Description:

Galdis M 50mg/1000mg Tablets (Vildagliptin 50mg + Metformin Hydrochloride 1000mg) is a fixed-dose combination oral antidiabetic medication used to improve glycaemic control in adults with type 2 diabetes mellitus when diet, exercise, and monotherapy with either agent alone are insufficient. Vildagliptin enhances insulin secretion and suppresses glucagon release in a glucose-dependent manner (via DPP-4 inhibition), while metformin reduces hepatic glucose production, improves insulin sensitivity, and decreases intestinal glucose absorption. The combination provides synergistic blood sugar control with lower risk of hypoglycaemia than some other agents. In Ghana (Accra), it is a common prescription medication available in pharmacies (e.g., Scab Pharmacy, Country Medical Pharmacy, Trafalgar Gate Pharma) for type 2 diabetes management.

Prescription:

Prescription-only (requires a doctor’s prescription in Ghana; dispensed by pharmacies with Rx for diabetes diagnosis, HbA1c monitoring, and renal function assessment; not OTC due to risk of lactic acidosis from metformin and need for monitoring).

Therapeutic Category:

Oral Antidiabetic / Fixed-Dose Combination (DPP-4 inhibitor + biguanide.

Active Ingredients/Composition: Each film-coated tablet contains:

• Vildagliptin – 50 mg (DPP-4 inhibitor).
• Metformin hydrochloride – 1000 mg (biguanide). Other ingredients (excipients, typical): Microcrystalline cellulose, hydroxypropyl cellulose, crospovidone, magnesium stearate, hypromellose, titanium dioxide, macrogol, talc, and colorants (e.g., iron oxides). Tablets are film-coated (often white/off-white or light yellow, oval/capsule-shaped).

Vitamins: None.

Minerals: None.

Variant:

• Galdis M 50mg/1000mg Tablets (standard fixed-dose combination). Related variants: Galdis M 50mg/500mg (lower metformin dose), Galdis M 50mg/850mg, or plain vildagliptin/metformin generics. The 50/1000 mg is the higher metformin strength for patients needing more glucose control.

Consume Type:

Oral – Film-coated tablet (swallow whole with water; do not crush/chew).

Directions/Usage: Take as prescribed (usually twice daily).

• Adults: 1 tablet twice daily (morning and evening) with meals (to reduce GI side effects from metformin).
• Maximum daily dose: 100 mg vildagliptin + 2000 mg metformin.
• Renal function monitoring required (eGFR >45 mL/min/1.73m² for full dose; adjust or avoid if impaired).
• Duration: Long-term (often lifelong) for type 2 diabetes; do not stop without doctor advice.
• Take with food to minimize GI upset.

Common Side Effects: Common:

• Gastrointestinal: Nausea, vomiting, diarrhoea, abdominal pain, loss of appetite (mainly from metformin).
• Headache
• Dizziness
• Nasopharyngitis (upper respiratory symptoms)
• Hypoglycaemia (low blood sugar – rare with this combination alone, higher if combined with sulfonylureas/insulin). Other: Fatigue, metallic taste. Rare/serious (seek help): Lactic acidosis (severe fatigue, muscle pain, breathing difficulty – metformin risk), pancreatitis (severe abdominal pain), severe allergic reactions, or liver enzyme elevation.

Package Type:

Blister packs (commonly 15 tablets per strip, packs of 2×15 = 30, 4×15 = 60, or 6×15 = 90 tablets; foil blisters in carton with patient information leaflet).

Storage Advice: Store at room temperature (below 25–30°C) in a cool, dry place, away from direct sunlight, heat, and moisture. Keep in original packaging, tightly closed. Out of reach of children.

Safety Advice:

• Contraindicated in hypersensitivity to vildagliptin/metformin, severe renal impairment (eGFR <30 mL/min/1.73m²), acute/chronic metabolic acidosis, diabetic ketoacidosis, or severe heart failure.
• Caution in elderly, renal impairment (dose adjustment needed), heart failure, liver disease, or alcohol use (increases lactic acidosis risk).
• Monitor renal function (eGFR) before start and periodically (metformin risk).
• Stop temporarily before/after surgery or iodinated contrast imaging (lactic acidosis risk).
• If severe abdominal pain, persistent vomiting, breathing difficulty, muscle pain, or unusual tiredness occurs, seek immediate care (possible lactic acidosis or pancreatitis).
• Regular blood sugar and HbA1c monitoring essential.

Product Substitutes: Similar vildagliptin 50mg + metformin 1000mg tablets in Ghana include:

• Generic vildagliptin/metformin 50/1000 mg (various importers).
• Galvus Met 50/1000 mg (Novartis original brand, higher price if stocked).
• Glikit 50/1000 mg or other local generics. Alternatives: Sitagliptin + metformin (Janumet generics), linagliptin + metformin, or separate vildagliptin + metformin tablets. Consult endocrinologist/pharmacist in Accra for switch.

Manufacturer/Marketer:

Cheplapharm Arzneimittel GmbH or similar (Galdis M often a generic/distributed brand; original Galvus Met by Novartis, but Cheplapharm handles many generics in export markets). Marketed/distributed in Ghana by local importers/pharmacies (widely stocked at outlets like Scab Pharmacy, Country Medical Pharmacy, Trafalgar Gate Pharma).

Country of Origin:

India (primary source for Galdis M / vildagliptin 50mg + metformin 1000mg tablets imported to Ghana; BP/USP-compliant generics common in African markets).