ONGLYZA 5 MG FILM-COATED TABLETS, SAXAGLIPTIN 5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Onglyza® 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.

This medicine is called by any of the above names but will be referred to as Onglyza throughout this leaflet.

Onglyza 2.5 mg film-coated tablets are also available.

What is in this leaflet

• 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

1. what onglyza is and what it is used for

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.

2. what you need to know before you take onglyzado not take onglyza 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 Onglyza:

• if you are taking insulin. Onglyza 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). Onglyza 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 Onglyza 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 Onglyza. If you are having haemodialysis then Onglyza is not recommended for you;
• if you have moderate or severe liver problems. If you have severe liver problems, then Onglyza is not recommended for you.

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.

Children and adolescents

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.

Other medicines and Onglyza

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 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.

Driving and using machines

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.

Onglyza contains lactose

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.

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 onglyza

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.

How to take Onglyza

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 Onglyza than you should

If you take more tablets than you should, talk to a doctor straight away.

If you forget to take Onglyza

• If you forget to take a dose of Onglyza, 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 Onglyza

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.

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 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:

• Rash
• Raised red patches on your skin (hives)
• Swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.

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:

• 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 Onglyza 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 Onglyza 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 Onglyza 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 Onglyza and metformin and a sulphonylurea:

• Common: dizziness, tiredness, stomach ache and flatulence.

Some patients have had the following additional side effects while taking Onglyza alone:

• Common: dizziness, diarrhoea and stomach ache.

Some patients have had the following side effects while taking Onglyza 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 cells (lymphocytes) shown in a blood test when Onglyza was used alone or in combination.

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: 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 onglyza

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.

If your tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

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 informationwhat onglyza contains the active substance is saxagliptin. each film-coated tablet contains 5 mg saxagliptin (as hydrochloride).

• The other ingredients are:

• – Tablet core: lactose monohydrate; cellulose, microcrystalline (E460i); croscarmellose sodium (E468); magnesium stearate.

• – Film-coating: polyvinyl alcohol; macrogol 3350; titanium dioxide (E171); talc (E553b) and iron oxide red (E172).

• – Printing ink: shellac; indigo carmine aluminium lake (E132).

What Onglyza looks like and contents of the pack

• 5 mg film-coated tablets are pink, biconvex, round.

They have “5” printed on one side and “4215” printed on the other side, in blue ink.

• Tablets available in aluminium foil blisters.
• 5 mg tablets are available in pack sizes of 30×1

film-coated tablets in perforated unit dose blisters.

Manufacturer:

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Germany.

Procured from within the EU.

Repackaged by the Product Licence Holder:

Cross Healthcare Ltd.,

Unit 2a Bandeath Industrial Estate,

Throsk,

Stirling,

FK7 7NP, UK.

Onglyza® is a registered trademark of AstraZeneca AB.

Onglyza 5 mg film-coated tablets PLGB 20504/0535

This leaflet was last revised in: 31/01/2022

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 01786–817707 (Regulatory department), to obtain the leaflet in a format suitable for you.

LFONG0535-CR-31/01/2022-R01

Package leaflet: Information for the patient

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.

This medicine is called by any of the above names but will be referred to as Saxagliptin throughout this leaflet.

Saxagliptin 2.5 mg film-coated tablets are also available.

What is in this leaflet

• 1. What Saxagliptin is and what it is used for

• 2. What you need to know before you take Saxagliptin

• 3. How to take Saxagliptin

• 4. Possible side effects

• 5. How to store Saxagliptin

• 6. Contents of the pack and other information

1. what saxagliptin is and what it is used for

Saxagliptin 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 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 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 saxagliptindo not take saxagliptin 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:

• if you are taking insulin. Saxagliptin 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 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 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. If you are having haemodialysis then Saxagliptin is not recommended for you;
• if you have moderate or severe liver problems. If you have severe liver problems, then Saxagliptin is not recommended for you.

Diabetic skin lesions are a common complication of diabetes. Rash has been seen with Saxagliptin (see section 4) and with certain anti-diabetic medicines in the same class as Saxagliptin. 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.

Children and adolescents

Saxagliptin 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

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 if you are pregnant or plan to become pregnant. You should not use Saxagliptin if you are pregnant.

Talk to your doctor if you want to breast-feed while taking this medicine. It is not known if Saxagliptin 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, 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.

Saxagliptin contains lactose

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.

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

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 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 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

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 than you should

If you take more tablets than you should, talk to a doctor straight away.

If you forget to take Saxagliptin

• If you forget to take a dose of Saxagliptin, 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

Keep taking Saxagliptin 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 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:

• Rash
• Raised red patches on your skin (hives)
• Swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.

If you have these symptoms, stop taking Saxagliptin 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 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 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 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 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 and metformin and a sulphonylurea:

• Common: dizziness, tiredness, stomach ache and flatulence.

Some patients have had the following additional side effects while taking Saxagliptin alone:

• Common: dizziness, diarrhoea and stomach ache.

Some patients have had the following side effects while taking Saxagliptin 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 cells (lymphocytes) shown in a blood test when Saxagliptin was used alone or in combination.

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: 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

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.

If your tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

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 informationwhat saxagliptin contains the active substance is saxagliptin. each film-coated tablet contains 5 mg saxagliptin (as hydrochloride).

• The other ingredients are:

• – Tablet core: lactose monohydrate; cellulose, microcrystalline (E460i); croscarmellose sodium (E468); magnesium stearate.

• – Film-coating: polyvinyl alcohol; macrogol 3350; titanium dioxide (E171); talc (E553b) and iron oxide red (E172).

• – Printing ink: shellac; indigo carmine aluminium lake (E132).

What Saxagliptin looks like and contents of the pack

• 5 mg film-coated tablets are pink, biconvex, round.

They have “5” printed on one side and “4215” printed on the other side, in blue ink.

• Tablets available in aluminium foil blisters.
• 5 mg tablets are available in pack sizes of 30×1