LEVETIRACETAM EXELTIS 500 mg COATED GRANULES IN SACHET

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

Do not take Levetiracetam Exeltis

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

Warnings and precautions

Consult your doctor before taking Levetiracetam Exeltis

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust the dose.
• If you notice any decrease in your child's growth or an unexpected delay in puberty development, 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 history of heart rhythm problems (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 get worse or last more than a few days:

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

Rarely, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) that causes multiple types of seizures and loss of skills, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while taking Levetiracetam Exeltis, see a doctor as soon as possible.

Children and adolescents

Levetiracetam Exeltis coated granules are not indicated in children and adolescents under 16 years of age as monotherapy, and are not recommended in children under 6 years of age as well as in the initial treatment of children under 25 kg.

Other medicines and Levetiracetam Exeltis

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) during the hour before and the hour after taking levetiracetam, as it may reduce its effect.

Using Levetiracetam Exeltis with food, drinks and alcohol

As a precaution, do not take Levetiracetam Exeltis with alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam can be used during pregnancy only if, after a careful evaluation, your doctor considers it necessary.

Do not stop treatment without consulting your doctor. The risk of birth defects for the baby cannot be completely excluded.

Driving and using machines

Levetiracetam Exeltis may affect your ability to drive or use any 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 it is established that your ability to perform such activities is not affected.

3. How to take Levetiracetam Exeltis

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Take the number of sachets as indicated by your doctor.

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

Concomitant therapy and monotherapy (from 16 years of age)

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

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

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

For example: for a daily dose of 1000 mg, your reduced starting dose is 1 sachet of 250 mg in the morning and 1 sachet of 250 mg in the evening, and the dose should be gradually increased to 1,000 mg per day after 2 weeks of treatment.

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

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

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

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

Levetiracetam oral solution is a more suitable formulation for infants and children under 6 years and for children and adolescents (from 6 to 17 years) with a weight below 50 kg and when sachets do not allow for precise dosing.

Method of administration:

1. 2. 3.

1. Hold the sachet above the arrow and shake to make the contents fall.
2. Tear along the incision (at the arrow) and cut along the dotted line.
3. Empty the contents directly into the mouth and swallow the granules immediately with a sufficient amount of liquid (e.g. a glass of water). Do not chew the granules, as they may have a slightly bitter taste. You can take levetiracetam with or without food.

The coated granules can also be suspended in at least 10 ml of water, shaken for at least 2 minutes and administered through a feeding tube, which should be rinsed twice with 10 ml of water immediately after administration. If this method of administration is used, the suspension should be prepared just before administration.

Each sachet is for single use.

Duration of treatment:

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

If you take more Levetiracetam Exeltis 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.

The possible side effects of an overdose of Levetiracetam Exeltis are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition and coma. Contact your doctor if you have taken more sachets than you should. Your doctor will establish the best possible treatment for the overdose.

If you forget to take Levetiracetam Exeltis:

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 Exeltis:

Stopping treatment with Levetiracetam Exeltis should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam Exeltis, he/she will give you instructions for gradual withdrawal of Levetiracetam Exeltis.

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

4. Possible side effects

Like all medicines, Levetiracetam Exeltis can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to the casualty department 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 (angioedema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high temperature, 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 legs, arms or feet, as this may be a sign of sudden decrease in kidney function

a skin rash that may form blisters and may look like targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)

• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form causing peeling of the skin over 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 behaviour or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), 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 people

• nasopharyngitis (inflammation of the nose or throat)
• somnolence (feeling drowsy), headache.

Common:may affect up to 1 in 10 people

• loss of appetite (anorexia)
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
• seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary tremor)
• vertigo (feeling of rotation)
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea
• skin rash
• asthenia/fatigue (feeling weak)

Uncommon:may affect up to 1 in 100 people

• decrease in platelet count, decrease in white blood cell count
• weight loss, weight gain
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (altered movement coordination), paraesthesia (tingling), attention disorders (loss of concentration)
• double vision, blurred vision
• elevated/abnormal liver function tests
• hair loss, eczema, itching
• muscle weakness, myalgia (muscle pain)
• injury

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

• infection
• decrease in certain types of white blood cells (neutrophils, granulocytes) or decrease in the number of all types of blood cells.
• severe allergic reactions (DRESS, anaphylactic reaction (severe and important allergic reaction), angioedema (swelling of face, lips, tongue and throat))
• decrease in sodium concentration in the blood
• suicide, personality disorders (behavioural 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 kidney function
• skin rash, which may lead to blisters that may appear as targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing peeling of the skin over more than 30% of the body surface (toxic epidermal necrolysis)
• rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.
• limping or difficulty walking
• combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called malignant neuroleptic syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare:may affect up to 1 in 10,000 people

• unwanted repeated thoughts or urges to do something over and over again (Obsessive Compulsive Disorder).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Exeltis

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

Do not use this medicine after the expiry date which is stated on the carton and on the sachets after EXP.

The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Content and Additional Information

Composition of Levetiracetam Exeltis

The active ingredient is levetiracetam. Each sachet contains 500 mg of levetiracetam.

The other components are:

Povidone K30

Microcrystalline cellulose

Anhydrous colloidal silica

Magnesium stearate

Polyvinyl alcohol

Titanium dioxide (E 171)

Macrogol 3350

Talc

Appearance of the Product and Packaging Content

Coated granules in a sachet; the coated granules are white or almost white and round (approximately 2 mm in diameter).

Levetiracetam Exeltis 500 mg coated granules in a sachet

Packaging of 20, 30, 50, 60, 100, 200 sachets

Only some packaging sizes may be marketed

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Exeltis Healthcare, S.L.

Avda. Miralcampo 7

Polígono Industrial Miralcampo 19200

Azuqueca de Henares (Guadalajara)

Spain

Manufacturer

Desitin Arzneimittel GmbH,

Weg beim Jäger 214,

22335 Hamburg,

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Levetiracetam Desitin 500 mg coated granules in a sachet

Portugal: Lovos 500 mg coated granules in a sachet

Romania: Levetiracetam Desitin 500 mg granules, in a sachet

Spain: Levetiracetam Exeltis 500 mg coated granules in a sachet

Date of the last revision of this leaflet: January 2024

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