Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alitretinoin
Ennogen Healthcare Ltd
D11AH04
Alitretinoin
10mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 13050100; GTIN: 05060254924182
Artwork No. Customer Description Market Language Size Min. Font Size Page No. Version No. Date Software 250119/5 Ennogen Alitretinoin Leaflet UK English 210 x 510 mm 9 pt 1 of 1 10 07-02-20 Coreldraw 12 Packaging Development Quality Assurance (QA) Quality Control (QC) Production e-mail : prasad.pdp@gmail.com Ph : +91-09845156610 Colours Used Black Keyline Alitretinoin is not recommended for people aged under 18 years old. It is not known how well it works in this age group. ! IF YOU HAVE HIGH BLOOD SUGAR (DIABETES), your blood sugar levels may need to be checked more often and your doctor may start you on a lower dose of Alitretinoin. TELL YOUR DOCTOR OR PHARMACIST if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, and herbal medicines. ! IF YOU HAVE HIGH BLOOD FATS, you may need blood tests more often. Alitretinoin commonly increases blood fats, such as cholesterol or triglycerides. If your blood fats stay high, your doctor may lower your dose or take you off Alitretinoin. YOU NEED TO TAKE CARE DURING TREATMENT: ! IF YOU EXPERIENCE ANY PROBLEMS WITH YOUR SIGHT, TELL YOUR DOCTOR IMMEDIATELY. Alitretinoin may need to be stopped and your sight monitored. ! MINIMISE YOUR EXPOSURE TO SUNLIGHT and avoid sun lamps. Your skin may become more sensitive to sunlight. Before you go out in the sun, use a sun protection product with a high protection factor (SPF 15 or higher). IF YOU GET DRY SKIN AND LIPS during treatment, use a moisturising ointment or cream and a lip balm. DO NOT TAKE OTHER RETINOID MEDICINES (e.g. isotretinoin), VITAMIN A SUPPLEMENTS OR TETRACYCLINES (a type of antibiotic) while taking Alitretinoin. This increases the risk of side effects. OTHER MEDICINES AND ALITRETINOIN ! you are taking AMIODARONE (a medicine that helps to regulate heart rate). Amiodarone is not recommended to be taken together with Alitretinoin. ! you are taking SIMVASTATIN (a medicine used to lower cholesterol). Alitretinoin may decrease the amount of this Olvassa el a teljes dokumentumot
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 4.8 for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT Alitretinoin 10 mg capsules, soft 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, soft contains 10 mg of alitretinoin Excipients with known effect Soya-bean oil. Each 10 mg capsule contains 92.94 mg soya-bean oil. Sorbitol. Each 10 mg capsule contains 13.28 mg sorbitol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft Alitretinoin 10 mg capsules are light brown, oval, soft-gelatin capsules, 10 mm x 6 mm, containing a yellow to orange, opaque, viscous suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alitretinoin is indicated for use in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids. Patients in whom the eczema has predominantly hyperkeratotic features are more likely to respond to treatment than in those in whom the eczema predominantly presents as pompholyx (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Alitretinoin should only be prescribed by dermatologists, or physicians with experience in the use of systemic retinoids who have full understanding of the risks of systemic retinoid therapy and monitoring requirements. Prescriptions of Alitretinoin for women of childbearing potential should be limited to 30 days of treatment and continuation of treatment requires a new prescription. Ideally, pregnancy testing, issuing a prescription and dispensing of Alitretinoin should occur on the same day. Dispensing of Alitretinoin should occur within a maximum of 7 days of the prescription. Posology The recommended dose for alitretinoin is 10 mg or 30 mg once daily. The recommended starting dose for alitretinoin is 30 mg once daily. A dose reduction to 10 mg once daily ma Olvassa el a teljes dokumentumot