PRECAUTIONS

* Divide your daily intake of fat evenly over your three main meals. Patients should be advised to adhere to dietary guidelines. The possibility of experiencing gastrointestinal events may increase when Xenical is taken with a diet high in fat (e.g. in a 2000 calories/day diet, >30% of calories from fat equates to >67 g of fat). If Xenical is taken with any one meal very high in fat, the possibility of gastrointestinal effects may increase.
* Watch your vitamin intake. Xenical can interfere with absorption of important fat-soluble vitamins and beta-carotene. Take a good multivitamin supplement that contains vitamins D, E, K and beta-carotene at least two hours before or after taking Xenical.
* Make sure that your doctor is aware of other medications you are currently using including those over the counter, herbal or homeopathic preparations. If you take cyclosporine your doctor may want to monitor you more closely.
* Diabetics may find that Xenical has an adverse affect on your blood sugar control. Your doctor will want to see you regularly to monitor the drug's effects.

Weight loss induced by Xenical is accompanied by improved metabolic control in type 2 diabetics which might allow or require reduction in the dose of oral hypoglycemic medication (e.g. sulfonylureas).

A reduction in cyclosporin plasma levels has been observed when Xenical is co-administered. Therefore it is recommended to monitor more frequently than usual the cyclosporin plasma levels when Xenical is co-administered.

May Xenical be taken during pregnancy or while breast-feeding?

You must tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of taking Xenical during pregnancy.

Pregnancy, Nursing Mothers

Pregnancy category B.

In animal reproductive studies, no embryotoxic or teratogenic effects were observed with Orlistat. In absence of a teratogenic effect in animals, no malformative effect is expected in human beings. However, Xenical is not recommended for use during pregnancy in the absence of clinical data.

The secretion of orlistat in human breastmilk has not been investigated. Xenical should not be taken during breastfeeding.

Hepatic and/or Renal Impairment

Clinical investigations in patients with hepatic and/or renal impairment have not been undertaken.

Special Remarks

This medicine should not be used after the expiry date shown on the pack.