Dapldm Tablet 5 mg (Dapagliflozin Monohydrate Mixture)

Adult dose

The recommended dose for this medication is 10 mg once daily for monotherapy and additional combination therapy. For initial combination therapy, it is 5 mg or 10 mg once daily. This medication can be taken orally at any time of day with or without food. The tablet should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in patients under 18 years of age have not been established.

This medication should not be used in certain patients. First, individuals allergic to the active ingredient or excipients, patients with type 1 diabetes, and those with diabetic ketoacidosis should not take this medication. Additionally, patients with lactose intolerance or specific genetic disorders, as well as those undergoing dialysis should not take this drug. Patients with reduced fluid volume or kidney function issues should use this medication cautiously, as it may lower blood pressure or decrease blood volume, potentially leading to hypotension or worsening of kidney function. Increased caution is particularly necessary for the elderly, patients on diuretics, and those with impaired kidney function. This medication contains Yellow No. 4 and Yellow No. 5 dyes, and patients allergic to these components should also use it cautiously. Common side effects that may occur while taking this medication include genital infections and urinary tract infections. These occur more frequently in female patients, and early treatment is necessary if symptoms of infection appear. Hypoglycemic symptoms may also occur, particularly when taken with blood sugar-lowering agents such as insulin or sulfonylureas, increasing the risk. Care should be taken to monitor blood sugar levels when taken with such medications. Dehydration or hypotension symptoms caused by reduced fluid volume may also occur, so consult a doctor if symptoms like dizziness or dry mouth arise. Rarely, a serious metabolic disorder called diabetic ketoacidosis may occur; if symptoms such as vomiting, abdominal pain, or difficulty breathing occur, medical attention should be sought immediately. This medication may affect kidney function, so regular kidney function tests are recommended, and if abnormalities are observed, consult healthcare professionals. Women who are pregnant or breastfeeding are advised not to use this medication, and it should be stopped immediately if pregnancy is confirmed. The safety and efficacy of this medication have not been established in children, so it should not be used in pediatric patients. In cases of overdose, as no specific antidote exists, immediate medical treatment should be sought if the prescribed dose is exceeded. This medication does not significantly affect driving or machine operation, but caution is needed due to the risk of hypoglycemia. Finally, this medication should be stored out of reach of children and kept in its original container to maintain its quality.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in the mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme drowsiness, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination problems

Mild side effects

• Vulvitis
• balanititis
• and related genital infections
• urinary tract infections
• hypoglycemia
• dizziness
• constipation
• dry mouth
• back pain
• dysuria

Store this medication in a tightly closed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This helps to preserve the medication's effectiveness for a longer period.

Appearance

Yellow, biconvex, round film-coated tablet

Package unit

PTP - 28 tablets/box [(7 tablets/PTP X 4)]