ONGLYZA 5 mg Фильм-Coated Таблетки

Содержание инструкции

1. Onglyza 2,5 mg film-coated tablets
   1. What is Onglyza and what is it 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. Package contents and other information
2. Onglyza 5 mg film-coated tablets
   1. What is Onglyza and what is it 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. Package contents and other information

Onglyza 2,5 mg film-coated tablets

saxagliptin

Read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 is Onglyza and what is it used for

Onglyza contains the active ingredient saxagliptin, which belongs to a class of drugs called
'oral antidiabetics'. These drugs work by helping to control the level of sugar in your
blood.
Onglyza is used for adult patients starting from 18 years of age with ‘type 2 diabetes’ if the disease is not
adequately controlled with an oral antidiabetic drug, diet and exercise. Onglyza is
used alone or together with insulin or other antidiabetic medicines.
It is important that you continue to follow the advice received from your doctor or nurse regarding
diet and exercise.

2. What you need to know before you take Onglyza

Do 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 severe allergic reactions to other medicines similar to those you take to control your blood sugar level. See section 4.

Warnings and precautions
Talk to your doctor or pharmacist before taking Onglyza:

• if you are taking insulin. Onglyza should not be taken instead of insulin;
• if you have type 1 diabetes (that is, if your body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes with a high level of sugar in the blood, 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 a medicine for diabetes known as ‘sulfonylurea’, your doctor may decide to reduce the dose of insulin or sulfonylurea when you take one of them together with Onglyza, so as to avoid a low blood sugar level;
• if you have a condition that reduces your defenses against infections, such as for example a disease like AIDS or related to drugs that may be given to you following an organ transplant;
• if you suffer from heart failure or have other risk factors for the development of heart failure such as kidney problems. Your doctor will inform you of the signs and symptoms of heart failure. Contact your doctor, pharmacist or nurse immediately if you notice any of these symptoms. Symptoms may include, but are not limited to, increased shortness of breath, rapid weight gain, swelling of the feet (foot edema);
• if you have reduced kidney function, your doctor will decide whether you should take a lower dose of Onglyza; if you are undergoing hemodialysis then Onglyza is not recommended for you;
• if you have moderate or severe liver problems. Onglyza is not recommended if you have severe liver problems.

Skin lesions characteristic of diabetes are a common complication of this disease. Rash has been observed with Onglyza (see section 4) and with some medicines in the same class as Onglyza. We recommend that you follow the recommendations given to you by your doctor or nurse for skin and foot care. 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 children and adolescents under the age of 18 years.

Other medicines and Onglyza
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, you should inform your doctor if you are taking medicines containing the following active substances:

• Carbamazepine, phenobarbital or phenytoin. These may be taken to control seizures or chronic pain.
• Dexamethasone - a steroid specialty. This can be used to treat inflammation in different parts and organs of the body.
• 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 breastfeeding
Before taking Onglyza, tell your doctor if you are pregnant or planning a pregnancy.
You should not take Onglyza if you are pregnant.
Ask your doctor if you want to breastfeed while taking this medicine. It is not known whether Onglyza passes into breast milk. You should not take this medicine if you are breastfeeding or planning to breastfeed.

Driving and using machines
If you feel dizzy when taking Onglyza, do not drive or use tools or machinery. Hypoglycemia can affect your ability to drive and use machines or work with protective devices and there is a risk of hypoglycemia while taking this medicine in combination with medicines known to cause hypoglycemia such as insulin and sulfonylureas.

Onglyza contains lactose
The tablets contain lactose (milk sugar). If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

Onglyza contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially "sodium-free”.

3. How to take Onglyza

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
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 equivalent to
one 2.5 mg tablet once a day.
Your doctor may prescribe Onglyza alone or together with insulin or other antidiabetic drugs. If
applicable, remember to also take the other medicines as indicated by your doctor, to obtain the best
results for your health.

How to take Onglyza
The tablets must not be divided or cut. Swallow the tablet whole with a little 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 the 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, contact your 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 to take the next dose, skip the dose you forgot.
• Do not take a double dose to make up for a missed dose. Never take two doses in the same day.

If you stop taking Onglyza
Continue taking Onglyza until your doctor tells you to stop. This will help you
control your blood sugar level.
If you have any doubts about 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.
li manifestino.

