Patient Information Leaflet

Levetiracetam TecniGen100 mg/ml Oral Solution EFG

Levetiracetam

Read this leaflet carefully before you or your child 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, consult your doctor, 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, consult 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 starting 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 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, and children 1 month of age,
• myoclonic seizures (shock-like, short, muscle or group of muscle seizures) 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 components of 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 an unexpected onset of puberty, contact your doctor.
• A small number of people taking antiepileptic medications such as Levetiracetam TecniGen 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 of irritability, 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 withLevetiracetam TecniGenis not indicated in children and adolescents under 16 years old.

Taking Levetiracetam TecniGen with other 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.

Taking Levetiracetam TecniGen with 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 undesirable 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 TecniGen may 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

Levetiracetam TecniGen contains parahydroxybenzoic acid methyl ester (E218), parahydroxybenzoic acid propyl ester (E216), and maltitol

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid methyl ester (E218) and parahydroxybenzoic acid propyl ester (E216).

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

This medication contains less than 23 mg of sodium (1mmol) 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 TecniGen 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

Dosage in adults and adolescents from 16 years of age:

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

Dosage: Levetiracetam TecniGen is taken twice a day, divided into two equal doses, each of between 5 ml (500 mg) and 15 ml (1,500 mg).

When starting to take Levetiracetam TecniGen, 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) 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.

Dosage: Levetiracetam TecniGen is taken twice a day, divided into two equal doses, each of between 5 ml (500 mg) and 15 ml (1,500 mg).

Dosage in children 6 months of age and older

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam TecniGen 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.

Dosage: Levetiracetam TecniGen is taken twice a day, divided into two equal doses, each of 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).

Dosage 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.

Dosage: Levetiracetam TecniGen is taken twice a day, divided into two equal doses, each of 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 TecniGen can be taken by dissolving the oral solution in a glass of water or in a bottle. It can be taken with or without food.

Instructions for correct administration:

• Open the bottle: by pressing the cap and turning in the opposite direction to the clock hands (figure 1)
• Insert the adapter of the syringe into the mouth of the bottle (figure 2). Make sure it is well fixed
• Put the syringe in the opening of the adapter (figure 2)
• Put the bottle upside down (figure 3)

• Fill the syringe with a small amount of solution by pulling the plunger down (figure 4 A), and then push the plunger up to eliminate any possible bubble (figure 4 B). Pull the plunger down until the mark corresponding to the amount in milliliters (ml) prescribed by your doctor (figure 4 C)

• Turn the bottle to the normal position. Remove the syringe from the adapter.

• Empty the contents of the syringe into a glass of water or a bottle, pressing the plunger until the end of the syringe (figure 5).
• Drink all the contents of the glass/bottle.
• Close the bottle with the plastic screw cap.
• Wash the syringe only with water (figure 6).

Treatment duration:

•Levetiracetam TecniGen is used as chronic treatment. You must continue with the treatment with Levetiracetam TecniGen for the time indicated by your doctor.

•Do not stop your 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 an overdose of Levetiracetam TecniGen 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 your treatment with Levetiracetam TecniGen, they will give you instructions for the gradual withdrawal of Levetiracetam TecniGen.

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

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;
• drowsiness (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 (dizziness), 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 10,000 patients)

• 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));
• decrease in sodium concentration in blood;
• suicide, personality disorders (behavior 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 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.

Mantenereradesisavisión yenlacancedelosniños.

This medication is for the treatment of the eye and the lacrimal gland.

Do not use this medication in the presence of the expiration date that appears on the box of CAD. The expiration date is the last date of the month that the medication is still effective.

Do not use this medication for more than 3 months after the prime date of the package.

Keep in the original packaging.

This medication does not require any special conditions for its 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. In this way, you will help protect the environment.

Composition ofLevetiracetam TecniGen

• The active ingredient is levetiracetam. Each ml contains 100 mg of levetiracetam.
• The other components are: sodium citrate dihydrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), monoammonium glycyrrhizate, glycerol, liquid maltitol, potassium acesulfame (E950), flavoring, and purified water.

Appearance of the productand contents of the package

Levetiracetam TecniGen 100 mg/ml oral solution is a clear, transparent, or slightly yellowish liquid.

The 300 ml glass bottle of Levetiracetam TecniGen (for children from 4 years old, adolescents, and adults) is packaged in a cardboard box accompanied by a 10 ml oral administration syringe (graduated every 0.25 ml).

For infants and small children from one month to four years of age, a suitable oral administration syringe should be used.

Each cardboard box also contains a syringe adapter.

Other presentations:

• Levetiracetam TecniGen 250 mg coated tablets EFG
• Levetiracetam TecniGen 500 mg coated tablets EFG
• Levetiracetam TecniGen 750 mg coated tablets EFG
• Levetiracetam TecniGen 1000 mg coated tablets 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) SPAIN

Email: [email protected]

Responsible for Manufacturing

Atlantic Pharma – Produções Farmacêuticas, S.A.

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

Sofarimex – Industria Química e Farmacêutica, S.A.

Av. das Indústrias, Alto do Colaride, Agualva, 2735-213 Cacém, Portugal

Last review date of this leaflet: November 2020

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