Do not take Onglyza

• if you are allergic to saxagliptin or any of the other ingredients of this medicine (listed in section 6).
• if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar. See section 4.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Onglyza:

• if you are taking insulin. Onglyza should not be used in place of insulin;
• if you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting). Onglyza should not be used to treat these conditions;
• if you have or have had a disease of the pancreas;
• if you are taking insulin or an anti-diabetic medicine known as ‘sulphonylurea’, your doctor may want to reduce your dose of insulin or the sulphonylurea when you take either of them together with Onglyza in order to avoid low blood sugar;
• if you have a condition that reduces your defence against infections, such as a disease like AIDS or from medicines that you might take after an organ transplant;
• if you suffer from heart failure or you have other risk factors for developing heart failure such as problems with your kidneys. Your doctor will advise you of the signs and symptoms of heart failure. You should call your doctor, pharmacist or nurse immediately if you experience any of these symptoms. Symptoms can include, but are not limited to, increasing shortness of breath, rapid increase in weight and swelling of the feet (pedal oedema);
• if you have reduced kidney function, your doctor will decide if you need to take a lower dose of Onglyza. If you are having haemodialysis then Onglyza is not recommended for you;
• if you have moderate or severe liver problems. If you have severe liver problems, then Onglyza is not recommended for you.

Diabetic skin lesions are a common complication of diabetes. Rash has been seen with Onglyza (see section 4) and with certain anti-diabetic medicines in the same class as Onglyza. You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse. Contact your doctor if you encounter blistering of the skin, as it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Onglyza.

Children and adolescents

Onglyza is not recommended for children and adolescents under 18 years. It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.

Other medicines and Onglyza

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, you should tell your doctor if you are using medicines containing any of the following active substances:

• Carbamazepine, phenobarbital or phenytoin. These may be used to control fits (seizures) or chronic pain.
• Dexamethasone – a steroid medicine. This may be used to treat inflammation in different body parts and organs.
• Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.
• Ketoconazole. This may be used to treat fungal infections.
• Diltiazem. This is a medicine used to lower blood pressure.

Pregnancy and breast-feeding

Talk to your doctor before you take Onglyza if you are pregnant or plan to become pregnant. You should not use Onglyza if you are pregnant.

Talk to your doctor if you want to breast-feed while taking this medicine. It is not known if Onglyza passes into human breast milk. You should not take this medicine if you are breast-feeding or plan to breast-feed.

Driving and using machines

If you feel dizzy while taking Onglyza, do not drive or use any tools or machines. Hypoglycaemia may affect your ability to drive and use machines or work with safe foothold and there is a risk of hypoglycaemia when taking this medicine in combination with medicines known to cause hypoglycaemia such as insulin and sulphonylureas.

Onglyza contains lactose

The tablets contain lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free’.

 How to store Onglyza

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use this medicine if the package is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.