- Diabetes medicine
- Reduces blood sugar
- Tablet for oral use
- Do not use while pregnant or breastfeeding
Galvus (Vildagliptin)
About Galvus
Galvus is used to treat adult patients with type 2 diabetes. The active ingredient vildagliptin works by making the pancreas produce more insulin and less glucagon. This helps to control the blood sugar level.
Having a stable blood sugar level may help you prevent complications from your diabetes, such as eye problems, kidney problems and nerve pain.
Galvus is used when type 2 diabetes cannot be controlled by diet and exercise alone. Your doctor will prescribe Galvus either alone or together with certain other antidiabetic medicines.
How to use Galvus
Take the tablet with a drink of water.
Dosage
The doctor will tell you in which dose and how long you need to use this medicine.
The usual dose in adults is either:
- 50 mg daily taken as one dose in the morning if you are taking Galvus 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 Galvus 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.
The maximum daily dose is 100 mg.
The use of Galvus in children and adolescents up to 18 years of age is not recommended.
Alcohol/driving
This medicine does not interact with alcohol.
If you feel dizzy while taking Galvus, do not drive or use machines.
Taken too much/forgot to take/stop taking Galvus
If you take too many Galvus tablets, or if someone else has taken your medicine, talk to your doctor straight away. 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 missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a forgotten tablet.
Do not stop using Galvus without talking to a doctor first.
When not to use Galvus
Do not use Galvus if you are allergic to any of its ingredients (see section 'What Galvus contains').
When should this medicine be used with caution?
Talk to your doctor, pharmacist or nurse before taking using Galvus if:
- You have type 1 diabetes (i.e. your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
- 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]).
- You have moderate or severe kidney disease (you will need to take a lower dose of Galvus).
- You are on dialysis.
- You have liver disease.
- You suffer from heart failure.
- 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 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.
Pregnancy and breastfeeding
Do not use Galvus if you are pregnant.
It is not known if Galvus is excreted in the breast milk. You should not use Galvus if you are breastfeeding, or if you are planning to breastfeed.
Other medicines and Galvus
Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.
Your doctor may wish to alter your dose of Galvus 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.
Side effects
Like all medicines, this medicine can cause side effects, although some people may not experience any.
Serious side effects
Stop taking Galvus and talk to your doctor immediately if you have any of the 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.
Other possible side effects associated with Galvus:
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 skin rash.
- Shaking.
- Headache.
- Dizziness.
- Muscle ache.
- Joint pain.
- Constipation.
- Swelling of hands, ankles or feet (oedema).
- Excessive perspiration.
- Vomiting.
- Pain in and around the stomach (abdominal pain).
- Diarrhoea.
- Heartburn.
- Nausea.
- Blurred vision.
Uncommon (may affect up to 1 in 100 people):
- Weight gain.
- Chills.
- Weakness.
- Sexual dysfunction.
- Low blood sugar.
- Flatulence.
For a complete list of possible side effects, see the package leaflet. 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 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.
Package leaflet
Read the package leaflet before use.