CERVAGEM Vaginal pessary Ref.[11079] Active ingredients: Gemeprost

Gemeprost should be used with caution in patients with obstructive airways disease, those with cardiovascular insufficiency, elevated intraocular pressure, cervicitis or vaginitis. Serious, potentially fatal, cardiovascular accidents (myocardial infarction and/or spasm of the coronary arteries and severe hypotension) have been reported with prostaglandins including gemeprost. Cardiac and vascular parameters should be monitored by taking regular measurements of the patients pulse and blood pressure.

Coagulopathy may occur following intra-uterine foetal death and should be monitored and managed actively according to current clinical standard practice.

Adequate follow up of a patient having a pregnancy terminated is essential to ensure that the process has been completed, as the embryopathic hazards of gemeprost have not been determined.

Patients with the following diseases have not been studied: ulcerative colitis; diabetes mellitus; sickle-cell anaemia; epilepsy; disorders of blood coagulation; cardiovascular or pulmonary disease.

When used for cervical dilatation, if it is necessary to postpone surgery much beyond the recommended 3 hour interval patients should be kept under observation, as there is a possibility that spontaneous abortion may occur.

Oxytocin and other labour inducers or accelerators can potentiate the action of Gemeprost.

Not applicable.

Not applicable.

Vaginal bleeding and mild uterine pain, similar to menstrual pain, may occur in the interval between the administration of the pessary and surgery, especially if this interval is prolonged beyond the recommended 3 hours. Nausea, vomiting, loose stools or diarrhoea may occur but are rarely severe enough to require treatment. However, standard anti-emetic or antidiarrhoeal agents may be administered if required. Other reported side effects include: headache, muscle weakness; dizziness; flushing; chills; backache; dyspnoea; chest pain; palpitations and mild pyrexia. Uterine rupture has been reported on rare occasions, most commonly in multiparous women and in those women with a history of uterine surgery. Anaphylactic reactions have not occurred with gemeprost but such reactions have very rarely been noted with other prostaglandins. In very rare cases, severe hypotension and coronary spasms with subsequent myocardial infarctions have been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.