Onglyza 5 mg film-coated tablets

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 together with another oral anti-diabetic medicine.

It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse.

Do not take Onglyza

• if you are allergic (hypersensitive) to saxagliptin or any of the other ingredients of Onglyza (listed in section 6, ?What Onglyza contains?).

Take special care with Onglyza

Check with your doctor or pharmacist before taking Onglyza if you:

• have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidos (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting). Onglyza should not be used to treat these conditions;
• are taking an anti-diabetic medicine known as ?sulphonylurea?, your doctor may want to reduce your dose of sulphonylurea when you take it together with Onglyza in order to avoid low blood sugar;
• have had allergic reactions to any other medicines that you take to control the amount of sugar in your blood;
• have a condition that reduces your defense against infections, such as a disease like AIDS or from medicines that you might take after an organ transplant;
• suffer from heart failure;
• have moderate to severe kidney problems, you will need to take a lower dose of Onglyza;
• 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 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.

Onglyza is not recommended for children and adolescents under 18 years.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription.

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.

Taking Onglyza with food and drink

You can take Onglyza with or without food.

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.

Driving and using machines
If you feel dizzy while taking Onglyza, do not drive or use any tools or machines.

Important information about some of the ingredients of Onglyza

Onglyza contains 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.

Always take Onglyza exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose of Onglyza is one 5 mg tablet once a day.

If you have kidney problems, your doctor may prescribe a lower dose. This is one 2.5 mg tablet once a day.

Your doctor will prescribe Onglyza together with another oral anti-diabetic medicine. Remember to take this other medicine as directed by your doctor to achieve the best results for your health.

How to take Onglyza

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 Onglyza 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Onglyza 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).

Side effects below may occur with certain frequencies, which are defined as follows:

• Very common: affects more than 1 user in 10
• Common: affects 1 to 10 users in 100
• Uncommon: affects 1 to 10 users in 1,000
• Rare: affects 1 to 10 users in 10,000
• Very rare: affects less than 1 user in 10,000
• Not known: frequency cannot be estimated from the available data

Some patients have had the following side effects while taking Onglyza and metformin:

• Common: infection of the upper airways, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the upper airways 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) and indigestion (dyspepsia).
• Uncommon: 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 airways, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the upper airways with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache and vomiting.
• Uncommon: fatigue, abnormal lipid (fatty acids) levels (dyslipidemia, hypertriglyceridemia).

Some patients have had the following side effects while taking Onglyza and a thiazolidinedione:

• Common: infection of the upper airways, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the upper airways with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache, vomiting, swelling of the hands, ankles or feet (peripheral oedema).

Some patients have had the following additional side effect while taking Onglyza alone: Common: dizziness.

Some patients have had a small reduction in the number of one type of white blood cells (lymphocytes) shown in a blood test. In addition, some patients have reported rash and skin reactions (hypersensitivity) while taking Onglyza.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Onglyza 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 Onglyza if the package is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Onglyza contains

• The active substance is saxagliptin. Each Onglyza 5 mg 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) and talc (E553b). Onglyza 5 mg tablets also contain iron oxide red (E172). Printing ink: shellac, indigo carmine aluminium lake (E132).

What Onglyza looks like and contents of the pack

• Onglyza 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.
• Onglyza is available in aluminum foil blisters.
• Onglyza 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 non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder
Bristol-Myers Squibb/AstraZeneca EEIG
Bristol-Myers Squibb House

Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex
UB8 1DH
United Kingdom

Manufacturer
Bristol-Myers Squibb Company
Contrada Fontana del Ceraso
IT-03012 Anagni (FR)
Italy

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

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Lietuva

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