Galvus

Package leaflet: Information for the user

Galvus 50 mg tablets

vildagliptin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Galvus is and what it is used for

The active substance in 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 control blood sugar levels. Your doctor will prescribe Galvus either alone or together with other antidiabetic medicines you may already be taking, if these have not been sufficiently effective in controlling your diabetes.
Type 2 diabetes develops when the body does not produce enough insulin, or when the insulin produced by the body does not work properly. It may also develop when the body produces too much glucagon.
Insulin is a substance that helps lower blood sugar levels, especially after meals. Glucagon is a substance that triggers the liver to produce sugar, causing blood sugar levels to rise. The pancreas produces both of these substances.
How Galvus works
Galvus works by causing the pancreas to produce more insulin and less glucagon. This helps control blood sugar levels. This medicine has been shown to reduce blood sugar. This may help prevent complications arising from your diabetes. Even though you are now starting treatment with a diabetes medicine, it remains important that you continue to follow the diet and/or exercise regimen recommended for you.

2. What you need to know before taking Galvus

Do not take Galvus:

• if you are allergic to vildagliptin or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptin or to any of the excipients in Galvus, do not take this medicine and consult 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 antidiabetic medicine known as a sulphonylurea (if taken together with Galvus, your doctor may want to reduce your dose of sulphonylurea to avoid low blood glucose levels [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 previously took vildagliptin but had to stop due to liver disease, you must not take this medicine.
Skin lesions are a common complication of diabetes. It is advisable to follow the skin and foot care recommendations provided by your doctor or nurse. You should also pay particular attention to the development of blisters or ulcers while taking Galvus. If this occurs, you should consult your doctor promptly.
Before starting treatment with Galvus, a liver function test will be performed. This test will be repeated every three months during the first year of treatment and periodically thereafter. This is to detect as early as possible any signs of increased liver enzymes.
Children and adolescents
The use of Galvus is not recommended in children and adolescents under 18 years of age.
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 need to adjust the dose of Galvus if you are taking other medicines such as:

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not use Galvus during pregnancy. It is not known whether Galvus passes into breast milk. You must not use Galvus if you are breastfeeding or planning to breastfeed.
Driving and using machines
If you feel dizzy when taking Galvus, do not drive or operate machinery.
Galvus contains lactose
Galvus contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Galvus contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, therefore it is essentially ‘sodium-free’.

3. How to take Galvus

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
How much to take and when
The amount of Galvus you need to take varies depending on your individual condition. Your doctor
will tell you exactly how many Galvus tablets you should take. The maximum daily dose is 100 mg.
The usual dose of Galvus is:

• 50 mg once daily in the morning if you are taking Galvus with another medicine called a sulfonylurea.
• 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Galvus alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.
• 50 mg once daily in the morning if you have moderate or severe kidney disease or if you are on dialysis.

How to take Galvus

• Take the tablets with some water.

How long to take Galvus

• Take Galvus every day for as long as your doctor recommends. You may need to continue this treatment for a long period of time.
• Your doctor will regularly check your condition to make sure the treatment is working as intended.

If you take more Galvus than you should
If you take too many Galvus tablets, or if someone else has taken your medicine, contact your doctor
immediately. Medical treatment may be required. If you need to see a doctor or go to hospital, bring 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 missed dose. Do not take a
double dose to make up for the forgotten tablet.
If you stop taking Galvus
Do not stop taking Galvus unless your doctor tells you to. If you have any doubts about how long you should continue treatment with this medicine, speak to 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 treatment:
You must stop taking Galvus and contact your doctor immediately if you experience any of the following side effects:

• Angioedema (rare: may occur in up to 1 in 1,000 people): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden appearance of skin rashes or hives, which may indicate a reaction called "angioedema".
• Liver disease (hepatitis) (frequency not known): Symptoms include yellowing of the skin or eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (rare: may occur in up to 1 in 1,000 people). Symptoms include severe and persistent pain in the abdomen (stomach area), which may extend to the back, as well as nausea and vomiting.

Other side effects
While taking Galvus, some patients have experienced the following side effects:

• 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, tremor, headache, dizziness, muscle pain, joint pain, constipation, swelling of hands, ankles or feet (oedema), excessive sweating, vomiting, stomach and around-stomach pain (abdominal pain), diarrhoea, heartburn, nausea (feeling unwell), blurred vision.
• Uncommon (may affect up to 1 in 10 people): weight gain, chills, weakness, sexual dysfunction, low blood glucose levels, flatulence.
• Rare (may affect up to 1 in 1,000 people): inflammation of the pancreas

The following side effects have also been reported during post-marketing use of this medicine:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Galvus

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and the carton after “EXP”/“Scad.”. The expiry date refers to the last day of that month.
• Store in the original packaging to protect the medicine from moisture.
• Do not use any pack of Galvus that is damaged or shows signs of tampering.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Galvus contains

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other components are anhydrous lactose, microcrystalline cellulose, sodium starch glycolate (type A) and magnesium stearate.

Description of the appearance of Galvus and contents of the pack
Galvus 50 mg tablets are round, flat, white to slightly yellowish, with “NVR” engraved 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 multiple packs containing 3 boxes, each box containing 112 tablets.
Not all pack sizes may be marketed in your country.

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

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

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

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

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

Latvija United Kingdom (Northern Ireland)
SIA Novartis Baltics Novartis Ireland Limited
Tel: +371 67 887 070 Tel: +44 1276 698370

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu