Dapagliflozin Dr. Reddy's

Italy
Brand name Dapagliflozin Dr. Reddy's
Form tablets, film-coated
Active substance / Dosage
DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
A10BK01
Registration number 051547
Manufacturer DR. REDDY'S S.R.L.
Dapagliflozin Dr. Reddy's tablets, film-coated

Table of Contents

Package leaflet: Information for the patient

Dapagliflozin Dr. Reddy’s 5 mg film-coated tablets

Dapagliflozin Dr. Reddy’s 10 mg film-coated tablets
dapagliflozin
Generic medicine
Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

  1. What Dapagliflozin Dr. Reddy’s is and what it is used for
  2. What you need to know before taking Dapagliflozin Dr. Reddy’s
  3. How to take Dapagliflozin Dr. Reddy’s
  4. Possible side effects
  5. How to store Dapagliflozin Dr. Reddy’s
  6. Contents of the pack and other information

1. What Dapagliflozin Dr. Reddy’s is and what it is used for

What Dapagliflozin Dr. Reddy’s is
Dapagliflozin Dr. Reddy’s contains the active substance dapagliflozin. It belongs to a class of
medicines called "sodium-glucose co-transporter 2 (SGLT2) inhibitors". These work by
blocking the SGLT2 protein in the kidneys. By blocking this protein, sugar in the blood (glucose),
salt (sodium), and water are removed from the body through the urine.

What Dapagliflozin Dr. Reddy’s is used for
Dapagliflozin Dr. Reddy’s is used to treat:

  • Type 2 diabetes
    • In adults and children from 10 years of age and older.
    • When type 2 diabetes cannot be controlled by diet and exercise.
    • Dapagliflozin Dr. Reddy’s can be used alone or together with other medicines to treat diabetes.
    • It is important to continue following your doctor’s, pharmacist’s, or nurse’s advice regarding diet and exercise.
  • Heart failure
    • In adults (from 18 years of age and older) when the heart does not pump blood as it should.
  • Chronic kidney disease
    • In adults with reduced kidney function.

What is diabetes and how can Dapagliflozin Dr. Reddy’s help?

  • In type 2 diabetes, the body either does not produce enough insulin or cannot properly use the insulin it produces. This leads to high levels of sugar in the blood. This can result in serious health problems such as heart or kidney disease, blindness, and poor circulation in the arms and legs.

  • Dapagliflozin Dr. Reddy’s works by removing excess sugar from the body. It may also help prevent heart disease.

What is heart failure and how can Dapagliflozin Dr. Reddy’s help?

  • This type of heart failure occurs when the heart does not pump blood to the lungs and the rest of the body as effectively as it should. This can lead to serious medical problems and the need for hospital treatment.
  • The most common symptoms of heart failure are shortness of breath, feeling tired or fatigued most of the time, and swelling in the ankles.
  • Dapagliflozin Dr. Reddy’s helps protect the heart from worsening and improves symptoms. It may reduce the need for hospitalisation and may help some patients live longer.

What is chronic kidney disease and how can Dapagliflozin Dr. Reddy’s help?

  • When you have chronic kidney disease, your kidneys may gradually lose their function. This means they are unable to clean and filter the blood as they should. Loss of kidney function can lead to serious medical problems and the need for hospital treatment.
  • Dapagliflozin Dr. Reddy’s helps protect the kidneys from further loss of function. This may help some patients live longer.

2. What you need to know before taking Dapagliflozin Dr. Reddy’s

Do not take Dapagliflozin Dr. Reddy’s

  • If you are allergic to dapagliflozin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Contact your doctor or nearest hospital immediately
Diabetic ketoacidosis:

  • If you have diabetes and experience nausea or vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, unusual drowsiness or fatigue, sweet-smelling breath, sweet or metallic taste in the mouth, a different smell of urine or sweat, or rapid weight loss.
  • The above symptoms may be signs of diabetic ketoacidosis, a rare but serious condition which can sometimes be life-threatening, caused by diabetes due to increased levels of “ketone bodies” in the urine or blood, detectable by laboratory tests.
  • The risk of developing diabetic ketoacidosis may be increased by prolonged fasting, excessive alcohol intake, dehydration, sudden reduction in insulin dose, or increased insulin requirement due to major surgery or serious illness.
  • When treated with Dapagliflozin Dr. Reddy’s, diabetic ketoacidosis can occur even if blood sugar levels are normal.

