Oneglyza 5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Onglyza 5 mg film-coated tablets

saxagliptin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Onglyza is and what it is used for
2. What you need to know before taking 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 an active substance called saxagliptin, which belongs to a group of medicines known as "oral antidiabetics". These work by helping to control your blood sugar levels.

Onglyza is used to treat adult patients aged 18 years or older with "type 2 diabetes" when the disease cannot be adequately controlled by an oral antidiabetic medicine, diet, and exercise. Onglyza may be used alone or in combination with insulin or other antidiabetic medicines.

It is important that you follow the dietary and exercise advice given to you by your doctor or healthcare professional.

2. What you need to know before taking Onglyza

Do not take Onglyza

• if you are allergic to saxagliptine or to any of the other ingredients of this medicine (listed in section 6);
• if you have had a severe allergic reaction to any other similar medicine used to control blood sugar. See section 4.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Onglyza:

• if you are taking insulin. Onglyza must not be used instead of insulin;
• if you have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a diabetes complication with high blood sugar levels, rapid weight loss, nausea or vomiting). Onglyza must not be used to treat these medical conditions;
• if you have or have had a disease of the pancreas;
• if you are taking insulin or an antidiabetic medicine known as a “sulfonylurea”, your doctor may want to reduce your insulin or sulfonylurea dose when taking either of them together with Onglyza to avoid low blood sugar levels;
• if you have a disorder that reduces your body's defences against infections, such as a disease like AIDS or due to medications you may be taking after an organ transplant;
• if you have heart failure or have other risk factors for developing heart failure such as kidney problems. Your doctor will inform you about the signs and symptoms of heart failure. You must contact your doctor, pharmacist, or nurse immediately if you experience any of these symptoms. Symptoms may include, but are not limited to, increasing shortness of breath, rapid weight gain, and swelling of the ankles (ankle edema);
• if you have reduced kidney function, your doctor will decide whether you need a lower dose of Onglyza. If you are on dialysis, Onglyza is not recommended for you;
• if you have moderate or severe liver problems. If you have severe liver problems, use of Onglyza is not recommended.

Diabetic skin lesions are a common complication of diabetes. Skin rash has been observed with Onglyza (see section 4) and with certain antidiabetic medicines in the same class as Onglyza. You are advised to follow the skin and foot care recommendations provided by your doctor or healthcare professional. Contact your doctor if you develop blisters on the skin, as this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Onglyza.

Children and adolescents

Onglyza is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Onglyza

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, you must inform your doctor if you are taking medicines containing any of the following active substances:

• Carbamazepine, phenobarbital, or phenytoin. These may be used to control epileptic seizures (convulsions) or chronic pain.
• Dexamethasone – a steroid medicine. It may be used to treat inflammation in different parts of the body and organs.
• Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.
• Ketoconazole. It may be used to treat fungal infections.
• Diltiazem. This is a medicine used to lower blood pressure.

Pregnancy and breastfeeding

Talk to your doctor before taking Onglyza if you are pregnant or planning to become pregnant. You must not use Onglyza if you are pregnant.

Talk to your doctor if you wish to breastfeed while taking this medicine. It is not known whether Onglyza passes into human breast milk. You must not take this medicine if you are breastfeeding or planning to breastfeed.

Driving and using machines

If you feel dizzy while taking Onglyza, do not drive or operate tools or machinery. Hypoglycaemia may affect your ability to drive and use machines safely, and there is a risk of hypoglycaemia when taking this medicine in combination with medicines known to cause hypoglycaemia, such as insulin or sulfonylureas.

Onglyza contains lactose

The tablets contain lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Onglyza contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially “sodium-free”.

3. How to take Onglyza

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 5 mg tablet once daily.

If you have reduced kidney function, your doctor may prescribe a lower dose. This is one 2.5 mg tablet once daily. For this dose, a tablet of different strength is available.

Your doctor may prescribe Onglyza alone or together with insulin or other antidiabetic medicines. If so, remember to take these other medicines exactly as directed by your doctor to achieve the best results for your health.

How to take Onglyza

Do not split or cut the tablets. Swallow the tablet whole with a little water. You may take the tablet with or without food. The tablet may be taken at any time of day; however, try to take it at the same time each day. This will help you remember to take it.

If you take more Onglyza than you should

If you take more tablets than you should, contact a doctor immediately.

