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
Please read all of this leaflet carefully before taking or giving the medicine to a child, as it contains important information for the patient.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:
1 What Vetira is and what it is used for
2 Important information before taking Vetira
3 How to take Vetira
4 Possible side effects
5 How to store Vetira
6 Contents of the pack and other information

1. WHAT VETIRA IS AND WHAT IT IS USED FOR
Vetira film-coated tablets is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Vetira is used:
as monotherapy (using Vetira alone) in the treatment of adults and adolescents aged 16 years and older with newly diagnosed epilepsy, for certain types of seizures. Epilepsy is a condition in which patients experience repeated seizures (convulsions). Levetiracetam is used to treat a type of epilepsy in which seizures start in one part of the brain and may then spread to larger areas of both brain hemispheres (secondarily generalized partial seizures or partial seizures without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures;
as an add-on medicine to another antiepileptic medicine:

• in adults, adolescents, children and infants aged 1 month and older for the treatment of partial seizures with or without secondary generalization;
• in adults and adolescents aged 12 years and older for the treatment of juvenile myoclonic epilepsy to control myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles);
• in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (a type of epilepsy likely to have a genetic basis) for the treatment of primary generalized tonic-clonic seizures (major seizures, including loss of consciousness).

2. IMPORTANT INFORMATION BEFORE TAKING VETIRA

When not to take Vetira

• if the patient is allergic to levetiracetam, pyrrolidone derivatives, or any of the ingredients
  of this medicine (listed in section 6).

Warnings and precautions
Before starting Vetira, discuss the following with your doctor:
If the patient has kidney disease, Vetira should be used according to the doctor’s recommendations. The doctor may decide to adjust the dosage.
If any growth retardation or unexpected early puberty in a child is observed, contact the doctor.
Some patients treated with antiepileptic medicines such as Vetira have experienced thoughts about self-harm or suicidal thoughts. If symptoms of depression and/or suicidal thoughts occur, contact the doctor immediately.
If the patient has a family history of, or has previously experienced, irregular heart rhythm (seen on electrocardiogram), or if the patient has a disease and/or is taking medicines that may predispose to irregular heart rhythm or electrolyte imbalance.
Inform your doctor or pharmacist if any of the following adverse effects worsen or persist for more than a few days:
Unusual thoughts, irritability, or more aggressive behaviour than usual, or if the patient or their family and friends notice significant changes in mood or behaviour.
Worsening of epilepsy
In rare cases, seizures may worsen or occur more frequently, especially during the first month of treatment or after an increase in dose. If any of these new symptoms occur while taking Vetira, contact your doctor as soon as possible.

Children and adolescents
Vetira is not indicated for use as monotherapy (Vetira alone) in children and adolescents under 16 years of age.

Vetira and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take macrogol (a medicine used for constipation) within one hour before or one hour after taking levetiracetam, as it may reduce the effectiveness of levetiracetam.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine. Levetiracetam may be used during pregnancy only if, after careful evaluation, the treating doctor considers it necessary.
Do not stop treatment without discussing it with your doctor.
The risk of congenital malformations in the unborn child cannot be completely ruled out. Breastfeeding is not recommended during treatment.

Driving and operating machinery
Vetira may impair the ability to drive or operate tools or machines, as it may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. Do not drive or operate machinery until you know how this medicine affects your ability to perform these activities.

Vetira 750 mg film-coated tablets contain aluminium lake of orange yellow FCF (E110).
The colouring agent aluminium lake of orange yellow FCF (E110) may cause allergic reactions.

3. HOW TO USE VETIRA

This medicine should always be used as directed by the physician or pharmacist. If in doubt,
consult the physician or pharmacist.
The number of tablets taken should be in accordance with the physician's instructions.
Vetira must be taken twice daily, in the morning and evening, approximately at the same
time each day.

Adjunctive therapy and monotherapy (from 16 years of age)
Adults (aged ≥18 years) and adolescents (12 to 17 years) with body weight of 50 kg or more:
The usual dose ranges from 1000 mg to 3000 mg per day.
If the patient is taking this medicine for the first time, the physician will usually prescribe a lower initial dose for the first 2 weeks, followed by the lowest commonly used dose.
For example, if the daily dose is 1000 mg, the lower initial dose would be 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening. The dose will then be gradually increased so that the daily dose of 1000 mg is reached after 2 weeks.

