Special Warning : אזהרת שימוש

4.4       Special warnings and precautions for use

In women of childbearing potential Cytotec® must not be started on misoprostol until pregnancy is excluded, and should be fully counselled on the importance of adequate contraception while undergoing treatment. If pregnancy is suspected, use of the product should be discontinued (see sections 4.3, 4.6 and 4.8).
.


In such patients it is advised that Cytotec® should only be used if the patient: 
•         takes effective contraceptive measures

•         has been advised of the risks of taking Cytotec® if pregnant (see section 4.3) 
Gastrointestinal bleeding, ulceration, and perforation have occurred in NSAID-treated patients receiving misoprostol. Physicians and patients should remain alert for ulceration, even in the absence of gastrointestinal symptoms, and, where appropriate, endoscopy and biopsy should be carried out before use to ensure that malignant disease is absent in the upper gastrointestinal tract. These investigations and any others considered necessary by the clinician should be repeated at appropriate intervals for follow-up purposes.

Symptomatic responses to misoprostol do not preclude the presence of gastric malignancy.

Misoprostol should be used with caution in patients with conditions that predispose them to diarrhoea, such as inflammatory bowel disease. To minimise the risk of diarrhoea, misoprostol should be taken with food, and magnesium-containing antacids should be avoided (see section 4.5).

Misoprostol should be used with caution in patients in whom dehydration would be dangerous. These patients should be monitored carefully.

The results of clinical studies indicate that Cytotec® does not produce hypotension at dosages effective in promoting the healing of gastric and duodenal ulcers. Nevertheless, Cytotec® should be used with caution in the presence of disease states where hypotension might precipitate severe complications, e.g. cerebrovascular disease, coronary artery disease or severe peripheral vascular disease including hypertension.

There is no evidence that Cytotec® has adverse effects on glucose metabolism in human volunteers or patients with diabetes mellitus.


Excipient information
Cytotec contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

Effects on Driving

4.7    Effects on ability to drive and use machines

Cytotec® can cause dizziness. Patients should be cautioned about operating machinery and driving.