Petinimid

Leaflet included in the packaging: patient information

Petinimid, 250 mg, capsules

Ethosuximide

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including those not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Petinimid and what is it used for
• 2. Important information before taking Petinimid
• 3. How to take Petinimid
• 4. Possible undesirable effects
• 5. How to store Petinimid
• 6. Contents of the packaging and other information

1. What is Petinimid and what is it used for

Ethosuximide, the active substance of Petinimid, is used in the treatment of primary generalized epilepsy with typical and atypical absence seizures. If the patient suffers from mixed types of epileptic seizures, the doctor may prescribe Petinimid together with another antiepileptic medicine.

2. Important information before taking Petinimid

When not to take Petinimid:

• In case of allergy to ethosuximide or other substances from the same group (succinimides) and to any of the excipients of this medicine listed in section 6.

Warnings and precautions:

Before starting to take Petinimid, the patient should discuss it with their doctor or pharmacist. In particular, the patient should inform their doctor if:

• they have kidney or liver function disorders, or if they suffer from porphyria (a rare metabolic disease)
• they suffer from a mental illness or have suffered from it in the past, as taking Petinimid may lead to undesirable effects such as irritability, excitement, anxiety, drowsiness, aggression, concentration difficulties, or other mental changes
• they observe symptoms similar to those of a cold (e.g., sore throat, fever), they should immediately consult their doctor. This may be a sign of serious, potentially life-threatening blood disorders - the doctor will recommend immediate blood tests
• there are changes in the blood count (early symptoms, see section "Undesirable effects"), they should immediately consult their doctor. The doctor may switch to a different active substance
• they plan to become pregnant, are pregnant, or suspect they may be pregnant while taking Petinimid, they should immediately consult their doctor (see also section "Pregnancy, breastfeeding, and fertility")

During treatment with Petinimid, severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred. If the patient notices the occurrence of any of the symptoms described in section 4, they should stop taking Petinimid and seek medical help immediately. The doctor may change the treatment to a different active substance. Petinimid, when used as monotherapy, is not effective in tonic-clonic seizures and may even increase their frequency. It may be necessary to add another antiepileptic medicine. Therefore, it is crucial to follow the doctor's recommendations carefully. During the treatment, the doctor will recommend regular blood, urine, and liver function tests. It is essential to ensure that all clinical and laboratory tests have been performed according to the recommendations. Antiepileptic treatment is usually long-term and often lasts for several years. The doctor will decide on the appropriate dosage, changes in dosage, duration of treatment, and the proper time and method of ending the treatment. As with all antiepileptic medicines, Petinimid should be taken regularly. Any changes in dosage or addition of another medicine should be made gradually, never abruptly. The doctor will inform the patient about the procedure.

Petinimid and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as those they plan to take. Medicines and other substances can interact with each other. This also applies to other antiepileptic medicines used together with Petinimid. In case of mixed seizures, it may be necessary to use an additional antiepileptic medicine. The doctor will carefully monitor the treatment and may recommend regular laboratory tests for certain combinations of medicines. Valproic acid or sodium valproate may enhance or weaken the effect of Petinimid. Carbamazepine may weaken the effect of Petinimid. Taking Petinimid may enhance the effect of phenytoin. The patient should avoid taking sedatives or tranquilizers while taking Petinimid, as this may enhance the sedative effects. For the same reason, the patient should not consume alcohol while taking Petinimid. Petinimid may reduce the effectiveness of hormonal contraception (pill, patches). Therefore, the patient should use other contraceptive methods.

Taking Petinimid with food, drink, and alcohol

Petinimid should be taken during a meal. During treatment with Petinimid, the patient should not consume alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. During pregnancy and breastfeeding, Petinimid may only be used on the explicit recommendation of a doctor. PregnancyIf the patient has taken Petinimid before becoming pregnant, they should not stop the treatment without consulting their doctor, as sudden withdrawal of the medicine may pose a risk to the patient and the child. After careful consideration of the risk, the doctor may recommend continued use of Petinimid during pregnancy, as epileptic seizures may pose a significant risk to the child and the mother. On the other hand, if the mother takes an antiepileptic medicine during pregnancy, especially if she is taking a combination of several antiepileptic medicines, the risk of congenital malformations in the child increases. In this regard, the doctor will carefully select the dosage (the smallest possible) and recommend appropriate tests, and if necessary, recommend taking folic acid and vitamin K to minimize the risk. BreastfeedingPetinimid passes into breast milk and into the child's body. The doctor will decide whether the patient can take Petinimid during breastfeeding.

Driving and operating machines

Petinimid may impair the ability to drive a car and operate machines. At the beginning of treatment, the patient should refrain from driving vehicles, operating machines, and engaging in other activities that may pose a risk. Depending on the response to treatment, the doctor will decide whether the patient can drive a car and operate machines.

The medicine contains sodium, sodium ethyl parahydroxybenzoate, and sodium propyl parahydroxybenzoate.

The medicine may cause allergic reactions (possible allergic reactions). The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Petinimid

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. The dosage is individual and depends on the individual response to treatment. Treatment is started with a low dose, which is then gradually and slowly increased over several weeks. The dosage schedule provided below should be treated as a general recommendation; the dosage for each patient will be determined individually by the doctor. After the initial treatment phase, the doctor will determine the appropriate dosage and duration of long-term treatment. If the patient has severe kidney function disorders, the doctor may recommend a lower dose. Dialyzed patients require an additional dose after each dialysis or a change in the dosage schedule. The patient should be particularly cautious if they have severe liver function disorders; a dose reduction may be necessary.

