Patient Information Leaflet

Levetiracetam TecniGen 500 mg Film-Coated Tablets

Levetiracetam

Read this leaflet carefully before you start taking 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, ask your doctor or pharmacist or nurse.
• 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 side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Levetiracetam TecniGen

3.How to take Levetiracetam TecniGen

4.Possible side effects

5Storage of Levetiracetam TecniGen

6.Contents of the pack and additional information

Levetiracetam TecniGen is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam TecniGen is used:

•alone in adults and adolescents 16 years of age or older with recently diagnosed epilepsy, to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used to treat the form of epilepsy in which the seizures initially affect only one side of the brain, but may later spread to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.

•in combination with other antiepileptic medications to treat:

• partial onset seizures with or without generalization in adults, adolescents, and children 1 month of age,
• myoclonic seizures (shock-like, short, muscle or group of muscles) in adults and adolescents 12 years of age with juvenile myoclonic epilepsy,
• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Do not take Levetiracetam TecniGen

• if you are allergic to levetiracetam or any of the other ingredients in this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to takeLevetiracetam TecniGen:

• If you have kidney problems, follow your doctor's instructions. He will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or unexpected puberty development, contact your doctor.
• A small number of people taking antiepileptic medications like Levetiracetam TecniGen have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Children and adolescents

• Monotherapy withLevetiracetam TecniGenis not indicated in children and adolescents under 16 years old.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last more than a few days:

• Abnormal thoughts, feeling irritable, or reacting more aggressively than normal, or if you or your family and friends notice significant changes in mood or behavior.

TakingLevetiracetam TecniGen withother medications

Inform your doctor or pharmacistif you are taking, have taken recently, or may need to take any other medication.

Do not take Macrogol (laxative medication) within one hour before and one hour after taking levetiracetam, as it may reduce its effect.

TakingLevetiracetam TecniGenwith food, drinks, and alcohol

You can take Levetiracetam TecniGen with or without food. As a precaution, do not take

Levetiracetam TecniGen with alcohol.

Pregnancy, breastfeeding, and fertility

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

Levetiracetam TecniGen should not be used during pregnancy unless strictly necessary.The risk of birth defects for the baby cannot be completely ruled out.In animal studies, levetiracetam has shown unwanted effects on reproduction at doses higher than those you may need to control your seizures.

Breastfeeding is not recommended during treatment.

Driving and operating machinery

Levetiracetam TecniGenmay impair 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 operate machinery until it is confirmed that your ability to perform these activities is not affected.

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

Levetiracetam TecniGen should be taken twice a day, once in the morning and once at night, approximately at the same hour every day.

Take the number of tablets following your doctor's instructions.

Monotherapy

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

General dosage: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) per day.

When starting to take Levetiracetam TecniGen, your doctor will prescribe a lower dosage for 2 weeks before administering the general lowest dosage.

Example: if your daily dosage is 2,000 mg, you should take 2 tablets of 500 mg in the morning and 2 tablets of 500 mg at night.

Concomitant therapy

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

General dosage: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) per day.

Example: if your daily dosage is 1,000 mg, you should take 1 tablet of 500 mg in the morning and 1 tablet of 500 mg at night.

• Dosage in infants (1 month to 23 months), children (2 to 11 years), and adolescents (12 to 17 years) with a weight less than 50 kg:

Your doctor will prescribe the most suitable pharmaceutical form of Levetiracetam TecniGen according to age, weight, and dosage.

The most suitable presentation for infants and children under 6 years is an oral solution, and for children and adolescents (6 to 17 years) weighing less than 50 kg and when tablets do not allow for dosage adjustment.

Administration form:

Swallow Levetiracetam TecniGen tablets with sufficient liquid (e.g., a glass of water). You can take Levetiracetam with and without food.

Treatment duration:

• Levetiracetam TecniGen is used as chronic treatment. Continue treatment with Levetiracetam TecniGen for the time indicated by your doctor.
• Do not stop treatment without your doctor's recommendation, as this may increase your seizures..

If you take moreLevetiracetam TecniGenthan 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 a Levetiracetam TecniGen overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

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

If you forgot to takeLevetiracetam TecniGen

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 withLevetiracetam TecniGen

The discontinuation of treatment with Levetiracetam TecniGen should be done gradually to avoid an increase in seizures.

If your doctor decides to discontinue treatment with Levetiracetam TecniGen, they will give you instructions for the gradual withdrawal of Levetiracetam TecniGen.

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

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

Inform your doctor immediately, or go to the emergency service of your nearest hospital 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)
• flu-like symptoms and a rash on the face followed by a prolonged rash with high temperature, elevated liver enzyme levels 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 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 can 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, drowsiness (drowsiness), amnesia (memory loss), memory decline (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are: nasopharyngitis, drowsiness (drowsiness), headache, fatigue (weakness), and dizziness. These last side effects may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Very common(affects more than 1 in 10 patients)

• nasopharyngitis;
• somnolence (drowsiness), headache.

Common(affects between 1 and 10 in 100 patients)

• anorexia (loss of appetite);
• depression, hostility or aggressiveness, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorder, dizziness (sensation of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (weakness).

Rare(affects between 1 and 10 in 1,000 patients)

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental alterations, 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 alterations (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function test results;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.
• possible symptoms of rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase blood levels associated. Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Rare(affects between 1 and 10 in 10,000 patients)

• infection;
• decreased levels of all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction (severe and life-threatening allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat));
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• involuntary and uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver insufficiency, hepatitis (inflammation of the liver);
• skin rash that can 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).
• sudden decline in kidney function.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

This medication should be kept out of the sight and reach of children.

Do not use this medication from the expiration date printed on the box of CAD. The expiration date is the last date of the month that the manufacturer guarantees the product's safety and effectiveness.

This medication does not require special conditions for conservation.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition ofLevetiracetam TecniGen

• The active ingredient is levetiracetam. Each tablet contains 500 mg of levetiracetam.
• The other components are:
• Tablet core: anhydrous colloidal silica, magnesium stearate, cornstarch, povidone, talc.
• Capsule: Opadry 85F32004 (polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, iron oxide yellow (E172)).

Appearance of the productand contents of the packaging

Levetiracetam TecniGen 500 mg tablets are yellow, oval-shaped, and coated with a film.

The cardboard box contains 20, 30, and 60 film-coated tablets.

Only some packaging sizes may be commercially available.

Other presentations:

• Levetiracetam TecniGen 250 mg film-coated tablets EFG
• Levetiracetam TecniGen 750 mg film-coated tablets EFG
• Levetiracetam TecniGen 1000 mg film-coated tablets EFG
• Levetiracetam TecniGen 100 mg/ml oral solution EFG

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) ESPAÑA

Email: [email protected]

Responsible for Manufacturing

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal

O

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro da Armada, 5, Condeixa-a-Nova

3150-194 Sebal

Portugal

Last review date of this leaflet:May 2016

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