Forflozin 10 mg 30 tablets

Trade name:

Forflozin 10 mg (Dapagliflozin 10 mg)  30 Film coated tablets

Composition:

Each tablet contains 12.3 mg dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.

Description:

Dapagliflozin is indicated as an adjunct treatment to improve glycemic control in adult patients with type 2 diabetes mellitus along with diet and exercise.

Indication:

Forflozin is indicated in adults for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

-As monotherapy when metformin is considered inappropriate due to intolerance.

-In addition to other medicinal products for the treatment of type 2 diabetes.

Heart failure: Forflozin is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.

Posology and method of administration:

Type 2 diabetes mellitus:

The recommended dose is 10 mg dapagliflozin once daily.

When dapagliflozin is used in combination with insulin or an insulin secretagogue, such as a sulphonylurea, a lower dose of insulin or insulin secretagogue may be considered to reduce the risk of hypoglycaemia.

Heart failure:

The recommended dose is 10 mg dapagliflozin once daily.

Special populations:

Treatment of diabetes mellitus in patients with renal impairment.

As glycaemic efficacy is dependent on renal function, Dapagliflozin should not be initiated to improve glycaemic control in patients with a glomerular filtration rate [GFR] < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min.

Hepatic impairment:

No dose adjustment is necessary for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, a starting dose of 5 mg is recommended. If well tolerated, the dose may be increased to 10 mg.

Patients with type 1 diabetes mellitus:

Forflozin 10 mg is not recommended for the treatment of heart failure in patients with type 1 diabetes mellitus.

Paediatric population:

The safety and efficacy of dapaliflozin in children aged 0 to < 18 years have not yet been established. No data are available.

Method of administration:

Forflozin can be taken orally once daily at any time of day with or without food. Tablets are to be swallowed whole.

Take dapagliflozin exactly as your healthcare provider tells you to take it.

Do not change your dose of dapagliflozin without talking to your healthcare provider.

Take dapagliflozin by mouth 1 time each day, with or without food.

Stay on your prescribed diet and exercise program while taking dapagliflozin.

Contraindications:

Forflozin 10 mg is not recommended for the treatment of heart failure in patients with type 1 diabetes mellitus.

Do not take dapagliflozin if you:

are allergic to dapagliflozin or any of the ingredients in dapagliflozin. 

Symptoms of a serious allergic reaction to dapagliflozin may include: skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing

If you have any of these symptoms, stop taking dapagliflozin and contact your healthcare provider or go to the nearest hospital emergency room right away.

Pregnancy:

There are no data from the use of dapagliflozin in pregnant women. 

The use of dapagliflozin is not recommended during the second and third trimesters of pregnancy.

When pregnancy is detected, treatment with dapagliflozin should be discontinued.

Breast feeding:

As unknown whether dapagliflozin and/or is metabolites are excreted in human milk.

A risk to the newborns/infants can not be excluded. Dapaglitlozin should not be used while breast-feeding.

Side Effects:

Stop taking dapagliflozin and call your healthcare provider right away if you get any of the following symptoms:

nausea

vomiting

stomach area (abdominal) pain

tiredness

trouble breathing

Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin. 

Low blood sugar (hypoglycemia) in patients with diabetes mellitus. If you take dapagliflozin with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. 

A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum).

The most common side effects of dapagliflozin include:

vaginal yeast infections and yeast infections of the penis

stuffy or runny nose and sore throat

changes in urination, including urgent need to urinate more often, in larger amounts, or at night

These are not all the possible side effects of dapagliflozin. For more information, ask your healthcare provider or pharmacist.

Storage:

Store at a temperature not exceeding 30°C in a dry place.

Package:

A Carton Box contains  blisters with tablets. 30 tablets