Patient leaflet - Saxagliptin 2.5 mg film-coated tablets
1. What Saxagliptin film-coated tablets are and what they are used for
Saxagliptin film-coated tablets 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. Saxagliptin film-coated tablets 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. Saxagliptin film-coated tablets 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.
2. What you need to know before you take Saxagliptin film-coated tablets
Do not take Saxagliptin film-coated tablets
- if you are allergic to saxagliptin or any of the other ingredients of this medicine (listed in section 6).
- if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar. See section 4.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Saxagliptin film-coated tablets:
- if you are taking insulin. Saxagliptin film-coated tablets should not be used in place of insulin;
- if you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting). Saxagliptin film-coated tablets should not be used to treat these conditions;
- if you have or have had a disease of the pancreas;
- if you are taking insulin or an anti-diabetic medicine known as ‘sulphonylurea’, your doctor may want to reduce your dose of insulin or the sulphonylurea when you take either of them together with Saxagliptin film-coated tablets in order to avoid low blood sugar;
- if you have a condition that reduces your defence against infections, such as a disease like AIDS or from medicines that you might take after an organ transplant;
- if you suffer from heart failure or you have other risk factors for developing heart failure such as problems with your kidneys. Your doctor will advise you of the signs and symptoms of heart failure. You should call your doctor, pharmacist or nurse immediately if you experience any of these symptoms. Symptoms can include, but are not limited to, increasing shortness of breath, rapid increase in weight and swelling of the feet (pedal oedema);
if you have reduced kidney function, your doctor will decide if you need to take a lower dose of
Saxagliptin film-coated tablets. If you are having haemodialysis, then Saxagliptin film-coated tablets is not recommended for you;
- if you have moderate or severe liver problems. If you have severe liver problems, then Saxagliptin film-coated tablets is not recommended for you.
Diabetic skin lesions are a common complication of diabetes. Rash has been seen with Saxagliptin film-coated tablets (see section 4) and with certain anti-diabetic medicines in the same class as Saxagliptin film-coated tablets. 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 Saxagliptin film-coated tablets.
Children and adolescents
Saxagliptin film-coated tablets 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.
Other medicines and Saxagliptin film-coated tablets
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:
- Carbamazepine, phenobarbital or phenytoin. These may be used to control fits (seizures) or chronic pain.
- Dexamethasone – a steroid medicine. This may be used to treat inflammation in different body parts and organs.
- Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.
- Ketoconazole. This may be used to treat fungal infections.
- Diltiazem. This is a medicine used to lower blood pressure.
Pregnancy and breast-feeding
Talk to your doctor before you take Saxagliptin film-coated tablets if you are pregnant or plan to become pregnant. You should not use Saxagliptin film-coated tablets if you are pregnant. Talk to your doctor if you want to breast-feed while taking this medicine. It is not known if Saxagliptin film-coated tablets passes into human breast milk. You should not take this medicine if you are breast-feeding or plan to breast-feed.
Driving and using machines
If you feel dizzy while taking Saxagliptin film-coated tablets, 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.
Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free’.
3. How to take Saxagliptin film-coated tablets
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 Saxagliptin film-coated tablets 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 Saxagliptin film-coated tablets 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.
How to take Saxagliptin film-coated tablets
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 Saxagliptin film-coated tablets than you should
If you take more tablets than you should, talk to a doctor straight away.
If you forget to take Saxagliptin film-coated tablets
If you forget to take a dose of Saxagliptin film-coated tablets, take it as soon as you remember it.
However, if it is nearly time for the next dose, skip the missed dose.
- Do not take a double dose to make up for a forgotten dose. Never take two doses on the same day. If you stop taking Saxagliptin film-coated tablets
Keep taking Saxagliptin film-coated tablets 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some symptoms need immediate medical attention:
You should stop taking Saxagliptin film-coated tablets 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:
o Rash
o Raised red patches on your skin (hives)
o Swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have these symptoms, stop taking Saxagliptin film-coated tablets 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 Saxagliptin film-coated tablets and contact a doctor immediately if you notice any of the following serious side effects:
- severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis). You should call your doctor if you experience the following side effect:
- Severe joint pain.
