2.5 mg film-coated tablets
Saxagliptin
What Onglyza is and what it is used for
Onglyza contains the active substance saxagliptin, which belongs to a group of medicines called ‘oral diabetes medicines’ (ie oral diabetes medicines). They work by helping to control your blood sugar levels.
Onglyza is used in adult patients 18 years of age and older with “type 2 diabetes” when the disease cannot be adequately controlled with oral diabetes medicine, diet and exercise. Onglyza is used alone or in combination with insulin or other antidiabetic medicines.
It is important to continue to follow the advice on diet and exercise that you have received from your doctor or nurse.
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 a severe allergic reaction to any other similar medicine that you are taking to control your blood sugar. See section 4.
Warnings and cautions
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 (your body does not produce 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 a diabetes medicine called sulphonylurea, your doctor may want to lower your dose of insulin or sulphonylurea when you take one of them with Onglyza to avoid low blood sugar.
- If you have a condition that reduces your defenses against infection , such as an illness such as AIDS or medications that you can take after an organ transplant.
- if you have heart failure or 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 should contact a doctor, pharmacist or nurse immediately if you get any of these symptoms. Symptoms may include, but are not limited to, increased shortness of breath, rapid weight gain, and swollen feet (foot edema).
- If you have impaired kidney function, your doctor will decide if you need to take a lower dose of Onglyza. If you are on hemodialysis , Onglyza is not recommended for you.
- if you have moderate or severe liver disease. If you have severe liver disease, Onglyza is not recommended for you.
Diabetic skin lesions are a common complication of diabetes. Skin rashes have occurred with Onglyza (see section 4) and with certain diabetes medicines in the same class as Onglyza. You are advised to follow the skin and foot care recommendations given to you by your doctor or nurse. Contact your doctor if you have blisters on your skin as it may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Onglyza.
Children and young people
Onglyza is not recommended for children and adolescents under 18 years of age. It is not known if this medicine is safe and effective 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 take any other medicines.
In particular, you should tell your doctor if you are taking medicines that contain any of the following substances:
- Carbamazepine, phenobarbital or phenytoin . These drugs can be used to control seizures or chronic pain.
- Dexamethasone – a cortisone preparation. This drug can be used to treat inflammation in various parts of the body and organs.
- Rifampicin. This is an antibiotic used to treat infections such as tuberculosis .
- Ketoconazole . This can be used to treat fungal infections.
- Diltiazem . This is a drug 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 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 breast milk. You should not take this medicine if you are breast-feeding or planning to breast-feed.
Driving and using machines
Do not drive or use any tools or machines if you feel dizzy while taking Onglyza. Low blood sugar ( hypoglycaemia ) may affect your ability to drive and use machines or work without a secure foothold, and there is a risk of hypoglycaemia if you take this medicine in combination with medicines known to cause low blood sugar, 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, ie essentially ‘sodium-free’. is essentially “sodium-free”.
How to take Onglyza
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose of Onglyza is 5 mg once daily.
If you have impaired kidney function, your doctor may prescribe a lower dose. This is a 2.5 mg tablet once a day.
Your doctor may prescribe Onglyza alone or in combination with insulin or other antidiabetic medicines. If you are taking Onglyza with insulin or other oral diabetes medicines, remember to take these other medicines as your doctor advised you to get the best results for your health.
How to take Onglyza
The tablets must not be split or broken. 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 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. If it is soon time to take your 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. It helps keep your blood sugar under control.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms require immediate medical attention:
You should stop taking Onglyza and contact a doctor immediately if you experience the following symptoms of low blood sugar ( hypoglycaemia ): shaking, sweating, anxiety, blurred vision, tingling in the lips, you become pale, changing your mood, feel unfocused or confused. These side effects are very common (may affect more than 1 in 10 people).
Symptoms of a severe allergic reaction (rare, may affect up to 1 in 1,000 people) can be:
- Rash
- Elevated red spots on the skin ( hives )
- Swelling of the face, lips, tongue and throat, which may make it difficult to breathe or swallow.
If you get these symptoms, stop taking Onglyza and contact your doctor or nurse immediately. Your doctor may prescribe a medicine to treat your allergic reaction and another medicine for your diabetes.
You should stop taking Onglyza and contact your doctor immediately if you notice any of the following serious side effects:
- Severe and persistent pain in the abdomen (stomach), which may radiate to the back, as well as nausea and vomiting, as this may be a sign of inflamed pancreas ( pancreatitis ).
You should contact your doctor if you get the following side effect:
- Severe joint pain
Some patients have experienced the following side effects while taking Onglyza and metformin:
- Common (may affect up to 1 in 10 users in 100): Upper chest and lung infections , urinary tract infections, inflamed stomach or intestines, usually caused by an infection ( gastroenteritis ), sinus infections with a feeling of pain and pressure behind cheeks and eyes ( sinusitis ), inflamed nose or throat ( nasopharyngitis ) (signs of this may be cold or sore throat), headache, muscle pain ( myalgia ), vomiting, inflammation of the stomach ( gastritis ), abdominal pain and indigestion ( dyspepsia ) .
- Uncommon (may affect 1 to 10 users in 1,000): joint pain ( arthralgia ) and difficulty getting or maintaining an erection ( erectile dysfunction ).
Some patients have experienced the following side effects while taking Onglyza and a sulphonylurea:
- Very common: low blood sugar ( hypoglycaemia ).
- Common: infection of the upper chest and lungs, infection of the urinary tract, inflamed stomach or intestine, usually caused by an infection ( gastroenteritis ), infection of the sinuses with a feeling of pain and pressure behind the cheeks and eyes ( sinusitis ), headache, abdominal pain and vomiting.
- Uncommon (may affect 1 to 10 users in 1000): fatigue, abnormal levels of fatty acids ( dyslipidemia , hypertriglyceridemia ).
Some patients have experienced the following side effects while taking Onglyza and a thiazolidinedione:
- Common: infection of the upper chest and lungs, infection of the urinary tract, inflamed stomach or intestine, most often caused by an infection ( gastroenteritis ), infection of the sinuses with a feeling of pain and pressure behind the cheeks and eyes ( sinusitis ), headache, vomiting , abdominal pain and swelling of the hands, ankles or feet (peripheral edema ).
Some patients have experienced the following side effects after taking Onglyza and metformin and a sulphonylurea:
- Common: dizziness, tiredness, abdominal pain and flatulence.
Some patients have experienced the following additional side effects when taking Onglyza alone:
- Common: dizziness, diarrhea and abdominal pain.
Some patients have experienced the following side effects while taking Onglyza alone or in combination:
- No known frequency (can not be calculated from the available data): constipation, blisters on the skin (bullous pemphigoid ).
Some patients have had a slight decrease in the number of a type of white blood cell ( lymphocyte ) that appears in a blood test when Onglyza is used alone or in combination.
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 pack and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if the package is broken or shows signs of exposure.
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.
Contents of the package and other information
Content declaration
- The active substance is saxagliptin. Each film-coated tablet contains 2.5 mg saxagliptin (as hydrochloride).
- 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 yellow iron oxide (E172).
- Printing ink: shellac, indigo carmine (E132).
What the medicine looks like and contents of the pack
- 2.5 mg film-coated tablets are pale yellow to light yellow, biconvex, round. They have “2.5” printed on one side and “4214” printed on the other side in blue ink.
- The tablets are available in aluminum blisters.
- Pack sizes are 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 30×1 or 90×1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire
SK10 2NA
UK
Contact the representative of the marketing authorization holder to find out more about this medicine:
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