LEVETIRACETAM TECNIGEN 100 mg/ml ORAL SOLUTION

2. What you need to know before you take Levetiracetam TecniGen

Do not take Levetiracetam TecniGen

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Levetiracetam TecniGen:

• If you have kidney problems, follow your doctor's instructions. He/she will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or an unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptics, such as Levetiracetam TecniGen, have had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Tell your doctor or pharmacist if any of the following side effects get worse or last more than a few days:

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

Children and adolescents

• Monotherapy with Levetiracetam TecniGen is not indicated in children and adolescents under 16 years.

Taking Levetiracetam TecniGen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Macrogol (a laxative) for 1 hour before and 1 hour after taking levetiracetam, as it may lose its effect.

Taking Levetiracetam TecniGen with food, drinks, and alcohol

You can take Levetiracetam TecniGen with or without food. As a precautionary measure, do not take Levetiracetam TecniGen with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam TecniGen may affect your ability to drive or use tools or machinery, as it may cause drowsiness. This is more likely at the start of treatment or when the dose is increased. You should not drive or use machinery until you are sure that your ability to perform these activities is not affected.

Levetiracetam TecniGen contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and maltitol

It may cause allergic reactions (which can be delayed) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

This medicine contains liquid maltitol. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Levetiracetam TecniGen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Levetiracetam TecniGen should be taken twice a day, once in the morning and once in the evening, approximately at the same time each day.

Take the oral solution as instructed by your doctor.

Monotherapy

Dose in adults and adolescents from 16 years of age:

Measure the appropriate dose using the 10 ml syringe included in the pack for patients from 4 years of age onwards.

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

When starting Levetiracetam TecniGen, your doctor will prescribe a lower dosefor two weeks before giving you the lowest general dose.

Concomitant therapy

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

Measure the appropriate dose using the 10 ml syringe included in the pack for patients from 4 years of age onwards.

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

Dose in children from 6 months of age onwards

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

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

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

General dose: Levetiracetam TecniGen is taken twice a day, divided into two equal doses, each of 0.1 ml (10 mg) to 0.3 ml (30 mg) per kg of the child's body weight (see dose examples in the table below).

Dose in children from 6 months of age onwards:

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

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

General dose: Levetiracetam TecniGen is taken twice a day, divided into two equal doses, each of 0.07 ml (7 mg) to 0.21 ml (21 mg) per kg of the infant's body weight (see dose examples in the table below).

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

Method of administration:

After measuring the correct dose with an appropriate syringe, Levetiracetam TecniGen can be taken by diluting the oral solution in a glass of water or in a baby bottle. It can be taken with or without food.

Instructions for correct administration:

• Open the bottle: by pressing the cap and turning it counterclockwise (figure 1)
• Insert the syringe adapter into the bottle mouth (figure 2). Make sure it is well fixed
• Put the syringe into the adapter opening (figure 2)
• Turn the bottle upside down (figure 3)

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

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

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

Duration of treatment

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

If you take more Levetiracetam TecniGen than you should

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 medicine and the amount taken.

The possible side 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 forget to take Levetiracetam TecniGen

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

Do not take a double dose to make up for forgotten doses.

If you stop taking Levetiracetam TecniGen

Stopping treatment with Levetiracetam TecniGen should be done gradually to avoid an increase in seizures.

If your doctor decides to stop your treatment with Levetiracetam TecniGen, he/she will give you instructions for the gradual withdrawal of Levetiracetam TecniGen.

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

4. Possible Adverse Effects

Like all medicines, Levetiracetam TecniGen can cause adverse effects, although not all people suffer from 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 (anaphylaxis)
• swelling of the face, lips, tongue, or throat (Quincke's edema)
• flu-like symptoms and 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 cells (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 legs, arms, or feet, as these may be signs of sudden renal function decrease
• a skin rash that can form blisters and may appear as small targets (dark central spots surrounded by a paler 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 impairment (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported adverse effects are: nasopharyngitis, somnolence (feeling of sleep), headache, fatigue (feeling of weakness), and dizziness. These latter adverse effects may be more frequent when treatment is initiated or the dose is increased. However, these adverse effects should decrease over time.

Very Common(affect more than 1 in 10 patients)

• nasopharyngitis;
• somnolence (feeling of sleep), headache.

Common(affect between 1 and 10 in 100 patients)

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

Uncommon(affect between 1 and 10 in 1,000 patients)

• decrease in platelet count, decrease in white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (lack of memory), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disorders (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal values in liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.
• possible symptoms of rhabdomyolysis (muscle tissue breakdown) and increased blood creatine phosphokinase associated with it. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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

• infection;
• decrease in all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction (important and severe allergic reaction), Quincke's edema (swelling of face, lips, tongue, and throat));
• decrease in sodium concentration in blood;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• skin rash that can lead to blisters that may appear as small targets (dark central spots surrounded by a paler 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 decrease in renal function.

Reporting of Adverse Effects

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

5. Conservation of Levetiracetam TecniGen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the label or box after CAD. The expiration date is the last day of the month indicated.

Do not use 3 months after the first opening of the bottle.

Store in the original packaging.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 Package Contents

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, adolescents, and adults) is packaged in a cardboard box accompanied by a 10 ml oral syringe (graduated every 0.25 ml).

For infants and young children from 1 month to 4 years of age, an appropriate oral syringe should be used.

Each cardboard box also contains a syringe adapter.

Other presentations:

• Levetiracetam TecniGen 250 mg film-coated tablets EFG
• Levetiracetam TecniGen 500 mg film-coated tablets EFG
• Levetiracetam TecniGen 750 mg film-coated tablets EFG
• Levetiracetam TecniGen 1000 mg film-coated tablets EFG

Marketing Authorization Holder and Manufacturers

Marketing Authorization Holder

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]

Manufacturers

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

Date of the last revision of this prospectus: November 2020

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