Some patients have had the following side effects while taking Saxagliptin film-coated tablets and metformin:
- Common (may affect 1 to 10 users in 100): infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), inflamed nose or throat (nasopharyngitis) (signs of this may include a cold or a sore throat), headache, muscle pain (myalgia), vomiting, inflammation of the stomach (gastritis), stomach ache and indigestion (dyspepsia).
- Uncommon (may affect 1 to 10 users in 1,000): joint pain (arthralgia) and difficulties in getting or maintaining an erection (erectile dysfunction).
Some patients have had the following side effects while taking Saxagliptin film-coated tablets and a sulphonylurea:
- Very common: low blood sugar (hypoglycaemia)
- Common: infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache, stomach ache and vomiting.
- Uncommon: tiredness, abnormal lipid (fatty acids) levels (dyslipidaemia, hypertriglyceridaemia). Some patients have had the following side effects while taking Saxagliptin film-coated tablets and a thiazolidinedione:
- Common: infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache, vomiting, stomach ache and swelling of the hands, ankles or feet (peripheral oedema).
Some patients have had the following side effects while taking Saxagliptin film-coated tablets and metformin, and a sulphonylurea:
- Common: dizziness, tiredness, stomach ache and flatulence.
Some patients have had the following additional side effects while taking Saxagliptin film-coated tablets alone:
- Common: dizziness, diarrhoea, and stomach ache.
Some patients have had the following side effects while taking Saxagliptin film-coated tablets alone or in combination:
- Not known (frequency cannot be estimated from the available data): constipation, blistering of the skin (bullous pemphigoid)
Some patients have had a small reduction in the number of one type of white blood cell (lymphocytes) shown in a blood test when Saxagliptin film-coated tablets was used alone or in combination. Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 Saxagliptin 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 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.
6. Contents of the pack and other information What Saxagliptin film-coated tablets contain
Saxagliptin 2.5 mg film-coated tablets
- The active substance is saxagliptin. Each film-coated tablet contains 2.5 mg saxagliptin (as hydrochloride dihydrate).
- The other ingredients are:
Tablet core: microcrystalline cellulose 101 (E460); croscarmellose sodium; hypromellose
2910 (E464); phosphoric acid (for pH adjustment); magnesium stearate (470b).
Film-coating: Hypromellose 2910 (E464); macrogol 4000 (E1521); talc (E553b); titanium dioxide
(E171); iron oxide yellow (E172); iron oxide black (E172); phosphoric acid (for pH adjustment). Saxagliptin 5 mg film-coated tablets
- The active substance is saxagliptin. Each film-coated tablet contains 5 mg saxagliptin (as hydrochloride dihydrate).
- The other ingredients are:
Tablet core: microcrystalline cellulose 101 (E460); croscarmellose sodium; hypromellose
2910 (E464); phosphoric acid (for pH adjustment); magnesium stearate (470b).
Film-coating: Hypromellose 2910 (E464); macrogol 4000 (E1521); talc (E553b); titanium dioxide
(E171); iron oxide yellow (E172); iron oxide black (E172); iron oxide red (E172); phosphoric acid (for pH adjustment).
What Saxagliptin film-coated tablets look like and contents of the pack
Saxagliptin 2.5 mg film-coated tablets
Yellow, biconvex, round film-coated tablets with ‘2.5’ debossed on one side and plain on the other side. Saxagliptin 5 mg film-coated tablets
Brownish-pink, biconvex, round film-coated tablets with ‘5’ debossed on one side and plain on the other side.
The film-coated tablets are supplied in aluminium blister packs or in white HDPE containers with child-resistant caps.
Presentation:
2.5 mg film-coated tablets
Blister pack: 28 and 30 film-coated tablets
Unit dose blister pack: 28x1 and 30x1 film-coated tablets
HDPE container: 98 tablets
5 mg film-coated tablets
Blister pack: 28 and 30 film-coated tablets
Unit dose blister pack: 28x1 and 30x1 film-coated tablets
HDPE container: 98 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zydus Pharmaceuticals UK Ltd
Sandretto Building
Cavalry Hill Industrial Park
Weedon Northampton
England NN7 4PP UK
Manufacturer
PharOS MT Ltd
HF62X, Hal Far Industrial Estate, Birzebbugia BBG3000, Malta
This leaflet was last revised in Jul-2025
Other sources of information: To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 0800 995034 / email: drugsafety@zydusuk.com.
165 mm