GALVUS MET 50 mg/1000 mg TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Novartis South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS METFORMIN HYDROCHLORIDE 1000,0 mg VILDAGLIPTIN 50,0 mg

Authorization status:

Registered

Authorization date:

2014-03-07

Patient Information leaflet

GALVUS MET 50 MG/850 MG TABLET
GALVUS MET 50 MG/1 000 MG TABLET
Vildagliptin 50 mg per tablet
Metformin hydrochloride 850 mg or 1000 mg per tablet
Patient Information Leaflet
Document status:
Final
Release date:
06 July 2022
Novartis
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GALVUS MET
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S3
GALVUS MET 50 / 850 MG
GALVUS MET 50 / 1000 MG
VILDAGLIPTIN 50 MG / METFORMIN 850 MG OR VILDAGLIPTIN 50 MG /
METFORMIN 1000 MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING GALVUS MET
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other
health care provider.
•
GALVUS MET has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same
as yours.
WHAT IS IN THIS LEAFLET
1. What GALVUS MET is and what it is used for
2. What you need to know before you take GALVUS MET
3. How to take GALVUS MET
4. Possible side effects
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GALVUS MET
5. How to store GALVUS MET
6. Contents of the pack and other information
1.
WHAT GALVUS MET IS AND WHAT IT IS USED FOR
GALVUS MET is available as tablets. Each tablet of GALVUS MET contains
two active
substances: vildagliptin and metformin hydrochloride.
Two dosage strengths are available:
•
One tablet containing 50 mg vildagliptin and 850 mg metformin
hydrochloride.
•
One tablet containing 50 mg vildagliptin and 1 000 mg metformin
hydrochloride.
GALVUS MET is a medicine used to treat type 2 diabetes.
GALVUS MET helps to control the level of sugar in the blood. Such
medicines are known as
oral antidiabetics.
Your doctor has prescribed GALVUS MET for you if your blood sugar
level has been controlled
when you take vildagliptin and metformin hydrochloride as separate
tablets and at the same
dosages.
GALVUS MET can also be prescribed for you in combination with a
sulphonylurea if your blood
sugar level has been controlled on vildagliptin, metformin
hydrochloride and a su

Summary of Product characteristics

GALVUS MET 50 MG/850 MG TABLET
GALVUS MET 50 MG/1 000 MG TABLET
Vildagliptin 50 mg per tablet
Metformin hydrochloride 850 mg or 1000 mg per tablet
Professional Information
Document status:
Final
Release date:
06 July 2022
Novartis
Page 2
06 July 2022
GALVUS MET
PROFESSIONAL INFORMATION LEAFLET
SCHEDULING STATUS S3
1
NAME OF THE MEDICINE
GALVUS MET 50 mg/850 mg tablet
GALVUS MET 50 mg/1 000 mg tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
GALVUS MET 50 mg/850 mg: Each tablet contains 50 mg vildagliptin and
850 mg metformin
hydrochloride.
GALVUS MET 50 mg/1 000 mg: Each tablet contains 50 mg vildagliptin and
1 000 mg metformin
hydrochloride.
3
PHARMACEUTICAL FORM
GALVUS MET 50 mg/850 mg: yellow, ovaloid bevelled edge, film-coated
tablet imprinted with "NVR"
on one side and "SEH" on the other side.
GALVUS MET 50 mg/1 000 mg: dark yellow, ovaloid bevelled edge,
film-coated tablet imprinted with
"NVR" on one side and "FLO" on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For patients with Type 2 diabetes mellitus (T2DM):
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GALVUS MET
GALVUS MET is indicated as an adjunct to diet and exercise in patients
who are already stabilised
with the combination of vildagliptin and metformin hydrochloride at
the same dosages, as separate
tablets.
GALVUS MET is indicated as add-on to insulin as an adjunct to diet and
exercise in patients on a
stable dose of insulin plus vildagliptin and metformin hydrochloride.
GALVUS MET is indicated as an add-on to insulin at the same dosages as
the separate tablets of
vildagliptin and metformin hydrochloride.
GALVUS MET is indicated in combination with sulphonylurea (SU) (i.e.
triple combination therapy) as
an adjunct to diet and exercise in patients stabilised on
vildagliptin, metformin hydrochloride and a
sulphonylurea.
GALVUS MET can be used to replace the vildagliptin and metformin
hydrochloride at the same
dosages as the separate tablets.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
In using GALVUS MET do not exceed the maximum daily dose of