The active substances of Sensityn, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”. Sensityn is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as noninsulin-dependent diabetes mellitus.

Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should. It can also develop if the body produces too much glucagon.

Both insulin and glucagon are made in the pancreas. Insulin helps to lower the level of sugar in the blood, especially after meals. Glucagon triggers the liver to make sugar, causing the blood sugar level to rise.

How Sensityn works

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.

Do not take Sensityn  

- 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 Sensityn.

- 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”).

Warnings and precautions

·         Risk of lactic acidosis:

Sensityn 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 Sensityn  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 Sensityn 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.

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

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

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 Sensityn. If these occur, you should promptly consult your doctor.

If you need to have major surgery you must stop taking Sensityn during and for sometime after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Sensityn.

A test to determine your liver function will be performed before the start of Sensityn 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 Sensityn, 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.

Children and adolescents

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

Other medicines and Sensityn  

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 Sensityn  before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Sensityn.

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 Sensityn.

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, or certain medicines affecting the nervous system.

Sensityn with alcohol

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

Pregnancy and breast-feeding

- 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 Sensityn during pregnancy.

- Do not use Sensityn if you are pregnant or breast-feeding (see also “Do not take Sensityn”).

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

Driving and using machines

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

The amount of Sensityn that people have to take varies depending on their condition. Your doctor will tell you exactly the dose of Sensityn to take.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one film-coated tablet of either 50 mg/850 mg or 50 mg/1000 mg taken twice a day.

If you have reduced kidney function, your doctor may prescribe a lower dose.

Your doctor may prescribe this medicine alone or with certain other medicines that lower the level of sugar in your blood.

When and how to take Sensityn  

- Swallow the whole tablet with a glass of water

- Take one tablet in the morning and the other in the evening with or 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 Sensityn.

If you take more Sensityn than you should

If you take too many Sensityn 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 Sensityn  

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

If you stop taking Sensityn  

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 Sensityn unless your doctor tells you to. If you have any questions about how long to take this medicine, talk to your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

 Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking Sensityn and see your doctor immediately if you experience the following side effects:

• Lactic acidosis (very rare: may affect up to 1 user in 10,000):

Sensityn may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens you must stop taking Sensityn and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

• Angioedema (rare: may affect up to 1 in 1,000 people):

Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives, which may indicate a reaction called “angioedema”.

• Liver disease (hepatitis) (rare):

Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).

• Inflammation of the pancreas (pancreatitis) (frequency not known):

Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back, as well as nausea and vomiting.

Other side effects

• Very common (may affect more than 1 in 10 people):

Nausea, vomiting, diarrhoea, pain in and around the stomach (abdominal pain), and loss of appetite.

• Common (may affect up to 1 in 10 people):

Dizziness, headache, trembling that cannot be controlled, metallic taste, low blood glucose.

• Uncommon (may affect up to 1 in 100 people):

Joint pain, tiredness, constipation, swollen hands, ankle or feet (oedema).

• Very rare (may affect up to 1 in 10,000 people):

Sore throat, runny nose, fever; 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).

Some patients have had the following side effects while taking Sensityn and insulin:

• Common: headache, chills, nausea (feeling sick), low blood glucose, heartburn.

• Uncommon: diarrhoea, flatulence.

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

• Frequency not known (cannot be estimated from the available data): itchy rash, inflammation of the pancreas, localised peeling of skin or blisters, muscle pain.

To report any side effect(s):

•          Saudi Arabia:

•          Other GCC States:

Please contact the relevant competent authority.

-          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 carton after “EXP”. The expiry date refers to the last day of that month.

-          Do not store above 30°C.

-          Do not use this medicine if you notice that the pack is changed or showing signs of tampering.  

-          Do not throw away any medicine via wastewater or household waste.

-          Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

-          Store in the original package (blister) in order to protect from moisture.