Dapagliflozin Zydus 5 mg Film-Coated Tablets

DAPAGLIFLOZIN ZYDUS contains the active ingredient dapagliflozin, which belongs to a group of medicines called oral antidiabetics. DAPAGLIFLOZIN ZYDUS is used if your type 2 diabetes cannot be controlled with different medicines for diabetes, diet and exercise.

• Your doctor may ask you to take DAPAGLIFLOZIN ZYDUS alone or with another diabetes medicines.
• DAPAGLIFLOZIN ZYDUS increases the amount of sugar excreted by your kidneys.

DAPAGLIFLOZIN ZYDUS is not recommended for children and young people under the age of 18 years. It is imponant to keep following the advice about diet and exercise given to you by your doclor, nurse, pharmacist or other health ca re provider.

Do not take DAPAGLIFLOZIN ZYDUS:

• If you are hypersensitive (allergic) to dapagliflozin or any of the other ingredients of DAPAGLIFLOZIN ZYDUS listed in section 6 of this leaflet.
• If you have kidney disease or are on dialysis.
• If you have type 1 diabetes mellitus.
• If you are pregnant or plan on becoming pregnant.
• If you are breastfeeding.

Warnings and precautions

DO NOT USE DAPAGLIFLOZIN ZYDUS IF YOU HAVE TYPE 1 DIABETES. DAPAGLIFLOZIN ZYDUS MUST NOT BE USED FOR THE TREATMENT OF ANY OTHER CONDITIONS EXCEPT TYPE 2 DIABETES.

There have been reports of metabolic acidosis, including ketoacidosis, in patients taking DAPAGLIFLOZIN ZYDUS. Metabolic acidosis is an imbalance of acids in your blood, shown on blood tests. It is a serious and sometimes fatal condition that requires hospitalisation. Risk factors for metabolic acidosis include sudden decrease of your insulin dose, prolonged fasting from food and drink, or increasing your insulin dose due to major surgery or serious illness, or alcohol abuse. Caution is advised when using DAPAGLIFLOZIN ZYDUS if you have these conditions.

Diabetic ketoacidosis is a type of metabolic acidosis. Diabetic ketoacidos is an increase of ketone bodies in your blood or urine, shown on blood or urine tests. Risk factors for diabetic ketoacidosis include pancreatic conditions, such as inflammation of the pancreas or previous pancreatic surgery. Do not use DAPAGLIFLOZIN ZYDUS if you have these conditions.

Metabolic acidosis, including diabetic ketoacidosis, may occur in patients with type 2 diabetes mellitus with normal (blood glucose test result below 11 mmol/L) or high blood sugar levels who are treated with DAPAGLIFLOZIN ZYDUS. Contact a doctor or the nearest hospital straight away if you have the following symptoms even if your blood sugar levels are normal: nausea, vomiting, abdominal pain, fatigue, thirst, passing of large volumes of urine, shortness of breath and confusion. These symptoms could be a sign of metabolic or diabetic ketoacidosis.

Tell your doctor or pharmacist if:

• You are going to have surgery.
• You are eating less due to illness, surgery or you are dieting.
• You have or have previously had pancreas problems.
• You drink large amounts of alcohol.
• You develop any of the following symptoms, which may be an indication of diabetic ketoacidosis: nausea (feeling sick), vomiting (being sick), pain in the stomach area, excessive thirst, difficulty breathing, confusion and tiredness.
• Tell your doctor or pharmacist immediately if you develop a combination of pain, tenderness, redness or swelling in your genital area or the area between the genitals and anus, with fever or a general unwell feeling. These symptoms could be a sign of a rare but serious infection called necrotising fasciitis of the perineum, or Fournier’s gangrene.

Take special care with DAPAGLIFLOZIN ZYDUS:

• If you have kidney problems. Your doctor may prescribe you a different medicine or monitor your kidney function while you are being treated with DAPAGLIFLOZIN ZYDUS.
• If you have liver problems.
• If you are taking medicines to lower your blood pressure or a diuretic medicine (water pill) and have a history of low blood pressure.
• If your blood sugar levels are very high, as this may cause your body to dehydrate (lose too much water and salts).
• If you have or develop diarrhoea, nausea (feeling sick) or vomiting (being sick). This may also cause your body to dehydrate and your doctor may ask you to stop taking DAPAGLIFLOZIN ZYDUS until you recover.
• If you often get infections of the urinary tract. As a diabetic patient, it is important to check your feet regularly and adhere to any other advice regarding foot care given to you by your doctor, pharmacist or other health care provider.

