Vetira

Package Leaflet: Information for the Patient

Vetira, 250 mg, Film-Coated Tablets

Vetira, 500 mg, Film-Coated Tablets

Vetira, 750 mg, Film-Coated Tablets

Vetira, 1000 mg, Film-Coated Tablets

Levetiracetam

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:
1
What is Vetira and what is it used for
2
Before you take Vetira
3
How to take Vetira
4
Possible side effects
5
How to store Vetira
6
Contents of the pack and other information
l.

WHAT IS VETIRA AND WHAT IS IT USED FOR

Vetira film-coated tablets is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Vetira is used:
as monotherapy (Vetira used alone) in adults and adolescents from 16 years of age with newly diagnosed epilepsy, for the treatment of certain types of epilepsy. Epilepsy is a condition where patients have repeated seizures (fits). Levetiracetam is used for the treatment of a type of epilepsy where seizures first start in one part of the brain and then spread to other parts of the brain (partial onset seizures with or without secondary generalisation). The doctor has prescribed levetiracetam to reduce the number of seizures;
as an additional treatment in combination with other antiepileptic medicines:

• in adults, adolescents, children and infants from 1 month of age with partial onset seizures with or without secondary generalisation;
• in adults and adolescents from 12 years of age with idiopathic generalized epilepsy for the treatment of myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles),
• in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy that is thought to have a genetic basis) for the treatment of primary generalised tonic-clonic seizures (major fits, with loss of consciousness).

2. BEFORE YOU TAKE VETIRA

Do not take Vetira

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

Warnings and precautions

Before taking Vetira, talk to your doctor:
If kidney problems have been diagnosed, Vetira should be used with caution and under the guidance of your doctor. Your doctor may need to adjust the dose;
If you notice any slowing of growth or unexpected pubertal delay in your child, contact your doctor;
Some patients with epilepsy treated with antiepileptic medicines such as Vetira have thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor;
If you or your family/carer notice any change in your behaviour or mood, contact your doctor immediately. You may experience changes such as becoming aggressive, agitated, irritable, hostile, anxious, depressed, or restless;
If you experience any of the following, contact your doctor immediately: severe skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome), anaphylaxis, serious blood disorders, serious liver disorders, and serious allergic reactions;

Children and adolescents

Vetira should not be used in children and adolescents below 16 years of age for monotherapy (use of Vetira alone).

Vetira with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Pregnancy and breastfeeding

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

Driving and using machines

Vetira may cause drowsiness, which may be enhanced by alcohol. Therefore, you should not drive or use machines until it is established that your ability to perform such activities is not affected.

3. HOW TO TAKE VETIRA

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Treatment with Vetira and monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:

Usual dose: 1000 mg to 3000 mg per day.
When you first start taking Vetira, your doctor will prescribe a lower dose during the first two weeks, which will then be gradually increased.

Adolescents (12 to 17 years) weighing less than 50 kg:

Your doctor will determine the most appropriate formulation of Vetira based on your weight and dose.

Dose in infants and children (1 to 23 months), children (2 to 11 years) weighing less than 50 kg:

Your doctor will determine the most appropriate formulation of Vetira based on your age, weight, and dose.

Method of administration:

Swallow the tablets with a sufficient amount of liquid (e.g., a glass of water). Vetira can be taken with or without food.

Duration of treatment:

Vetira is used for long-term treatment. Continue to take Vetira for as long as your doctor has told you.

What to do if you take more Vetira than you should:

Adverse reactions after an overdose are similar to those seen at therapeutic doses, but may be more severe. If you have taken more tablets than you should, contact your doctor or go to the nearest hospital immediately.

What to do if you forget to take a dose of Vetira:

Speak to your doctor or pharmacist if you have missed one or more doses.

What to do if you stop taking Vetira:

Do not stop taking Vetira without first discussing this with your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine and seek immediate medical attention if you experience any of the following:

• 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);
• symptoms of a flu-like illness and a rash on the face, then spreading to other parts of the body, with a high temperature, increased levels of liver enzymes seen in blood tests, increased numbers of certain white blood cells (eosinophilia), and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms - DRESS);
• symptoms such as decreased urine output, tiredness, nausea, vomiting, confusion, and swelling of the feet, ankles, or hands, as these may be signs of kidney failure;
• a rash on the skin, which may form blisters and looks like the skin around the blister has been scratched (erythema multiforme);
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
• a more severe form of rash, causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes, or if you notice any changes in your mood or behaviour, such as becoming aggressive, agitated, irritable, hostile, anxious, depressed, or restless;

The most common side effects are: nasal congestion, somnolence, headache, fatigue, and dizziness. At the beginning of treatment or after an increase in dose, side effects like somnolence, fatigue, or dizziness may be more common. These effects should decrease over time.

Very common:may affect more than 1 in 10 people

• nasal congestion;
• fatigue;

Common:may affect up to 1 in 10 people

loss of appetite (decreased appetite);
depression, feeling hostile or aggressive, anxiety, insomnia, nervousness, or irritability;
seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
dizziness (feeling of spinning);
cough;
abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
rash;
asthenia (fatigue).

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.

5. HOW TO STORE VETIRA

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 blister after EXP.

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

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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vetira contains

The active substance is levetiracetam.

What Vetira looks like and contents of the pack

Vetira 250 mg film-coated tablets: blue, oval, biconvex, scored film-coated tablets, 12.9 x 6.1 mm in size, packaged in PVC/PE/PVDC/Aluminium blisters, placed in cardboard boxes, containing 20, 30, 50, 60, 100, and 200 film-coated tablets.

Vetira 500 mg film-coated tablets: yellow, oval, biconvex, scored film-coated tablets, 16.5 x 7.7 mm in size, packaged in PVC/PE/PVDC/Aluminium blisters, placed in cardboard boxes, containing 10, 20, 30, 50, 60, 100, 120, and 200 film-coated tablets.

Vetira 750 mg film-coated tablets: orange, oval, biconvex, scored film-coated tablets, 18.8 x 8.9 mm in size, packaged in PVC/PE/PVDC/Aluminium blisters, placed in cardboard boxes, containing 20, 30, 50, 60, 80, 100, and 200 film-coated tablets.

Vetira 1000 mg film-coated tablets: white, oval, biconvex, scored film-coated tablets, 19.2 x 10.2 mm in size, packaged in PVC/PE/PVDC/Aluminium blisters, placed in cardboard boxes, containing 10, 20, 30, 50, 60, 100, and 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Adamed Pharma S.A.

Manufacturer

Adamed Pharma S.A.

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

{Poland}
{Vetira}

Date of revision of the leaflet:08.2022