Adolescents (aged 12 to 17 years) with body weight of 50 kg or less:
The physician will prescribe the most appropriate pharmaceutical form of Vetira based on body weight and required dose.

Dosage in infants and children (aged 1 to 23 months), children (aged 2 to 11 years) with body weight below 50 kg:
The physician will recommend the most appropriate form of Vetira depending on age, body weight, and required dose.
Vetira 100 mg/ml oral solution is the more suitable formulation for infants and children under 6 years of age, as well as for children and adolescents (aged 6 to 17 years) with body weight below 50 kg, and when the correct dose cannot be administered in tablet form.

Administration method:
Tablets should be swallowed with sufficient fluid (e.g. a glass of water). Vetira may be taken with or without food. After oral administration, levetiracetam may leave a bitter taste in the mouth.

Duration of treatment:
Vetira is used for long-term treatment. Treatment with Vetira should be continued for as long as directed by the treating physician.
Do not discontinue treatment without consulting the treating physician, as this may lead to an increased frequency of seizures.

Use of a higher than recommended dose of Vetira
Possible adverse effects following overdose with Vetira include: drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma. If a higher than recommended dose has been taken, seek immediate medical advice from a physician or pharmacist. The physician will recommend the most appropriate treatment for overdose.

Missed dose of Vetira
If one or more doses have been missed, contact the treating physician.
Do not take a double dose to make up for a missed tablet.

Discontinuation of Vetira
If treatment with Vetira is to be discontinued, the medicine should be withdrawn gradually to avoid an increased frequency of epileptic seizures. If the physician decides to discontinue treatment, instructions on how to taper the dose gradually will be provided.

If in doubt about the use of this medicine, consult the physician or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like any medicine, Vetira can cause adverse reactions, although not everyone will experience them.
You should immediately inform a doctor or contact the nearest hospital emergency department (ED) if the patient experiences:

• weakness, dizziness, or difficulty breathing, as these symptoms may indicate a severe allergic reaction (anaphylaxis);
• swelling of the face, lips, tongue, and throat (angioedema, Quincke's edema);
• flu-like symptoms and rash on the face, followed by a rash spreading over the entire body, accompanied by high fever, increased liver enzyme activity detected in blood tests, elevated levels of certain white blood cells (eosinophilia), and enlarged lymph nodes (drug rash with eosinophilia and systemic symptoms – DRESS syndrome);
• symptoms such as reduced urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, ankles, or feet, as these may indicate sudden worsening of kidney function;
• skin rash that may lead to blistering and appear as small target-like lesions (a dark center surrounded by a lighter area and a dark ring around it) (erythema multiforme);
• extensive rash with blisters and peeling skin, mainly affecting areas around the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome);
• a more severe form of rash causing skin detachment from over 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental disturbances, or if the patient shows symptoms of disorientation, drowsiness, amnesia (memory loss), memory impairment (forgetfulness), behavioral changes, or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most commonly reported adverse reactions are: inflammation of the nasal and throat mucosa, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, adverse reactions such as drowsiness, fatigue, or dizziness may occur more frequently. These effects should diminish over time.

Very common: may affect more than 1 in 10 people

• inflammation of the nasal and throat mucosa;
• drowsiness, headache.

Common: may affect up to 1 in 10 people
loss of appetite;
depression, feelings of hostility or aggression, anxiety, insomnia, nervousness or irritability;
seizures, balance disorders, dizziness (feeling of unsteadiness), somnolence (lack of energy and motivation), tremors (involuntary shaking);
vertigo (spinning sensation);
cough;
abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
rash;
asthenia/fatigue (tiredness).

