GALVUS 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Galvus 50mg tablets

vildagliptin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Galvus and what is it used for
2. What you need to know before you take Galvus
3. How to take Galvus
4. Possible side effects
5. Storage of Galvus
6. Contents of the pack and other information

1. What is Galvus and what is it 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 when diabetes cannot be controlled by diet and exercise alone. It helps to control blood sugar levels. Your doctor will prescribe Galvus alone or in combination with other antidiabetic medicines that you are already taking if they are not sufficiently effective to control your diabetes.

Type 2 diabetes occurs when the body does not produce enough insulin or when the insulin produced does not work properly. It can also occur when the body produces too much glucagon.

Insulin is a substance that helps to lower blood sugar levels, especially after meals. Glucagon is a substance that promotes the production of sugar by the liver and increases blood sugar levels. Both substances are produced in the pancreas.

How Galvus works

Galvus stimulates the pancreas to produce more insulin and less glucagon. This helps to control blood sugar levels. This medicine has been shown to reduce blood sugar, which will help to prevent complications of your diabetes. Although you start taking this medicine for your diabetes, it is important that you continue with the diet and/or exercise that your doctor has recommended.

2. What you need to know before you take Galvus

Do not take Galvus

• if you are allergic to vildagliptina or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptina or any other ingredient of Galvus, do not take this medicine and consult your doctor.

Warnings and precautions

Consult 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 antidiabetic medicine known as a sulfonylurea (your doctor may want to reduce your dose of sulfonylurea when taken in combination with Galvus to avoid low blood sugar levels [hypoglycemia]).
• if you have moderate or severe kidney disease (you will need to take a lower dose of Galvus).
• if you are undergoing dialysis.
• if you have liver disease.
• if you have heart failure.
• if you have or have had pancreatitis.

If you have previously taken vildagliptina but had to stop taking it due to liver disease, you should not take this medicine.

Skin lesions are common complications of diabetes. Follow your doctor's or nurse's recommendations for skin and foot care, paying special attention to the appearance of blisters or ulcers while taking Galvus. If this occurs, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with Galvus, at intervals of three months during the first year, and periodically thereafter. This is done to detect any signs of increased liver enzymes (transaminases) as soon as possible.

Children and adolescents

The administration of Galvus is not recommended in children and adolescents under 18 years of age.

Use of Galvus with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Your doctor may change your dose of Galvus if you are taking other medicines such as:

• thiazides or other diuretics (also known as water pills)
• corticosteroids (generally used to treat inflammation)
• thyroid medicines
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not use Galvus during pregnancy. It is not known if Galvus passes into breast milk. Do not take Galvus if you are breastfeeding or plan to breastfeed.

Driving and using machines

If you feel dizzy while taking Galvus, do not drive or operate tools or machines.

Galvus contains lactose

Galvus contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Galvus contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Galvus

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take and when

The dose of Galvus that you should take varies depending on your condition. Your doctor will tell you exactly how many Galvus tablets to take.

The maximum daily dose is 100 mg.

The recommended dose of Galvus is:

• 50 mg once daily in the morning if you are taking Galvus with another medicine known as a sulfonylurea.

• 100 mg daily in two doses of 50 mg in the morning and evening if you are taking Galvus alone, with another medicine known as metformin, or with a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.

• 50 mg daily in the morning if you have moderate or severe kidney disease or if you are undergoing dialysis.

How to take Galvus

• Swallow the tablet whole with a little water.

Duration of treatment with Galvus

• Take Galvus every day as long as your doctor prescribes it. You may need to continue this treatment for a long time.
• Your doctor will perform periodic checks to ensure that the treatment has the desired effect.

If you take more Galvus than you should

If you have taken too many Galvus tablets or if someone else has taken your medicine, consult your doctor immediately.You may need medical attention. If you have to visit a doctor or go to the nearest hospital, take the package 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 the next dose at the usual time. If it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Galvus

Do not stop taking Galvus unless your doctor tells you to. If you have doubts about the duration of treatment with Galvus, consult your doctor.

4. Possible side effects

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

Some symptoms require immediate medical attention

You should stop taking Galvus and consult your doctor immediately if you experience any of the following side effects:

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms that include swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may be indicative of a reaction called "angioedema".
• Liver disease (hepatitis) (frequency not known): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (rare: may affect up to 1 in 1,000 people): symptoms that include severe and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients experienced the following side effects while taking Galvus:

• Very common (may affect more than 1 in 10 people): sore throat, nasal congestion, fever.
• Common (may affect up to 1 in 10 people): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, swelling of hands, ankles, or feet (edema), excessive sweating, vomiting, stomach pain, and abdominal pain (abdominal discomfort), diarrhea, heartburn, nausea (discomfort).
• Uncommon (may affect up to 1 in 100 people): weight gain, chills, weakness, sexual dysfunction, low blood sugar levels, flatulence.
• Rare (may affect up to 1 in 1,000 people): pancreatitis.

Since the marketing of this product, the following side effects have also been reported:

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that can cause skin rash or pinpoint red and round spots under the skin surface or bruising.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Galvus

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister and on the carton after "EXP"/"CAD". The expiry date is the last day of the month shown.
• Store in the original package to protect from moisture.
• Do not use Galvus if you notice that the package is damaged or shows signs of deterioration.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Galvus

• The active substance is vildagliptin.

Each tablet contains 50 mg of vildagliptin.

• The other ingredients are anhydrous lactose, microcrystalline cellulose, sodium starch glycolate (type A), and magnesium stearate.

Appearance of the product and pack size

Galvus 50 mg tablets are white to slightly yellowish, flat, round tablets 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 consisting of 3 packs, each containing 112 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Lek d.d.

Verovskova ulica 57

Ljubljana 1526

Slovenia

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nuremberg

Germany

Novartis Pharmaceutical Manufacturing LLC

Verovskova ulica 57

Ljubljana 1000

Slovenia

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu