ORGAMETRIL Tablet Ref.[10965] Active ingredients: Lynestrenol

• Chloasma is occasionally seen during the use of estrogen and/or progestagencontaining preparations, especially in women with a history of chloasma gravidarum. In women with a tendency to develop 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 test become abnormal, treatment should be discontinued. An increase in LDL and a decrease in HDL cholesterol may occur during Orgametril therapy.
• During prolonged treatment with progestagens, periodic medical examinations

are advisable.

• As determined by the effects on SHBG, lynsterol has weak androgenic activity. This is confirmed by slight signs of virilization (mainly acne and Hirsutisum) observed in some patients.
• Patients with any of the following conditions should be examined regularly:
  • circulatory disorders (or a history of this condition), since with estrogen/progestagen-containing oral contraceptive preparations a slightly increased risk of specific cardiovascular disorders have been reported;
  • some forms of severe depression if likely to be exacerbated by sex steroids.

There are some interactions, mainly obtained with other progestagen containing preparations, activated charcoal, barbiturates (primidone included). Hydantoins and Rafampicin may possibly decrease the effectiveness of Orgametril. Conversely, Orgametril may possibly increase the effectiveness of certain beta-adrenergic blockers and cyclosporin and decrease the effectiveness of insulin.

This medicine is contraindicated during pregnancy.

There are insufficient data on the use of this medicine during breast-feeding to assess potential harm.

During continuous treatment regimens with Orgametril, breakthrough bleeding or spotting will occur frequently (over 10%) during the first two months. Later on the frequency gradually decreases.

During cyclic treatment regimens break through bleeding or spotting will be seen occasionally (1-10%).

Temporarily increasing the dose will control the bleeding in most cases.

Other adverse events which occur frequently (over 10%) 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%) or rare (less than 1 %) are: Headache or migrane, dizziness, nervousness, depression, sweating, acne, hirsuitisum, cholasma, rash, pruritus, jaundice, change in lipoprotein profile, alterations in liver function tests , amenonorrohoea, menstrual irregularity , reduced glucose tolerance, breast pain, oedema. Most of these adverse events are transient and of minor importance in many cases.