Do not take Komboglyze

• If you are allergic to saxagliptin, metformin or any of the other ingredients of this medicine (listed in section 6);
• If you have had a serious allergic (hypersensitive) reaction to any other similar medications that you take to control your blood sugar.
  Symptoms of a serious allergic reaction may include:
  • Rash
  • Raised red patches on your skin (hives)
  • Swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.

If you have these symptoms, stop taking this medicine and call your doctor or nurse right away.

• If you have ever had a diabetic coma;
• If you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a condition in which substances called ‘ketone bodies’ accumulate in the blood and which can lead to a diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell;
• If you have severely reduced kidney function or problems with your liver;
• If you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing which could be a sign of heart problems;
• If you have a severe infection or are dehydrated (have lost a lot of water from your body);
• If you are breast-feeding (see also “Pregnancy and breast-feeding”);
• If you drink a large amount of alcohol (either every day or only from time to time) (please see section “Komboglyze with alcohol”);

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions:

Risk of lactic acidosis

Komboglyze may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).

If any of the above apply to you, talk to your doctor for further instructions.

Stop taking Komboglyze for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Komboglyze and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of not being well with severe tiredness
• difficulty in breathing
• reduced body temperature and heartbeat

Lactic acidosis is a medical emergency and must be treated in a hospital.

Talk to your doctor or pharmacist before taking Komboglyze

• If you have type 1 diabetes (your body does not produce any insulin). This medicine should not be used to treat this condition;
• If you have or have had a disease of the pancreas;
• If you are taking insulin or an antidiabetic 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 this medicine, in order to avoid low blood sugar;
• If you have had allergic reactions to any other medicines that you take to control the amount of sugar in your blood;
• If you have a problem or take a medicine that can lower your body’s defence against infections;
• If you have ever had 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 need to have major surgery, you must stop taking Komboglyze during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Komboglyze.

Diabetic skin lesions are a common complication of diabetes. Rash has been seen with saxagliptin and with certain anti-diabetic medicines in the same class as saxagliptin. Follow the recommendations for skin and foot care that your doctor or nurse gave you. 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 Komboglyze.

If any of the above apply to you, or if you are not sure talk to your doctor or pharmacist before taking this medicine.

Kidney tests or checks

During treatment with this medicine, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.

Children and adolescents

Komboglyze is not recommended for use in 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 Komboglyze

If you need to have an injection of contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Komboglyze before or at the time of the injection. Your doctor will decide when you can restart your treatment with Komboglyze.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may adjust the dosage of Komboglyze. It is especially important to mention the following:

• cimetidine, a medicine used to treat stomach problems
• ketoconazole which is used to treat fungal infections
• bronchodilators (beta-2 agonists) which are used to treat asthma
• diltiazem which is used for high blood pressure
• rifampicin, an antibiotic used to treat infections such as tuberculosis
• corticosteroids, which are used to treat inflammation in diseases like asthma and arthritis
• carbamazepine, phenobarbital or phenytoin, which are used to control fits (seizures) or long-term pain
• medicines which increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
• certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before taking this medicine.

Komboglyze with alcohol

Avoid excessive alcohol intake while taking Komboglyze since this may increase the risk of lactic acidosis (see “Warnings and precautions”).

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or might become pregnant. This is because it may affect the baby.

Do not take this medicine if you are breast-feeding or plan to breast-feed. This is because metformin passes into human milk in small amounts.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Saxagliptin and metformin have a negligible influence on the ability to drive and use 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.

 How to store Komboglyze

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.

Store below 25°C.

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.