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 17901/0337 .
Onglyza 5mg film-coated tablets
Onglyza® 5 mg film-coated tablets
1. What Onglyza is and what it is used for
2. What you need to know before you take Onglyza
3. How to take Onglyza
4. Possible side effects
5. How to store Onglyza
6. Contents of the pack and other information
Onglyza contains the active substance saxagliptin, which belongs to a group of medicines called ‘oral anti-diabetics’. They work by helping to control the level of sugar in your blood.
Onglyza is used for adult patients aged 18 years and older with ‘type 2 diabetes’, if the disease cannot be adequately controlled with one oral anti-diabetic medicine, diet and exercise. Onglyza is used alone or together with insulin or other anti-diabetic medicines.
It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse.
Talk to your doctor or pharmacist before taking Onglyza:
Diabetic skin lesions are a common complication of diabetes. Rash has been seen with Onglyza (see section 4) and with certain anti-diabetic medicines in the same class as Onglyza. You are advised to follow the recommendations for skin and foot 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 Onglyza.
Onglyza is not recommended for children and adolescents under 18 years. It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, you should tell your doctor if you are using medicines containing any of the following active substances:
Talk to your doctor before you take Onglyza if you are pregnant or plan to become pregnant. You should not use Onglyza if you are pregnant.
Talk to your doctor if you want to breast-feed while taking this medicine. It is not known if Onglyza passes into human breast milk. You should not take this medicine if you are breast-feeding or plan to breast-feed.
If you feel dizzy while taking Onglyza, do not drive or use any tools or machines. Hypoglycaemia may affect your ability to drive and use machines or work with safe foothold and there is a risk of hypoglycaemia when taking this medicine in combination with medicines known to cause hypoglycaemia such as insulin and sulphonylureas.
The tablets contain 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.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Onglyza is 5 mg once a day.
If you have reduced kidney function, your doctor may prescribe a lower dose. This is one 2.5 mg tablet once a day.
Your doctor may prescribe Onglyza alone or together with insulin or other anti-diabetic medicines. If applicable remember to take these other medicines as directed by your doctor to achieve the best results for your health.
The tablets must not be split or cut. Swallow the tablet whole with some water. You can take the tablet with or without food. The tablet can be taken at any time of the day, however, try to take your tablet at the same time each day. This will help you to remember to take it.
If you take more tablets than you should, talk to a doctor straight away.
Keep taking Onglyza until your doctor tells you to stop. This is to help keep your blood sugar under control.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking Onglyza and see your doctor immediately if you experience the following symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change, vagueness or confusion (hypoglycaemia); seen very commonly (may affect more than 1 in 10 people).
Symptoms of a serious allergic reaction (seen rarely, may affect up to 1 in 1,000 people) may include:
If you have these symptoms, stop taking Onglyza and call your doctor or nurse right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
You should stop taking Onglyza and contact a doctor immediately if you notice any of the following serious side effects:
You should call your doctor if you experience the following side effect:
Some patients have had the following side effects while taking Onglyza and metformin:
Some patients have had the following side effects while taking Onglyza and a sulphonylurea:
Some patients have had the following side effects while taking Onglyza and a thiazolidinedione:
Some patients have had the following side effects while taking Onglyza and metformin and a sulphonylurea:
Some patients have had the following additional side effects while taking Onglyza alone:
Some patients have had the following side effects while taking Onglyza alone or in combination:
Some patients have had a small reduction in the number of one type of white blood cells (lymphocytes) shown in a blood test when Onglyza was used alone or in combination.
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.
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 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 use this medicine if the package is damaged or shows signs of tampering.
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.
Not all pack sizes may be marketed.
This leaflet was last revised in 09/2022
© AstraZeneca 2022
ONGLYZA is a registered trademark of the AstraZeneca group of companies.
CV 22 0115
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Onglyza 5 mg film-coated tablets 17901/0337
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