Galvus 50 mg tablets

 

What is it and how is it used?

Galvus belongs to a group of medicines called “oral antidiabetics”.

Galvus is used to treat 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.

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.

Galvus works by making the pancreas produce more insulin and less glucagon. This helps to control the blood sugar level.

Your doctor will prescribe Galvus together with certain other antidiabetic medicines which you will already be taking to control diabetes, if one medicine alone is not enough to control your blood sugar level.

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 do you have to consider before using it?

Do not take Galvus:
- if you are allergic (hypersensitive) to vildagliptin or any of the other ingredients of Galvus (see section 6: Further information). 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.

Take special care with Galvus If any of these apply to you, tell your doctor before taking Galvus. if you have type 1 diabetes i.e. your body does not produce insulin. if you have moderate or severe kidney disease. if you are on dialysis. if you have liver disease. if you suffer from heart failure.

If you have previously taken vildagliptin but had to stop taking it because of side effects (liver disease), you should not take this product.

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.

The use of Galvus in children and adolescents is not recommended.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Your doctor may wish to alter your dose of Galvus if you are taking other medicines (such as medicines so called thiazides, corticosteroids, thyroid products and certain products affecting the nervous system).

Taking Galvus with food and drink
You can take Galvus with or without food.

Pregnancy and breast-feeding
Women who are pregnant or plan to become pregnant should consult their doctor before taking Galvus. 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.

Important information about some of the ingredients of Galvus
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.

How is it used?

Always take Galvus exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take
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 usual dose of Galvus is either:
- 50 mg daily taken as one dose in the morning if you are taking Galvus with another medicine called a sulphonylurea, or
- 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Galvus with another medicine called metformin or a glitazone.

Your doctor will prescribe Galvus together with another medicine to control your blood sugar level.

When and how to take Galvus
- Take this medicine in the morning or in the morning and evening.
- 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.
- 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.

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.

What are possible side effects?

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

These side effects may occur with certain frequencies, which are defined as follows very common affects more than 1 patient in 10 common affects 1 to 10 patients in 100 uncommon affects 1 to 10 patients in 1,000 rare affects 1 to 10 patients in 10,000 very rare affects less than 1 patient in 10,000 not known frequency cannot be estimated from the available data.

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): 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).

Other side effects
Some patients have had the following side effects while taking Galvus and metformin: - Common: Trembling, headache, dizziness, nausea, low blood glucose
- Uncommon: Tiredness

Some patients have had the following side effects while taking Galvus and a sulphonylurea: - Common: Trembling, headache, 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: Weight increase, swollen hands, 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: Headache, constipation, swollen hands, ankle or feet (oedema), joint pain, low blood glucose
- Very rare: Sore throat, runny nose, fever

Since this product has been marketed, the following side effects have also been reported (frequency not known):
- Itchy rash
- Inflammation of the pancreas

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

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

What is it?

Galvus is a medicine that contains the active substance vildagliptin. It is available as round, yellow tablets (50 mg).

What is it used for?

Galvus is used to treat type 2 diabetes mellitus. It is used together with another antidiabetes medicine (as ‘dual therapy’) when the patient’s diabetes is insufficiently controlled by this other medicine taken alone. Galvus can be used with metformin, a thiazolidinedione or a sulphonylurea, but it is only used in combination with a sulphonylurea in patients who cannot take metformin.

The medicine can only be obtained with a prescription.

How is it used?

In adults, the recommended dose of Galvus is:

one tablet in the morning and another in the evening when used with metformin or a thiazolidinedione

one tablet in the morning when taken with a sulphonylurea.

The daily dose should not exceed two tablets (100 mg).

Galvus is not recommended for patients who have moderate or severe problems with their kidneys, including those on haemodialysis (a blood clearance technique) with end-stage renal disease. Galvus is not recommended for patients with liver problems.

How does it work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. The active substance in Galvus, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor. It works by blocking the breakdown of ‘incretin’ hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low. Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes.

How has it been studied?

Galvus has been studied in seven main studies involving a total of over 4,000 patients with type 2 diabetes and insufficient control of blood glucose levels.

Three of these studies looked at the effects of Galvus taken alone in a total of 2,198 patients who had not taken diabetes treatment before, comparing it with placebo (a dummy treatment), metformin or rosiglitazone (a thiazolidinedione).

The other four studies compared the effects of Galvus, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients). In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.

What benefits has it shown during the studies?

Galvus reduced levels of HbA1c in all studies. When used alone, it caused a reduction in HbA1c levels by approximately 1 percentage point from a starting level of around 8% after 24 weeks, but it was not as effective as metformin or rosiglitazone.

When used as an add-on to existing treatment for type 2 diabetes, Galvus was more effective than placebo in reducing HbA1c levels. With metformin and with pioglitazone, the 100 mg daily dose was more effective than the 50 mg daily dose, with a reduction in HbA1c levels of between 0.8 and 1.0 percentage points. In combination with glimepiride, both 50 mg and 100 mg daily doses caused a reduction of around 0.6 percentage points. In contrast, patients adding placebo to their existing treatment showed smaller changes in HbA1c levels, ranging from a fall of 0.3 to a rise of 0.2 percentage points.

Although adding Galvus to existing insulin therapy caused a greater reduction in HbA1c levels than placebo, the size of this effect was too small to be considered meaningful for patients.

The company withdrew its application for the use of Galvus on its own and as an add-on to insulin during the assessment of the medicine.

What is the risk associated?

The most common side effect with Galvus (seen in between 1 and 10 patients in 100) is dizziness. For the full list of all side effects reported with Galvus, see the package leaflet.

Galvus should not be used in people who may be hypersensitive (allergic) to vildagliptin or any of the other ingredients. Its use in patients with heart disease should be limited to patients with mild disease.

Because vildagliptin has been associated with liver problems, patients should have tests to check their liver before treatment with Galvus and at regular intervals during treatment.

Why has it been approved?

The CHMP concluded that Galvus’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Galvus to Novartis Europharm Limited on 19 November 2008. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Galvus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 01-2011.