Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
OXCARBAZEPINE
NOVARTIS ISRAEL LTD
N03AF02
FILM COATED TABLETS
OXCARBAZEPINE 300 MG
PER OS
Required
NOVARTIS FARMA S.P.A., ITALY
OXCARBAZEPINE
OXCARBAZEPINE
Treatment of primary generalised tonic-clonic seizures and partial seizures with or without secondary generalization.
2022-07-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 THE MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY TRILEPTIN ® TRILEPTIN ® 300 MG 600 MG FILM-COATED TABLETS FILM-COATED TABLETS THE ACTIVE INGREDIENT: Each tablet contains: Each tablet contains: Oxcarbazepine 300 mg Oxcarbazepine 600 mg Inactive ingredients: See section 6 ’Further Information‘. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? For treating epilepsy. THERAPEUTIC GROUP: Anti-epileptic. Epilepsy is a disease characterized by repeated seizures and convulsions. Trileptin is intended for the treatment of primary generalized tonic-clonic seizures and partial seizures, with or without secondary generalized spread. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: You have a known hypersensitivity )allergy( to oxcarbazepine )the active ingredient of Trileptin(, eslicarbazepine )an active ingredient similar to oxcarbazepine( or to any of the other ingredients contained in the medicine )see section 6 ’Further Information‘(. If this applies to you, inform the doctor before taking Trileptin. If you think that you may be allergic, consult the doctor. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE Refer to your doctor immediately if you experience side effects that suggest a hypersensitivity reaction. These may manifest by swelling of the lips, face or neck, accompanied by difficulty breathing, speaking or swallowing, skin rash, fever and joint pain. If you take Trileptin when using oral contraceptives )birth- control pills(, your periods may become irregular. The pill may no longer work and you should talk to your doctor about which other additional c Prečítajte si celý dokument
TRI API Aug23 V3 1 Trileptal prescribing information Approved by SwissMedic on 23/07/23 1. NAME OF THE MEDICINAL PRODUCT Trileptin ® 300mg Trileptin ® 600mg 2. Composition _Active substance:_ Oxcarbazepine _Excipients:_ For the full list of excipients see section 6.1 ‘List of excipients’. 3. Pharmaceutical form and quantity of active substance per unit _Film-coated _ _tablets_ (scored on both sides) containing 300 mg or 600 mg oxcarbazepine. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of primary generalised tonic-clonic seizures and partial seizures, with or without secondary generalization. 4.2 Dosage and administration Trileptin is not approved for use in children less than 2 years of age. Dosage Trileptin is suitable for use either as monotherapy or in combination with other antiepileptic drugs. In mono- and adjunctive therapy, treatment with Trileptin is initiated with a clinically effective dose given in two divided doses. The dose may be increased depending on the clinical response of the patient. When other antiepileptic drugs are replaced by Trileptin, the dose of the concomitant antiepileptic drugs(s) should be reduced gradually on initiation of Trileptin therapy. In adjunctive therapy, as the total antiepileptic drug load of the patient is increased, the dose of concomitant antiepileptic drug(s) may need to be reduced and/or the Trileptin dose increased more slowly (see section 4.5 Interactions). Therapeutic drug monitoring The therapeutic effect of oxcarbazepine is primarily exerted through the active metabolite 10-monohydroxy derivative (MHD) of oxcarbazepine (section 5 Clinical pharmacology). Plasma level monitoring of oxcarbazepine or MHD is not routinely warranted. However, plasma level monitoring of MHD may be considered during Trileptin therapy in order to rule out noncompliance, or in situations where an alteration in MHD clearance is to be expected, including: • changes in renal function (see section Dosage in renal impairment) TRI API Aug23 V3 2 Trileptal prescribing Prečítajte si celý dokument