If you forget to take Onglyza

• If you forget to take a dose of Onglyza, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
• Do not take a double dose to make up for forgotten doses. Never take two doses on the same day.

If you stop taking Onglyza

Continue taking Onglyza until your doctor tells you to stop. This is to help you keep your blood sugar levels under control.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some symptoms require immediate medical attention:

You must stop taking Onglyza and contact your doctor immediately if you experience the following symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling in the lips, paleness, mood changes, disorientation or confusion (hypoglycaemia); observed very commonly (may affect more than 1 in 10 patients).

Symptoms of a serious allergic reaction (rarely observed, may affect up to 1 in 1,000 patients) may include:

• Skin rash.
• Raised red welts on the skin (urticaria).
• Swelling of the face, lips, tongue and throat which may cause difficulty breathing or swallowing.

If you experience any of these symptoms, stop taking Onglyza and contact your doctor or nurse immediately. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

You must stop taking Onglyza and contact your doctor immediately if you notice any of the following serious adverse effects:

• Severe and persistent pain in the abdomen (in the stomach area) which may radiate to the back, along with nausea and vomiting, which could be signs of an inflamed pancreas (pancreatitis).

Contact your doctor if you experience the following adverse effect:

• Severe joint pain.

Some patients experienced the following adverse effects while taking Onglyza and metformin:

• Common (may affect up to 1 in 100 patients): chest or lung infection, urinary tract infection, inflammation of the stomach or intestine usually caused by infection (gastroenteritis), sinus infection with pain and pressure behind the cheekbones and eyes (sinusitis), inflammation of the nose or throat (nasopharyngitis) (signs may include cold symptoms or sore throat), headache, muscle pain (myalgia), vomiting, inflammation of the stomach (gastritis), stomach pain and indigestion (dyspepsia).

• Uncommon (may affect up to 1 in 1,000 patients): joint pain (arthralgia) and difficulty achieving or maintaining an erection (erectile dysfunction).

Some patients experienced the following adverse effects while taking Onglyza and a sulfonylurea:

• Very common: low blood sugar levels (hypoglycaemia).

• Common: chest or lung infection, urinary tract infection, inflammation of the stomach or intestine usually caused by infection (gastroenteritis), sinus infection with pain and pressure behind the cheekbones and eyes (sinusitis), headache, stomach pain and vomiting.

• Uncommon: fatigue, abnormal lipid (fatty acid) levels (dyslipidaemia, hypertriglyceridaemia).

Some patients experienced the following adverse effects while taking Onglyza and a thiazolidinedione:

• Common: chest or lung infection, urinary tract infection, inflammation of the stomach or intestine usually caused by infection (gastroenteritis), sinus infection with pain and pressure behind the cheekbones and eyes (sinusitis), headache, vomiting, stomach pain and swelling of the hands, ankles or feet (peripheral oedema).

Some patients experienced the following adverse effects while taking Onglyza, metformin and a sulfonylurea:

• Common: dizziness, fatigue, stomach pain and flatulence.

Some patients experienced the following additional adverse effects while taking Onglyza alone:

• Common: dizziness, diarrhoea and stomach pain.

Some patients experienced the following additional adverse effects while taking Onglyza alone or in combination:

• Frequency not known (frequency cannot be estimated from available data): constipation, development of blisters on the skin (bullous pemphigoid).

Some patients experienced a slight decrease in the number of a type of white blood cells (lymphocytes), detected by blood tests, while taking Onglyza alone or in combination.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Onglyza Storage

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and on the outer packaging following EXP/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if the packaging is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Onglyza

• The active substance is saxagliptin. Each film-coated tablet contains 5 mg of saxagliptin (as hydrochloride).

• The other components are:

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

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

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

Nature of the product and contents of the container

• The 5 mg film-coated tablets are pink, biconvex, round tablets. They are printed with “5” on one side and “4215” on the other side in blue ink.
• The tablets are supplied in aluminium blisters.
• The 5 mg tablets are available in pack sizes of 14, 28, 56 or 98 film-coated tablets in non-perforated blisters, 14, 28, 56 or 98 film-coated tablets in calendar non-perforated blisters, and 30x1 or 90x1 film-coated tablets in single-dose perforated blisters.

Only certain pack sizes may be marketed in your country.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE‑152 57 Södertälje

Sweden

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

United Kingdom

For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.