Figozap

Italy
Brand name Figozap
Form tablets, film-coated
Active substance / Dosage
DAPAGLIFLOZIN
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
A10BK01
Registration number 051945
Manufacturer SUN PHARMACEUTICAL INDUSTRIES (EUROPE) B.V.

Table of Contents

Package leaflet: Information for the user

Figozap 5 mg film-coated tablets, 10 mg film-coated tablets

dapagliflozin
Generic medicine
Read this leaflet carefully before 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 other people, even if their symptoms are the same as yours, because it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Figozap is and what it is used for

What Figozap is
Figozap contains the active substance dapagliflozin. It belongs to a group of medicines called
"sodium-glucose co-transporter 2 (SGLT2) inhibitors". It works 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 urine.

What Figozap is used for
Figozap is used to treat:

  • Type 2 diabetes
    • in adults and children aged 10 years and older.
    • when type 2 diabetes cannot be controlled by diet and exercise alone.
    • Figozap can be used alone or together with other medicines for the treatment of diabetes.
    • It is important to continue following the dietary and exercise advice provided by your doctor, pharmacist, or nurse.
  • Heart failure
    • in adults (aged 18 years and older) when the heart does not pump blood properly.
  • Chronic kidney disease
    • in adults with reduced kidney function.

What is type 2 diabetes and how can Figozap 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 problems such as heart or kidney disease, blindness, and poor circulation in the arms and legs.
  • Figozap works by removing excess sugar from the body. It may also help prevent heart disease.

What is heart failure and how can Figozap help?

  • This type of heart failure occurs when the heart does not pump blood to the lungs and the rest of the body 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 unusually fatigued all the time, and swelling in the ankles.
  • Figozap 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 Figozap help?

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

2. What you should know before taking Figozap

Do not take Figozap

  • 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 ache, excessive thirst, rapid and deep breathing, confusion, unusual drowsiness or fatigue, a sweet smell on your breath, a sweet or metallic taste in your mouth, a different odour in your urine or sweat, or rapid weight loss.
  • The symptoms listed above may be signs of "diabetic ketoacidosis", a rare but serious condition, sometimes life-threatening, which can occur in people with diabetes due to increased levels of "ketone bodies" in the blood or urine, detectable by laboratory tests.
  • The risk of developing diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or increased insulin requirements due to major surgery or serious illness.
  • When being treated with Figozap, diabetic ketoacidosis may occur even if your blood sugar level is 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 develop a combination of symptoms such as pain, tenderness, redness, or swelling in the genital area or the region between the genitals and the anus, accompanied by fever or a general feeling of being unwell. These symptoms could indicate a rare but serious and potentially 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.

Talk to your doctor, pharmacist, or nurse before taking Figozap

  • if you have "type 1 diabetes", the type of diabetes that usually develops when you are young and in which your body produces no insulin. Figozap must not be used to treat this condition.
  • If you have diabetes and have kidney problems – your doctor may advise you to take an additional or different medicine to control your blood glucose.
  • If you have liver problems – your doctor may start you on a lower dose.
  • if you are taking medicines to lower your blood pressure (antihypertensives) and have a history of low blood pressure (hypotension). More information is provided below in the section "Other medicines and Figozap".
  • if you have very high blood sugar levels that could lead to dehydration (loss of too much body fluid). Possible signs of dehydration are listed in section 4. Inform your doctor before starting Figozap if you have any of these signs.
  • if you develop nausea (feeling unwell), vomiting, or fever, or if you are unable to eat or drink. These conditions may lead to dehydration. Your doctor may instruct you to stop taking Figozap until you recover, to prevent dehydration.
  • if you frequently get urinary tract infections.

If any of the conditions listed above apply to you (or if you are unsure), talk to your doctor,
pharmacist, or nurse before taking Figozap.
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
Because of how Figozap works, your urine will test positive for glucose while you are taking this medicine.
Children and adolescents
Figozap 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.
Figozap 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 patient groups.
Other medicines and Figozap
Tell 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 used to remove water from the body (diuretic).
  • if you are taking other medicines that lower blood sugar levels, such as insulin or a "sulfonylurea". Your doctor may want to reduce the dose of these other medicines to prevent low blood sugar levels (hypoglycaemia).
  • if you are taking lithium, because Figozap may reduce the amount of lithium in your blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist 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. Discuss with your doctor the best way to manage your blood glucose during pregnancy.
Talk to your doctor if you are planning or currently breastfeeding before taking this medicine. Do not use Figozap if you are breastfeeding. It is not known whether this medicine passes into human breast milk.
Driving and using machines
Figozap does not affect, or has negligible effect on, the ability to drive or operate machinery.
However, taking this medicine together with other medicines called sulfonylureas or with insulin may cause blood sugar levels to become too low (hypoglycaemia), which may cause symptoms such as tremors, sweating, and blurred vision, and may affect your ability to drive or operate machinery.
Do not drive or operate tools or machinery if you feel dizzy while taking Figozap.
Figozap contains lactose
Figozap contains lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Figozap

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.
How much to take

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

Taking 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 Figozap together with other medicines. Remember to take these other medicines as instructed by your doctor. This will help you achieve the best results for your health.
Diet and exercise may help your body use blood sugars more effectively. If you have diabetes, it is important to follow any diet and exercise plan recommended by your doctor while taking Figozap.
If you take more Figozap than you should
If you take more Figozap tablets than prescribed, contact a doctor or go to the hospital immediately. Take the medicine pack with you.
If you forget to take Figozap
If you forget to take a tablet, the action to take depends on how long it is until your next dose.

  • If there are 12 hours or more until your next dose, take the missed dose 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 of Figozap to make up for a forgotten dose.

If you stop taking Figozap
Do not stop taking Figozap without first talking to your doctor. If you have diabetes, your blood sugar levels may rise without this medicine.
If you have any questions about using this medicine, consult 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 immediately if you experience any of the following
side effects:

  • Angioedema, very rarely observed (may affect up to 1 in 10,000 people). These are 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).

These are the signs of diabetic ketoacidosis (see also section 2 Warnings and
precautions):

  • increased levels of "ketone bodies" in urine or blood
  • feeling unwell or being sick
  • stomach pain
  • excessive thirst
  • rapid and deep breathing
  • confusion
  • unusual drowsiness or tiredness
  • a sweet smell on the breath, a sweet or metallic taste in the mouth, or a different odour in 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 Figozap.
    • 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 Figozap and contact your doctor as soon as possible if you notice any of the following
serious side effects:

  • Urinary tract infection, commonly observed (may affect up to 1 in 10 people). These are signs of a serious urinary tract infection:
    • fever and/or chills
    • burning sensation during urination
    • back or side pain. Although uncommon, if you see blood in your urine, inform your doctor immediately.

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

  • Low blood sugar levels (hypoglycaemia), very commonly observed (may affect more than 1 in 10 people) in patients with diabetes taking this medicine with a sulphonylurea or insulin.

These are signs of low blood sugar levels:

  • trembling, sweating, feeling very anxious, rapid heartbeat
  • feeling of hunger, headache, vision changes
  • mood changes or a feeling of confusion. Your doctor will advise you on how to treat low blood sugar levels and what to do if you experience any of the above symptoms.

Other side effects during treatment with Figozap:
Common

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

Uncommon (may affect up to 1 in 100 people)

  • excessive loss of body fluids (dehydration, signs may include very dry or sticky mouth, little or no urine, or rapid heartbeat)
  • thirst
  • constipation
  • waking up at night to urinate
  • dry mouth
  • weight loss
  • increased creatinine (shown in laboratory blood tests) at the beginning of treatment
  • increased urea (shown in laboratory blood tests)

Very rare

  • inflammation of the kidneys (tubulointerstitial nephritis)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell 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 Figozap

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 the 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 Figozap contains

  • The active substance is dapagliflozin. Each film-coated tablet (tablet) of Figozap 5 mg contains dapagliflozin propylene glycol monohydrate equivalent to 5 mg of dapagliflozin. Each film-coated tablet (tablet) of Figozap 10 mg contains dapagliflozin propylene glycol monohydrate equivalent to 10 mg of dapagliflozin.
  • The other components are:
    • tablet core: microcrystalline cellulose (E460i), crospovidone (E1202), anhydrous lactose (see section 2 "Figozap contains lactose"), colloidal anhydrous silica (E551) and sodium stearate fumarate.
    • film coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol MW 3350 (E1521), talc and yellow iron oxide (E172).

Description of the appearance of Figozap and contents of the pack
Figozap 5 mg film-coated tablets are yellow, biconvex, round film-coated tablets with a diameter of 7 mm, smooth on both sides.
Figozap 10 mg film-coated tablets are yellow, biconvex, diamond-shaped film-coated tablets with diagonals of approximately 11 mm x 8 mm, smooth on both sides.
Figozap is supplied in packs of:
Cold-form blister (structure: oriented polyamide/aluminum foil/PVC) with a backing of cold-tempered aluminum foil lacquered with heat-seal coating on the inner side.
Pack sizes: 10, 14, 28, 30, 60, 98 film-coated tablets per pack.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Local representative:
Sun Pharma Italia Srl
Viale Giulio Richard, 3
20143 Milano
Italy

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH, Hoofddorp
The Netherlands
Terapia SA
124 Fabricii Street,
400632, Cluj-Napoca, Romania

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Sweden (RMS) Figozap 5 mg filmdragerade tabletter
Figozap 10 mg filmdragerade tabletter
Germany FIGOZAP 5 mg Filmtabletten
FIGOZAP 10 mg Filmtabletten
Denmark Figozap
Spain FIGOZAP 5 mg comprimidos recubiertos con película EFG
FIGOZAP 10 mg comprimidos recubiertos con película EFG
Finland FIGOZAP 5 mg kalvopäällysteiset tabletit
FIGOZAP 10 mg kalvopäällysteiset tabletit
France Figozap 5 mg, comprimé pelliculé
Figozap 10 mg, comprimé pelliculé
Italy FIGOZAP
The Netherlands Figozap 5 mg filmomhulde tabletten
Figozap 10 mg filmomhulde tabletten
Norway Figozap
Poland Figozap
Romania Figozap 5 mg comprimate filmate
Figozap 10 mg comprimate filmate