Some symptoms require immediate medical attention:
You must stop taking Onglyza and consult your doctor immediately if you experience the following
symptoms due to low blood sugar levels: tremor, sweating, anxiety, blurred vision,
tingling lips, paleness, mood changes, drowsiness or confusion (hypoglycemia); very
commonly observed (may affect more than 1 in 10 people).
Symptoms of a severe allergic reaction (rarely observed, may affect up to 1 in 1,000
people) may include:
o Skin rashes.
o Raised red patches on the skin (urticaria).
o Swelling of the face, lips, tongue and throat which can cause difficulty
breathing or swallowing.
If you experience these symptoms, stop taking Onglyza and call your doctor or
nurse immediately. Your doctor may prescribe a medicine to treat the allergic reaction and a
different medicine for diabetes.
Stop taking Onglyza and consult your doctor immediately if you notice any of the following severe
side effects:

• Severe and persistent abdominal pain (stomach area) that may radiate to the back, as well as nausea and vomiting, as it could be a sign of inflamed pancreas (pancreatitis).

Contact your doctor if you notice any of the following side effects:

• Severe joint pain

Some patients have experienced the following side effects when taking Onglyza with
metformin:

• Common (may affect 1 to 10 patients out of 100): upper respiratory tract or lung infection, urinary tract infection, inflammation of the stomach or intestines usually caused by an infection (gastroenteritis), sinus infection with a feeling of pain and congestion behind the cheeks and eyes (sinusitis), inflammation of the nose or throat (nasopharyngitis) (symptoms of this may include a cold or sore throat), headache, muscle pain (myalgia), vomiting, inflammation of the stomach (gastritis), stomach discomfort and indigestion (dyspepsia).
• Uncommon (may affect 1 to 10 patients out of 1,000): joint pain (arthralgia) and difficulty achieving or maintaining an erection (erectile dysfunction).

Some patients have experienced the following side effects when taking Onglyza with a
sulfonylurea:

• Very common: low blood sugar level (hypoglycemia).
• Common: upper respiratory tract or lung infection, urinary tract infection, inflammation of the stomach or intestines usually caused by an infection (gastroenteritis), sinus infection with a feeling of pain and congestion behind the cheeks and eyes (sinusitis), headache, stomach discomfort and vomiting.
• Uncommon: fatigue, abnormal lipid (fatty acid) levels (dyslipidemia, hypertriglyceridemia).

Some patients have experienced the following side effects when taking Onglyza with a
thiazolidinedione:

• Common: upper respiratory tract or lung infection, urinary tract infection, inflammation of the stomach or intestines usually caused by an infection (gastroenteritis), sinus infection with a feeling of pain and congestion behind the cheeks and eyes (sinusitis), headache, vomiting, stomach discomfort, swelling in the hands, ankles or feet (peripheral edema).

Some patients have experienced the following side effects when taking Onglyza with
metformin and a sulfonylurea:

• Common: dizziness, fatigue, stomach discomfort and flatulence

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

• Common: dizziness, diarrhea and stomach discomfort.

Some patients have experienced the following side effects when taking Onglyza alone or in
combination:

• Not known (frequency cannot be estimated based on available data): constipation, blisters on the skin (bullous pemphigoid).

Some patients have had a mild decrease in the number of white blood cells (lymphocytes) detected by
blood tests 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 side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system detailed in Annex V .
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 packaging after
the abbreviation EXP/Scad. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice that the box is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Onglyza contains

• The active ingredient is saxagliptin. Each film-coated tablet contains 2.5 mg of saxagliptin (as hydrochloride).
• The other ingredients are:
• Tablet core: lactose monohydrate, microcrystalline cellulose (E460i), sodium croscarmellose (E468), magnesium stearate.
• Film coating: polyvinyl alcohol, macrogol 3350; titanium dioxide (E171), talc (E553b) and yellow iron oxide (E172).
• Printing ink: shellac, indigotine carmine aluminum lake (E132).

Description of Onglyza and package contents

• The 2.5 mg film-coated tablets are pale yellow to light yellow in color, biconvex, round. They have “2.5” printed on one side and “4214” printed on the other side, with blue ink.
• The tablets are available in aluminum blisters.
• The 2.5 mg tablets are available in packs of 14, 28, or 98 film-coated tablets in non-perforated calendar blisters and in 30x1 and 90x1 film-coated tablets in perforated unit-dose blisters.

