Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alitretinoin
Ennogen Healthcare Ltd
D11AH04
Alitretinoin
30mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 13050100; GTIN: 05060254924199
Artwork No. Customer Description Market Language Size Min. Font Size Page No. Version No. Date Software 250119/6 Ennogen Alitretinoin 30mg Leaflet UK English 210 x 510 mm 9 pt 1 of 1 11 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 YOU NEED TO TAKE CARE DURING TREATMENT: ! IF YOU DEVELOP ANY MENTAL HEALTH PROBLEMS including depression, aggressive tendencies, mood changes, thoughts about hurting yourself or ending your life, YOU MUST STOP TAKING ALITRETINOIN IMMEDIATELY and contact your doctor as soon as possible. YOU SHOULD NEVER GIVE THIS MEDICINAL PRODUCT TO ANOTHER PERSON. PLEASE TAKE ANY UNUSED CAPSULES TO YOUR PHARMACIST AT THE END OF TREATMENT. TELL YOUR DOCTOR OR PHARMACIST IF: ! you are taking SIMVASTATIN (a medicine used to lower cholesterol). Alitretinoin may decrease the amount of this medicine in your body. ADDITIONAL PRECAUTIONS ! IF YOU HAVE BEEN SUFFERING FROM THYROID DISEASE. Alitretinoin may lower your thyroid hormone levels. If your thyroid hormone level is low, your doctor may prescribe supplements. ! IF YOU DEVELOP DRY EYES, lubricating eye ointment or tear replacement drops can help. If you wear contact lenses, you may need to wear glasses during alitretinoin treatment. Dry eyes and sight problems normally return to normal once treatment is stopped. ! you are taking KETOCONAZOLE, FLUCONAZOLE, MICONAZOLE (medicines used to treat infections). Your doctor may decide to reduce your dose of Alitretinoin. ! 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. ! 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 Perskaitykite visą dokumentą
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 30 mg capsules, soft 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, soft contains 30 mg of alitretinoin Excipients with known effect Soya-bean oil. Each 30 mg capsule contains 278.94 mg soya-bean oil. Sorbitol. Each 30 mg capsule contains 25.55 mg sorbitol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft Alitretinoin 30 mg capsules are yellow, oval, soft-gelatin capsules, 13 mm x 8 mm, containing a yellow to orange, opaque, viscous suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alitretinoin capsules 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 dai Perskaitykite visą dokumentą