VDIA 50 mg Tablets
Vildagliptin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, or 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, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
- What Vdia is and what it is used for.
- Before you use Vdia.
- How to use Vdia.
- Possible side effects.
- How to store Vdia.
- Further information.
What Vida is and what it is used for.
Vdia contains an active substance called, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.
Vdia 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 Vdia 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.
What you need to know before you use Vdia
Do not use Vdia:
• If you are allergic to Vildagliptin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Vdia:
• 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 Vdia 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 Vdia).
• 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 Vdia. Should these occur, you should promptly consult your doctor.
A test to determine your liver function will be performed before the start of Vdia 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.
Also see section “Other medicines and Vdia”.
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.
Children and adolescents
The use of Vdia in children and adolescents up to 18 years of age is not recommended.
Other medicines and Vdia
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 Vdia 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.
Pregnancy, breast feeding and Fertility
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 Vdia during pregnancy. It is not known if Vdia passes into breast milk. You should not use Vdia if you are breast-feeding or plan to breast-feed.
Driving and using machines
If you feel dizzy while taking Vdia, do not drive or use machines.
Vdia contains lactose:
Vdia contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Vdia
Always take this medicine 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 Vdia people have to take varies depending on their condition. Your doctor will tell you exactly how many tablets of Vdia to take. The maximum daily dose is 100 mg.
The usual dose of Vdia is either:
• 50 mg daily taken as one dose in the morning if you are taking Vdia 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 Vdia 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 Vdia
Swallow the tablets whole with some water.
How long to take Vdia
• Take Vdia 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 Vdia than you should
If you take too many Vdia 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 Vdia
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 Vdia
Do not stop taking Vdia unless your doctor tells you to. If you have 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 or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms need immediate medical attention:
You should stop taking Vdia 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) (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
Some patients have had the following side effects while taking Vdia and metformin:
• Common (may affect up to 1 in 10 people): Trembling, headache, dizziness, nausea, low blood glucose.
• Uncommon (may affect up to 1 in 100 people): Tiredness.
Some patients have had the following side effects while taking Vdia and a sulphonylurea:
• Common: Trembling, headache, dizziness, weakness, low blood glucose.
• Uncommon: Constipation.
• Very rare (may affect up to 1 in 10,000 people): Sore throat, runny nose.
Some patients have had the following side effects while taking Vdia and a Glitazone:
• Common: Weight increase, swollen hands, ankle or feet (oedema).
• Uncommon: Headache, weakness, low blood glucose.
Some patients have had the following side effects while taking Vdia alone:
• Common: Dizziness.
• Uncommon: Headache, constipation, swollen hands, ankle or feet (oedema), joint pain, low blood glucose.
• Very rare: Sore throat, runny nose, fever.
Some patients have had the following side effects while taking Vdia, metformin and a
sulphonylurea:
• Common: Dizziness, tremor, weakness, low blood glucose, excessive sweating.
Some patients have had the following side effects while taking Vdia and insulin (with or without metformin):
• 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
How to store Vdia
• 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 carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
• Store in the original package in order to protect from moisture. store below 30°C.
• Do not use this medicine if you notice any visible signs of deterioration
• 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 protect the environment.
Further information
What Vdia contains:
• The active substance is Vildagliptin. Each tablet contains 50 mg of Vildagliptin.
• The other ingredients are:
Tablet core: Microcrystalline cellulose, Anhydrous Lactose, Sodium starch glycolate and Magnesium stearate.
What Vdia looks like and contents of the pack:
Vdia 50mg: white to off white, round shape, and has “JS4” marked on one side.
Vdia 50mg is available in packs containing 28 tablets and 56 tablets.
Marketing Authorization Holder and Manufacturer
Alpha Pharma
King Abdullah Economic City, Rabigh. Saudi Arabia
Email: regulatory@alphapharma.com.sa
Tel: +966 12 21 29013
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