LEVETIRACETAM STADA 100 mg/ml ORAL SOLUTION

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

Do not take Levetiracetam Stada:

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

Warnings and precautions

Consult your doctor before taking Levetiracetam Stada:

• if you have kidney problems, follow the instructions of your doctor who will decide if you need to adjust the dose to be taken.

• if you notice any decrease in your child's growth or an unexpected delay in puberty, contact your doctor.

• a small number of people taking antiepileptics, such as levetiracetam, have had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• if you have a medical history or a family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or are taking a treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

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

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

On rare occasions, epileptic seizures may worsen or occur more frequently, mainly during the first month after the start of treatment or after a dose increase. If you experience any of these new symptoms while taking levetiracetam, see a doctor as soon as possible.

Children and adolescents

Monotherapy with levetiracetam (taking only levetiracetam) is not indicated in children and adolescents under 16 years.

Other medicines and Levetiracetam Stada

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

Do not take macrogol (a medicine used as a laxative) for one hour before and one hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam can only be used during pregnancy if, after a careful evaluation, your doctor considers it necessary. You should not stop your treatment without discussing it with your doctor. It cannot be completely excluded that the risk of birth defects for the baby is higher than for women who do not take levetiracetam. Breast-feeding is not recommended during treatment with levetiracetam.

Driving and using machines

Levetiracetam may affect your ability to drive or use tools or machines, as it may cause somnolence. This is more likely at the start of treatment or when the dose is increased. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Levetiracetam Stada contains methyl parahydroxybenzoate (E218), liquid maltitol (E965), sodium and benzyl alcohol.

This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

This medicine also contains maltitol. If your doctor tells you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e., it is essentially “sodium-free”.

This medicine contains 0.0016 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions.

Do not use for more than one week in young children (under 3 years) unless advised by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build up in your body and cause side effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can build up in your body and cause side effects (metabolic acidosis).

3. How to take Levetiracetam Stada

Follow exactly the instructions of your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Levetiracetam should be taken twice daily, once in the morning and once in the evening, approximately at the same time every day.

Take the oral solution as instructed by your doctor.

Monotherapy (from 16 years of age)

Adults (≥18 years) 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 is taken twice daily, divided into two equal doses, each of 5 ml (500 mg) to 15 ml (1500 mg).

When starting levetiracetam, 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):

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

General dose: Levetiracetam is taken twice daily, divided into two equal doses, each of 5 ml (500 mg) to 15 ml (1500 mg).

Dose in children from 6 months of age onwards:

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

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

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

General dose: Levetiracetam is taken twice daily, 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 examples of doses 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 is taken twice daily, 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 examples of doses 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 can be taken by diluting the oral solution in a glass of water or in a baby's bottle. You can take levetiracetam with or without food. After oral administration of levetiracetam, you may notice a bitter taste.

Instructions for correct administration:

• Open the bottle: press the cap and unscrew in the opposite direction of the clock hands (figure 1).
• Separate the syringe adapter (figure 2). Insert the adapter into the neck of the bottle. Make sure it is well fixed.
• Take the syringe and insert it into the adapter opening. Place the bottle upside down (figure 3).
• Fill the syringe with a small amount of solution by lowering the plunger (figure 4a) and then raising it to eliminate any possible bubbles (figure 4b). Lower the plunger to the graduation mark corresponding to the dose in milliliters (ml) prescribed by your doctor (figure 4c).
• Place the bottle upright. Remove the syringe from the adapter.
• Empty the contents of the syringe into a glass of water or a baby's bottle, lowering the plunger to the end of the syringe (figure 5).
• Drink the entire contents of the glass or bottle.
• Close the bottle with the child-resistant cap.
• Wash the syringe only with water (figure 6).

Duration of treatment

• Levetiracetam is used as a chronic treatment. You should continue treatment with levetiracetam 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 Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

The possible side effects of a levetiracetam overdose are somnolence, agitation, aggression, decreased alertness, respiratory inhibition and coma.

Your doctor will establish the best possible treatment for the overdose.

If you forget to take Levetiracetam Stada

Contact your doctor if you have missed one or more doses. Do not take a double dose to make up for the missed doses.

If you stop treatment with Levetiracetam Stada

Treatment with levetiracetam should be discontinued gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with levetiracetam, he/she will give you instructions for gradual withdrawal of the medicine.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Tell your doctor immediately, or go to the emergency department 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 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 it may be a sign of sudden decrease in renal function.
• 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 widespread 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 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, drowsiness (feeling of sleep), headache, fatigue, and dizziness. Adverse effects such as drowsiness, weakness, and dizziness may be more frequent when treatment is initiated or the dose is increased. However, these adverse effects should decrease over time.

Very common(may affect more than 1 in 10 people):

• nasopharyngitis;

• drowsiness (feeling of sleep), headache.

Common(may affect up to 1 in 10 people):

• 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, burning, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon(may affect up to 1 in 100 people):

• decrease in platelet count, decrease in white blood cells;

• weight loss, weight gain;
• suicidal thoughts and attempts, 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 liver function test values;
• 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 (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);
• delirium.
• encephalopathy (see subsection "Tell your doctor immediately" for a detailed description of symptoms);
• epileptic seizures may worsen or occur more frequently;
• uncontrolled muscle spasms affecting the head, torso, and limbs,

difficulty controlling movements, hyperkinesia (hyperactivity);

• change in heart rhythm (electrocardiogram);

• pancreatitis;

• liver failure, hepatitis.
• sudden decrease in renal function.
• skin rash, which 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 widespread 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 increased creatine phosphokinase in blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.
• limping or difficulty walking.

Reporting of Adverse Effects

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

5. Storage of Levetiracetam Stada

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

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

This medicine does not require special storage conditions.

After first opening: Do not store above 25°C.

Do not use after 7 months of opening the bottle.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levetiracetam Stada

• The active ingredient is levetiracetam.

Each ml of solution contains 100 mg of levetiracetam.

• The other components are: sodium citrate (to adjust pH), citric acid (to adjust pH), methyl parahydroxybenzoate (E218), glycerol (E422), acesulfame potassium (E950), liquid maltitol (E965), raspberry liquid (contains benzyl alcohol).

Appearance of the Product and Package Contents

Levetiracetam Stada 100 mg/ml oral solution is a clear liquid.

The 300 ml glass bottle of Levetiracetam Stada (for children from 4 years of age, adolescents, and adults) is packaged in a cardboard box with a 10 ml oral syringe (graduated every 0.25 ml) and a syringe adapter.

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

Limassol 3056

Cyprus

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2, 1

190 Vienna

Austria

or

Galenica Pharmaceutical Industry S.A.

3rd Km Old National Road Chalkida Athens,

Chalcis, 341 00

Greece

Date of the Last Revision of this Prospectus:October 2021

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/.