Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
VALPROIC ACID AS SODIUM
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
N03AG01
TABLETS ENTERIC COATED
VALPROIC ACID AS SODIUM 200 MG
PER OS
Required
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
VALPROIC ACID
VALPROIC ACID
Anti-epileptic.
2015-01-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only Depalept syrup 200 mg/5 ml Depalept 200 mg enteric-coated tablets Depalept 500 mg enteric-coated tablets Depalept syrup Sodium Valproate 200 mg/5 ml Depalept 200 mg Enteric-coated tablets, each tablet contains: Sodium Valproate 200 mg Depalept 500 mg Enteric-coated tablets, each tablet contains: Sodium Valproate 500 mg Inactive ingredients and allergens in the preparation – see section 6 and section 2 “Important information about some of the ingredients of the medicine”. Read the entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or the 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. The medicine is not intended for children weighing less than 17 kg. Warning DEPALEPT MAY SEVERELY HARM THE FETUS WHEN taken during pregnancy Neonates born to mothers who have taken valproate during pregnancy are at an increased risk of serious developmental disorders )mental and physical( and behavioral disorders )approximately 30-40% of cases( and/or congenital malformations )approximately 11% of cases(. If you are a woman of childbearing age or if you are pregnant, the doctor will prescribe valproate for you only if other treatments are unsuitable. Women of childbearing age should use effective contraception while taking this medicine. If despite using contraception you become pregnant unintentionally, contact your doctor immediately in order to discuss the options for alternative therapy, if possible. Do not stop using the medicine without consulting the treating doctor, because your condition may worsen. In addition to the leaflet, the Depalept preparation has a patient safety information card. This card contains important safety information tha Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Depalept 200 enteric coated tablets Depalept 500 enteric coated tablets Depalept Syrup Depalept oral Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Depalept 200 enteric coated tablets_: Sodium valproate 200 mg/tab _Depalept 500 enteric coated tablets_: Sodium valproate 500 mg/tab _Depalept Syrup_: Each 5 ml contains: Sodium Valproate 200 mg/5ml _Depalept oral Solution_: Each ml contains: Sodium Valproate 200 mg/1ml This medicinal product contains sodium (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Depalept 200 enteric coated tablets Depalept 500 enteric coated tablets Depalept Syrup Depalept oral Solution Patient safety information Card The marketing of Depalept is subject to a risk management plan (RMP) including a 'Patient safety information card'. The 'Patient safety information card', emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Depalept is indicated for the treatment of generalized or partial epilepsy secondary generalized epilepsy and mixed forms of epilepsy. 4.2. Posology and method of administration In female children, female adolescents, women of childbearing potential and pregnant women Depalept should be initiated and supervised by a specialist experienced in the management of epilepsy. Treatment should only be initiated if other treatments are ineffective or not tolerated (see Section 4.4 and Section 4.6) and the benefit and risk should be carefully reconsidered at regular treatment reviews. Preferably Depalept should be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation. The daily dose should be divided into at least two single doses. In view of the dosage strength this medicinal product is for use in adults and children weighing o Aqra d-dokument sħiħ