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• Individual circumstances should be evaluated in each case, when choosing the contraception method, involving the patient in the discussion, to guarantee her engagement and compliance with the chosen measures. Visual problems should be carefully monitored (see section 4.8). The treating physician must determine the dosage individually for each patient.
Decreased night vision has been reported with Acitretin therapy.
Bioavailability of orally administered acitretin is enhanced by food. Afin de mieux vous servir, sélectionnez votre succursale favorite An increase of intracranial pressure (pseudotumor cerebri) may occur, which may be accompanied by severe headache, lightheadedness, nausea, vomiting, dizziness or visual disturbances, but subsides after discontinuation of treatment.
The effect of Acitretin is purely symptomatic: the mechanism of action is still largely unknown. Store in the original package, in order to protect from moisture. As etretinate may be stored in fatty tissue and has a longer elimination half-time (approximately 120 days) than acitretin, women of childbearing age must not consume alcohol (in drinks, food or medicines) during treatment with acitretin and for 2 months after cessation of acitretin therapy (see section 4.4, 4.5 and 5.2). In these cases, care must be taken to wear adequate sun protection. a user-independent form), or two complementary user-dependent forms of contraception.
The dates and results of pregnancy tests should be documented.If pregnancy occurs in a woman treated with acitretin, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.If pregnancy occurs after stopping treatment there remains a risk of severe and serious malformation of the foetus. From the longest elimination half-life observed in these patients for acitretin (96 hours) and cis acitretin (123 hours), and assuming linear kinetics, it can be predicted that more than 99% of the drug is eliminated within 36 days after cessation of long-term therapy.
per day (dosing every other day may be considered).The effects of UV light are enhanced by retinoid therapy, therefore patients should avoid excessive exposure to sunlight and the unsupervised use of sun lamps.Decreased night vision has been reported with acitretin therapy.
4) It is absolutely essential that every woman of childbearing potential who is to undergo treatment with acitretin uses effective contraception (preferably 2 complementary methods) without interruption for four weeks before, during and for 3 years after the discontinuation of treatment with acitretin. After this initial phase, it may be necessary in some cases to increase the dose up to a maximum of 75 mg acitretin per day (i.e. Not known (frequency cannot be estimated from the available data) over 80% of patients experienced: hypervitaminosis A as e.g. Conjunctivitis (10 to 40%), visual disturbances, e.g. In animal studies, acitretin passed the placental barrier in quantities sufficient to produce foetal malformations.
• The patient understands that she must consistently and correctly use one highly effective method of contraception (i.e. of the vertebral column, long bones, including ankles and wrists) must be taken at regular intervals (every year) in view of possible ossification abnormalities (see section 4.8).
Adults. In rare cases, this has continued after the treatment has stopped. up to 10% of patients experienced: development of rhagades, inflammation of oral mucosa and gingiva associated with taste disturbances, blistering of the skin, change in pigmentation of the skin and hair, change in growth rate of hair, change in hair structure.Marked dose dependence has been observed especially with regard to After this initial phase, it may be necessary in some cases to increase the dose up to a maximum of 75 mg acitretin per day (i.e.
Due to its lipophilic nature, it can be assumed that acitretin passes into breast milk in considerable quantities.
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