Prospecto: information for the patient
Levetiracetam Almus1000 mg film-coated tablets EFG
Read this prospectus carefully before you or your child starts taking this medicine, because it contains important information for you.
−Keep this prospectus, as you may need to read it again.
−If you have any doubts, consult your doctor or pharmacist.
−This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
−If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.
1.What isLevetiracetam Almusand what it is used for
2.What you need to know before starting to takeLevetiracetam Almus
3.How to takeLevetiracetam Almus
4.Possible adverse effects
5.Storage ofLevetiracetam Almus
6.Contents of the pack and additional information
This medicine contains1000 mg of levetiracetam in a film-coated tablet.
Levetiracetam is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).
It is used:
- partial onset seizures with or without generalization in adults, adolescents, children, and infants aged 1 month or older.
- myoclonic seizures (shock-like, short, muscle or group of muscles) in adults and adolescents aged 12 years or older with juvenile myoclonic epilepsy.
- primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).
Do not takeLevetiracetam Almus
Warnings and precautions
Consult your doctor before starting to takeLevetiracetam Almus:
Inform your doctor or pharmacist if any of the following adverse effects worsen or last more than a few days:
In rare cases, seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. If you experience any of these new symptoms while takingLevetiracetam tablets, see a doctor as soon as possible.
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 Almus, see a doctor as soon as possible.
Children and adolescents
•Monotherapy with Levetiracetam Almus is not indicated in children and adolescents under 16 years old.
Use ofLevetiracetam Almuswith other medications
Inform your doctor or pharmacist if you are using, have used recentlyor 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.
Pregnancy and breastfeeding
If you are pregnant orbreastfeeding,believe you may be pregnant, or intend to become pregnant,consult your doctorbefore using this medication.
Levetiracetam can only be used during pregnancy if, after a 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 ruled out.
Nursing is not recommended during treatment.
Driving and operating machinery
Levetiracetam Almusmay 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.
Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.
Take the number of tablets prescribed by your doctor.
This medicationshould be taken twice a day, once in the morning and once at night, approximately at the same time each day.
Concomitant therapy and monotherapy (from 16 years of age)
• Adults (≥18 years) and adolescents (12 to 17 years) with a weight of 50 kg or more:
Recommended dose: between 1,000 mg and 3,000 mg per day.
When starting to take levetiracetam tablets, your doctor will prescribe alower dosefor two weeks before administering the daily dose.
For example: for a daily dose of 1,000 mg, your reduced starting dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg at night, and the dose should be increased gradually to reach 1,000 mg per day after 2 weeks of treatment.
• Adolescents (12 to 17 years) with a weight equal to or less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form oflevetiracetam tabletsbased on weight and dose.
• Dose in infants (1 month to 23 months) and children (2 to 11 years) with a weight less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form oflevetiracetambased on age, weight, and dose.
The oral solution is a more suitable formulation for infants and children under 6 yearsand for children and adolescents (6 to 17 years) with a weight less than 50 kg and when tablets do not allow for precise dosing.
Administration form
Swallow the tablets ofthis medicationwith a sufficient amount of liquid (e.g. a glass of water).You can take levetiracetam tablets with or without food. After oral administration of levetiracetam, its bitter taste may be perceived.
Treatment duration
If you take moreLevetiracetam Almusthan you should
The possible adverse effects of a levetiracetam overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.
Contact your doctor if you have taken more tablets 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 Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested).
If you forgot to take Levetiracetam Almus:
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 Almus:
The discontinuation of treatment withthis medicationshould be done gradually under the guidance of your doctor to avoid an increase in seizures.If your doctor decides to stop your treatment with levetiracetam, they will give you instructionsfor the gradual withdrawal of that medication.
If you have any other doubts 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 hospitalif you experience:
The most frequently reported side effects are nasopharyngitis, drowsiness (feeling sleepy), headache, fatigue, and dizziness. Side effects such as feeling sleepy, feeling weak, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.
Most common: may affect more than 1 in 10 people:
Frequent: mayaffect up to 1 in 10 people:
Uncommon:may affect up to 1 in 100 people:
Rare:may affect up to 1 in 1000 people:
Very rare:may affect up to 1 in 10,000 people:
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 Vigilance of Medicinal Products for Human Use (Website:www.notificaRAM.es).
By reporting side effects, you can contribute to providing more information on the safety of the medicine.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
This medication does not require special conditions for conservation.
Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.
Levetiracetam Almus Composition
The active ingredient is levetiracetam.
Each tablet contains 1000 mg of levetiracetam.
The other components are:
Core tablet: Cornstarch, Povidone K30, anhydrous colloidal silica, magnesium stearate, talc.
Coating: Opadry 85F18422: macrogol 3350, polyvinyl alcohol, titanium dioxide (E171), talc.
Levetiracetam Almus is presented in blisters in cardboard boxes.
Each blister contains 10 tablets.
Product Appearance and Packaging Content
The film-coated tablets are yellow, oblong, scored, and marked with “1000” on the same side.
The tablet can be divided into equal doses.
The packaging contains 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 100 (10x10), 120 (12x10), and 200 (20x10) film-coated tablets and packs of 2x50 (100) and 4x50 (200) film-coated tablets.
Not all packaging sizes may be marketed.
Marketing Authorization Holder and Responsible Manufacturer
Marketing Authorization Holder:
Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Phone: 93 739 71 80
Email: [email protected]
Responsible Manufacturer:
Laboratoires BTT
ZI de Krafft, 67150 Erstein,France
Holsten Pharma GmbH
Hahnstraße 31-35, 60528 Frankfurt am Main, Germany
Last Review Date of this Leaflet:May 2024
“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/”
The average price of Levetiracetam almus 1000 mg comprimidos recubiertos con pelÍcula efg in July, 2025 is around 54.53 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.