Uncommon: may affect up to 1 in 100 people
decreased platelet count, decreased white blood cell count;
weight loss, weight gain;
suicidal thoughts and suicide attempts, mental disorders, abnormal behavior, hallucinations, feeling of anger, disorientation, panic attacks, emotional lability/mood swings, agitation;
amnesia (memory loss), memory impairment (forgetfulness), ataxia (impaired coordination of movements), paresthesia (tingling sensations), difficulty concentrating;
double vision, blurred vision;
elevated/abnormal liver function test results;
hair loss, skin rash, itching;
muscle weakness, muscle pain;
injuries.

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

• infection;
• decreased number of all types of blood cells;
• severe hypersensitivity reactions (drug rash with eosinophilia and systemic symptoms – DRESS syndrome), angioedema (swelling of the face, lips, tongue, and throat);
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioral disturbances), thought disorders (slowed thinking, inability to concentrate);
• delirium;
• encephalopathy (detailed description of symptoms, see section "You should immediately inform a doctor");
• seizures may worsen or occur more frequently;
• involuntary muscle contractions of the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (excessive activity);
• change in heart rhythm (detected by electrocardiographic examination);
• pancreatitis;
• liver function disorders, hepatitis;
• sudden worsening of kidney function;
• skin rash that may lead to blistering and appear as small target-like lesions (a dark center surrounded by a lighter area and a dark ring around it) (erythema multiforme), extensive rash with blisters and peeling skin, mainly affecting areas around the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome), and a more severe form of rash causing skin detachment from over 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of striated muscles) and associated increase in creatine kinase activity in the blood. Occurrence is significantly more frequent in Japanese patients compared to other (non-Japanese) patients;
• limping or difficulty walking.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, you should inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl .
Reporting adverse reactions helps to gather more information on the safety of the medicine.
Adverse reactions can also be reported to the responsible entity.

5. HOW TO STORE VETIRA MEDICINE

Keep this medicine out of sight and reach of children.
Do not use Vetira after the expiry date stated on the carton and blister pack following:
Expiry date (EXP).
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Vetira contains
The active substance is levetiracetam.
Each Vetira 250 mg coated tablet contains 250 mg of levetiracetam.
Each Vetira 500 mg coated tablet contains 500 mg of levetiracetam.
Each Vetira 750 mg coated tablet contains 750 mg of levetiracetam.
Each Vetira 1000 mg coated tablet contains 1000 mg of levetiracetam.

The other ingredients are:
Tablet core:
Crosspovidone (type B)
Povidone K 30
Colloidal anhydrous silica
Magnesium stearate

Coating:
Vetira 250 mg coated tablets
Hypromellose
Macrogol 400
Titanium dioxide (E171)
Purified talc
Indigo carmine lake (E132)

Vetira 500 mg coated tablets
Hypromellose
Macrogol 400
Titanium dioxide (E171)
Purified talc
Iron oxide yellow (E172)

Vetira 750 mg coated tablets
Hypromellose
Macrogol 400
Titanium dioxide (E171)
Purified talc
Orange yellow S (E110)
Iron oxide red (E172)

Vetira 1000 mg coated tablets
Hypromellose
Macrogol 400
Titanium dioxide (E171)
Purified talc

What Vetira looks like and contents of the pack
Vetira 250 mg coated tablets: blue, oval, film-coated tablets with a score line on one side, measuring 12.9 x 6.1 mm, packed in PVC/PE/PVDC/Aluminium blisters, placed in cardboard boxes containing 20, 30, 50, 60, 100 and 200 film-coated tablets.

Vetira 500 mg coated tablets: yellow, oval, film-coated tablets with a score line on one side, measuring 16.5 x 7.7 mm, packed 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 coated tablets: orange, oval, film-coated tablets with a score line on one side, measuring 18.8 x 8.9 mm, packed 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 coated tablets: white, oval, film-coated tablets with a score line on one side, measuring 19.2 x 10.2 mm, packed 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.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Remedica Ltd
Limassol Industrial Estate,
P.O. Box 51706,
CY-3508 Limassol,
Cyprus

Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area,
Larisa, 41004,
Greece

PharOs MT Ltd.
HF 62X, Hal Far Industrial Estate,
Birzebbugia, BBG 3000, Malta

This medicinal product is authorised for marketing in the European Economic Area under the following names:
{Poland} {Vetira}