Patient Information Leaflet: Information for the Patient

levetiracetam cinfa 100 mg/ml oral solution EFG

Read this leaflet carefully before you or your child 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, consult 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

Levetiracetam cinfa is used:

• alone in adults and adolescents aged 16 years 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 extend 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.
• concurrently with other antiepileptic medications to treat:
• • partial onset seizures with or without generalization in adults, adolescents, children, and infants from 1 month of age.
  • myoclonic seizures (shock-like, short, muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
  • primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Do not take levetiracetam cinfa

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

Warnings and precautions

Consult your doctor before starting to take levetiracetam cinfa.

• 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 levetiracetam cinfa, have had thoughts of self-harm or suicide.If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

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.

Children and adolescents

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

Use of levetiracetam cinfa 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 effect.

Taking levetiracetam cinfa with food, drinks, and alcohol

You can take levetiracetam with or without meals. As a safety measure, do not take levetiracetam with alcohol.

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 excluded.It is not recommended to breastfeed naturally during treatment.

Driving and operating machinery

Levetiracetam may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your reaction time. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

levetiracetam cinfa contains parahydroxybenzoic acid methyl ester and parahydroxybenzoic acid propyl ester.

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid methyl ester (E-218) and parahydroxybenzoic acid propyl ester (E-216).

levetiracetam cinfa contains liquid maltitol.

This medication contains liquid maltitol (E-965).If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

levetiracetam cinfa contains sodium.

This medication contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free."

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

Levetiracetam cinfa should be taken 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 (from 16 years of age):

For patients from 4 years of age, measure the appropriate dose using the 10 ml syringe included in the package.

Dose in general: levetiracetam cinfa is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1500 mg).

When starting to take levetiracetam cinfa, 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):

For patients from 4 years of age, measure the appropriate dose using the 10 ml syringe included in the package.

Dose in general: levetiracetam cinfa is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1500 mg).

Dose in children from 6 months of age:

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

For children from 6 months to 4 years of age, measure the appropriate dose using the3 mlsyringe included in the package.

For children over 4 years of age, measure the appropriate dose using the10 mlsyringe included in the package.

Dose in general: levetiracetam cinfa is taken twice a day, in two equal doses, each individual dose between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kilogram of body weight of the child (see the following table for dose examples).

Dose in children from6 months of age:

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

For infants from 1 month to less than 6 months of age, measure the appropriate dose using the1 mlsyringe included in the package.

Dose in general: levetiracetam cinfa is taken twice a day, in two equal doses, each individual dose between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of body weight of the infant (see the following table for dose examples).

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

Administration form:

After measuring the correct dose with the appropriate syringe, levetiracetam cinfa can be diluted in a glass of water or in a bottle. You can take levetiracetam with or without food. After oral administration of levetiracetam, its bitter taste may be appreciated.

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 into the neck of the bottle (figure 2). Make sure it is securely attached.

Take the syringe and insert it into the opening of the adapter (figure 3) Turn the bottle upside down (figure 4)

Fill the syringe with a small amount of solution by lowering the plunger (figure 5A) and then raising it to eliminate any possible bubbles (figure 5B). Lower the plunger to the graduation mark corresponding to the dose in milliliters (ml) prescribed by your doctor (figure 5C).

Turn the bottle right side up (figure 6A). Remove the syringe from the adapter (figure 6B).

Empty the contents of the syringe into a glass of water or a bottle by lowering the plunger to the end of the syringe (figure 7).

Drink the contents of the glass or bottle entirely.

• Close the bottle with the plastic screw cap.
• Wash the syringe only with water (figure 8).

Treatment duration:

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

If you take more levetiracetam cinfa than you should:

The possible adverse effects of an overdose of levetiracetam cinfa 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.

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

If you forget to take levetiracetam cinfa

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 levetiracetam cinfa

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

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

Like all medicines, this medicine can 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 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, and dizziness. 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.

Very common:may affect more than 1 in 10 patients

• nasopharyngitis;
• drowsiness (drowsiness), headache.

Common:may affect up to 1 in 10 patients

• anorexia (loss of appetite);
• depression, hostility or aggression, 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 (sensation of weakness).

Rare:may affect up to 1 in 100 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.

Rare:may affect up to 1 in 1,000 patients

• infection;
• decreased count 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);
• hyponatremia (low sodium levels in the blood);
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see "Inform your doctor immediately" for a detailed description of symptoms);
• involuntary and uncontrolled 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);
• sudden decline in kidney function;
• skin rash, which 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);
• rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase levels associated with it. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• gait disturbance or difficulty walking.

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from light.

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

Do not use levetiracetam cinfa 100 mg/ml oral solution 2 months after the container has been opened.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of levetiracetam cinfa

• The active ingredient is levetiracetam. Each ml contains 100 mg of levetiracetam.
• The other components are: sodium citrate dihydrate, citric acid monohydrate, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), ammonium glycyrrhizate, glycerol (E-422), liquid maltitol (E-965), acesulfame K (E-950), grape flavor, purified water.

Appearance of the product and contents of the package

Levetiracetam cinfa 100 mg/ml oral solution is a transparent liquid.

The 300 ml glass bottle(for children aged 4 years and above, adolescents and adults)is packaged in a cardboard box accompanied by a 10 ml oral syringe (graduated every 0.25 ml) and a syringe adapter.

The 150 ml glass bottle(for infants and small children from 6 months to less than 4 years of age)is packaged in a cardboard box accompanied by a 3 ml oral syringe (graduated every 0.1 ml) and a syringe adapter.

The 150 ml glass bottle(for infants from 1 month to less than 6 months of age)is packaged in a cardboard box accompanied by a 1 ml oral syringe (graduated every 0.05 ml) and a syringe adapter.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible manufacturer:

Laboratorium Sanitatis, S.L.

P.T. Alava – C/ Leonardo Da Vinci, 11 01510 Miñano (Álava) - Spain

Last review date of this leaflet: June 2020

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/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/76440/P_76440.html

QR code to:https://cima.aemps.es/cima/dochtml/p/76440/P_76440.html