Active ingredient
- saxagliptin hydrochloride
- 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 17901/0339 .
Qtern 5 mg/10 mg film-coated tablets
Package leaflet: Information for the patient
Qtern 5 mg/10 mg film-coated tablets
saxagliptin/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 Qtern is and what it is used for
2. What you need to know before you take Qtern
3. How to take Qtern
4. Possible side effects
5. How to store Qtern
6. Contents of the pack and other information
1. What Qtern is and what it is used for
Qtern contains the active substances saxagliptin and dapagliflozin. Each belongs to a group of medicines called “oral anti-diabetics”.
Qtern is used for a type of diabetes called “type 2 diabetes mellitus” in adult patients (aged 18 years and older). “Type 2 diabetes mellitus” is the type of diabetes that usually starts when you are older. If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use the insulin it produces properly. This leads to a high level of sugar in your blood. The two active substances in Qtern work in different ways to help control the level of sugar in your blood and remove excess sugar from your body via your urine.
It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.
2. What you need to know before you take Qtern
Do not take Qtern:
Do not take Qtern if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking Qtern.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Qtern, and during treatment:
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Qtern.
Diabetic skin lesions (skin damage such as sores or ulcers) are a common complication of diabetes. Rash has been seen with both saxagliptin and dapagliflozin when given separately (see section 4). You are advised to follow the recommendations for skin care that you are given by your doctor or nurse. Contact your doctor if you encounter blistering of the skin, as it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Qtern.
Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.
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.
Kidney function
Your kidneys should be checked before you start taking and whilst you are on this medicine.
Urine tests
Because of how Qtern works, your urine will test positive for sugar while you are on this medicine.
Children and adolescents
Qtern is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Other medicines and Qtern
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Especially tell your doctor:
If any of the above apply to you (or if you are not sure), talk to your doctor before taking Qtern.
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. Qtern is not recommended during pregnancy and your doctor will ask you to stop taking this medicine if you become pregnant. Talk to your doctor about the best way to control your blood sugar while you are pregnant.
You should not use Qtern if you are breast-feeding. It is not known if this medicine passes into human breast milk. Talk to your doctor if you would like to or are breast-feeding before taking this medicine.
Driving and using machines
Qtern is not expected to affect you being able to drive a car or use any tools or machines. If you feel dizzy while taking Qtern, do not drive or use any tools or machines. Taking this medicine can cause blood sugar levels to fall too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines.
Qtern contains lactose
Qtern 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.
Sodium content
Qtern contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free’.
3. How to take Qtern
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
Taking this medicine
Your doctor may prescribe other medicines to lower the amount of sugar in your blood. Remember to take other medicine(s) as your doctor has told you. This will help get the best results for your health.
Diet and exercise
To control your diabetes, you still need to keep to diet and exercise, even when you are taking this medicine. So it is important to keep following the advice about diet and exercise from your doctor, pharmacist or nurse. In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking Qtern.
If you take more Qtern than you should
If you take more Qtern tablets than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Qtern
What to do if you forget to take a tablet.
If you stop taking Qtern
Do not stop taking Qtern without talking to your doctor first. 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.
Some symptoms need immediate medical attention:
Stop taking Qtern and see a doctor straight away if you notice any of the following serious side effects:
Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Although uncommon, if you see blood in your urine, tell your doctor immediately.
Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.
This may occur regardless of blood glucose level. Your doctor may decide to temporarily or permanently stop your treatment with Qtern.
Stop taking Qtern and see a doctor or nurse straight away, if you notice any of the serious side effects above.
Other side effects when taking Qtern alone or in combination with metformin:
Common
Uncommon
Not known (frequency cannot be estimated from the available data)
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 Qtern
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 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 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 Qtern contains
What Qtern looks like and contents of the pack
Qtern 5 mg/10 mg film-coated tablets are light brown to brown, biconvex, round, film-coated tablets, with “5/10” printed on one side, and “1122” printed on the other side, in blue ink.
Qtern 5 mg/10 mg tablets are available in aluminium blisters in pack sizes of 14, 28, or 98 film-coated tablets in calendar blisters and 30 film-coated tablets in blister.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in January 2021
© AstraZeneca 2021
QTERN is a registered trademark of the AstraZeneca group of companies.
CV 21 0003
Other sources of information
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Product name Reference number
Qtern 5mg/10mg film-coated tablets 17901/0339
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