Due to the way DAPAGLIFLOZIN ZYDUS works, your urine will test positive for sugar while you are taking DAPAGLIFLOZIN ZYDUS.

Children and adolescents

DAPAGLIFLOZIN ZYDUS is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.

Other medicines and DAPAGLIFLOZIN ZYDUS

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

Tell your doctor:

• If you are taking diuretic medicine (water pill) (used to lower blood pressure or remove excessive water from the body).
• If you are taking other medicines to lower your blood sugar levels, such as insulin or a group of medicines called sulphonylureas. Your doctor may want to lower the dose of your other medicines to prevent hypoglycaemia (too low levels of sugar in the blood).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking DAPAGLIFLOZIN ZYDUS. The use of DAPAGLIFLOZIN ZYDUS is not recommended during pregnancy or breastfeeding.

Do not share medicines prescribed for you with any other person. Always take DAPAGLIFLOZIN ZYDUS exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is one DAPAGLIFLOZIN ZYDUS 10 mg tablet each day. Your doctor may prescribe you a different strength that is right for you. Your doctor may prescribe you DAPAGLIFLOZIN ZYDUS together with other medicines to lower your blood sugar levels. Your doctor will tell you how long your treatment with DAPAGLIFLOZIN ZYDUS will last. Do not stop treatment early.

If you have the impression that the effect of DAPAGLIFLOZIN ZYDUS is too strong or too weak, tell your doctor or pharmacist. Swallow the tablet whole with water.

DAPAGLIFLOZIN ZYDUS can be taken with or without food.

If you take more DAPAGLIFLOZIN ZYDUS than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Always take the labelled medicine package with you.

If you forget to take DAPAGLIFLOZIN ZYDUS

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for forgotten individual doses.

If you stop taking DAPAGLIFLOZIN ZYDUS

Do not stop taking DAPAGLIFLOZIN ZYDUS unless your doctor tells you to. If you have any further questions on the use of DAPAGLIFLOZIN ZYDUS, ask your doctor or pharmacist.

DAPAGLIFLOZIN ZYDUS can have side effects. Not all side effects reported for DAPAGLIFLOZIN ZYDUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while DAPAGLIFLOZIN ZYDUS, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, stop taking DAPAGLIFLOZIN ZYDUS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching, fainting,
• diabetic ketoacidosis (diabetic coma) (causing nausea (feeling sick), vomiting (being sick), pain in the stomach area, tiredness, thirst, passing of large volumes of urine, shortness of breath and confusion),
• necrotising fasciitis of the perineum (causing pain, tenderness, redness and swelling of the genital area or area between the genitals and anus, along with fever and a general unwell feeling).

These are all very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Frequent side effects:

• urinary tract infection (causing fever and/or chills, a burning sensation while urinating, an urge to frequently urinate, pain in your back or side and sometimes blood in your urine),
• low blood sugar levels, especially when taking DAPAGLIFLOZIN ZYDUS with insulin or a sulphonylurea (causing shaking, sweating, fast heartbeat, headache, changes in vision, a change in your mood and confusion),

Less frequent side effects:

• dehydration, volume depletion and hypovolaemia (loss of too much water from your body, causing dry mouth and thirst, feeling tired or sleepy, passing little or no urine and a fast heartbeat).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• changes in test results when testing the amount of red blood cells in your blood,
• changes in test results when testing the amount of cholesterol (fat) in your blood,
• changes in test results when testing your kidney function,
• genital infections, including vaginal and penile thrush (causing irritation and itching in the area, discomfort while urinating and an increased amount of discharge) and inflammation of the penis glans (head) (causing tightness and redness of the skin, itching, irritation, an unpleasant smell and painful urination),
• high glucose (sugar) levels in the urine when tested,
• painful or difficult urination, urinating more or more frequently than usual,
• dizziness,
• rash,
• back pain,

Less frequent side effects:

• changes in test results when testing your blood creatinine or urea levels,
• decreased blood pressure,
• urinating more frequently during the night,
• genital itching,
• thirst or a dry mouth,
• constipation,
• excessive sweating,
• decreased weight.

Side effects with an unknown frequency:

• headache when DAPAGLIFLOZIN ZYDUS is taken with metformin,
• diarrhoea and nasopharyngitis (causing a runny or stuffy nose, coughing, sore throat, watery eyes, headache and tiredness) when DAPAGLIFLOZIN ZYDUS is taken with pioglitazone,
• bone fractures if you suffer from kidney problems.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of DAPAGLIFLOZIN ZYDUS.

• Store at or below 25°C.

• Keep tablets in original container until required for use.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Do not use after the expiry date printed on the carton.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).