Vetira

Package leaflet: Information for the patient

Vetira, 100 mg/ml, oral solution
Levetiracetam
Please read this leaflet carefully before taking the medicine or giving it 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell 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, 100 mg/ml, oral solution, 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 epilepsy. Epilepsy is a condition in which patients have recurrent seizures (convulsions). Levetiracetam is used to treat a type of epilepsy in which seizures start in one part of the brain but 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 other antiepileptic medicines:

• in adults, adolescents, children, and infants from 1 month of age for the treatment of partial seizures with or without secondary generalization,
• in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy for the treatment of 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 with a probable 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
Do not take Vetira if you are allergic to levetiracetam, pyrrolidone derivatives, or to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting Vetira, discuss the following with your doctor:

• If you have kidney disease, Vetira should be used according to your doctor’s recommendations. Your doctor may decide to adjust the dosage. If you notice any growth retardation or unexpected early puberty in a child, contact your doctor. Some patients treated with antiepileptic medicines such as Vetira have had thoughts of self-harm or suicide. If you experience symptoms of depression and/or suicidal thoughts, contact your doctor. If you or a family member have a history of irregular heart rhythm (seen on electrocardiogram), or if you have a heart condition and/or are taking medicines that may predispose you to irregular heart rhythm or electrolyte imbalances.

Tell your doctor or pharmacist if any of the following side effects worsen or persist for more than a few days:
Unusual thoughts, irritability, or more aggressive reactions than usual, or if you or your family and friends notice significant changes in mood or behavior.

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 with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan 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 you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine. Levetiracetam may be used during pregnancy only if, after careful evaluation, your 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 affect your ability to drive or operate tools or machinery, as Vetira may cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose. Do not drive or operate machinery until you know how this medicine affects you.

Vetira contains liquid maltitol (E965).
If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Vetira contains methyl parahydroxybenzoate (E218).
Methyl parahydroxybenzoate may cause allergic reactions.

Vetira contains sodium.
Vetira 100 mg/ml, oral solution, contains less than 1 mmol (23 mg) of sodium per 15 ml, meaning the medicine is considered "sodium-free".

3. HOW TO USE VETIRA

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Vetira should be taken twice daily, in the morning and evening, approximately at the same time each day. The oral solution should be used according to the physician's instructions.

Monotherapy (from 16 years of age)
Adults and adolescents (from 16 years of age)
Measure the appropriate dose using the 10 ml syringe provided with the packaging intended for patients aged 4 years and older.
Typical dosage:
Vetira is administered twice daily in two equal doses; each dose ranges from 5 ml (500 mg) to 15 ml (1500 mg).
When a patient starts Vetira for the first time, the physician will usually recommend starting with a lower dose for 2 weeks, followed by the lowest commonly used maintenance dose.

Adjunctive therapy
Dosage in adults and adolescents (from 12 to 17 years of age) with body weight of 50 kg or more:
Measure the appropriate dose using the 10 ml syringe provided with the packaging intended for patients aged 4 years and older.
Typical dosage:
Vetira should be taken twice daily in two equal doses; each dose ranges from 5 ml (500 mg) to 15 ml (1500 mg).

Dosage in children from 6 months of age with body weight below 50 kg:
The physician will recommend the most appropriate formulation of Vetira based on the child's age, body weight, and required dose.

• For children from 6 months to 4 years of age, measure the appropriate dose using the 3 ml syringe provided with the packaging.
• For children above 4 years of age, measure the appropriate dose using the 10 ml syringe provided with the packaging.
  Typical dosage:
  Vetira is administered twice daily in two equal doses, each dose ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kilogram of the child's body weight. (See table below for examples of dosing.)

Dosage in children from 6 months of age

Dosage for infants (aged 1 month to less than 6 months):
For infants aged 1 month to less than 6 months, the appropriate dose should be measured using the 1 ml syringe provided with the package.
Typical dosage:
Vetira should be administered twice daily in two equal doses; each dose should be between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of infant body weight (see table below for dose examples).
Dosage for infants (aged 1 month to less than 6 months)

Method of administration:
After measuring the correct dose using the appropriate syringe, Vetira oral solution can be
diluted in a glass of water or in a baby feeding bottle. After oral administration,
levetiracetam may leave a bitter taste in the mouth.

Instructions for preparing the medicine for use:

• Open the bottle: press down on the cap and turn it counterclockwise (Figure 1).
• Insert the syringe adapter into the neck of the bottle (Figure 2). Ensure it is securely attached.
• Insert the dosing syringe into the opening of the adapter. Turn the bottle upside down (Figure 3).
• Draw a small amount of solution into the syringe by pulling the plunger down (Figure 4a). Then, by pushing the plunger, remove any air bubbles from the syringe (Figure 4b), and pull the plunger down to the mark corresponding to the dose prescribed by the doctor in millilitres (ml) (Figure 4c).
• Turn the bottle upright. Remove the syringe from the adapter.
• Empty the syringe contents into a glass of water or a baby feeding bottle by pressing the syringe plunger (Figure 5).
• Drink the entire contents of the glass or feeding bottle.
• Close the bottle with the plastic cap.
• Rinse the syringe with water (Figure 6).

