Active ingredient
- dapagliflozin propanediol monohydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 17901/0326 .
Forxiga 5 mg film coated tablets
Package leaflet: Information for the patient
Forxiga® 5 mg film-coated tablets
dapagliflozin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Forxiga is and what it is used for
2. What you need to know before you take Forxiga
3. How to take Forxiga
4. Possible side effects
5. How to store Forxiga
6. Contents of the pack and other information
1. What Forxiga is and what it is used for
What Forxiga is
Forxiga 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 Forxiga is used for
Forxiga is used in adult patients (aged 18 years and older) to treat:
Heart failure
What is diabetes and how does Forxiga help?
There are 2 types of diabetes:
What is heart failure and how does Forxiga help?
2. What you need to know before you take Forxiga
Do not take Forxiga
Warnings and precautions
Contact a doctor or the nearest hospital straight away:
Diabetic ketoacidosis:
If you have type 1 diabetes:
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, pharmacist or nurse before taking Forxiga:
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Forxiga.
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.
Kidney function
If you have diabetes, your kidneys should be checked before you start taking and whilst you are on this medicine.
Urine glucose
Because of how Forxiga works, your urine will test positive for sugar while you are on this medicine.
Children and adolescents
Forxiga is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Other medicines and Forxiga
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 Forxiga for type 1 diabetes, it is important that you keep using insulin.
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 Forxiga if you are breast-feeding. It is not known if this medicine passes into human breast milk.
Driving and using machines
Forxiga 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 Forxiga.
Forxiga contains lactose
Forxiga 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 Forxiga
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
If you are taking Forxiga for type 1 diabetes:
If you are taking Forxiga for type 2 diabetes or for heart failure:
Taking this medicine
Your doctor may prescribe Forxiga 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 Forxiga.
If you take more Forxiga than you should
If you take more Forxiga 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 Forxiga
What to do if you forget to take a tablet depends on how long it is until your next dose.
If you stop taking Forxiga
Do not stop taking Forxiga 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:
This may occur regardless of blood sugar level. Your doctor may decide to temporarily or permanently stop your treatment with Forxiga.
Stop taking Forxiga and see a doctor as soon as possible if you notice any of the following serious side effects:
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:
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 Forxiga:
Common
Uncommon (may affect up to 1 in 100 people)
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 Forxiga
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 Forxiga contains
What Forxiga looks like and contents of the pack
Forxiga 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 12/2020.
© AstraZeneca 2020
FORXIGA is a registered trademark of the AstraZeneca group of companies.
CV 20 0072
Other sources of information
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0800 198 5000
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Product name Reference number
Forxiga 5 mg film-coated tablets 17901/0326
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