Not all pack sizes may be marketed.

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 further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
AstraZeneca S.A./N.V.
Tel: +32 2 370 48 11

Lietuva
UAB AstraZeneca Lietuva
Tel: +370 5 2660550

България
АстраЗенека България ЕООД
Тел.: +359 (2) 44 55 000

Luxembourg/Luxemburg
AstraZeneca S.A./N.V.
Tél/Tel: +32 2 370 48 11

Česká republika
AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 111

Magyarország
AstraZeneca Kft.
Tel.: +36 1 883 6500

Danmark
AstraZeneca A/S
Tlf: +45 43 66 64 62

Malta
Associated Drug Co. Ltd
Tel: +356 2277 8000

Deutschland
AstraZeneca GmbH
Tel: +49 40 809034100

Nederland
AstraZeneca BV
Tel: +31 85 808 9900

Eesti
AstraZeneca
Tel: +372 6549 600

Norge
AstraZeneca AS
Tlf: +47 21 00 64 00

Ελλάδα
AstraZeneca A.E.
Τηλ: +30 2 106871500

Österreich
AstraZeneca Österreich GmbH
Tel: +43 1 711 31 0

España
AstraZeneca Farmacéutica Spain, S.A.
Tel: +34 91 301 91 00

Polska
AstraZeneca Pharma Poland Sp. z o.o.
Tel.: +48 22 245 73 00

France
AstraZeneca

Portugal
AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska
AstraZeneca d.o.o.
Tel: +385 1 4628 000

România
AstraZeneca Pharma SRL
Tel: +40 21 317 60 41

Ireland
AstraZeneca Pharmaceuticals (Ireland) DAC
Tel: +353 1609 7100

Slovenija
AstraZeneca UK Limited
Tel: +386 1 51 35 600

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
AstraZeneca AB, o.z.
Tel: +421 2 5737 7777

Italia
AstraZeneca S.p.A.
Tel: +39 02 00704500

Suomi/Finland
AstraZeneca Oy
Puh/Tel: +358 10 23 010

Κύπρος
Αλέκτωρ Φαρµακευτική Λτδ
Τηλ: +357 22490305

Sverige
AstraZeneca AB
Tel: +46 8 553 26 000

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

United Kingdom (Northern Ireland)
AstraZeneca UK Ltd
Tel: +44 1582 836 836
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http// www.ema.europa.eu.

Onglyza 5 mg film-coated tablets

saxagliptin

Read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 is Onglyza and what is it used for

Onglyza contains the active ingredient saxagliptin, which belongs to a class of medicines called
'oral antidiabetics'. These medicines work by helping to control the level of sugar in your
blood.
Onglyza is used for adult patients aged 18 years and over with ‘type 2 diabetes’, if the disease is not
adequately controlled with an oral antidiabetic medicine, diet and exercise. Onglyza is
used alone or together with insulin or other antidiabetic medicines.
It is important that you continue to follow the advice received from your doctor or nurse regarding
diet and exercise.

2. What you need to know before you take Onglyza

Do 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 severe allergic reactions to other similar medicines that you take to control your blood sugar level. See section 4.

Warnings and precautions
Talk to your doctor or pharmacist before taking Onglyza:

• if you are taking insulin. Onglyza should not be taken instead of insulin;
• if you have type 1 diabetes (i.e. your body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes with a high level of sugar in the blood, 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 a medicine for diabetes known as ‘sulfonylurea’, your doctor may decide to reduce the dose of insulin or sulfonylurea when you take one of them together with Onglyza, so as to avoid a low blood sugar level;
• if you have a condition that reduces your defenses against infections, such as for example a disease like AIDS or related to drugs that may be given to you following an organ transplant;
• if you suffer from heart failure or have other risk factors for the development of heart failure such as kidney problems. Your doctor will inform you of the signs and symptoms of heart failure. Contact your doctor, pharmacist or nurse immediately if you notice any of these symptoms. Symptoms may include, but are not limited to, increased shortness of breath, rapid weight gain, swelling of the feet (foot edema);
• if you have reduced kidney function, your doctor will decide if you should take a lower dose of Onglyza; If you are undergoing hemodialysis then Onglyza is not recommended for you;
• if you have moderate or severe liver problems. Onglyza is not recommended if you have severe liver problems.

