GALVUS 50 mg Film-Coated Tablets

Зміст інструкції

1. Galvus 50 mg tablets
   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. How to store Galvus
   6. Package contents and other information

Galvus 50 mg tablets

vildagliptin

Read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 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. It is used when diabetes cannot be controlled only by diet and exercise. It helps to control blood sugar levels. Your doctor will prescribe Galvus alone or together with other antidiabetic medicines that you are already taking, if these have not proven sufficiently effective in controlling diabetes.
Type 2 diabetes develops when the body does not produce enough insulin, or if the insulin produced by the body does not work as it should. It can 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 production of sugar by the liver, causing an increase in blood sugar levels. The pancreas produces both of these substances.

How Galvus works
Galvus works by inducing the pancreas to produce more insulin and less glucagon. This helps to control blood sugar levels. It has been shown that this medicine reduces blood sugar. This can help prevent complications arising from your diabetes. Even if you are now starting to take a medicine for diabetes, it is important that you continue to follow the diet and/or exercise that has been recommended to you.

2. What you need to know before you take Galvus

Do not take Galvus:

• if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptin or any of the excipients of 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 suffer from a condition called diabetic ketoacidosis.
• if you are taking a medicine for diabetes known as a sulfonylurea (if you take it together with Galvus, your doctor may want to reduce your dose of sulfonylurea, to avoid low blood glucose levels [hypoglycemia]).
• 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 have previously taken vildagliptin but had to stop due to liver disease, do 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.
It is also advisable to pay particular attention to the appearance of blisters or ulcers while
taking Galvus. If this occurs, you should consult your doctor quickly.
Before starting treatment with Galvus, a test will be performed to assess the functioning of the
liver, which will be repeated every three months during the first year of treatment and subsequently
periodically. This is to detect signs of increased liver enzymes as early as possible.

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 want to adjust the dose of Galvus if you are taking other medicines such as
for example:

• thiazides or other diuretics (also called water tablets)
• corticosteroids (usually used for the treatment of inflammation)
• thyroid medicines
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.
You should not use Galvus during pregnancy. It is not known whether Galvus passes into breast milk. You should not
use Galvus if you are breastfeeding or plan to breastfeed.

Driving and using machines
If you feel dizzy when taking Galvus, do not drive or use machines.

Galvus contains lactose
Galvus contains lactose (milk sugar). If your doctor has diagnosed you with intolerance to
certain sugars, contact him before taking this medicine.

Galvuscontains 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

How much to take and when
The amount of Galvus that you need to take varies depending on individual conditions. Your doctor will
tell you exactly how many Galvus tablets you need to take. The maximum daily dose is 100 mg.
The usual dose of Galvus is:

• 50 mg per day taken as a single dose in the morning if you take Galvus with another medicine called a sulfonylurea.
• 100 mg per day taken as 50 mg in the morning and 50 mg in the evening if you take Galvus alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.
• 50 mg per day 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 a little water.

For how long to take Galvus

• Take Galvus every day until your doctor advises you to do so. It is possible that you may need to continue this treatment for a long period of time.
• Your doctor will regularly check your condition to verify that the treatment is having the desired effect.

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 care may be needed. If you need to see a
doctor or go to hospital, take the packaging 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 your next dose, skip the dose you have
forgotten. 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 do so. If you have any doubts about the duration of
treatment with this medicine, ask 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 must stop taking Galvus and contact your doctor immediately if you experience any of the
following side effects:

• Angioedema (rare: may affect 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 and eyes, nausea, loss of appetite or dark urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (rare: may affect up to 1 in 1,000 people). Symptoms include severe and persistent abdominal pain (stomach area), which may spread 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 skin rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swelling of hands, ankles or feet (oedema), excessive sweating, vomiting, pain in the stomach and around the stomach (abdominal pain), diarrhoea, heartburn, nausea (feeling sick), blurred vision.
• Uncommon (may affect up to 1 in 100 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 the post-marketing of this medicine:

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 that is 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 a pack of Galvus that is damaged or shows signs of tampering.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Galvus contains

• The active ingredient 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.

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

Marketing authorisation 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 on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
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

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

United Kingdom (Northern Ireland)
Novartis Ireland Limited
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