If you suspect you have diabetic ketoacidosis, contact your doctor or nearest hospital immediately and do not take this medicine.
Necrotizing fasciitis of the perineum:

  • Seek immediate medical attention if you notice a combination of symptoms such as pain, tenderness, redness or swelling of the genitals or the area between the genitals and the anus, accompanied by fever or a general feeling of being unwell. These symptoms may indicate a rare but serious and potentially life-threatening infection called necrotizing fasciitis of the perineum or Fournier’s gangrene, which destroys subcutaneous tissue. Fournier’s gangrene requires immediate treatment.

Talk to your doctor, pharmacist, or nurse before taking Dapagliflozin Dr. Reddy’s

  • if you have "type 1 diabetes" – the type of diabetes that usually develops at a young age and in which the body produces no insulin. Dapagliflozin Dr. Reddy’s must not be used to treat this condition.
  • if you have diabetes and have kidney problems – your doctor may ask you to take an additional or different medicine to control blood sugar levels.
  • if you have liver problems – your doctor may start you on a lower dose.
  • if you are taking medicines to lower blood pressure (antihypertensives) and have previously experienced low blood pressure (hypotension). Further information is provided below in section “Other medicines and Dapagliflozin Dr. Reddy’s”.
  • if you have very high blood sugar levels that may cause dehydration (excessive loss of body fluids). Possible signs of dehydration are listed in section 4. Inform your doctor before starting Dapagliflozin Dr. Reddy’s if you have any of these signs.
  • if you have or develop nausea (feeling unwell), vomiting, or fever, or if you are unable to eat or drink. These conditions can lead to dehydration. Your doctor may ask you to stop taking Dapagliflozin Dr. Reddy’s until you recover to prevent dehydration.
  • if you frequently have urinary tract infections.

If any of the above conditions apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before taking Dapagliflozin Dr. Reddy’s.
Diabetes and foot care
If you have diabetes, it is important to regularly check your feet and follow any other foot care advice provided by healthcare professionals.
Glucose in urine
Due to the mechanism of action of Dapagliflozin Dr. Reddy’s, urine tests will show the presence of sugar during treatment with this medicine.
Children and adolescents
Dapagliflozin Dr. Reddy’s can be used in children aged 10 years and older for the treatment of type 2 diabetes. Data are not available in children under 10 years of age.
Dapagliflozin Dr. Reddy’s is not recommended for children and adolescents under 18 years of age for the treatment of heart failure or chronic kidney disease, as it has not been studied in these patients.
Other medicines and Dapagliflozin Dr. Reddy’s
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor:

  • if you are taking a medicine to remove water from the body (diuretics).
  • if you are taking other medicines that lower blood sugar levels, such as insulin or a “sulphonylurea”-based medicine. Your doctor may consider reducing the dose of these other medicines to prevent excessively low blood sugar levels (hypoglycaemia).
  • if you are taking lithium, because Dapagliflozin Dr. Reddy’s may reduce the amount of lithium in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. You must stop taking this medicine if you become pregnant, as it is not recommended during the second and third trimesters of pregnancy. Ask your doctor how best to manage your blood sugar levels during pregnancy.
Inform your doctor if you intend to breastfeed or are currently breastfeeding before taking this medicine. Do not use Dapagliflozin Dr. Reddy’s if you are breastfeeding. It is not known whether this medicine passes into breast milk.
Driving and using machines
Dapagliflozin Dr. Reddy’s has negligible or no effect on the ability to drive or use machines.
Taking this medicine with other medicines called sulphonylureas or with insulin may cause excessively low blood sugar levels (hypoglycaemia), which can lead to symptoms such as trembling, sweating, and vision disturbances, and may impair your ability to drive and use machines.
Do not drive or operate tools or machinery if you experience dizziness while taking Dapagliflozin Dr. Reddy’s.
Dapagliflozin Dr. Reddy’s contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Dapagliflozin Dr. Reddy’s contains isomalt
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Dapagliflozin Dr. Reddy’s

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor, pharmacist, or nurse.

How much to take

  • The recommended dose is one 10 mg tablet once daily.
  • Your doctor may start with a 5 mg dose if you have liver problems.
  • Your doctor will prescribe the appropriate dose for you.

How to take this medicine

  • Swallow the tablet whole with half a glass of water.
  • You may take the tablet with or without food.
  • You may take the tablet at any time of 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 Dr. Reddy’s together with other medicines. Remember to take these other medicines as directed by your doctor. This will help you achieve the best health outcomes.

Diet and physical exercise can help your body use blood sugar more effectively. If you have diabetes, it is important to follow the diet and exercise plan recommended by your doctor while taking Dapagliflozin Dr. Reddy’s.

If you take more Dapagliflozin Dr. Reddy’s than you should
If you take more Dapagliflozin Dr. Reddy’s tablets than prescribed, contact your doctor immediately or go to hospital immediately. Take the medicine pack with you.

If you forget to take Dapagliflozin Dr. Reddy’s
If you forget to take a tablet, the action you should take depends on how long it is until your next dose.

  • If there are 12 hours or more until your next dose, take a dose of Dapagliflozin Dr. Reddy’s 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 your next dose at the usual time.

  • Do not take a double dose to make up for a forgotten dose.

If you stop taking Dapagliflozin Dr. Reddy’s
Do not stop treatment with Dapagliflozin Dr. Reddy’s without first talking to your doctor. If you have diabetes, your blood sugar levels may increase without this medicine.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor or nearest hospital immediately if you experience any of the following
side effects:

  • Angioedema, very rarely observed (may occur in up to 1 person in 10,000). Symptoms of angioedema include:
    • swelling of the face, tongue or throat
    • difficulty swallowing
    • hives and breathing problems
  • Diabetic ketoacidosis, which is rare in patients with type 2 diabetes (may occur in up to 1 person in 1,000). Symptoms of diabetic ketoacidosis (see also section 2 “Warnings and precautions”) include:
    • increased levels of “ketone bodies” in urine or blood
    • nausea and vomiting
    • stomach pain
    • excessive thirst
    • rapid and deep breathing
    • confusion
    • unusual drowsiness or tiredness
    • sweet breath, sweet or metallic taste in mouth, or a different smell of urine or sweat
    • rapid weight loss. This may occur regardless of blood sugar levels. Your doctor may decide to temporarily or permanently discontinue treatment with Dapagliflozin Dr. Reddy’s.
  • Necrotizing fasciitis of the perineum or Fournier’s gangrene, a serious infection of the soft tissues of the genitals or the area between the genitals and the anus, very rarely observed.

Stop taking Dapagliflozin Dr. Reddy’s and consult a doctor as soon as possible if you notice any of
the following serious side effects:

  • Urinary tract infections, commonly observed (may occur in up to 1 person in 10). Symptoms of severe urinary tract infection include:
    • fever and/or chills
    • burning sensation when urinating
    • back or flank pain. Although uncommon, if you see blood in your urine, contact your doctor immediately.

Contact your doctor as soon as possible if you experience any of the following side effects:

  • Low blood sugar levels (hypoglycaemia), very commonly observed (may occur in more than 1 person in 10) in diabetic patients taking this medicine with a sulphonylurea or insulin. Symptoms of low blood sugar include:
    • trembling, sweating, feeling very anxious, rapid heartbeat
    • feeling hungry, headache, changes in vision
    • mood changes or feeling confused. Your doctor will advise you on how to treat low blood sugar levels and what to do if any of the symptoms listed above occur.

Other side effects when taking Dapagliflozin Dr. Reddy’s:
Common

  • genital infection (candidiasis) of the penis or vagina (signs may include irritation, itching, unusual discharge or odour)
  • back pain
  • increased amount of urine or increased urge to urinate more frequently
  • changes in cholesterol or fat levels in the blood (observed in blood tests)
  • increase in red blood cells (observed in blood tests)
  • decrease in creatinine renal clearance (observed in blood tests), at the beginning of treatment
  • dizziness
  • rash

Uncommon (may occur in up to 1 person in 100)

  • excessive loss of body fluids (dehydration, signs may include very dry or sticky mouth, reduced or absent urination, or rapid heartbeat)
  • thirst
  • constipation
  • waking up during the night to urinate
  • dry mouth
  • weight loss
  • increase in creatinine (observed in blood tests) at the beginning of treatment
  • increase in urea (observed in blood tests)

Very rare

  • inflammation of the kidneys (tubulo-interstitial nephritis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dapagliflozin Dr. Reddy’s

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dapagliflozin Dr. Reddy’s contains

  • The active substance is dapagliflozin. Each film-coated tablet (tablet) of Dapagliflozin Dr. Reddy’s 5 mg contains dapagliflozin propylene glycol monohydrate equivalent to 5 mg of dapagliflozin. Each film-coated tablet (tablet) of Dapagliflozin Dr. Reddy’s 10 mg contains dapagliflozin propylene glycol monohydrate equivalent to 10 mg of dapagliflozin.
  • The other components are:
    • Tablet core: microcrystalline cellulose, lactose, crospovidone Type-A, anhydrous colloidal silica (E551), sodium stearyl fumarate.
    • Film coating: rice starch, isomalt (E953), hypromellose 6 mPas (E464), hypromellose 15 mPas (E464), medium-chain triglycerides, yellow iron oxide (E172).

Description of the appearance of Dapagliflozin Dr. Reddy’s and contents of the pack
The 5 mg film-coated tablets of Dapagliflozin Dr. Reddy’s are yellow to light yellow in colour, round biconvex in shape (approximately 7 mm in diameter), smooth on both sides.
The 10 mg film-coated tablets of Dapagliflozin Dr. Reddy’s are yellow to light yellow in colour, round biconvex in shape (approximately 9 mm in diameter), with a “│” breakline on one side and smooth on the other.
Dapagliflozin Dr. Reddy’s 5 mg tablets are available in blisters in packs of 10, 14, 28, 30, 90, 98 or 100 film-coated tablets.
Dapagliflozin Dr. Reddy’s 10 mg tablets are available in blisters in packs of 10, 14, 28, 30, 56, 90, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade 1
20123, Milan (MI)
Italy

Manufacturer
betapharm Arzneimittel GmbH,
Kobelweg 95, 86156 Augsburg,
Germany
Rual Laboratories SRL,
313, Splaiul Unirii, Building H, 1st floor, sector 3,
Bucharest, 030138,
Romania
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park, Paola PLA 3000,
Malta
DR. REDDY’S LABORATORIES ROMÂNIA S.R.L.,
Str. Daniel Danielopolu, nr. 30-32,
Space 2, 5th floor, Sector 1,
Bucharest, 014134,
Romania

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria Dapagliflozin Reddy 5 mg Filmtabletten
Dapagliflozin Reddy 10 mg Filmtabletten
Germany Dapagliflozin beta 5 mg Filmtabletten
Dapagliflozin beta 10 mg Filmtabletten
Italy Dapagliflozin Dr. Reddy’s
Czech Republic Dapagliflozin Reddy
Netherlands Dapagliflozine Reddy 5 mg filmomhulde tabletten
Dapagliflozine Reddy 10 mg filmomhulde tabletten
Poland Dapagliflozin Reddy
Romania Dapagliflozin Dr. Reddy’s 5 mg comprimate filmate
Dapagliflozin Dr. Reddy’s 10 mg comprimate filmate
Slovakia Dapagliflozin Reddy
Spain DAPAGLIFLOZINA DR. REDDYS 5 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG;
DAPAGLIFLOZINA DR. REDDYS 10 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG
Sweden Dapagliflozin Reddy