Skin lesions characteristic of diabetes are a common complication of this disease. Rash has been observed with Onglyza (see section 4) and with some medicines in the same class as Onglyza. We recommend that you follow the recommendations given to you by your doctor or nurse for the care of your skin and feet. Contact your doctor if you develop blisters on the skin, it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to discontinue Onglyza.

Children and adolescents
Onglyza is not recommended for children and adolescents under the age of 18 years.

Other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, you should inform your doctor if you are taking medicines containing the following active substances:

• Carbamazepine, phenobarbital or phenytoin. These may be taken to control seizures or chronic pain.
• Dexamethasone - a steroid specialty. This may be used to treat inflammation in different parts and organs of the body.
• 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 breastfeeding
Before taking Onglyza, tell your doctor if you are pregnant or planning a pregnancy.
You should not take Onglyza if you are pregnant.
Ask your doctor if you want to breastfeed while taking this medicine. It is not known whether Onglyza passes into breast milk. You should not take this medicine if you are breastfeeding or planning to breastfeed.

Driving and using machines
If you feel dizzy when taking Onglyza, do not drive or use tools or machinery. Hypoglycemia can affect your ability to drive and use machines and there is a risk of hypoglycemia when taking this medicine in association with medicines known to cause hypoglycemia such as insulin and sulfonylureas.

Onglyza contains lactose
The tablets contain lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine.

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

3. How to take Onglyza

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one 5 mg tablet once a day.
If you have reduced kidney function, your doctor may prescribe a lower dose. This is equivalent to
one 2.5 mg tablet once a day. A different dosage tablet is available for this dose.
Your doctor may prescribe Onglyza alone or together with insulin or other antidiabetic drugs. If
applicable, remember to also take the other medicines as indicated by your doctor to obtain the best
results for your health.

How to take Onglyza
The tablets must not be divided or cut. Swallow the tablet whole with a little 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 the 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, contact your 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 to take the next dose, skip the dose you forgot.
• Do not take a double dose to make up for a missed dose. Never take two doses in the same day.

If you stop taking Onglyza
Continue to take Onglyza until your doctor tells you to stop. This will help you
to control your blood sugar level.
If you have any doubts about 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 everyone will experience them.

Some symptoms require immediate medical attention:
You must stop taking Onglyza and consult your doctor immediately if you experience the following
symptoms due to low blood sugar levels: tremor, sweating, anxiety, blurred vision,
tingling lips, pallor, mood changes, drowsiness or confusion (hypoglycemia); very
commonly observed (may affect more than 1 in 10 people).
Symptoms of a severe allergic reaction (rarely observed, may affect up to 1 in 1,000
people) may include:
o Skin rashes.
o Raised red patches on the skin (urticaria).
o Swelling of the face, lips, tongue and throat which can cause difficulty in
breathing or swallowing.
If you experience these symptoms, stop taking Onglyza and call your doctor or
nurse immediately. Your doctor may prescribe a medicine to treat the allergic reaction and a
different medicine for diabetes.
Stop taking Onglyza and seek immediate medical attention if you notice any of the following severe
side effects:

• Severe and persistent abdominal (stomach) pain that may radiate to the back, as well as nausea and vomiting, as it could be a sign of inflamed pancreas (pancreatitis).

Contact your doctor if you notice any of the following side effects:

• Severe joint pain

Some patients have experienced the following side effects when taking Onglyza with
metformin:

• Common (may affect from 1 to 10 patients in 100): upper respiratory tract or lung infection, urinary tract infection, inflammation of the stomach or intestines usually caused by an infection (gastroenteritis), sinus infection with a feeling of pain and congestion behind the cheeks and eyes (sinusitis), inflammation of the nose or throat (nasopharyngitis) (symptoms of this may include a cold or sore throat), headache, muscle pain (myalgia), vomiting, inflammation of the stomach (gastritis), stomach discomfort and indigestion (dyspepsia).
• Uncommon (may affect from 1 to 10 patients in 1,000): joint pain (arthralgia) and difficulty achieving or maintaining an erection (erectile dysfunction).

