Levetiracetam Tecnigen 1000 mg film-coated tablets EFG: detailed information

Brand name Levetiracetam Tecnigen 1000 mg film-coated tablets EFG

Form tablets, film-coated

Active substance / Dosage

LEVETIRACETAM · 1000 mg

Prescription type Prescription Only Medicine

ATC code

N03A N03AX N03AX14

Registration number 75784

Manufacturer Tecnimede Espana Industria Farmaceutica S.A.

Levetiracetam Tecnigen 1000 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 1000 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, consult 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.

Leaflet contents:

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 aged 16 years 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 then 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 secondary generalization in adults, adolescents, and children from 1 month of age,
- myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy,
- primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (a type of epilepsy thought 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 symptoms of depression and/or suicidal thoughts, contact your doctor.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last longer than a few days:

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

Children and adolescents

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

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 precaution, do not take Levetiracetam TecniGen with alcohol.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might 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 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 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 dosing instructions for this medicine as given by your doctor. If in doubt, 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):

Usual dose: between 1,000 mg and 3,000 mg 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 usual dose.

Example: if your daily dose is 2,000 mg, you should take 1 tablet of 1000 mg in the morning and 1 tablet of 1000 mg at night.

Concomitant therapy

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

Usual dose: between 1,000 mg and 3,000 mg daily.

Example: if your daily dose is 2,000 mg, you should take 1 tablet of 1000 mg in the morning and 1 tablet of 1000 mg at night.

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 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, especially when tablets do not allow for more precise dose adjustment.

Method of administration:

Swallow Levetiracetam TecniGen tablets with sufficient liquid (for example, a glass of water). Levetiracetam may be taken with or without food.

Duration of treatment

Levetiracetam TecniGen is used as a chronic treatment. You should continue treatment with Levetiracetam TecniGen 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 drowsiness, agitation, aggression, 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 forgotten 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 your treatment with Levetiracetam TecniGen, they will provide you with instructions for gradually tapering off the medication.

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

4. Possible adverse effects

Like all medicines, Levetiracetam TecniGen can cause adverse effects, although not everyone will experience 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 serious 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 legs, arms, or feet, as these may indicate sudden decrease 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)
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 skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis)
signs of serious 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 (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 (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
vertigo (sensation of spinning);
cough;
abdominal pain, diarrhea, dyspepsia (indigestion, burning sensation and acid reflux), vomiting, nausea;
skin rash;
asthenia/fatigue (feeling of weakness).

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

decrease in platelet count, decrease in white blood cells;
weight loss, weight gain;
suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, 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;
serious allergic reactions (DRESS, anaphylactic reaction (severe and serious allergic reaction), angioedema (swelling of face, lips, tongue, and throat));
decrease in blood sodium concentration;
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), 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 skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis);
sudden decrease in kidney function.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the label or the outer packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 1000 mg of levetiracetam.
The other components are:
Tablet core: colloidal anhydrous silica, magnesium stearate, corn starch, povidone, talc.
Coating: Opadry II 85F18422 white (polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc).

Nature of the product and pack sizes

Levetiracetam TecniGen 1000 mg tablets are white, oval-shaped, film-coated tablets.

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

Only certain pack sizes may be marketed.