Glidap tab 10mg #30

Active ingredient: dapagliflozin – 10 mg. It belongs to a group of medicinal products known as “sodium-glucose co-transporter-2 (SGLT2) inhibitors.” They inhibit the SGLT2 protein in your kidneys. By inhibiting this protein, blood sugar (glucose), salt (sodium), and water are removed from your body through urine.

Dapagliflozin is used for:
• Type 2 diabetes:

- in adults and children aged 10 years and older;

- when type 2 diabetes cannot be controlled by diet and exercise;

- dapagliflozin may be used alone or together with other medicines for treating diabetes;

- it is important to follow the recommendations on diet and exercise given by your doctor, pharmacist, or nurse.

• Heart failure:

- dapagliflozin is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.

• Chronic kidney disease

- for the treatment of chronic kidney disease in adults.

Excipients: sufficient quantity.

Colorant: titanium dioxide BP, iron oxide (yellow) USP NF.

Do not take this medicine if you have any of the following:
Consult your doctor, pharmacist, or nurse before taking dapagliflozin if:

• you are allergic to dapagliflozin or any of the other ingredients of this medicine.
• you have “type 1 diabetes” – a type that usually starts in young people and your body cannot produce insulin.
• you have diabetes and kidney problems – your doctor may ask you to take an additional or different medicine to control your blood glucose.
• you have liver problems – your doctor may start treatment with a lower dose.
• you are taking medicines to lower blood pressure (antihypertensives) and have a history of low blood pressure (hypotension).
• you have very high levels of sugar in your blood, which may cause dehydration (loss of a large amount of fluid from the body).
• you have or develop nausea (feeling sick), vomiting, or fever, or if you cannot eat or drink. These conditions may cause dehydration. Your doctor may ask you to stop taking dapagliflozin tablets until you recover to prevent dehydration.
• you often get urinary tract infections.

Necrotizing fasciitis of the perineum:
• Contact your doctor immediately if you develop a combination of symptoms such as pain, tenderness, redness, or swelling of the genitals or the area between the genitals and anus, with fever and a general feeling of being unwell. These symptoms may be a sign of a rare but serious or life-threatening infection called necrotizing fasciitis of the perineum or Fournier’s gangrene, which destroys tissue under the skin. Fournier’s gangrene requires immediate treatment.

Diabetic ketoacidosis:
• If you have diabetes and feel or have nausea, stomach pain, excessive thirst, rapid and deep breathing, confusion, unusual sleepiness or fatigue, a sweet smell on the breath, a sweet or metallic taste in the mouth, or a different smell of urine or sweat, or rapid weight loss. These symptoms may be a sign of “diabetic ketoacidosis” – a serious, sometimes life-threatening condition that can occur in diabetes due to increased levels of “ketone bodies” in your urine or blood, as shown by tests.
• The risk of developing diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased insulin requirements due to major surgery or serious illness.
• While being treated with dapagliflozin, diabetic ketoacidosis can occur even if your blood sugar level is normal.
If you suspect diabetic ketoacidosis, contact a doctor immediately or go to the nearest hospital and do not take this medicine.

Glucose in urine:
Due to the way dapagliflozin works, your urine test for sugar may be positive while taking this medicine.

Other medicines and dapagliflozin tablets:
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor if:
• you are taking diuretics, to remove fluid from the body.
• you have type 2 diabetes or are taking other medicines that lower blood sugar, such as insulin or a “sulfonylurea.” Your doctor may consider lowering the dose of these other medicines to avoid low blood sugar levels (hypoglycemia).

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should stop taking this medicine if you become pregnant, as it is not recommended during the second and third trimesters of pregnancy. Talk to your doctor about the best ways to control your blood sugar during pregnancy.
Tell your doctor if you wish to breastfeed or are breastfeeding before taking this medicine. Do not use dapagliflozin tablets while breastfeeding. It is unknown whether this medicine passes into breast milk.

Driving and using machines: if you feel dizzy after taking dapagliflozin, do not drive or use machines.

Contains: dapagliflozin contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take dapagliflozin?
Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor, pharmacist, or nurse.

