Patient leaflet - Figozap 5 mg film-coated tablets
1. What FIGOZAP film-coated tablets is and what it is used for
What FIGOZAP film-coated tablets is
FIGOZAP film-coated tablets 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 FIGOZAP film-coated tablets is used for
FIGOZAP film-coated tablets 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.
FIGOZAP film-coated tablets 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.
Heart failure
in adults (aged 18 years and older) when
the heart does not pump blood as well as it should.
Chronic kidney disease
- in adults with reduced kidney function.
What is type 2 diabetes and how does FIGOZAP film-coated tablets 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.
FIGOZAP film-coated tablets works by
removing excess sugar from your body. It can also help prevent heart disease.
What is heart failure and how does FIGOZAP film-coated tablets help?
This type of heart failure occurs when the
heart does not pump blood to the lungs and the rest of the body as well as it should. This can lead to serious medical problems and need for hospital care.
The most common symptoms of heart
failure are feeling breathless, feeling tired or very tired all the time, and ankle swelling.
FIGOZAP film-coated tablets helps protect
your heart from getting worse and improves your symptoms. It can lower the need to go to hospital and can help some patients to live longer.
What is chronic kidney disease and how does FIGOZAP film-coated tablets help?
When you have chronic kidney disease,
your kidneys may gradually lose their function. This means they would not be able to clean and filter your blood the way they should. Loss of kidney function can lead to serious medical problems and need for hospital care.
FIGOZAP film-coated tablets helps protect
your kidneys from losing their function. That can help some patients to live longer.
2. What you need to know before you take FIGOZAP film-coated tablets
Do not take FIGOZAP film-coated tablets
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 FIGOZAP film-
coated tablets, 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 FIGOZAP film-coated tablets
if you have “type 1 diabetes” – the type that
usually starts when you are young, and your body does not produce any insulin.
if you have diabetes and have a kidney
problem – your doctor may ask you to take additional or a different medicine to control your blood sugar.
if you have a liver problem – your doctor
may start you on a lower dose.
if you 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 FIGOZAP film-coated tablets'.
if you 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 FIGOZAP film-coated tablets if you have any of these signs.
if you 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 FIGOZAP film-coated tablets until you recover to prevent dehydration.
- if you 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 FIGOZAP film-coated tablets.
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 FIGOZAP film-coated tablets works, your urine will test positive for sugar while you are on this medicine.
Children and adolescents
FIGOZAP film-coated tablets 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. FIGOZAP film-coated tablets is not
recommended for children and adolescents under 18 years of age for the treatment of heart failure or for the treatment of chronic kidney disease, because it has not been studied in these patients.
Other medicines and FIGOZAP film-coated tablets
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 FIGOZAP
film-coated tablets 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 FIGOZAP film-coated tablets if you are breast-feeding. It is not known if this medicine passes into human breast milk.
Driving and using machines
FIGOZAP film-coated tablets 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 FIGOZAP film-coated tablets.
FIGOZAP film-coated tablets contains lactose
FIGOZAP film-coated tablets contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take FIGOZAP film-coated tablets
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 FIGOZAP film-coated tablets 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 FIGOZAP film-coated tablets.
If you take more FIGOZAP film-coated tablets than you should
If you take more FIGOZAP film-coated tablets tablets than you should, talk to a doctor or go to a hospital immediately. Take the medicine pack with you.
If you forget to take FIGOZAP film-coated tablets
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 FIGOZAP film-coated tablets 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 of FIGOZAP film-
coated tablets to make up for a forgotten dose.
If you stop taking FIGOZAP film-coated tablets
Do not stop taking FIGOZAP film-coated tablets 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 FIGOZAP film-coated tablets.
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 FIGOZAP film-coated tablets 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:
(hypoglycaemia),
low blood sugar levels
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
heart beat
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 FIGOZAP film-coated tablets:
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)
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 FIGOZAP film-coated tablets
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 storage conditions.
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 to protect the environment.
6. Contents of the pack and other information
What FIGOZAP film-coated tablets contains
- The active substance is dapagliflozin.
FIGOZAP 5 mg film-coated tablet
Each film-coated tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
FIGOZAP 10 mg film-coated tablet
Each film-coated tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
The other ingredients are:
- tablet core: microcrystalline cellulose, crospovidone, lactose anhydrous, colloidal anhydrous silica, sodium stearyl fumarate.
- film-coating: polyvinyl alcohol, titanium dioxide, macrogol, talc, yellow iron oxide.
What FIGOZAP film-coated tablets looks like and contents of the pack
FIGOZAP 5 mg film-coated tablets are yellow colored, biconvex, round film coated tablets plain on both sides.
FIGOZAP 10 mg film-coated tablets are yellow colored, biconvex, diamond shaped film coated tablets plain on both sides.
FIGOZAP film-coated tablets 5 mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters. FIGOZAP film-coated tablets 10 mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sun Pharma UK Limited
6 - 9 The Square
Stockley Park
Uxbridge
UB11 1FW
United Kingdom
Manufacturer
Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Terapia S.A.
Str. Fabricii nr. 124
Cluj-Napoca, 400632
Romania
This leaflet was last revised in March 2025. Package leaflet: Information for the patient
FIGOZAP 5 mg
film-coated tablets FIGOZAP 10 mg film-coated tablets
dapagliflozin
140 mm
Dimension - Flat: 140 x 500 mm Dimension - Folded: 140 x 250 mm