Administration in children

Other forms of the medicine, e.g., syrup, containing the same active substance, may be more suitable for children over 3 years old. Petinimid should not be used in children under 3 years old due to insufficient evidence in this age group.

Method of administration and duration of treatment

The recommended daily dose is usually divided into two doses throughout the day. The capsules should be swallowed whole, washed down with a sufficient amount of liquid, during a meal. The treatment of epilepsy is usually long-term and often lasts for several years. The doctor will decide on the appropriate dosage, changes in dosage, duration of treatment, and the proper time and method of ending the treatment. As with all antiepileptic medicines, Petinimid should be taken regularly. Any changes in dosage or addition of another medicine should be made gradually, never abruptly. The doctor will inform the patient about the procedure.

Overdose of Petinimid

Overdose of Petinimid is characterized by the following: increased drowsiness, lethargy, mood changes or excitement, sometimes irritability. Additionally, nausea, vomiting, and central nervous system disorders (sometimes leading to dizziness and shallow breathing or respiratory depression) may occur. In such a case, immediate medical help is necessary.

Missing a dose of Petinimid

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.

Stopping treatment with Petinimid

The patient should not stop taking Petinimid without consulting their doctor, even if they have not had seizures for a long time. Stopping the medicine may lead to a recurrence of seizures. Any changes in dosage, addition or withdrawal of another medicine, and especially the end of treatment, should be made gradually over several weeks and always under the doctor's supervision. If the patient has any other questions or doubts related to the use of this medicine, they should consult their doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, Petinimid can cause undesirable effects, although not everybody gets them.

Severe undesirable effects

The patient should stop taking Petinimid and seek medical help immediately if they notice the occurrence of any of the following symptoms:

• red patches on the torso, which are round or target-shaped, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of these severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);

a widespread rash, high body temperature, and swollen lymph nodes [drug reaction with eosinophilia and systemic symptoms (DRESS)].

• a widespread rash, high body temperature, and swollen lymph nodes [drug reaction with eosinophilia and systemic symptoms (DRESS)].

Uncommon (may occur in up to 1 in 100 patients):

• drowsiness, headache, dizziness, excessive activity, euphoria, irritability, movement or gait disturbances, drowsiness or sleep disturbances.

Frequency not known (cannot be estimated from the available data):

• blood changes (easier bruising or bleeding, fever, sore throat, mouth ulcers, fatigue, recurring infections or infections that do not heal) (The patient should seek medical help if they notice any of these symptoms. The doctor may regularly take blood samples to perform tests to detect such symptoms).
• allergic reactions, hives, and other skin reactions, including rash, and anaphylactic shock.
• with high doses, decreased appetite and weight loss.
• irritability, excitement, anxiety, restlessness, aggression, concentration difficulties, or other mental changes (especially in patients who have experienced similar changes in the past).
• increased sexual desire, paranoid psychosis, and worsening of depression with possible suicidal behavior.
• symptoms similar to Parkinson's disease and increased sensitivity to light.
• short-sightedness.
• with high doses or in patients with sensitive stomachs, the following symptoms may occur: stomach or abdominal pain, nausea, vomiting, hiccups, cramps, and diarrhea, swelling of the tongue and palate. These symptoms are usually temporary, rarely severe, and usually do not require discontinuation of treatment.
• changes in liver enzyme activity, porphyria (a rare metabolic disease that can lead to liver damage in severe cases).
• skin discoloration, scleroderma (skin thickening), excessive hair growth on the face or body.
• kidney function disorders.
• vaginal bleeding.
• changes in blood count, liver and kidney function disorders.

Reporting undesirable effects

If the patient experiences any undesirable effects, including those not mentioned in the leaflet, they should inform their doctor or pharmacist. Undesirable effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Undesirable effects can also be reported to the marketing authorization holder. By reporting undesirable effects, more information can be collected on the safety of the medicine.

5. How to store Petinimid

Store in a place out of sight and reach of children. Do not store above 25°C. Store in the original packaging to protect from light. Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Petinimid contains

The active substance of Petinimid is ethosuximide. One capsule contains 250 mg of ethosuximide. The other ingredients are: capsule shell: macrogol 400, shell composition: gelatin, glycerol 85%, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, titanium dioxide (E 171), yellow iron oxide (E 172), ethyl vanillin.

What Petinimid looks like and contents of the packaging

Petinimid is a long, soft gelatin capsule, ivory-colored. Petinimid is available in blisters of PVC/PVDC/Aluminum foil, 10 capsules per blister, in a cardboard box. Packaging sizes: 100 capsules - 10 blisters of 10 capsules each.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH, Schloßplatz 1, A-8502 Lannach, Austria. For more detailed information, the patient should contact the local representative of the marketing authorization holder: G.L. PHARMA POLAND Sp. z o.o., ul. Sienna 75, 00-833 Warsaw, Poland, Tel: 022/ 636 52 23, 636 53 02, [email protected]

Date of the last update of the leaflet: