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GALVUS (VILDAGLIPTIN): MEDICATION GUIDE

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, pharmacist or diabetes 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. This includes any possible side effects not listed in this leaflet.

    What Galvus (Vildagliptin) is and what it is used for?

    The active substance of Galvus is vildagliptin, belongs to a group of medicines called "oral antidiabetics".

    Galvus 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 or other healthcare professional will prescribe Galvus 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 Galvus works?

    Vildagliptin (Galvus) 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.

    What you need to know before you take Galvus (Vildagliptin)?

    Do not take Galvus if you are allergic to vildagliptin or any of the other ingredients of this medicine. If you think you may be allergic to vildagliptin or any of the other ingredients of Galvus, do not take this medicine and talk to your doctor, pharmacist, or other healthcare professional.

    Warnings and precautions

    Talk to your doctor, physician, pharmacist or diabetes nurse before taking Galvus (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 have moderate or severe kidney disease (you will need to take a lower dose of Galvus).
  • 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 Galvus in order to avoid low blood glucose, hypoglycaemia).
  • if you are on dialysis.
  • if you suffer from heart failure.
  • if you have liver disease.
  • if you have or have had a disease of the pancreas.

    If you have previously taken Vildagliptin (Galvus) but had to stop taking it because of liver disease, you should not take this medication.

    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 Galvus. Should these occur, you should promptly consult your doctor.

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

    Children and adolescents

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

    Other medicines and Galvus

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

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

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

    Pregnancy and breast-feeding

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

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

    Driving and using machines

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

    Galvus contains lactose

    Galvus tablets 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.

    How to take Galvus (Vildagliptin)?

    Always take this medication exactly as your doctor has told you. Check with your doctor, pharmacist, or other healthcare professional if you are not sure.

    How much to take and when

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

    The usual dose of Vildagliptin (Galvus) is either:

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

    How to take Galvus

  • Swallow the tablets whole with some water.

    How long to take Vildagliptin (Galvus)

  • Take this medicine 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 or other healthcare professional will regularly monitor your condition to check that the treatment is having the desired effect.

    If you take more Galvus than you should

    If you take too many Galvus tablets, or if someone else has taken your medicine, talk to your physician 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 Galvus (Vildagliptin)

    If you forget to take a dose of this drug, 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 Galvus

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

    Possible side effects

    Like all medicines, Galvus (Vildagliptin) can cause side effects, although not everybody gets them.

    Some symptoms need immediate medical attention:

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

  • Angioedema (rare): Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulties breathing, sudden onset rash or hives, which may indicate a reaction called "angioedema".
  • 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.
  • Liver disease (hepatitis), rare: Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).

    Other side effects

    Some patients have had the following side effects while taking Galvus and metformin:

  • Common: trembling, dizziness, nausea, headache, low blood glucose
  • Uncommon: tiredness

    Some patients have had the following side effects while taking Galvus (Vildagliptin) and a sulphonylurea:

  • Common: headache, trembling, dizziness, weakness, low blood glucose
  • Uncommon: constipation
  • Very rare: sore throat, runny nose

    Some patients have had the following side effects while taking Galvus and a glitazone:

  • Common: swollen hands, weight increase, ankle or feet (oedema)
  • Uncommon: headache, weakness, low blood glucose

    Some patients have had the following side effects while taking Galvus alone:

  • Common: dizziness
  • Uncommon: constipation, headache, swollen hands, joint pain, ankle or feet (oedema), low blood glucose
  • Very rare: runny nose, sore throat, fever

    Some patients have had the following side effects while taking Galvus, metformin and a sulphonylurea:

  • Common: dizziness, weakness, tremor, low blood glucose, excessive sweating

    Some patients have had the following side effects while taking Galvus and insulin (with or without metformin):

  • Common: chills, headache, nausea (feeling sick), heartburn, low blood glucose
  • Uncommon: flatulence, diarrhoea

    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

    Reporting of side effects

    If you get any side effects, talk to your doctor, pharmacist, diabetes nurse, or other healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects you can help provide more information on the safety of this medication.

    How to store Galvus (Vildagliptin)?

  • Keep this medicine out of the sight and reach of children.
  • Store in the original package in order to protect from moisture.
  • Do not use this medicine after the expiry date which is stated on the blister and the carton after "EXP". The expiry date refers to the last day of that month.
  • Do not use any Galvus pack that is damaged or shows signs of tampering.

    Contents of the pack and other information

    What Galvus contains

  • The active substance is vildagliptin. Each tablet contains 50 mg vildagliptin.
  • The other ingredients are lactose anhydrous, microcrystalline cellulose, sodium starch glycolate (type A) and magnesium stearate.

    What Galvus looks like and contents of the pack

    Galvus 50 mg tablets are round, white to light yellowish and flat, with "NVR" on one side and "FB" on the other.

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

    Not all pack sizes may be marketed in your country.

    Manufacturer and marketing authorisation holder: Novartis

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