Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Isotretinoin
Ennogen Healthcare Ltd
D10BA01
Isotretinoin
20mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 13060200; GTIN: 05060254921945 05060254922317
ISOTRETINOIN 10/20 MG CAPSULES (PIL) UK 180 X 580 MM (FOLDED SIZE: 180 X 35 MM) 0000000 5179440 00000 26.07.2018/ 15.03.2019/ 18.03.2019/ 22.03.2019 REF. BLUE It is very common to experience dryness of the skin, especially of the lips and face. You may get an inflamed skin (dermatitis), chapped and inflamed lips (cheilitis), a rash, some mild itching and slight peeling. This dryness can be relieved by the regular use of a good moisturising cream from the start of treatment. If you develop a rash or these skin symptoms, stop taking isotretinoin and contact your doctor immediately. Serious skin rashes (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which are potentially life-threatening and require immediate medical attention. These appear initially as circular patches often with central blisters usually on arms and hands or legs and feet, more severe rashes may include blistering of the chest and back. Additional symptoms such as infection of the eye (conjunctivitis) or ulcers of the mouth, throat or nose may occur. Severe forms of rash may progress to widespread peeling of the skin which can be life threatening. These serious skin rashes are often preceded by headache, fever, body aches (flu-like symptoms). These side effects have been reported with unknown frequency. SKIN PROBLEMS CONTACT YOUR DOCTOR STRAIGHT AWAY IF YOU GET SIGNS OF ANY OF THESE MENTAL PROBLEMS. Your doctor may tell you to stop taking Isotretinoin Capsules. That may not be enough to stop the effects: you may need more help and your doctor can arrange this. As mental problems can be caused by many different factors, it is important to tell your doctor if you have ever had any mental illness including depression, suicidal behaviour or psychosis (psychosis means a loss of contact with reality, such as hearing voices or seeing things that are not there). Also tell your doctor if you take medicines for any of these conditions. - Signs of psychosis: a loss of contact with reality, such as hearing voices or seeing thin Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isotretinoin 20mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains isotretinoin 20 mg. Excipient(s) with known effect: For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsules, Soft. Oval shaped, maroon coloured, opaque soft gelatin capsules imprinted with `RR` in black edible ink containing orange-yellow coloured oily suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Isotretinoin should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements. The capsules should be taken with food once or twice daily. _Adults including adolescents and the elderly:_ Isotretinoin therapy should be started at a dose of 0.5 mg/kg daily. The therapeutic response to isotretinoin and some of the adverse effects are dose-related and vary between patients. This necessitates individual dosage adjustment during therapy. For most patients, the dose ranges from 0.5-1.0 mg/kg per day. Long-term remission and relapse rates are more closely related to the total dose administered than to either duration of treatment or daily dose. It has been shown that no substantial additional benefit is to be expected beyond a cumulative treatment dose of 120-150 mg/kg. The duration of treatment will depend on the individual daily dose. A treatment course of 16-24 weeks is normally sufficient to achieve remission. In the majority of patients, complete clearing of the acne is obtained with a single treatment course. In the event of a definite relapse a further course of isotretinoin therapy may be considered using the same daily Les hele dokumentet