GALVUS TAB

Galvus is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in patients with type 2 diabetes mellitus.

The active substance in Galvus, vildagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of ‘incretin’ hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin.

 Before you take Galvus

When you must not take it

Do not take Galvus if you have an allergy to:

• vildagliptin (the active ingredient) or to any of the other ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include:

• shortness of breath;
• wheezing or difficulty breathing;
• swelling of the face, lips, tongue or other parts of the body;
• rash, itching or hives on the skin.
• Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. In that case, return it to your pharmacist.
• Before you start to take it

Tell your doctor if:

• you have allergies to any other medicines, foods, dyes or preservatives.
• Your doctor will want to know if you are prone to allergies.
• you are pregnant or intend to become pregnant.
• Your doctor will discuss the possible risks and benefits involved.
• you are breast-feeding or plan to breast-feed.
• It is not known if the active ingredient of Galvus passes into breast milk and could affect your baby.
• you have any of the following medical conditions:

             – problems with your kidneys

            – problems with your liver

            – heart failure

– type 1 diabetes (formerly called ‘juvenile onset’ or ‘insulin-dependent’ diabetes mellitus or ‘IDDM’), where the body does not produce any insulin

– diabetic ketoacidosis, a condition where chemicals called ketones build up in the body due to very low insulin levels.

Galvus is not a substitute for insulin. You should therefore not receive Galvus for the treatment of type 1 diabetes or diabetic ketoacidosis.

If you are not sure whether any of the above conditions apply to you, your doctor can advise you.

If you have not told your doctor about any of the above, tell him/her before you take any Galvus. Your doctor will do some blood and urine tests for sugar level regularly, and for liver functions at the start of treatment and regularly while you are on treatment. Your doctor will also test your kidney function before you start treatment with Galvus.

If your doctor has told you to stop your treatment with Galvus because of liver problems, you should never start taking Galvus again.

Tell your doctor if you suffer from lactose intolerance. This is because Galvus tablets contain lactose.

Alcohol, diet, exercise and your general health all strongly affect the control of your diabetes.