Keppra 500 mg comprimidos recubiertos con pelicula

Package Insert: Information for the Patient

Keppra 250 mg Film-Coated Tablets

Keppra 500 mg Film-Coated Tablets

Keppra 750 mg Film-Coated Tablets

Keppra 1 000 mg Film-Coated Tablets

Levetiracetam

Read this package insert carefully before you or your child start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should 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 package insert. See section 4.

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

Keppra 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 for 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, children, and infants 1 month of age or older

myoclonic seizures (shock-like, brief, muscle or group of muscle seizures) in adults and adolescents 12 years of age or older with juvenile myoclonic epilepsy.

primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Do not take Keppra

If you are allergic to levetiracetam, pyrrolidone derivatives, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Keppra

• If you have kidney problems, follow your doctor's instructions, who 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 such as Keppra have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a medical history or family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

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.
• Worsening of epilepsy

In rare cases, seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. If you experience any of these new symptoms while taking Keppra, see a doctor as soon as possible.

Children and adolescents

• Monotherapy with Keppra (exclusive treatment) is not indicated in children and adolescents under 16 years old.

Use of Keppra with other medications

Inform your doctor or pharmacistif you are using, have used recently, or may need to use any other medication.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Levetiracetam can only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

Do not stop your treatment without discussing it with your doctor first.

The risk of birth defects for the baby cannot be completely ruled out. Breastfeeding is not recommended during treatment.

Driving and operating machinery

Keppra 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 increasing the dose. Do not drive or operate machinery until it is confirmed that your ability to perform these activities is not impaired.

Keppra 750 mg tablets contain yellow-orange S (E110) colorant.

The yellow-orange S (E110) colorant may cause allergic reactions.

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

Take the number of tablets prescribed by your doctor.

Keppra should be taken twice a day, once in the morning and once at night, approximately at the same time each day.

Concomitant therapy and monotherapy (from 16 years of age)

• Adults (≥18 years) and adolescents (12 to 17 years) with a weight of 50 kg or more:

Recommended dose: between 1,000 mg and 3,000 mg per day.

When starting to take Keppra, your doctor will prescribe a lower dose for 2 weeks before administering the daily dose.

For example: for a daily dose of 1,000 mg, your reduced initial dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg at night, and the dose should be gradually increased to reach 1,000 mg per day after 2 weeks of treatment.

• Adolescents (12 to 17 years) with a weight equal to or less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Keppra according to your weight and dose.

• Dose in infants (1 month to 23 months) and children (2 to 11 years) with a weight less than 50 kg:

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

Keppra 100 mg/ml oral solution is a more suitable formulation for infants and children under 6 years old and for children and adolescents (6 to 17 years) with a weight less than 50 kg and when tablets do not allow for precise dosing.

Administration form

Swallow Keppra tablets with a sufficient amount of liquid (e.g. a glass of water). You can take Keppra with or without food. After oral administration of levetiracetam, its bitter taste may be perceived.

Treatment duration

• Keppra is used as a chronic treatment. You should continue treatment with Keppra for the time indicated by your doctor.
• Do not stop treatment without your doctor's recommendation, as seizures may increase.

If you take more Keppra than you should

The possible adverse effects of a Keppra overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

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

If you forgot to take Keppra:

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 treatment with Keppra:

Stopping treatment with Keppra should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Keppra, they will give you instructions for the gradual withdrawal of Keppra.

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

Like all medications, Keppra 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 fever, elevated liver enzymes 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 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 (feeling sleepy), headache, fatigue, and dizziness. Side effects such as feeling sleepy, feeling weak, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Very common:may affect more than 1 in 10 people

• nasopharyngitis;
• drowsiness (feeling sleepy), headache.

Common:may affect up to 1 in 10 people

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

Rare:may affect up to 1 in 100 people

• decrease in platelet count, decrease in 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:may affect up to 1 in 1,000 people

• infection;
• decrease in 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 concentration in the blood;
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see "Inform your doctor immediately" for a detailed description of symptoms);
• seizures may worsen or occur more frequently;
• involuntary and uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis (inflammation of the pancreas);
• liver insufficiency, hepatitis (inflammation of the liver);
• sudden decline in kidney function;
• 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);
• rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• gait disturbance or difficulty walking;
• combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and low level of consciousness (may be signs of a condition calledneuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the carton after CAD and on the blister after EXP.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and of the medications that you no longer need. In this way, you will help protect the environment.

Keppra Composition

The active ingredient is levetiracetam. Each tablet contains 250 mg of levetiracetam. A Keppra 250 mg tablet contains 250 mg of levetiracetam.

A Keppra 500 mg tablet contains 500 mg of levetiracetam. A Keppra 750 mg tablet contains 750 mg of levetiracetam.

A Keppra 1,000 mg tablet contains 1,000 mg of levetiracetam.

The other components are:

Tablet core: sodium croscarmellose, macrogol 6000, anhydrous colloidal silica, magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, colorants*.

* The colorants are:

250 mg tablets: aluminum lake with indigo carmine (E132) 500 mg tablets: yellow iron oxide (E172)

750 mg tablets: aluminum lake with yellow-orange S (E110), red iron oxide (E172)

Appearance of the product and contents of the pack

Keppra 250 mg film-coated tablets are blue, 13 mm, oblong, scored, and have the code "ucb" and "250" engraved on one side.

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Keppra 500 mg film-coated tablets are yellow, 16 mm, oblong, scored, and have the code "ucb" and "500" engraved on one side.

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Keppra 750 mg film-coated tablets are orange, 18 mm, oblong, scored, and have the code "ucb" and "750" engraved on one side.

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Keppra 1,000 mg film-coated tablets are white, 19 mm, oblong, scored, and have the code "ucb" and "1,000" engraved on one side.

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Keppra tablets are packaged in blisters included in cartons that contain:

• 250 mg: 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multiple packagings containing 200 (2 packagings of 100) film-coated tablets

• 500 mg: 10, 20, 30, 50, 60, 100 x 1, 100, 120 film-coated tablets and multiple packagings containing 200 (2 packagings of 100) film-coated tablets

• 750 mg: 20, 30, 50, 60, 80, 100 x 1, 100 film-coated tablets and multiple packagings containing 200 (2 packagings of 100) film-coated tablets

• 1,000 mg: 10, 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multiple packagings containing 200 (2 packagings of 100) film-coated tablets

The 100 x 1 tablet packaging is available in pre-scored aluminum/PVC single-dose blisters. The other packagings are available in standard aluminum/PVC blisters.

Not all packaging sizes may be marketed.

Marketing Authorization Holder

UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium.

Responsible for manufacturing

UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.

or Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza, Italy

For more information about this medicine, please contact the local representative of the marketing authorization holder.

Last review date of this leaflet:

Other sources of information

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu