Exprogest Special Precautions

Under the recommended conditions for use, this treatment is NOT A CONTRACEPTIVE.
The risks of combined use of estrogen and progestogen for postmenopausal hormone therapy are described in detail in the summaries of product characteristics of the particular estrogen-containing medicinal products.
Patients must be monitored closely if they have a past history of venous thrombosis.
If uterine bleeding is present, do not prescribe before establishing a cause, particularly with endometrial investigations.
Because of the metabolic risks and risks of thromboembolism which cannot be entirely excluded, administration should be discontinued in the event of: Ocular disorders such as reduced vision, diplopia and retinal vascular lesions; Venous thromboembolic or thrombotic events, regardless of location; Severe headaches.
If the patient develops amenorrhoea during treatment, ensure that she is not pregnant. The use of progesterone in cases of threatened abortion or prevention of repetitive abortion should be reserved for cases in which the secretion of the corpus luteum is insufficient. More than half of early miscarriages are due to genetic disorders. Other infectious or mechanical processes may be the cause of the abortion. In these cases the administration of progesterone would only have the effect of delaying the expulsion of a dead embryo or delaying the interruption of a nonevolutive pregnancy.
The use of Progesterone (Exprogest) in the course of pregnancy should be reserved for the first trimester and should only be used vaginally. There are risks of undesirable effects on the liver during the 2nd and 3rd trimesters of pregnancy.
Medical examination/follow-up: Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse. Investigations, including appropriate imaging tools, e.g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Endometrial hyperplasia: In women with intact uterus, regular period-like bleeding is likely to occur upon withdrawal during the treatment with estrogen and Progesterone (Exprogest). Such bleeding may decrease or stop altogether with increasing atrophy of the endometrium in the course of long-term treatment. In the absence of withdrawal bleeding, endometrial hyperplasia should be excluded by suitable measures.
Breakthrough bleeding and spotting may occur during the first few months of treatment. If such breakthrough bleeding or spotting occurs later in the course or the therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
Long-term treatment (>5 years) with combinations of estrogen and progesterone, such as Progesterone (Exprogest), may offer less endometrial protection than combinations of estrogen and progestogen. Therefore, regular endometrial monitoring is recommended.
Progesterone (Exprogest) contains soya bean lecithin: Progesterone (Exprogest) contains soya bean lecithin and may cause hypersensitivity reactions (urticaria and anaphylactic shock). If a patient is allergic to peanut or soya, the patient should not use this medicinal product (see Contraindications).