Janumet (sitagliptin phos metformin hcl) 56 Film Coated Tablets

JANUMET 50/1000 mg film-coated tablet To be taken orally.

Active ingredient
Each film-coated tablet contains 50 mg of sitagliptin (64.25 mg as sitagliptin phosphate monohydrate) and 1000 mg of metformin hydrochloride.

Excipients
Microcrystalline cellulose, polyvinylpyrrolidone, sodium lauryl sulfate, sodium stearyl fumarate, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, black iron oxide.

1. What is JANUMET and what is it used for?

JANUMET consists of two prescription drugs, sitagliptin and metformin, which lower blood sugar. Sitagliptin is a DPP-4 (dipeptidyl peptidase-4) inhibitor and metformin is a biguanide class drug and both work together to keep blood sugar levels under control in patients with type II diabetes.

These two agents together control blood sugar levels in patients with type II diabetes. JANUMET helps improve post-meal insulin levels and lowers the amount of sugar your body produces.

When used with diet and exercise, this medicine helps lower your blood sugar. JANUMET can be used alone or in combination with another diabetic medicine called a sulfonylurea.

JANUMET is available in packages of 56 tablets. Each tablet contains 50 mg of sitagliptin and 1000 mg of metformin.

What is Type II diabetes (Type II diabetes)?

Type II diabetes is also known as non-insulin dependent diabetes mellitus (NIDDM). Type II diabetes is a disease in which your body cannot produce enough insulin and the insulin produced cannot work as it should. Your body may also produce too much sugar. In this case, sugar (glucose) builds up in your blood and can lead to serious medical problems such as heart disease, kidney disease, blindness and amputation.

2.How to use JANUMET?
Instructions for proper use and dose/frequency of administration

Always use JANUMET exactly as your doctor has told you. Your doctor may increase the dose of the drug to keep your blood sugar under control.

Recommended dose to use:

• 1 tablet twice a day

During Janumet treatment, you should continue your diet and take care to distribute your carbohydrate intake evenly throughout the day. If you are overweight, continue with your calorie-restrictive diet as instructed.

Application route and method

• Should be taken orally

• Take with meals to reduce the possibility of stomach discomfort.

• Take the tablets with a sufficient amount of liquid (eg with a glass of water).

Use in children

No studies have been conducted with JANUMET in children under 18 years of age.
Use in the elderly

Since Janumet is excreted by the kidneys, it should be used with caution as age increases and renal function should be closely monitored. Your doctor will decide the appropriate dose for you.

Special use cases

Use in the elderly

Janumet alone is not likely to cause abnormally low blood sugar (hypoglycemia). When Janumet is used with a sulfonylurea medicine, blood sugar may drop and your doctor may reduce the dose of your sulfonylurea medicine. Sometimes you may need to stop taking your medicine for a short time. Contact your doctor if you have:

• Severe vomiting with nausea,

• if you have a condition associated with dehydration, such as diarrhea or fever, or if you drink much less fluid than usual,

• If you are planned to have a surgical operation,

• If you are going to be injected with dye or contrast agent for radiography.

Do not forget to take your medicine.

If you have the impression that the effect of Janumet is too strong or too weak, talk to your doctor or pharmacist.

3. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to the substances contained in JANUMET.

Side effects are listed as shown in the categories below. Very common: may occur in at least 1 in 10 patients.

Common: less than 1 in 10 patients, but more than 1 in 100 patients. Uncommon: less than 1 in 100 patients, but more than 1 in 1000 patients. Rare: less than 1 in 1000 patients. Very rare: less than 1 in 10000 patients.

Unknown frequency: It can be seen in too few patients to be determined with the available data. Very rare:

Patients taking metformin (one of the active ingredients of JANUMET) have experienced a condition called lactic acidosis (too high levels of lactic acid in your blood). This condition is more common in patients whose kidneys are not functioning adequately. If any of the following symptoms of lactic acidosis occur, stop taking Janumet and IMMEDIATELY inform your doctor or go to the nearest hospital emergency department:

• If you feel sick (nausea, vomiting)