Pterocin

PATIENT INFORMATION LEAFLET: USER INFORMATION

Pterocyn, 250 mg, coated tablets

Pterocyn, 500 mg, coated tablets

Pterocyn, 750 mg, coated tablets

Pterocyn, 1000 mg, coated tablets

Levetiracetam

You should read the leaflet carefully before taking the medicine.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If any of the side effects get worse, or if you notice any not listed in the leaflet, you should tell your doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is Pterocyn and what is it used for
• 2. Important information before taking Pterocyn
• 3. How to take Pterocyn
• 4. Possible side effects
• 5. How to store Pterocyn
• 6. Other information

1. WHAT IS PTEROCYN AND WHAT IS IT USED FOR

Pterocyn is an antiepileptic medicine (used to treat seizures in epilepsy).
Pterocyn is used:

• as the only medicine in patients from 16 years of age with newly diagnosed epilepsy, to treat partial seizures with or without secondary generalization.
• in patients who are already taking another antiepileptic medicine to treat:
• partial seizures with or without secondary generalization in patients from 1 month of age,
• myoclonic seizures in patients from 12 years of age with juvenile myoclonic epilepsy,
• primary generalized tonic-clonic seizures in patients from 12 years of age with idiopathic generalized epilepsy.

2. IMPORTANT INFORMATION BEFORE TAKING PTEROCYN

When not to take Pterocyn

• If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of the medicine

When to be cautious when taking Pterocyn

• If you have kidney disease, you should strictly follow your doctor's instructions, who may decide to adjust the dose.
• If you notice any slowing of growth or unexpected premature puberty in your child, you should contact your doctor.
• If you experience an increase in seizure frequency (e.g., an increase in the number of seizures), you should contact your doctor.
• In a small number of patients treated with antiepileptic medicines, such as Pterocyn, thoughts of self-harm or suicidal thoughts have occurred. If you experience symptoms of depression and/or suicidal thoughts, you should contact your doctor.

Taking other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those that are available without a prescription.

Taking Pterocyn with food and drink

Pterocyn can be taken with or without food.
For safety reasons, you should not take Pterocyn with alcohol.

Pregnancy and breastfeeding

Before taking any medicine, you should consult your doctor or pharmacist.
During pregnancy or if you suspect you are pregnant, you should consult your doctor before taking the medicine. Pterocyn should not be taken during pregnancy unless it is absolutely necessary. The risk to the fetus is not known. In animal studies, levetiracetam has shown an adverse effect on reproductive toxicity at doses higher than those used to control seizures.
During treatment, breastfeeding is not recommended.

Driving and using machines

Pterocyn may affect your ability to drive or operate any tools or machines, 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 operate machines until you know how the medicine affects you.

Important information about some ingredients of Pterocyn

Pterocyn 750 mg coated tablets contain the dye orange yellow FCF (E110), which may cause allergic reactions.

3. HOW TO TAKE PTEROCYN

You should always take Pterocyn exactly as your doctor has told you.
If you are unsure, you should consult your doctor or pharmacist.
The medicine should be taken twice a day, in the morning and evening, at about the same time each day.
You should take the number of tablets as instructed by your doctor.
Monotherapy

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

Usual dose: between 1000 mg and 3000 mg per day.
If you are taking Pterocyn for the first time, your doctor will usually prescribe a lower dose for the first two weeks, and then the usual dose.
Example: if the daily dose is 2000 mg, you should take one 1000 mg tablet in the morning and one 1000 mg tablet in the evening.
Adjunctive therapy

Dose in adults and adolescents (from 12 to 17 years of age) with a body weight of 50 kg or more:

Usual dose: between 1000 mg and 3000 mg per day.
Example: if the daily dose is 2000 mg, you should take one 1000 mg tablet in the morning and one 1000 mg tablet in the evening.

Dose in infants (from 6 to 23 months), children (from 2 to 11 years of age), and adolescents (from 12 to 17 years of age) with a body weight below 50 kg:

Your doctor will prescribe the most suitable form of Pterocyn, depending on age, body weight, and dose.
For infants and children under 6 years of age, the most suitable form of the medicine is the oral solution.
Usual dose: from 20 mg/kg body weight to 60 mg/kg body weight per day.
Example: if the dose is 20 mg/kg body weight per day, for a child weighing 25 kg, you should give 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening.

Dose in infants (from 1 to less than 6 months of age):

For infants, the most suitable form of the medicine is the oral solution.

Method of administration:

Tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water).

Duration of treatment:

• Pterocyn is used for long-term treatment. You should continue treatment for as long as your doctor tells you.
• You should not stop treatment without consulting your doctor, as this may cause an increase in seizure frequency. If your doctor decides to stop treatment, they will provide information on how to gradually discontinue the medicine.

Taking a higher dose of Pterocyn than recommended

Possible side effects after overdose of Pterocyn include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
If you have taken a higher dose of the medicine than recommended, you should immediately consult your doctor.
Your doctor will recommend the best possible treatment for overdose.

Missing a dose of Pterocyn

You should consult your doctor if you have missed one or more doses of the medicine.
You should not take a double dose to make up for a missed dose.