Recommended dose: 10 mg tablet once daily. Your doctor may start you on a 5 mg dose if you have liver problems. Your doctor will prescribe the dose that is right for you.
• Swallow the tablet whole with half a glass of water.
• The tablet can be taken with or without food.
• You can take the tablet at any time of the day. However, try to take it at the same time each day. This will help you remember to take it.
• Your doctor may prescribe dapagliflozin together with other medicine(s). Do not forget to take these other medicines as prescribed by your doctor. This will help achieve the best results for your health.
• Diet and exercise help your body use blood glucose better.

• If you have diabetes, it is important to follow the diet and exercise program recommended by your doctor while taking dapagliflozin.

If you take more dapagliflozin than you should: consult a doctor or go to a hospital immediately.

If you forget to take dapagliflozin:
• If there are 12 hours or more until your next dose, take dapagliflozin as soon as you remember. Then take your next dose at the usual time.
• If there are less than 12 hours until your next dose, skip the missed dose. Then take the next dose at the usual time.
• Do not take a double dose of dapagliflozin to make up for a missed dose.

If you stop taking dapagliflozin:
Do not stop taking dapagliflozin without consulting your doctor. If you have diabetes, your blood sugar levels may increase without this medicine.

Possible side effects:
Contact a doctor or the nearest hospital immediately if you experience any of the following side effects:
• Angioedema, which is rare (may affect up to 1 in 10,000 people).
Signs of angioedema:

- swelling of the face, tongue, or throat;

- difficulty swallowing;

- hives and breathing problems.

• Diabetic ketoacidosis, rare in patients with type 2 diabetes (may affect up to 1 in 1,000 people).
Signs of diabetic ketoacidosis:

- increased levels of “ketone bodies” in blood or urine – feeling sick or nausea – abdominal pain – excessive thirst – rapid and deep breathing;

- fatigue - unusual sleepiness and tiredness – sweet smell on the breath, sweet or metallic taste in the mouth or a different smell of urine or sweat – rapid weight loss.
All of the above are not dependent on blood sugar levels. Your doctor will decide whether to temporarily or permanently stop treatment.

• Necrotizing fasciitis of the perineum or Fournier’s gangrene, a severe infection of the soft tissue of the genitals or the area between the genitals and anus, which is very rare.

Stop taking dapagliflozin and contact your doctor quickly if you notice the following side effects:
• Urinary tract infection, which is common (may affect up to 1 in 10 people).
Signs of severe urinary tract infection:

- fever and/or chills;

- burning sensation when urinating;

- pain in your back or side.

- Although uncommon, if you notice blood in your urine, contact your doctor immediately.

• Low blood sugar levels (hypoglycemia), very common (may affect more than 1 in 10 people) in patients with diabetes taking this medicine together with sulfonylurea or insulin.
Signs of low blood sugar:

- shaking, sweating, feeling anxious, fast heartbeat;

- hunger, headache, changes in vision;

- changes in mood or confusion.
- Your doctor will tell you how to treat low blood sugar and what to do if you develop any of the above signs.

Other side effects with dapagliflozin:
Common: • infections of the penis or vagina (thrush) (signs may include irritation, itching, unusual discharge or smell) • back pain • passing more urine or needing to urinate more often • changes in the amount of cholesterol or fats in your blood (shown in tests) • increase in the number of red blood cells (shown in tests) • decrease in renal creatinine clearance (shown in tests) at the start of treatment • dizziness • rash.

Uncommon (may affect up to 1 in 100 people):
• loss of a large amount of fluid from the body (dehydration, signs may include very dry or sticky mouth, passing little or no urine, or a fast heartbeat) • thirst • constipation • waking up at night to urinate • dry mouth • weight loss • increase in creatinine (shown in blood laboratory tests) at the start of treatment • increase in urea (shown in blood laboratory tests).

Very rare: • inflammation of the kidneys (tubulointerstitial nephritis).

Storage: Store at a temperature not exceeding 30°C. Keep out of reach of children.

Dispensing conditions: pharmaceutical product group II, dispensed with prescription form No. 3

Manufactured by:
EXEMED PHARMACEUTICALS,
Plot No. 133/1 & 133/2, G.I.D.C., Selvas Road,
City: Vapi-396 195, District: Valsad,
State of Gujarat, India