Patient leaflet - Galvus 50 mg tablets
1. What Galvus is and what it is used for
The active substance of Galvus, 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 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
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.
2. What you need to know before you take Galvus
Do not take Galvus:
- 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 Galvus, do not take this medicine and talk to your doctor.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Galvus
- 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 Galvus 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 Galvus).
- 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 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 in children and adolescents up to 18 years of age is not recommended.
Other medicines and Galvus
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 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.
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 doctor or pharmacist 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, do not drive or use machines.
Galvus contains lactose
Galvus 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.
Galvus contains sodium
This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‘sodium free’.
3. How to take Galvus
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 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 will tell you exactly how many tablets of Galvus to take. The maximum daily dose is 100mg.
The usual dose of Galvus is either:
- 50mg daily taken as one dose in the morning if you are taking Galvus with another medicine called a sulphonylurea.
- 100mg daily taken as 50mg in the morning and 50mg 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.
- 50mg daily in the morning if you have moderate or severe kidney disease or if you are on dialysis.
How to take Galvus
- Swallow the tablets whole with some water.
How long to take Galvus
- Take Galvus 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 Galvus than you should
If you take too many Galvus 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 Galvus
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 Galvus
Do not stop taking Galvus unless your doctor tells you to. If you have questions about how long to take this medicine, talk to your doctor.
4. 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 Galvus 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 1000 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 side effects
Some patients have had the following side effects while taking 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 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.
Reporting of side effects
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 at: 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.
5. How to store Galvus
Keep out of the sight and reach of children.
Store in the original package in order to protect from moisture.
Do not take the tablets 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.
If the tablet becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist.
Do not use any Galvus pack that is damaged or shows signs of tampering.
Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Galvus contains
The active ingredient in the Galvus is vildagliptin. Each tablet contains 50mg 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 is round, white to light yellowish and flat, with ‘NVR’ on one side and ‘FB’ on the other.
It is available in pack size of 56 tablets.
Manufactured by:
Novartis Pharmaceutical Manufacturing LLC, Verovskova ulica 57, Ljubljana 1000, Slovenia.
OR
Novartis Pharma GmbH, Sophie-Germain-Strasse 10, 90443 Nuremberg, Germany.
OR
Novartis Farmaceutica SA, Ronda de Santa Maria 158, 08210 Barbera del Valles, Barcelona, Spain.
OR
Lek d.d., Verovskova ulica 57, Ljubljana 1526, Slovenia.
OR
Novartis Farmaceutica S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain.
OR
Novartis Pharma GmbH, Roonstrasse 25,
D-90429 Nuremberg, Germany.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Galvus® 50mg tablets; PL 18799/3588
Leaflet date: 19.08.2025
For any information about this medicine, please contact the Product Licence Holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Tel: 0800 049 9401
Email: regulatorygroup@bnshealthcare.com
Galvus is the registered trademark of Novartis AG.
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