Levetiracetam Tecnigen 500 mg film-coated tablets EFG: detailed information

Brand name Levetiracetam Tecnigen 500 mg film-coated tablets EFG

Form tablets, film-coated

Active substance / Dosage

LEVETIRACETAM · 500 mg

Prescription type Prescription Only Medicine

ATC code

N03A N03AX N03AX14

Registration number 75782

Manufacturer Tecnimede Espana Industria Farmaceutica S.A.

Levetiracetam Tecnigen 500 mg film-coated tablets EFG tablets, film-coated

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Levetiracetam TecniGen is and what it is used for
2. What you need to know before starting to take Levetiracetam TecniGen
3. How to take Levetiracetam TecniGen
4. Possible adverse effects
5. Storage of Levetiracetam TecniGen
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam TecniGen 500 mg film-coated tablets EFG

Levetiracetam

Read the entire leaflet carefully before you or your child starts 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, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet :

What Levetiracetam TecniGen is and what it is used for
What you need to know before taking Levetiracetam TecniGen
How to take Levetiracetam TecniGen
Possible side effects
How to store Levetiracetam TecniGen
Contents of the pack and other information

1. What Levetiracetam TecniGen is and what it is used for

Levetiracetam TecniGen is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam TecniGen is used:

as monotherapy in adults and adolescents 16 years of age and older with newly diagnosed epilepsy, to treat a type of epilepsy. Epilepsy is a condition in which patients experience seizures. Levetiracetam is used for the type of epilepsy in which seizures initially affect only one side of the brain but may subsequently spread to broader areas on 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 medicines to treat:
- partial-onset seizures with or without generalization in adults, adolescents, and children from 1 month of age,
- myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy,
- primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age and older with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic cause).

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

Do not take Levetiracetam TecniGen

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Levetiracetam TecniGen:

If you have kidney problems, follow your doctor's instructions. Your doctor will decide whether your dose needs to be adjusted.
If you notice any slowing in your child's growth or unexpected development of puberty, contact your doctor.
A small number of people taking antiepileptic medicines such as Levetiracetam TecniGen have had thoughts of harming themselves or of suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.

Children and adolescents

Treatment with Levetiracetam TecniGen alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last for 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 mood or behaviour.

Taking Levetiracetam TecniGen with other medicines

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

Do not take Macrogol (a laxative medicine) within one hour before or one hour after taking levetiracetam, as it may reduce its effectiveness.

Taking Levetiracetam TecniGen with food, drinks, and alcohol

You may take Levetiracetam TecniGen with or without food. As a safety 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 become pregnant, consult your doctor or pharmacist before using this medicine.

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 adverse effects on reproduction at doses higher than those required to control your seizures.

Breastfeeding is not recommended during treatment.

Driving and using machines

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

3. How to take Levetiracetam TecniGen

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

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

Take the number of tablets as directed by your doctor.

Monotherapy

Dosage in adults and adolescents (from 16 years of age):

General dose: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) daily.

When you first start taking Levetiracetam TecniGen, your doctor will prescribe a lower dose for the first 2 weeks before increasing to the lowest general dose.

Example: if your daily dose is 2,000 mg, you should take 2 tablets of 500 mg in the morning and 2 tablets of 500 mg in the evening.

Concomitant therapy

Dosage in adults and adolescents (from 12 to 17 years of age) weighing 50 kg or more:

General dose: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) daily.

Example: if your daily dose is 1,000 mg, you should take 1 tablet of 500 mg in the morning and 1 tablet of 500 mg in the evening.

Dosage in infants (from 1 month to 23 months), children (from 2 to 11 years), and adolescents (from 12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam TecniGen based on age, weight, and required dose.

The most suitable formulation for infants and children under 6 years of age is an oral solution, and for children and adolescents (from 6 to 17 years) weighing less than 50 kg, or when tablets do not allow for precise dose adjustment.

Method of administration:

Swallow Levetiracetam TecniGen tablets with a sufficient amount of liquid (e.g., a glass of water). You may take Levetiracetam with or without food.

Duration of treatment

Levetiracetam TecniGen is used as a chronic treatment. You must continue the treatment for the duration indicated by your doctor.
Do not stop treatment without consulting your doctor, as your seizures may increase.

If you take more Levetiracetam TecniGen than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

Possible adverse effects of an overdose of Levetiracetam TecniGen include somnolence, agitation, aggressiveness, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more Levetiracetam TecniGen than prescribed. Your doctor will determine the best 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 missed doses.

If you stop taking Levetiracetam TecniGen

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

If your doctor decides to stop treatment with Levetiracetam TecniGen, they will provide you with instructions for the gradual withdrawal of Levetiracetam TecniGen.

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

4. Possible adverse effects

Like all medicines, Levetiracetam TecniGen can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately or go to the nearest hospital emergency department if you experience:

weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction
swelling of the face, lips, tongue, or throat (angioedema)
flu-like symptoms and facial rash followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, 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 the legs, arms, or feet, as these may indicate sudden decline in kidney function
a skin rash that may blister and may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
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 serious mental changes or if someone around you notices 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 (drowsiness), headache, fatigue (feeling of weakness), and dizziness. These latter adverse effects may be more common when starting treatment or increasing the dose. However, these adverse effects should decrease over time.

Very common (affects more than 1 in 10 patients)

nasopharyngitis;
somnolence (drowsiness), headache.

Common (affects 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 unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
vertigo (sensation of spinning);
cough;
abdominal pain, diarrhea, dyspepsia (indigestion, heartburn, and acid reflux), vomiting, nausea;
skin rash;
asthenia/fatigue (feeling of weakness).

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

decreased platelet count, decreased white blood cell count;
weight loss, weight gain;
suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation;
amnesia (memory loss), memory impairment (memory problems), abnormal coordination/ataxia (impaired movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
diplopia (double vision), blurred vision;
elevated/abnormal results in liver function tests;
hair loss, eczema, itching;
muscle weakness, myalgia (muscle pain);
injury.
possible symptoms of rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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 serious allergic reaction), angioedema (swelling of face, lips, tongue, and throat));
decreased concentration of sodium in blood;
suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
uncontrollable 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 may lead to blisters appearing as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), 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);
sudden decline in kidney function.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam TecniGen

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 label or the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam TecniGen

The active substance is levetiracetam. Each tablet contains 500 mg of levetiracetam.
The other components are:
Tablet core: colloidal anhydrous silica, magnesium stearate, corn starch, povidone, talc.
Coating: Opadry 85F32004 (polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172)).

Appearance of the product and contents of the container

Levetiracetam TecniGen 500 mg tablets are yellow, oval-shaped, and film-coated.

The cardboard box contains 20, 30, or 60 film-coated tablets.

Only certain pack sizes may be marketed.