Land: Israel
Språk: engelsk
Kilde: Ministry of Health
ACITRETIN
ABIC MARKETING LTD, ISRAEL
D05BB02
CAPSULES
ACITRETIN 25 MG
PER OS
Required
ACTAVIS GROUP PTC EHF, ICELAND
ACITRETIN
Severe disorders of keratinization such as erythrodermic psoriasis local or generalized pustular psoriasis congenital ichthyosis pityriasis rubra pilaris darier's disease.
2019-12-12
PATIENT SAFETY INFORMATION CARD DOCTOR’S NAME: TELEPHONE: Neotigason is used TO TREAT SEVERE SKIN PROBLEMS including psoriasis, ichthyosis and keratosis. Treatment of the drug in a patient of childbearing age is for severe disease which is resistant to standard treatments. NEOTIGASON )ACITRETIN( MUST NOT BE TAKEN DURING PREGNANCY. NEOTIGASON )acitretin(, when taken by a pregnant woman, can cause severe malformation of the unborn baby such as skull, facial, cardiovascular, brain, skeletal and thymus defects. IF YOU BECOME PREGNANT OR THINK YOU MIGHT BE PREGNANT, STOP TAKING NEOTIGASON )ACITRETIN( IMMEDIATELY AND CONTACT YOUR DOCTOR. Read the package leaflet carefully before you start treatment. WHAT YOU HAVE TO DO IF YOU COULD BECOME PREGNANT: • YOU MUST USE AT LEAST 1 HIGHLY EFFECTIVE METHOD OF CONTRACEPTION )SUCH AS AN INTRA-UTERINE DEVICE OR AN IMPLANT( OR CORRECTLY USE 2 EFFECTIVE METHODS OF BIRTH CONTROL THAT WORK IN DIFFERENT WAYS )SUCH AS AN ORAL CONTRACEPTIVE TOGETHER WITH A CONDOM( BEFORE, DURING AND FOR 3 YEARS AFTER STOPPING TREATMENT. • YOU MUST NOT BECOME PREGNANT while taking NEOTIGASON )acitretin(, or for 3 years after stopping treatment. • YOU MUST ATTEND REGULAR FOLLOW-UP VISITS. • YOU MUST HAVE REGULAR PREGNANCY TESTS TO ENSURE YOU ARE NOT PREGNANT PRIOR TREATMENT, ONCE A MONTH DURING TREATMENT AND EVERY 1-3 MONTHS FROM STOPPING TREATMENT UNTIL 3 YEARS AFTERWARDS. This medication has been prescribed to you only, DO NOT SHARE IT WITH ANYBODY AND RETURN ANY UNUSED CAPSULES BACK TO THE PHARMACY. FOR YOUR CONVENIENCE, AN APPOINTMENT TABLE TO RECORD THE DATES OF YOUR VISITS TO THE ATTENDING DOCTOR IS AVAILABLE IN THE ISRAELI DRUG REGISTRY - ON THE MINISTRY OF HEALTH WEBSITE AND ON THE SITE OF THE DEPARTMENT OF RISKS MANAGEMENT UNDER MATERIALS FOR THE PATIENT. The format of this card and its contents were checked and approved by the Ministry of Health on February 2019. ."باصخلإا نس يف ءاسنلل ة ّ مهم تامولعم" تانيكاملا لامعتساو ةقايسلا ءا Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS ▼THIS MEDICINAL PRODUCT IS SUBJECT TO ADDITIONAL MONITORING. THIS WILL ALLOW QUICK IDENTIFICATION OF NEW SAFETY INFORMATION. HEALTHCARE PROFESSIONALS ARE ASKED TO REPORT ANY SUSPECTED ADVERSE REACTIONS. SEE SECTION “UNDESIRABLE EFFECTS” FOR HOW TO REPORT ADVERSE REACTIONS. NEOTIGASON 10MG AND 25MG CAPSULES ************************************************************************************* 1 NAME OF THE MEDICINAL PRODUCT Neotigason 10mg Capsules Neotigason25mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 10 mg Capsules: Each capsule, contains Acitretin 10 mg 25 mg Capsules: Each capsule, contains Acitretin 25 mg Excipients with known affect: Glucose (see section _4.3 Contraindications_). This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’. For a full list of excipients, see section _6.1 List of excipients_. 3 PHARMACEUTICAL FORM Capsules for oral administration 10 mg Capsules: Hard gelatin capsules with white body and brown cap with “10” printed in black on the body, containing 10 mg acitretin. 25mg Capsules: Hard gelatin capsules with yellow body and brown cap with “25” printed in black on the body, containing 25 mg acitretin. Neotigason Capsules 10mg, 25mg, SPC, 02-2020, HH, Notification 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe disorders of keratinization such as erythrodermic psoriasis local or generalized or pustular psoriasis congenital ichthyosis pityriasis rubra pilaris darier's disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Neotigason should only be prescribed by physicians who are experienced in the use of systemic retinoids and understand the risk of teratogenicity associated with acitretin therapy (see Section 4.6). The capsules should be taken once daily with meals or with milk. There is a wide variation in the absorption and rate of metabolism of Neotigason. This necessitates individual adjustment of dosage. For this reason the following dosage recommendations can Les hele dokumentet