Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
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.
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 filmcoated 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
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 breastfeeding 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'.
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 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.
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,
Date : 23.07.2025
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.
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
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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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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Package Leaflet: Information for the patient Saxagliptin 2.5 mg Film-Coated Tablets
Saxagliptin 5 mg Film-Coated Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
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).
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.
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: [email protected].
Saxagliptin 2.5mg film-coated tablets comes as tablet containing 2.5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Saxagliptin 2.5mg film-coated tablets is saxagliptin.
Medicines with the same active substance include: Saxagliptin 2.5 mg Film-coated Tablet, Saxagliptin 5 mg Film-coated Tablet. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Saxagliptin 2.5mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Saxagliptin is indicated in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
‐ as monotherapy when metformin is inappropriate due to intolerance or contraindications
‐ in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Posology
The recommended dose of saxagliptin is 5 mg once daily. When saxagliptin is used in combination with insulin or a sulphonylurea, a lower dose of the insulin or sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established.
Special populations
Elderly (≥ 65 years)
No dose adjustment is recommended based solely on age (see also sections 5.1 and 5.2).
Renal impairment
No dose adjustment is recommended for patients with mild renal impairment or in patients with moderate renal impairment that have GFR ≥ 45 mL/min.
The dose should be reduced to 2.5 mg once daily in patients with moderate renal impairment that have GFR < 45 mL/min and in patients with severe renal impairment.
Saxagliptin is not recommended for patients with end-stage renal disease (ESRD) requiring haemodialysis (see section 4.4).
Because the dose should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of treatment, and, in keeping with routine care, renal assessment should be done periodically thereafter (see sections 4.4 and 5.2).
Hepatic impairment
No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2). Saxagliptin should be used with caution in patients with moderate hepatic impairment, and is not recommended for use in patients with severe hepatic impairment (see section 4.4).
Paediatric population
The efficacy of Saxagliptin in children aged 10 to < 18 years has not been established. Therefore, treatment of children and adolescents with saxagliptin is not recommended. Currently available data are described in sections 5.1 and 5.2. Saxagliptin has not been studied in children under 10 years of age.
Method of administration
The tablets can be taken with or without a meal at any time of the day. Tablets must not be split or cut.
If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl peptidase-4 (DPP4) inhibitor (see sections 4.4 and 4.8).
Clinical data described below suggest that the risk for clinically meaningful interactions with co-administered medicinal products is low.
The metabolism of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).
The co-administration of saxagliptin and CYP3A4/5 inducers, other than rifampicin (such as carbamazepine, dexamethasone, phenobarbital and phenytoin) have not been studied and may result in decreased plasma concentration of saxagliptin and increased concentration of its major metabolite. Glycaemic control should be carefully assessed when saxagliptin is used concomitantly with a potent CYP3A4/5 inducer.
Concomitant administration of saxagliptin with the moderate inhibitor of CYP3A4/5 diltiazem, increased the Cmax and AUC of saxagliptin by 63% and 2.1-fold, respectively, and the corresponding values for the active metabolite were decreased by 44% and 34%, respectively.
Concomitant administration of saxagliptin with the potent inhibitor of CYP3A4/5 ketoconazole, increased the Cmax and AUC of saxagliptin by 62% and 2.5-fold, respectively, and the corresponding values for the active metabolite were decreased by 95% and 88%, respectively.
Concomitant administration of saxagliptin with the potent CYP3A4/5 inducer rifampicin, reduced Cmax and AUC of saxagliptin by 53% and 76%, respectively. The exposure of the active metabolite and the plasma DPP4 activity inhibition over a dose interval were not influenced by rifampicin (see section 4.4).
In in vitro studies, saxagliptin and its major metabolite neither inhibited CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, nor induced CYP1A2, 2B6, 2C9, or 3A4. In studies conducted in healthy subjects, neither the pharmacokinetics of saxagliptin nor its major metabolite, were meaningfully altered by metformin, glibenclamide, pioglitazone, digoxin, simvastatin, omeprazole, antacids or famotidine. In addition, saxagliptin did not meaningfully alter the pharmacokinetics of metformin, glibenclamide, pioglitazone, digoxin, simvastatin, the active components of a combined oral contraceptive (ethinyl estradiol and norgestimate), diltiazem or ketoconazole.
The effects of smoking, diet, herbal products, and alcohol use on the pharmacokinetics of saxagliptin have not been specifically studied.
Pregnancy
The use of saxagliptin has not been studied in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3). The potential risk for humans is unknown. Saxagliptin should not be used during pregnancy unless clearly necessary.
Breast-feeding
It is unknown whether saxagliptin is excreted in human breast milk. Animal studies have shown excretion of saxagliptin and/or metabolite in milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy to the woman.
Fertility
The effect of saxagliptin on fertility in humans has not been studied. Effects on fertility were observed in male and female rats at high doses producing overt signs of toxicity (see section 5.3).
Saxagliptin may have a negligible influence on the ability to drive and use machines.
When driving or using machines, it should be taken into account that dizziness has been reported in studies with saxagliptin. In addition, patients should be alerted to the risk of hypoglycaemia when saxagliptin is used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin, sulphonylureas).
Saxagliptin had no clinically meaningful effect on QTc interval or heart rate at oral doses up to 400 mg daily for 2 weeks (80 times the recommended dose). In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status. Saxagliptin and its major metabolite can be removed by haemodialysis (23% of dose over 4 hours).
Ask anything about Saxagliptin 2.5mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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