Folgazene 5mg (Dapagliflozin Propanediol Hydrate)

Adult dose

This medication can be taken orally once daily at any time during the day, regardless of food intake. The tablet should be swallowed whole.

Child dose

Efficacy and safety of dapagliflozin in children under 18 years have not been established. There are no relevant data.

This medication should not be administered to certain patients. Patients allergic to the active ingredient or excipients of this medication, those with type 1 diabetes, diabetic ketoacidosis, lactate intolerance or related genetic diseases, and patients undergoing dialysis should not use this medication. It should be administered with caution to patients with decreased fluid volume or renal function issues. This medication can cause low blood pressure or rapid changes in kidney function, particularly in elderly patients with impaired renal function or those taking diuretics, increasing their risk. Therefore, fluid status and renal function should be assessed prior to administration, and symptoms of hypotension and kidney function should be monitored periodically after administration. This medication is not recommended for patients with severely reduced renal function, and its effect on blood sugar control varies according to renal function. While taking this medication, side effects such as genital infections, urinary tract infections, hypoglycemia, dehydration, and diabetic ketoacidosis may occur. Especially, genital infections are more common in females, with a higher chance of recurrence in those with a history of infections. Hypoglycemia may occur primarily when taken with insulin or sulfonylureas, so dosage adjustments may be necessary when used in combination with these medications. Dehydration or hypotensive symptoms may occur due to decreased fluid volume, so immediate consultation with healthcare professionals is necessary if these symptoms appear. Diabetic ketoacidosis can occur even if blood sugar levels are not high, so if symptoms such as vomiting, abdominal pain, or difficulty breathing occur, immediate examination and treatment are required. This medication is not recommended for patients with severely impaired liver function, and additional caution is needed for elderly patients or those on diuretics. Furthermore, it is advised not to use this medication during pregnancy and to avoid use while breastfeeding. This medication may interact with other drugs, so inform healthcare professionals, especially if you are taking diuretics, insulin, or sulfonylureas. In case of overdose, there is no specific antidote, so treatment should be provided according to the symptoms, and immediate contact with a medical institution is necessary if needed. Finally, the safety and efficacy of this medication have not been established in children and should not be used in pediatric patients. While taking this medication, caution is needed when driving or operating machinery to account for the risk of hypoglycemia. This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and should be kept at room temperature between 1°C and 30°C.

Serious side effects

• Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat → severe allergic reactions
• High fever with severe rash, blisters, skin peeling, pain in mucous membranes of the mouth/eyes → severe skin adverse reactions
• Shortness of breath or difficulty breathing, asthma attacks, cough + fever accompanied by respiratory abnormalities → respiratory problems
• Yellowing of the skin or eyes (jaundice), extreme lethargy → liver problems (jaundice)

Mild side effects

• Vulvovaginitis
• balanitis and related genital infections
• urinary tract infections
• hypoglycemia
• dizziness
• constipation
• dry mouth
• lumbar pain
• dysuria
• polyuria

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1°C and 30°C.

Appearance

Yellow, biconvex, round film-coated tablet

Package unit

Domestic - 30 tablets/bottle, Export - 28 tablets/box [(7 tablets/Alu-Alu) x 4]