Jalra^® M

Vildagliptin / Metformin

50 mg/850 mg – 50 mg/1,000 mg.

Product leaflet summary

Therapeutic Indications:

JALRA M is a medicine used to treat type 2 diabetes. It is prescribed together with diet and exercise in patients who have already received treatment with vildagliptin and metformin hydrochloride together, or whose diabetes is not adequately controlled with metformin hydrochloride or vildagliptin alone, or as a first diabetes treatment in patients whose diabetes is not adequately controlled by diet and exercise alone.

Dosage and Administration:

Your doctor will tell you exactly how many tablets of JALRA M to take. The usual dose of JALRA M is one or two tablets a day. Do not exceed two tablets a day. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose. Your doctor will prescribe JALRA M either alone or in combination with another antidiabetic treatments depending on your condition.

Contraindications:

Hypersensitivity to the active substances or to any of the excipients listed.
− Diabetic ketoacidosis or diabetic pre-coma
− Renal failure or renal dysfunction defined as creatinine clearance < 60 ml/min
− Acute conditions with the potential to alter renal function, such as:
– dehydration,
– severe infection,
– shock,
– intravascular administration of iodinated contrast agents.
− Acute or chronic disease which may cause tissue hypoxia, such as:
– cardiac or respiratory failure,
– recent myocardial infarction,
– shock.
− Hepatic impairment
− Acute alcohol intoxication, alcoholism
− Breast-feeding

Pregnancy and Lactation:

Pregnancy:

There are no adequate data from the use of JALRA M in pregnant women. For vildagliptin studies in animals have shown reproductive toxicity at high doses. For metformin, studies in animals have not shown reproductive toxicity. Studies in animals performed with vildagliptin and metformin have not shown evidence of teratogenicity, but foetotoxic effects at maternotoxic doses. The potential risk for humans is unknown. JALRA M should not be used during pregnancy.
Breast-feeding:
Studies in animals have shown excretion of both metformin and vildagliptin in milk.
It is unknown whether vildagliptin is excreted in human milk, but metformin is excreted in human milk in low amounts. Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, JALRA M should not be used during breast-feeding.

Ability to Drive and Use Machinery:

No studies on the effects of JALRA M on the ability to drive and use machines have been performed. Patients who may experience dizziness as an adverse reaction should avoid driving vehicles or using machines

Package Presentation:

1. A box of 60 tablets each contains 50 mg vildagliptin / 1000 mg metformin
2. A box of 60 tablets each contains 50 mg vildagliptin / 850 mg metformin