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

Use of a higher than recommended dose of Vetira
Possible adverse effects following an overdose of Vetira include: drowsiness, agitation, aggression, reduced alertness, respiratory depression, and coma. In case of ingestion of a higher than recommended dose, seek immediate medical advice from a doctor or pharmacist. The doctor will advise on the best possible treatment for overdose.

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

Discontinuation of Vetira
If treatment with Vetira needs to be discontinued, the medicine should be tapered off gradually to avoid an increased frequency of epileptic seizures. If the physician decides to discontinue treatment, they will also advise on how to taper the medicine gradually.

If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, 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 breathing difficulties, as these symptoms may indicate a severe allergic reaction (anaphylaxis);
• swelling of the face, lips, tongue, and throat (angioedema);
• 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 observed in blood tests, an increase in 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, which may indicate sudden worsening of kidney function;
• skin rash that may lead to blister formation and appear as 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 affecting more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental disturbances, or if the patient shows signs of disorientation, drowsiness, memory loss (amnesia), memory impairment (forgetfulness), behavioral disturbances, 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 mucous membranes of the nose and throat, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or after an increase in dose, 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 mucous membranes of the nose and throat;
• 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 (sensation of swaying), lethargy (lack of energy and motivation), tremors (involuntary shaking);
dizziness (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, feelings of anger, disorientation, panic attacks, emotional instability/mood swings, agitation;
amnesia (memory loss), memory impairment (forgetfulness), ataxia (impaired coordination of movement), paresthesia (tingling), difficulty concentrating;
double vision, blurred vision;
elevated/abnormal liver function test results;
hair loss, skin eruption, itching;
muscle weakness, muscle pain;
injuries.
Rare: may affect up to 1 in 1,000 people
infection;
decreased count 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 (slow thinking, inability to concentrate);
delirium;
encephalopathy (for 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);
changes in heart rhythm (electrocardiographic findings);
pancreatitis;
liver function disorders, hepatitis;
sudden worsening of kidney function;
skin rash that may cause 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 affecting more than 30% of the body surface (toxic epidermal necrolysis);
rhabdomyolysis (breakdown of skeletal muscle) and associated increase in creatine phosphokinase activity in the blood. Occurrence is significantly more frequent in Japanese patients compared to other (non-Japanese) patients;
clumsiness or difficulty walking.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, 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 provide more information on the safety of this medicine.
Adverse reactions can also be reported to the responsible entity.

5. HOW TO STORE VETIRA

Keep this medicine out of sight and reach of children.
Do not use Vetira after the expiry date stated on the carton and bottle:
Expiry date (EXP). The expiry date refers to the last day of the specified month.
Do not use more than 4 months after first opening the bottle.
Store in the original bottle to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. PACKAGING QUANTITY AND OTHER INFORMATION

What Vetira contains
The active substance is levetiracetam. Each 1 ml of solution contains 100 mg of levetiracetam.
The other ingredients are: sodium citrate (for pH adjustment), anhydrous citric acid (for pH adjustment), methyl 4-hydroxybenzoate (E218), glycerol (E422), potassium acesulfame (E950), maltitol liquid (E965), raspberry flavour, purified water.

What Vetira looks like and contents of the pack
Vetira 100 mg/ml oral solution is a colourless liquid.

A glass bottle containing 300 ml of Vetira 100 mg/ml oral solution (for children from 4 years of age, adolescents and adults) is placed in a cardboard box containing a 10 ml dosing syringe (graduated in 0.25 ml increments) and a syringe adapter.

A glass bottle containing 150 ml of Vetira 100 mg/ml oral solution (for infants and children from 6 months up to 4 years of age) is placed in a cardboard box containing a 3 ml dosing syringe (graduated in 0.1 ml increments) and a syringe adapter.

A glass bottle containing 150 ml of Vetira 100 mg/ml oral solution (for infants from 1 month up to below 6 months of age) is placed in a cardboard box containing a 1 ml dosing syringe (graduated in 0.05 ml increments) and a syringe adapter.

Graphical differentiation is indicated on outer packaging and labels to avoid confusion when measuring Vetira depending on the age group.

A different dosing syringe (1 ml, 3 ml, or 10 ml) is provided for each age group; therefore, particular attention must be paid when administering Vetira to a specific age group.

After use of Vetira and when the bottle is empty, the dosing syringe supplied with the package should be discarded and not kept, as each package contains a different dosing syringe.

Not all pack sizes may be marketed.

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

Manufacturer
Remedica Ltd
Aharnon Street
Limassol Industrial Estate,
3056 Limassol
Cyprus

Galenica Pharmaceutical Industry S.A.
3rd Km Old National Road Chalkida Athens
Chalcis, 341 00
Greece

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

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