Vildagliptin/Metformin 50 mg/1000 mg Film-coated Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Vildagliptin/Metformin is and what it is used for
2. What you need to know before you take Vildagliptin/Metformin
3. How to take Vildagliptin/Metformin
4. Possible side effects
5. How to store Vildagliptin/Metformin
6. Contents of the pack and other information

Both active substances, vildagliptin and metformin, help to control the level of sugar in the blood. The substance vildagliptin works by making the pancreas produce more insulin and less glucagon. The substance metformin works by helping the body to make better use of insulin. This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes.

• if you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of these, talk to your doctor before taking Vildagliptin/Metformin.
• 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 diabetic pre-coma.
  Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
• 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 severely reduced kidney function.
• if you have a severe infection or are seriously dehydrated (have lost a lot of water from your body).
• if you are going to have a contrast x-ray (a specific type of x-ray involving an injectable dye).

Please also see information about this in section “Warnings and precautions”.

• if you have liver problems.
• if you drink alcohol excessively (whether every day or only from time to time).
• if you are breast-feeding (see also “Pregnancy and breast-feeding”).

Risk of lactic acidosis

Vildagliptin/Metformin 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).

Talk to your doctor promptly for further instructions if:

• You are known to suffer from a genetically inherited disease affecting mitochondria (the energy producing components within cells) such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic acidosis and Stroke-like episodes) or Maternal inherited diabetes and deafness (MIDD).
• You have any of these symptoms after starting metformin: seizure, declined cognitive abilities, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), migraine and deafness.

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

Stop taking Vildagliptin/Metformin 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 Vildagliptin/Metformin 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.

Vildagliptin/Metformin is not a substitute for insulin. Therefore, you should not receive Vildagliptin/Metformin for the treatment of type 1 diabetes.

Talk to your doctor, pharmacist or nurse before taking Vildagliptin/Metformin if you have or have had a disease of the pancreas.

Talk to your doctor, pharmacist or nurse before taking Vildagliptin/Metformin if you are taking an anti-diabetic medicine known as a sulphonylurea. Your doctor may want to reduce your dose of the sulphonylurea when you take it together with Vildagliptin/Metformin in order to avoid low blood glucose (hypoglycaemia).

If you have previously taken vildagliptin but had to stop taking it because of liver disease, you should not take this medicine.

Diabetic skin lesions are a common complication of diabetes. You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse. You are also advised to pay particular attention to new onset of blisters or ulcers while taking Vildagliptin/Metformin. Should these occur, you should promptly consult your doctor.

If you need to have major surgery you must stop taking Vildagliptin/Metformin during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Vildagliptin/Metformin.

A test to determine your liver function will be performed before the start of Vildagliptin/Metformin treatment, at three-month intervals for the first year and periodically thereafter. This is so that signs of increased liver enzymes can be detected as early as possible.

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

Your doctor will test your blood and urine for sugar regularly.

The use of Vildagliptin/Metformin in children and adolescents up to 18 years of age is not recommended.

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

Tell your doctor 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 need to adjust the dosage of Vildagliptin/Metformin. It is especially important to mention the following:

• glucocorticoids generally used to treat inflammation
• beta-2 agonists generally used to treat respiratory disorders
• other medicines used to treat diabetes
• 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)
• certain medicines affecting the thyroid
• certain medicines affecting the nervous system
• certain medicines used to treat angina (e.g. ranolazine)
• certain medicines used to treat HIV infection (e.g. dolutegravir)
• certain medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g. vandetanib)
• certain medicines used to treat heartburn and peptic ulcers (e.g cimetidine).

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

• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will discuss with you the potential risk of taking Vildagliptin/Metformin during pregnancy.
• Do not use Vildagliptin/Metformin if you are pregnant or breast-feeding (see also “Do not take Vildagliptin/Metformin”).

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

If you feel dizzy while taking Vildagliptin/Metformin, do not drive or use any tools or machines.

• Swallow the tablets whole with a glass of water,
• Take one tablet in the morning and the other in the evening with or just after food. Taking the tablet just after food will lower the risk of an upset stomach.

Continue to follow any advice about diet that your doctor has given you. In particular, if you are following a diabetic weight control diet, continue with this while you are taking Vildagliptin/Metformin.

If you take too many Vildagliptin/Metformin tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately. Medical attention may be necessary. If you have to go to a doctor or hospital, take the pack and this leaflet with you.

If you forget to take a tablet, take it with your next meal unless you are due to take one then anyway. Do not take a double dose (two tablets at once) to make up for a forgotten tablet.

Continue to take this medicine as long as your doctor prescribes it so that it can continue to control your blood sugar. Do not stop taking Vildagliptin/Metformin unless your doctor tells you to. If you have any questions about how long to take this medicine, talk to your doctor.

Some patients have experienced the following side effects while taking Vildagliptin/Metformin:

• Common (may affect up to 1 in 10 people): sore throat, runny nose, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, trembling that cannot be controlled, constipation, nausea (feeling sick), vomiting, diarrhoea, flatulence, heartburn, pain in and around the stomach (abdominal pain).
• Uncommon (may affect up to 1 in 100 people): tiredness, weakness, metallic taste, low blood glucose, loss of appetite, swollen hands, ankles or feet (oedema), chills, inflammation of the pancreas, muscle pain.
• Very rare (may affect up to 1 in 10 000 people): signs of a high level of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heart beat or deep, rapid breathing; redness of the skin, itching; decreased vitamin B12 levels (paleness, tiredness, mental symptoms such as confusion or memory disturbances).

Since this product has been marketed, the following side effects have also been reported:

• Frequency not known (cannot be estimated from the available data): localised peeling of skin or blisters, blood vessel inflammation (vasculitis) which may result in skin rash or pointed, flat, red, round spots under the skin's surface or bruising.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substances are vildagliptin and metformin hydrochloride.
• Each Vildagliptin/Metformin 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
• Each Vildagliptin/Metformin 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
• The other ingredients are:
  Tablet core: Copovidone, silica colloidal anhydrous, magnesium stearate.
  Film-coating: Hypromellose 2910 (E464), polydextrose (E1200), titanium dioxide (E171), talc (E553b), iron oxide, yellow (E172), maltodextrin/ dextrin and medium-chain triglycerides.

Vildagliptin/Metformin 50 mg/850 mg film-coated tablets are Yellow, ovaloid film-coated tablet with bevelled edge engraved with “50” on one side and “850” on the other side.

Vildagliptin/Metformin 50 mg/1000 mg film-coated tablets Dark yellow, ovaloid film-coated tablet with bevelled edge engraved with “50” on one side and “1000” on the other side.

Vildagliptin/Metformin film-coated tablets are available in OPA/ALU/PVC-Aluminium foil blister or PVC/PCTFE transparent - Aluminium foil blister.

Pack size of 60 film-coated tablets

Or