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How does it work?
Galvus tablets contain the active ingredient vildagliptin, which is a type of medicine called a dipeptidyl peptidase-4 (DPP-4) inhibitor. It is used to treat type 2 or non-insulin dependent diabetes (NIDDM).
Vildagliptin works by increasing the amount of two incretin hormones found in the body, called glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). These hormones are normally produced naturally by the body in response to food intake. Their function is to help control blood sugar (glucose) levels.
GLP-1 and GIP have two main actions that help to control blood glucose.
Firstly, they stimulate the pancreas to produce insulin in response to increasing levels of glucose in the blood. (Insulin is the main hormone responsible for controlling sugar levels in the blood. It causes cells in the body to remove sugar from the blood.)
GLP-1 also reduces the production of glucagon. (Glucagon is a hormone that normally increases glucose production by the liver.)
GLP-1 and GIP are normally broken down by an enzyme in the body called dipeptidyl peptidase-4 (DPP-4). Vildagliptin works by binding to this enzyme and preventing it from breaking down the GLP-1 and GIP. This increases the levels of these hormones in the body and so increases their effect on controlling blood sugar.
What is it used for?
Galvus is used for people with type 2 diabetes whose blood sugar is not sufficiently controlled by other antidiabetic medicines. It can be added to treatment with metformin; a sulphonylurea, for example gliclazide; or another type of antidiabetic medicine known as a thiazolidinedione, for example pioglitazone or rosiglitazone.
Warning!
- Hypoglycaemia (low blood glucose) has been commonly reported when this medicine is used in combination with metformin or sulphonylurea medicines, eg glimepiride. Symptoms of hypoglycaemia usually occur suddenly and may include cold sweats, cool pale skin, tremor, anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, excessive hunger, temporary vision changes, headache, nausea and palpitations. You should talk to your doctor or diabetes specialist about this and make sure you know what to do if you experience these symptoms.
- Your ability to concentrate or react may be reduced if you have low blood sugar, and this can cause problems driving or operating machinery. You should take precautions to avoid low blood sugar when driving - discuss this with your doctor. This medicine may also cause dizziness or fatigue. If affected you should take care driving or operating machinery.
- People with diabetes have a higher risk of developing foot ulcers and blistering of the skin. It is therefore important to have a good foot care routine. Consult your doctor if you get any new blisters or ulcers while taking this medicine.
- Rare cases of inflammation of the liver (hepatitis) have been reported in people taking this medicine. For this reason, your liver function should be checked before starting treatment, every three months during the first year of treatment, and regularly thereafter. You should consult your doctor if you develop any of the following symptoms while taking this medicine, so that your liver can be checked: unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, darkened urine or yellowing of the eyes or skin (jaundice).
Use with caution in
- People with mild heart failure.
- People taking ACE inhibitor medicines, eg captopril.
Not to be used in
- Type 1 diabetes.
- Diabetic ketoacidosis.
- Decreased liver function.
- Pregnancy.
- Breastfeeding.
- This medicine is not recommended for people receiving dialysis or who have moderate to severe kidney disease.
- This medicine is not recommended for people with severe heart failure.
- This medicine is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group.
- This medicine contains lactose and should not be taken by people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- The safety of this medicine for use during pregnancy has not been established. It should not be used during pregnancy. Diabetes mellitus is usually controlled using insulin during pregnancy, because this provides a more stable control of blood sugar. If you get pregnant while taking this medicine, or are planning a pregnancy, you should seek medical advice from your doctor.
- It is not known if this medicine passes into breast milk. The manufacturer states that it should not be used by breastfeeding mothers. Seek medical advice from your doctor.
Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Common (affect between 1 in 10 and 1 in 100 people)
- Tremor (when used with metformin or a sulphonylurea).
- Headache (when used with metformin or a sulphonylurea).
- Dizziness (when used with metformin or a sulphonylurea).
- Low blood sugar levels (when used with metformin or a sulphonylurea).
- Nausea (when used with metformin).
- Feeling weak (when used with a sulphonylurea).
- Weight gain (when used with a glitazone).
- Swelling of the legs and ankles due to excess fluid retention (when used with a glitazone).
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Fatigue (when used with metformin).
- Constipation (when used with a sulphonylurea).
- Headache (when used with a glitazone).
- Feeling weak (when used with a glitazone).
Rare (affect between 1 in 1000 and 1 in 10,000 people)
- Changes in liver function.
- Inflammation of the liver (hepatitis).
- Allergic reaction called angioedema, which may involve swelling of the face, tongue or throat, difficulty swallowing or breathing, rash or hives (stop taking this medicine and consult your doctor immediately if you experience these symptoms).
Very rare (affects less than 1 in 10,000 people)
- Inflammation of the nose and throat, causing a blocked or runny nose and sore throat (nasopharyngitis).
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
Medicines that increase blood sugar levels as a side effect may make this medicine, and other antidiabetic medicines, less effective at controlling blood sugar. Medicines that can increase blood sugar levels include the following:
- bronchodilators (beta agonists), eg salbutamol, terbutaline, salmeterol
- corticosteroids, eg prednisolone
- levothyroxine
- thiazide diuretics, eg bendroflumethiazide.
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain vildagliptin as the only active ingredient.
Eucreas contains vildagliptin in combination with metformin.
