50 mg tablets
vildagliptin
1. What Galvus is and what it is used for
Galvus is used in the treatment of adult patients with type 2 diabetes. It is used when the disease can not be regulated with only diet and exercise. It helps regulate blood sugar levels. Your doctor will prescribe that Galvus be taken either alone or at the same time as some other diabetes medicines that you are already taking if these have not been shown to be effective enough to control diabetes.
Type 2 diabetes develops if the body does not produce enough insulin or if the insulin it produces does not work satisfactorily. Diabetes can also develop if 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 sugar production in the liver, which causes blood sugar levels to rise. Both of these substances are produced in the pancreas.
How Galvus works
Galvus works by causing the pancreas to produce more insulin and less glucagon. This helps regulate blood sugar levels. This medication has been shown to lower blood sugar, which can help prevent complications of your diabetes. Even if you are now starting medication for your diabetes, it is important that you continue to follow the diet and/or exercise regulations recommended.
The active substance for Galvus, vildagliptin, belongs to a group of medicines called ‘oral diabetes medicines.
2. What you need to know before taking 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 other ingredients of Galvus, do not take this medicine without talking to a doctor.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Galvus.
- if you have type 1 diabetes (ie your body does not produce insulin ) or if you have a condition called diabetic ketoacidosis.
- if you are taking a diabetes medicine known as a sulphonylurea (your doctor may want to lower your dose of a sulphonylurea when you take it with Galvus to avoid low blood sugar [hypoglycaemia]).
- if you have moderate or severe kidney disease (you will need to take a lower dose of Galvus).
- if you are being treated with 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 taken vildagliptin before but have had to stop taking it due to liver disease, you should not take this medicine.
Skin disorders are a common complication in diabetics. Follow the recommendations you receive from your doctor or nurse for skin and foot care. Take special care to detect new blisters or sores when taking Galvus. If this happens, contact your doctor immediately.
Liver function tests will be performed before starting treatment with Galvus at three-month intervals during the first year and periodically thereafter. This is to detect elevated liver enzyme values as early as possible.
Children and young people
The use of Galvus in children and adolescents up to 18 years of age is not recommended.
Other drugs and Galvus
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
Your doctor may want to change your dose of Galvus if you are taking other medicines such as:
- thiazides or other diuretics (also called diuretics )
corticosteroids (commonly used to treat inflammation ) - drugs for thyroid disease
- certain drugs that affect the nervous system.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 unknown if Galvus passes into breast milk. You should not use Galvus if you are breastfeeding or planning to breastfeed.
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 (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.
3. How to take Galvus
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much to take and when
Dose a Galvus varies from person to person depending on their condition. Your doctor will tell you exactly how many tablets to take Galvus. The maximum daily dose is 100 mg.
The usual dose of Galvus is either:
- 50 mg daily, taken as a dose in the morning if you are taking Galvus with another medicine called sulphonylurea.
- 100 mg daily, 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, in combination with metformin and a sulphonylurea, or with insulin .
- 50 mg daily in the morning if you have moderate or severe kidney disease or if you receive dialysis .
How to take Galvus
- Swallow the tablets whole along with a little water.
How long to take Galvus
- Take Galvus every day for as long as your doctor tells you. You may need to be treated for a long time.
- Your doctor will check you regularly to see if the treatment has the desired effect.
If you take more Galvus than you should
If you take more Galvus than you should, or if someone else has taken your medicine, contact a doctor immediately. You may need medical attention. If you need to see a doctor or go to a hospital, bring your medicine pack.
If you forget to take Galvus
If you forget to take a dose, take it as soon as you remember. Then take your next dose at the usual time. However, if it is soon time to take your next dose, skip the missed dose. 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. Talk to your doctor if you have any questions about how long to take this medicine.
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 see a doctor immediately if you get any of the following side effects:
- Angioedema (rare: affects up to 1 in 1,000 people): symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives, which may be a sign of a reaction called “angioedema” ”.
- Liver disease ( hepatitis ) (rare): symptoms include yellowing of the skin and whites of the eyes, nausea, decreased appetite or dark-colored urine, which may be signs of liver disease ( hepatitis ).
- Inflammation of the pancreas ( pancreatitis ) (no known frequency): Symptoms include severe and persistent abdominal pain, which can reach the back of your back, as well as nausea and vomiting.
Other side effects are
Some patients have experienced the following side effects while taking Galvus with metformin:
- Common (affects up to 1 in 10 people): Tremors, headache, dizziness, nausea, low blood sugar
- Uncommon (affects up to 1 in 100 people): Fatigue
Some patients have experienced the following side effects while taking Galvus with a sulphonylurea:
- Common: Tremors, headache, dizziness, weakness, low blood sugar
- Uncommon: Constipation
- Very rare (affects up to 1 in 10,000 people): Sore throat, runny nose
Some patients have experienced the following side effects while taking Galvus with a glitazone:
- Common: Weight gain, swollen hands, ankles and feet ( edema )
- Uncommon: Headache, weakness, low blood sugar
Some patients have experienced the following side effects when taking Galvus as the only medicine:
- Common: Dizziness
- Uncommon: Headache, constipation, swollen hands, ankles and feet ( edema ), joint pain, low blood sugar
- Very rare: Sore throat, runny nose, fever
Some patients have experienced the following side effects while taking Galvus, metformin, and a sulphonylurea:
- Common: Dizziness, tremors, weakness, low blood sugar, excessive sweating
Some patients have experienced the following side effects while taking Galvus with insulin (with or without metformin ):
- Common: Headache, chills, nausea, low blood sugar, heartburn
- Uncommon: Diarrhea, flatulence
Following the marketing authorization of the medicinal product, the following side effects have also been reported:
- No known frequency (can not be calculated from the available data): Itchy rash, inflammation of the pancreas, localized flaking of skin or blisters, muscle pain.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
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 which is stated on the carton and carton after EXP. The expiration date is the last day of the specified month.
- Store in the original package. Moisture sensitive.
- Do not use Galvus if the packaging is damaged or shows signs of change.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- 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.
What the medicine looks like and contents of the pack
Galvus 50 mg tablets are round, white to light yellowish and flat, debossed with “NVR” on one side and “FB” on the other side.
Galvus 50 mg tablets are available in packs of 7, 14, 28, 30, 56, 60, 90, 112, 180, or 336 tablets and in multiple packs of 3 packs, each pack containing 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Lek dd
Verovskova ulica 57
Ljubljana 1526
Slovenia
Novartis Pharmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
| Czech RepublicNovartis sroTel: +420 225 775 111 | HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872 |
| GermanyNovartis Pharma GmbHTel: +49 911 273 0 | The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111 |
| EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 | NorwayNovartis Norge ASTel: +47 23 05 20 00 |
| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600 |
| CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 | SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439 |
| ItalyNovartis Farma SpATel: +39 02 96 54 1 | Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200 |
| ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 | SwedenNovartis Sverige ABTel: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsTel: +371 67 887 070 | United Kingdom (Northern Ireland)Novartis Ireland LimitedTel: +44 1276 698370 |