Stopping treatment with Pterocyn

If treatment with Pterocyn is to be stopped, the medicine should be discontinued gradually, as with other antiepileptic medicines, to avoid an increase in seizure frequency.
If you have any further questions about taking the medicine, you should consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Pterocyn can cause side effects, although not everybody gets them.
If any of the side effects get worse, or if you notice any not listed in the leaflet, you should tell your doctor or pharmacist.
Some of these side effects, such as drowsiness, fatigue, or dizziness, are more common at the beginning of treatment or when the dose is increased. These effects should decrease over time.
Side effects can be defined according to the following categories:
Very common (affects more than 1 in 10 people)
Common (affects 1 to 10 in 100 people)
Uncommon (affects 1 to 10 in 1000 people)
Rare (affects 1 to 10 in 10,000 people)
Very rare (affects less than 1 in 10,000 people)
Frequency not known (frequency cannot be estimated from the available data)

Very common

• Nasopharyngitis
• Somnolence, headache

Common

• Anorexia (loss of appetite)
• Depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
• Seizures, balance disorders (feeling of instability), dizziness, somnolence, involuntary tremor
• Dizziness (feeling of spinning)
• Cough
• Abdominal pain, diarrhea, nausea, vomiting, nausea
• Rash
• Asthenia (fatigue, exhaustion)

Uncommon

• Decreased platelet count, decreased white blood cell count
• Weight decrease, weight increase
• Suicidal attempts and suicidal thoughts, mental disorders, abnormal behavior, hallucinations, confusion, emotional instability/mood changes, agitation
• Amnesia (memory loss), memory impairment (forgetfulness), ataxia (coordination disorders), paresthesia (tingling), attention disorders (lack of concentration)
• Double vision, vision disorders
• Abnormal liver function tests
• Hair loss, rash, pruritus
• Muscle weakness, myalgia (muscle pain)
• Injuries

Rare

• Infection
• Decreased red and/or white blood cell count
• Suicide, personality disorders (behavioral disorders), thinking disorders (slow thinking, inability to concentrate)
• Involuntary muscle contractions of the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
• Pancreatitis
• Liver failure, hepatitis
• Blisters on the skin, mouth, eyelids, and genital areas, skin eruptions.

If you experience any side effects, including any possible side effects not listed in the leaflet, you should consult your doctor or pharmacist.

5. HOW TO STORE PTEROCYN

Keep out of the reach and sight of children.
Do not take Pterocyn after the expiry date stated on the carton/bottle/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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. OTHER INFORMATION

What Pterocyn contains

The active substance is levetiracetam 250, 500, 750, 1000mg.
The medicine also contains:
Core:
Crospovidone (type B), povidone K 30, colloidal anhydrous silica, magnesium stearate.
Pterocyn 250 mg coated tablets, coating:
Hypromellose, macrogol 400, titanium dioxide (E 171), talc, indigo carmine, lake (E 132)
Pterocyn 500 mg coated tablets, coating:
Hypromellose, macrogol 400, titanium dioxide (E 171), talc, yellow iron oxide (E 172)
Pterocyn 750 mg coated tablets, coating:
Hypromellose, macrogol 400, titanium dioxide (E 171), talc, orange yellow FCF, lake (E 110),
red iron oxide (E 172)
Pterocyn 1000 mg coated tablets, coating:
Hypromellose, macrogol 400, titanium dioxide (E 171), talc

What Pterocyn looks like and what the pack contains

Pterocyn 250 mg coated tablets are blue, elongated with a dividing line on one side, measuring 12.9 x 6.1 mm, packaged in PVC/PE/PVDC/Aluminum blisters and cartons.
The pack contains: 10, 20, 30, 50, 60, 80, 120, and 200 coated tablets.
Pterocyn 500 mg coated tablets are yellow, elongated with a dividing line on one side, measuring 16.5 x 7.7 mm, packaged in PVC/PE/PVDC/Aluminum blisters and cartons.
The pack contains: 10, 20, 30, 50, 60, 80, 120, and 200 coated tablets.
Pterocyn 750 mg coated tablets are orange, elongated with a dividing line on one side, measuring 18.8 x 8.9 mm, packaged in PVC/PE/PVDC/Aluminum blisters and cartons.
The pack contains: 10, 20, 30, 50, 60, 80, 120, and 200 coated tablets.
Pterocyn 1000 mg coated tablets are white, elongated with a dividing line on one side, measuring 19.2 x 10.2 mm, packaged in PVC/PE/PVDC/Aluminum blisters and cartons.
The pack contains: 10, 20, 30, 50, 60, 80, 120, and 200 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder, manufacturer

SVUS Pharma a.s., Smetanovo nábřeží 1238/20a, 500 02 Hradec Králové, Czech Republic

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

Portugal: PTEROCYN 250, 500, 750, 1000 mg
Poland: PTEROCYN
Czech Republic: PTEROCYN 250, 500, 750, 1000 mg film-coated tablets
Slovakia: PTEROCYN 250, 500, 750, 1000 mg film-coated tablets

Date of last revision of the leaflet: