Patient leaflet - Dapagliflozin 5 mg film-coated tablets
1. What Dapagliflozin is and what it is used for
What Dapagliflozin is
Dapagliflozin Film-coated Tablet contains the active substance dapagliflozin. It belongs to a group of medicines called “sodium glucose co-transporter-2 (SGLT2) inhibitors”. They work by blocking the SGLT2 protein in your kidney. By blocking this protein, blood sugar (glucose), salt (sodium) and water are removed from your body via the urine.
What Dapagliflozin is used for
Dapagliflozin is used to treat:
Type 2 diabetes
- in adults and children aged 10 years and older.
if your type 2 diabetes cannot be controlled with diet
and exercise.
dapagliflozin can be used on its own or together with other
medicines to treat diabetes.
it is important to continue to follow the advice on diet and
exercise given to you by your doctor, pharmacist or nurse.
What is type 2 diabetes and how does Dapagliflozin help?
In type 2 diabetes your body does not make enough insulin or is not
able to use the insulin it makes properly. This leads to a high level of sugar in your blood. This can lead to serious problems like heart or kidney disease, blindness, and poor circulation in your arms and legs.
Dapagliflozin works by removing excess sugar from your body. It can
also help prevent heart disease.
Dapagliflozin which is contained in Dapagliflozin Film-coated Tablets is also authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.
2. What you need to know before you take Dapagliflozin
Do not take Dapagliflozin
if you are allergic to dapagliflozin or any of the other ingredients of
this medicine (listed in section 6).
Warnings and precautions
Contact a doctor or the nearest hospital straight away
Diabetic ketoacidosis:
If you have diabetes and experience feeling sick or being sick,
stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat or rapid weight loss.
The above symptoms could be a sign of “diabetic ketoacidosis” - a rare
but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
The risk of developing diabetic ketoacidosis may be increased with
prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
When you are treated with Dapagliflozin, diabetic ketoacidosis can
occur even if your blood sugar is normal.
If you suspect you have diabetic ketoacidosis, contact a doctor or the nearest hospital straight away and do not take this medicine.
Necrotising fasciitis of the perineum:
Talk to your doctor immediately if you develop a combination of
symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell. These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier’s gangrene which destroys the tissue under the skin. Fournier’s gangrene has to be treated immediately.
Talk to your doctor, pharmacist or nurse before taking Dapagliflozin if you
have “type 1 diabetes” - the type that usually starts when you are
young, and your body does not produce any insulin. Dapagliflozin should not be used to treat this condition.
have diabetes and have a kidney problem - your doctor may ask you
to take additional or a different medicine to control your blood sugar.
have a liver problem - your doctor may start you on a lower dose.
are on medicines to lower your blood pressure (anti-hypertensives)
and have a history of low blood pressure (hypotension). More information is given below under “Other medicines and Dapagliflozin”.
- have very high levels of sugar in your blood which may make you dehydrated (lose too much body fluid). Possible signs of dehydration are listed in section 4. Tell your doctor before you start taking this medicine if you have any of these signs.
- have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or drink. These conditions can cause dehydration. Your doctor may ask you to stop taking this medicine until you recover to prevent dehydration.
- often get infections of the urinary tract.
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Diabetes and foot care
If you have diabetes, it is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.
Urine glucose
Because of how Dapagliflozin works, your urine will test positive for sugar while you are on this medicine.
Children and adolescents
Dapagliflozin can be used in children aged 10 years and older for the treatment of type 2 diabetes. No data are available in children below 10 years of age.
Other medicines and Dapagliflozin
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Especially tell your doctor:
if you are taking a medicine used to remove water from the body
(diuretic).
- if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine. Your doctor may want to lower the dose of these other medicines, to prevent you from getting low blood sugar levels (hypoglycaemia).
- if you are taking lithium because Dapagliflozin can lower the amount of lithium in your blood.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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, since it is not recommended during the second and third trimesters of pregnancy. Talk to your doctor about the best way to control your blood sugar while you are pregnant.
Talk to your doctor if you would like to or are breast-feeding before taking this medicine. Do not use this medicine if you are breast-feeding. It is not known if this medicine passes into human breast milk.
Driving and using machines
Dapagliflozin has no or negligible influence on the ability to drive and use machines.
Taking this medicine with other medicines called sulphonylureas or with insulin can cause too low blood sugar levels (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines.
Do not drive or use any tools or machines, if you feel dizzy taking Dapagliflozin.
Dapagliflozin Film-coated Tablet contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Dapagliflozin Film-coated Tablet contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium free’.
3. How to take Dapagliflozin
Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
How much to take
- The recommended dose is one 10 mg tablet each day.
- Your doctor may start you on a 5 mg dose if you have a liver problem.
- Your doctor will prescribe the strength that is right for you.
Taking this medicine
- Swallow the tablet whole with half a glass of water.
You can take your tablet 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 to remember to take it.
Your doctor may prescribe Dapagliflozin together with other medicine(s). Remember to take these other medicine(s) as your doctor has told you. This will help get the best results for your health.
Diet and exercise can help your body use its blood sugar better. If you have diabetes, it is important to stay on any diet and exercise program recommended by your doctor while taking Dapagliflozin.
If you take more Dapagliflozin than you should
If you take more Dapagliflozin than you should, talk to a doctor or go to a hospital immediately. Take the medicine pack with you. If you forget to take Dapagliflozin
What to do if you forget to take a tablet depends on how long it is until your next dose.
If it is 12 hours or more until your next dose, take a dose of
Dapagliflozin as soon as you remember. Then take your next dose at the usual time.
If it is 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
Do not stop taking Dapagliflozin without talking to your doctor first. If you have diabetes, your blood sugar may increase without this medicine.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor or the nearest hospital straight away if you have any of the following side effects:
angioedema, seen very rarely (may affect up to 1 in 10,000 people).
These are signs of angioedema:
- swelling of the face, tongue or throat
- difficulties swallowing
- hives and breathing problems
diabetic ketoacidosis - this is rare in patients with type 2 diabetes
(may affect up to 1 in 1,000 people).
These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):
- increased levels of “ketone bodies” in your urine or blood
- feeling sick or being sick
- stomach pain
- excessive thirst
- fast and deep breathing
- confusion
- unusual sleepiness or tiredness
a sweet smell to your breath, a sweet or metallic taste in your
mouth or a different odour to your urine or sweat
- rapid weight loss
This may occur regardless of blood sugar level. Your doctor may decide to temporarily or permanently stop your treatment with Dapagliflozin.
necrotising fasciitis of the perineum or Fournier’s gangrene,
a serious soft tissue infection of the genitals or the area between the genitals and the anus, seen very rarely.
Stop taking Dapagliflozin and see a doctor as soon as possible if you notice any of the following serious side effects:
urinary tract infection, seen commonly (may affect up to 1 in
10 people).
These are signs of a severe infection of the urinary tract:
- fever and/or chills
- burning sensation when passing water (urinating)
- pain in your back or side
Although uncommon, if you see blood in your urine, tell your doctor immediately.
Contact your doctor as soon as possible if you have any of the following side effects:
low blood sugar levels (hypoglycaemia), seen very commonly (may
affect more than 1 in 10 people) in patients with diabetes taking this medicine with a sulphonylurea or insulin.
These are the signs of low blood sugar:
- shaking, sweating, feeling very anxious, fast heartbeat
- feeling hungry, headache, change in vision
- a change in your mood or feeling confused
Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.
Other side effects when taking Dapagliflozin:
Common
genital infection (thrush) of your penis or vagina (signs may include
irritation, itching, unusual discharge or odour)
- back pain
passing more water (urine) than usual or needing to pass water
more often
changes in the amount of cholesterol or fats in your blood (shown
in tests)
increases in the amount of red blood cells in your blood (shown
in tests)
decreases in creatinine renal clearance (shown in tests) in the
beginning of treatment
- dizziness
- rash
Uncommon (may affect up to 1 in 100 people)
- fungal infection
- genital pruritus
loss of too much fluid from your body (dehydration, signs may include
very dry or sticky mouth, passing little or no urine or fast heartbeat)
- thirst
- constipation
- awakening from sleep at night to pass urine
- dry mouth
- weight decreased
increases in creatinine (shown in laboratory blood tests) in the
beginning of treatment
increases in urea (shown in laboratory blood tests)
Very rare
- inflammation of the kidneys (tubulointerstitial nephritis)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Dapagliflozin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Dapagliflozin Film-coated Tablets contains
The active substance is dapagliflozin.
Each 5 mg film-coated tablet contains 5 mg dapagliflozin. Each 10 mg film-coated tablet contains 10 mg dapagliflozin.
- The other ingredients are microcrystalline cellulose, lactose, crospovidone, colloidal anhydrous silica, sodium stearyl fumarate. The film-coating contains polyvinyl alcohol, macrogol, titanium dioxide (E171), talc, yellow iron oxide (E172) and sodium laurilsulfate.
What Dapagliflozin Film-coated Tablets looks like and contents of the pack
5 mg film-coated tablets are yellow, film-coated, round shaped tablet with diameter of 6.8 mm, debossed with “TV” on one side and “5D” on the other side.
10 mg film-coated tablets are yellow, film-coated, oval shaped tablet with dimensions of 11.3 mm x 6.9 mm, debossed with “TV” on one side and “1D” on the other side.
Dapagliflozin Film-coated Tablets are available in calendar blister packs of 14, 28 and 98 film-coated tablets and unit-dose blister packs of 28, 30, 50, 90, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom
Manufacturer
Actavis Group PTC ehf., Dalshraun 1, 220 Hafnarfjörður, Iceland
This leaflet was last revised in September 2026.
PL 00289/2590 and PL 00289/2591
306319_s1