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.

Further 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 containing 336 (3x112) tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma N.V. TélTel 32 2 246 16 11

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01

Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 50

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200

Novartis Pharma Services Inc. 357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00

Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

This leaflet was last approved in

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