Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - galvus

Document Subject

Generated Narrative: MedicinalProductDefinition mpc93f079fae06a5c704ad307341692636

identifier: http://ema.europa.eu/identifier/EU/1/07/414/001-010

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Galvus 50 mg tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-c93f079fae06a5c704ad307341692636

identifier: http://ema.europa.eu/identifier/EU/1/07/414/001-010

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - galvus

Attesters

What is in 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

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 by diet and exercise alone. It helps to control the level of sugar in the blood. Your doctor will prescribe Galvus either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes.

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.

How Galvus works Galvus works by making the pancreas produce more insulin and less glucagon. This helps to control the blood sugar level. This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes. 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.

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 other ingredients of Galvus, do not take this medicine and talk to 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 anti-diabetic medicine known as a sulphonylurea (your doctor may want to reduce your dose of the sulphonylurea when you take it together with Galvus in order to avoid low blood glucose [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 have previously taken vildagliptin but had to stop taking it because of liver disease, you should not take this medicine.

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.

A test to determine your liver function will be performed before the start of Galvus treatment, at three- month intervals for the first year and periodically thereafter. This is so that signs of increased liver enzymes can be detected as early as possible.

Children and adolescents The use of Galvus in children and adolescents up to 18 years of age is not recommended.

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 wish to alter your dose of Galvus if you are taking other medicines such as:

• thiazides or other diuretics (also called water tablets)
• corticosteroids (generally used to treat inflammation)
• thyroid medicines
• certain medicines affecting the nervous system.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

Galvus contains lactose 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.

Galvus contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium free .

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take and when 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 maximum daily dose is 100 mg.

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.

• 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 sulphonylurea, or with insulin.

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

How to take Galvus

• 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.

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.

If you stop taking Galvus 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.

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

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: may affect up to 1 in 1 000 people): 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) (frequency not known): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured 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 pain in the abdomen (stomach area), which might reach through to your back, as well as nausea and vomiting.

Other side effects

Some patients have had the following side effects while taking Galvus:

• 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, trembling, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles or feet (oedema), excessive sweating, vomiting, pain in and around the stomach (abdominal pain), diarrhoea, heartburn, nausea (feeling sick), blurred vision.
• Uncommon (may affect up to 1 in 100 people): weight increase, chills, weakness, sexual dysfunction, low blood glucose, flatulence.
• Rare (may affect up to 1 in 1 000 people): inflammation of the pancreas.

Since this product has been marketed, the following side effects have also been reported:

• Frequency not known (cannot be estimated from the available data): localised peeling of skin or blisters, blood vessel inflammation (vasculitis) which may result in skin rash or pointed, flat, red, round spots under the skin's 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• 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 the carton after EXP . 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.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 comprising 3 cartons, 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 Ljubljana 1Slovenia

Novartis Farmac utica S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

Novartis Pharma GmbH Roonstrasse D-90429 Nuremberg Germany

Novartis Pharmaceutical Manufacturing LLC Verovskova ulica Ljubljana 1Slovenia

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

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

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