Vildagliptin 50 mg 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 is and what it is used for
2. What you need to know before you take Vildagliptin
3. How to take Vildagliptin
4. Possible side effects
5. How to store Vildagliptin
6. Contents of the pack and other information

Vildagliptin 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.

• If you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptin or any of the other ingredients of Vildagliptin, do not take this medicine and talk to your doctor.

Talk to your doctor, pharmacist or nurse before taking Vildagliptin

• 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 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).
• 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 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 .Should these occur, you should promptly consult your doctor.

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

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

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

Your doctor may wish to alter your dose of Vildagliptin if you are taking other medicines such as:

• thiazides or other diuretics (also called water tablets)
• corticosteroids (generally used to treat inflammation)
• thyroid medicines
• certain medicines affecting the nervous system.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not use Vildagliptin during pregnancy. It is not known if vildagliptin passes into breast milk. You should not use Vildagliptin if you are breast-feeding or plan to breast-feed.

If you feel dizzy while taking Vildagliptin, do not drive or use machines.

Vildagliptin contains 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.

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

The usual dose of Vildagliptin is either:

• 50 mg daily taken as one dose in the morning if you are taking Vildagliptin 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 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.

• Swallow the tablets whole with some water.

• Take Vildagliptin 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 too many Vildagliptin tablets, or if someone else has taken your medicine, talk to your doctor straight away. Medical attention may be needed. If you need to see a doctor or go to the hospital, take the pack with you.

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.

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

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

• Angioedema (rare: may affect up to 1 in 1,000 people): 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) (frequency not known): 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) (rare: may affect up to 1 in 1 000 people): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back, as well as nausea and vomiting.

Some patients have had the following side effects while taking vildagliptin:

• Very common (may affect more than 1 in 10 people): sore throat, runny nose, fever.
• Common (may affect up to 1 in 10 people): itchy rash, trembling, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles or feet (oedema), excessive sweating, vomiting, pain in and around the stomach (abdominal pain), diarrhoea, heartburn, nausea (feeling sick), blurred vision.
• Uncommon (may affect up to 1 in 100 people): weight increase, chills, weakness, sexual dysfunction, low blood glucose, flatulence.
• Rare (may affect up to 1 in 1 000 people): inflammation of the pancreas.

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 Website: 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 substance is vildagliptin.
  Each tablet contains 50 mg vildagliptin.
• The other ingredients are lactose anhydrous, cellulose microcrystalline, hydroxypropylcellulose low substituted and magnesium stearate.

Vildagliptin 50 mg tablets are white to off white, round, flat faced, beveled edged tablet, debossed with “M” on one side and “V11” on the other side.

Vildagliptin 50 mg tablets are available in blister packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180, 336 tablets and in multipacks comprising 3 cartons, each containing 112 tablets.

Not all pack sizes may be marketed.

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