Some patients have experienced the following side effects when taking Onglyza with a
sulfonylurea:

• Very common: low blood sugar level (hypoglycemia).
• Common: upper respiratory tract or lung infection, urinary tract infection, inflammation of the stomach or intestines usually caused by an infection (gastroenteritis), sinus infection with a feeling of pain and congestion behind the cheeks and eyes (sinusitis), headache, stomach discomfort and vomiting.
• Uncommon: fatigue, abnormal lipid (fatty acid) levels (dyslipidemia, hypertriglyceridemia).

Some patients have experienced the following side effects when taking Onglyza with a
thiazolidinedione:

• Common: upper respiratory tract or lung infection, urinary tract infection, inflammation of the stomach or intestines usually caused by an infection (gastroenteritis), sinus infection with a feeling of pain and congestion behind the cheeks and eyes (sinusitis), headache, vomiting, stomach discomfort, swelling of hands, ankles or feet (peripheral edema).

Some patients have experienced the following side effects when taking Onglyza with
metformin and a sulfonylurea:

• Common: dizziness, fatigue, stomach discomfort and flatulence

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

• Common: dizziness, diarrhea and stomach discomfort. Some patients have experienced the following side effects when taking Onglyza alone or in combination:
• Not known (frequency cannot be estimated based on available data): blisters on the skin (bullous pemphigoid).

Some patients have had a mild decrease in the number of white blood cells (lymphocytes) detected by
blood tests when Onglyza was used alone or in combination.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V.
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 packaging after
the abbreviation EXP/Scad. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice that the box is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Onglyza contains

• The active ingredient is saxagliptin. Each film-coated tablet contains 5 mg of saxagliptin (as hydrochloride).
• The other ingredients are:
• Tablet core: lactose monohydrate, microcrystalline cellulose (E460i), sodium croscarmellose (E468), magnesium stearate.
• Film coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b) and red iron oxide (E172).
• Printing ink: shellac, aluminium lake indigotine carmine (E132).

Description of Onglyza and package contents

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

Not all pack sizes may be marketed.

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 further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
AstraZeneca S.A./N.V.
Tel: +32 2 370 48 11

Lietuva
UAB AstraZeneca Lietuva
Tel: +370 5 2660550

България
АстраЗенека България ЕООД
Тел.: +359 (2) 44 55 000

Luxembourg/Luxemburg
AstraZeneca S.A./N.V.
Tél/Tel: +32 2 370 48 11

Česká republika
AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 111

Magyarország
AstraZeneca Kft.
Tel.: +36 1 883 6500

Danmark
AstraZeneca A/S
Tlf: +45 43 66 64 62

Malta
Associated Drug Co. Ltd
Tel: +356 2277 8000

Deutschland
AstraZeneca GmbH
Tel: +49 40 809034100

Nederland
AstraZeneca BV
Tel: +31 85 808 9900

Eesti
AstraZeneca
Tel: +372 6549 600

Norge
AstraZeneca AS
Tlf: +47 21 00 64 00

Ελλάδα
AstraZeneca A.E.
Τηλ: +30 2 106871500

Österreich
AstraZeneca Österreich GmbH
Tel: +43 1 711 31 0

España
AstraZeneca Farmacéutica Spain, S.A.

Polska
AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00

France
AstraZeneca
Tél: +33 1 41 29 40 00

Portugal
AstraZeneca Produtos Farmacêuticos, Lda.
Tel: +351 21 434 61 00

Hrvatska
AstraZeneca d.o.o.
Tel: +385 1 4628 000

România
AstraZeneca Pharma SRL
Tel: +40 21 317 60 41

Ireland
AstraZeneca Pharmaceuticals (Ireland) DAC
Tel: +353 1609 7100

Slovenija
AstraZeneca UK Limited
Tel: +386 1 51 35 600

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
AstraZeneca AB, o.z.
Tel: +421 2 5737 7777

Italia
AstraZeneca S.p.A.
Tel: +39 02 00704500

Suomi/Finland
AstraZeneca Oy
Puh/Tel: +358 10 23 010

Κύπρος
Αλέκτωρ Φαρµακευτική Λτδ
Τηλ: +357 22490305

Sverige
AstraZeneca AB
Tel: +46 8 553 26 000

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

United Kingdom (Northern Ireland)
AstraZeneca UK Ltd
Tel: +44 1582 836 836
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .