaction with eosinophilia and systemic symptoms (DRESS))

- symptoms such as decreased urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as it may be a sign of sudden kidney function decline

- a skin rash that may form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge)) (erythema multiforme)

- a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)

- a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)

- signs of severe mental changes or if someone around you notices signs of confusion, somnolence (drowsiness), amnesia (memory loss), memory decline (forgetfulness), abnormal behavior, or other neurological signs, including involuntary or uncontrollable movements. These may be signs of encephalopathy.

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

Very common (may affect more than 1 in 10 patients)

Common (may affect up to 1 in 10 patients)

Uncommon (may affect up to 1 in 100 patients)

Rare (may affect up to 1 in 1,000 patients)

Very rare (may affect fewer than 1 in 1,000 patients)

Frequency unknown (cannot be estimated from available data)

Very common:

• nasopharyngitis;
• drowsiness (drowsiness), headache.

Common:

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorder, dizziness (sensation of instability), lethargy, tremor (involuntary shaking);

• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;
• skin rash;
• asthenia/ fatigue (sensation of weakness).

Uncommon:

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental changes, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;

• amnesia (memory loss), memory decline (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function test results;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare:

• infection;
• decreased levels of all types of blood cells;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);

• involuntary muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• hepatic insufficiency, hepatitis (inflammation of the liver);
• skin rash, which may lead to blisters that may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge)) (erythema multiforme), a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).
• decreased sodium levels in the blood.
• sudden decline in kidney function
• myoglobinuria (muscle tissue breakdown) and elevated creatine phosphokinase levels associated with it. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

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

Do not use this medication after the expiration date that appears on the box and on the bottle after CAD. The expiration date is the last day of the month indicated.

Do not use after 7 months of opening the packaging.

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

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Levetiracetam Tarbis

• The active ingredient 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), lemon flavoring, and purified water.

Appearance of the product and content of the container

Levetiracetam Tarbis 100mg/ml oral solution is a transparent and colorless liquid.

Levetiracetam Tarbis is packaged in glass containers of 300 ml or 150 ml contained in a cardboard box:

Amber glass container of 150 ml with a white child-resistant cap, accompanied by a 1 ml graduated syringe for oral administration and an adapter for the syringe.This presentationis suitable for infants from 1 month to less than 6 months of age.

Amber glass container of 150 ml with a white child-resistant cap, accompanied by a 3 ml graduated syringe for oral administration and an adapter for the syringe.This presentationis suitable for infants and small children from 6 months to less than 4 years of age.

Amber glass container of 300 ml with a white child-resistant cap, accompanied by a 10 ml graduated syringe for oral administration and an adapter for the syringe.This presentationis suitable for children from 4 years of age, adolescents, and adults.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Bluepharma Indústria Farmacêutica, S.A.

Cimo de Fala – S. Martinho do Bispo

3045-016 Coimbra

Portugal

Last review date of this leaflet: May 2017.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/