Vildagliptin

The active substance of VILDAGLIPTIN 50 ACCORD, vildagliptin, belongs to a group of medicines called “oral antidiabetics”. VILDAGLIPTIN 50 ACCORD is used to treat adult patients with type 2 diabetes. It is used when diabetes cannot be controlled by diet and exercise alone. It helps to control the level of sugar in the blood. Your doctor will prescribe VILDAGLIPTIN 50 ACCORD either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes. 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. Insulin is a substance which helps to lower the level of sugar in the blood, especially after meals. Glucagon is a substance which triggers the production of sugar by the liver, causing the blood sugar level to rise. The pancreas makes both of these substances.

How VILDAGLIPTIN 50 ACCORD works VILDAGLIPTIN 50 ACCORD works by making the pancreas produce more insulin and less glucagon. This helps to control the blood sugar level. This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes. Even though you are now starting a medicine for your diabetes, it is important that you continue to follow the diet and/or exercise which has been recommended for you.

Do not take VILDAGLIPTIN 50 ACCORD:

• if you are hypersensitive (allergic) to vildagliptin or any of the other ingredients of VILDAGLIPTIN 50 ACCORD (listed in section 6).
• if your liver is not functioning properly

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking VILDAGLIPTIN 50 ACCORD:

• if you have type 1 diabetes (i.e. your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
• 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 50 ACCORD in order to avoid low blood glucose [hypoglycaemia]).
• if you have moderate or severe kidney disease (you will need to take a lower dose of VILDAGLIPTIN 50 ACCORD).
• if you are on dialysis.
• if you have liver disease.
• if you suffer from heart failure.
• 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 VILDAGLIPTIN 50 ACCORD. 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 50 ACCORD. Should these occur, you should promptly consult your doctor. A test to determine your liver function will be performed before the start of VILDAGLIPTIN 50 ACCORD 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.

Do not share medicines prescribed for you with any other person. Always take VILDAGLIPTIN 50 ACCORD exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much to take and when

The amount of VILDAGLIPTIN 50 ACCORD people have to take varies depending on their condition. Your doctor will tell you exactly how many tablets of VILDAGLIPTIN 50 ACCORD to take. The maximum daily dose is 100 mg. The usual dose of VILDAGLIPTIN 50 ACCORD is either:

• 50 mg daily taken as one dose in the morning if you are taking VILDAGLIPTIN 50 ACCORD with another medicine called a sulphonylurea.
• 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking VILDAGLIPTIN 50 ACCORD alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.
• 50 mg daily in the morning if you have moderate or severe kidney disease or if you are on dialysis.

How to take VILDAGLIPTIN 50 ACCORD

Swallow the tablets whole with some water.

How long to take VILDAGLIPTIN 50 ACCORD

Take VILDAGLIPTIN 50 ACCORD every day for as long as your doctor tells you. You may have to take this treatment over a long period of time. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

If you take more VILDAGLIPTIN 50 ACCORD than you should: If you take too many VILDAGLIPTIN 50 ACCORD tablets, or if someone else has taken your medicine, talk to your doctor straight away. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take VILDAGLIPTIN 50 ACCORD: If you forget to take a dose of this medicine, take it as soon as you remember. Then take your next dose at the usual time. If it is almost time for your next dose, skip the dose you missed. Do not take a double dose to make up for a forgotten tablet.

If you stop taking VILDAGLIPTIN 50 ACCORD: Do not stop taking VILDAGLIPTIN 50 ACCORD unless your doctor tells you to. If you have questions about how long to take this medicine, talk to your doctor.

VILDAGLIPTIN 50 ACCORD can have side effects. Not all side effects for VILDAGLIPTIN 50 ACCORD are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VILDAGLIPTIN 50 ACCORD, please consult your doctor, pharmacist or other healthcare professional for advice.

Some symptoms need immediate medical attention: You should stop taking VILDAGLIPTIN 50 ACCORD and see your doctor immediately if you experience the following side effects:

• Angioedema: Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulties breathing, sudden onset rash or hives, which may indicate a reaction called “angioedema”.
• Liver disease (hepatitis): 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): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back, as well as nausea and vomiting. These are all very serious side effects. If you have them, you may have had a serious reaction to VILDAGLIPTIN 50 ACCORD. You may need urgent medical attention or hospitalisation.

Other side effects:

Frequent:

• trembling, headache, dizziness, nausea, low blood glucose
• weakness
• weight increase, swollen hands, ankle or feet (oedema)
• tremor, excessive sweating
• chills, heartburn

Less frequent:

• tiredness
• constipation
• sore throat, runny nose
• headache, weakness, low blood glucose

Frequency unknown:

• itchy rash, inflammation of the pancreas, inflammation of the gallbladder, localised peeling of skin or blisters, muscle pain

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of VILDAGLIPTIN 50 ACCORD.

• Store at or below 25 °C.

• Store all medicines out of reach of children.

• There are no special storage instructions for VILDAGLIPTIN 50 ACCORD.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).