Description

Lynestrenol is indicated in Polymenorrhoea, Menorrhagia and metrorrhagia, Selected cases of primary and secondary amenorrhoea and oligomenorrhoea, Premenstrual syndrome, Endometriosis, Selected cases of endometrial carcinoma, Benign breast disease, Suppression of menstruation ovulation and ovulation pain dysmenorrhoea, Postponement of menstruation, As an adjunct to estrogen therapy in pre-and postmenopause in order to avoid endometrial hyperplasia.

Lynestrenol tablets should be taken orally with some fluid.

There are some indications, mainly obtained with other progestagen-containing preparations, that activated charcoal, barbiturates (primidone included), hydantoins and rifampicin may possibly decrease the effectiveness of Lynestrenol. Conversely, Lynestrenol may possibly increase the effectiveness of certain beta-adrenergic blockers and cyclosporin and possibly decrease the effectiveness of insulins.

Pregnancy or suspected pregnancy. Severe liver disease such as cholestatic jaundice or hepatitis (or a history of severe liver disease if the results of liver function tests have failed to return to normal), hepatic cell tumours,Rotor syndrome and Dubin-Johnson syndrome. Undiagnosed vaginal bleeding. Conditions of rare occurrence known to be affected by sex steroids, or a history of these conditions (the condition may have occurred first or worsened during pregnancy or use of sex steroids); i.e. herpes gestationis, jaundice of pregnancy otosclerosis, severe pruritus or porphyria.

During continuous treatment regimens with Lynestrenol, breakthrough bleeding or spotting will occur frequently (over 10 per cent) during the first two months. Later on the frequency gradually decreases. During cyclic treatment regimens breakthrough bleeding and spotting will be seen occasionally (1-10 per cent). Temporarily increasing the dose will control the bleeding in most cases. Other adverse events which occur frequently (over 10 per cent) are : change in libido (both increase and decrease), nausea or other gastrointestinal disturbances, and weight increase. Adverse events which may be observed occasionally (1-10 per cent) or rare (less than 1 per cent) are : headache or migraine, dizziness, nervousness, depression, increased sweating, acne, hirsutism, chloasma, rash, pruritus, jaundice, change in lipoprotein profile, alterations in liver function tests, amenorrhoea, menstrual irregularity, reduced glucose tolerance, breast pain, oedema. Most of these adverse events are transient and of minor importance in many cases.

This medicine is contraindicated during pregnancy. There are insufficient data on the use of this medicine during breast feeding to assess potential harm.

Chloasma is occasionally seen during the use of estrogen and/or progestagen-containing preparations, especially in women with a history of chloasma gravidarum. In women with a tendency to chloasma exposure of the skin to natural or artificial sunlight may induce or aggravate the condition. Occasionally changes in parameters of liver function, carbohydrate metabolism and haemostasis may occur. If the results of relevant tests become abnormal, treatment should be discontinued. An increase in LDL-cholesterol and a decrease in HDL-cholesterol may occur during Lynestrenol therapy. During prolonged treatment with progestagens, periodic medical examinations are advisable. As determined by the effects on SHBG, lynestrenol has weak androgenic activity. This is confirmed by the slight signs of virilisation (such as acne and hirsutism) observed in some patients. Patients with any of the following conditions should be kept under close medical supervision: circulatory disorders (or a history of this condition), since with estrogen/progestagen  containing oral contraceptive preparations a slightly increased risk of some cardiovascular disorders has been reported; some forms of severe depression,if likely to be exacerbated by sex steroid