What Zytero Plus is
Zytero Plus contains two different medicines called alogliptin and metformin in one tablet:
- alogliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Alogliptin works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body.
- metformin belongs to a group of medicines called biguanides which also help to lower blood sugar by lowering the amount of sugar made in the liver and helping insulin to work more effectively.

What Zytero Plus is used for
 ZYTERO PLUS contains 2 prescription diabetes medicines, alogliptin (VIPIDIA) and metformin hydrochloride.
 ZYTERO PLUS is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
 ZYTERO PLUS is not for people with type 1 diabetes.
 ZYTERO PLUS is not for people with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if ZYTERO PLUS is safe and effective in children under the age of 18.

Plus Do NOT take Zytero Plus :
 if you are allergic to alogliptin, metformin 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 medications that you take to control your blood sugar. Symptoms of a serious allergic reaction 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 recently had a heart attack or have severe circulatory problems including shock
 if you have severe breathing difficulties
 if you have liver disease
 if you have moderate or severe kidney disease
 if you drink alcohol excessively (either every day or in large quantities only from time to time)
 if you have diabetic ketoacidosis (a serious complication of poorly controlled diabetes). Symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting and rapid weight loss
 if you have a severe infection or are seriously dehydrated (have lost a lot of water from your body)
Warnings and precautions
Talk to your doctor or pharmacist before taking Zytero Plus :
 if you have type 1 diabetes (your body does not produce insulin).

 if you are taking Zytero Plus with insulin or a thiazolidinedione. Your doctor may want to reduce your dose of insulin or a thiazolidinedione when you take it together with Zytero Plus in order to avoid too low blood sugar (hypoglycaemia).
 if you are taking another medicine for diabetes that contains a “sulphonylurea”, you should not start taking Zytero Plus .
 if you are going to have an operation under general, spinal or epidural anaesthetic. You may be advised to stop taking this medicine for some time before and after the procedure.
 if you have had allergic reactions to any other medications that you take to control your blood sugar. Symptoms may include general itching and feeling of heat especially affecting the scalp, mouth, throat, palms of hands and soles of feet (Stevens-Johnson syndrome)
 if you have or have had a disease of the pancreas
During treatment with Zytero Plus , your doctor will check your kidney function at least once a year and more frequently if you are elderly or if your kidney function is borderline or at risk of worsening.
Children and adolescents
Zytero Plus is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Other medicines and Zytero Plus
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular tell your doctor or pharmacist if you are taking any of the following:
 hydrocortisone and prednisolone (corticosteroids) used to treat diseases that involve inflammation like asthma and arthritis

 cimetidine, used to treat stomach problems
 bronchodilators (beta-2 agonists) which are used to treat asthma
 ramipril, lisinopril and enalapril (ACE inhibitors) used to treat high blood pressure
 water tablets (diuretics) which increase urine production
 iodinated contrast agents used in taking X-rays
 medicines containing alcohol
Zytero Plus with alcohol
Do not take this medicine with excessive amounts of alcohol as you could be at greater risk of developing lactic acidosis, a serious complication which must be treated in a hospital (see section 4 ‘Possible side effects’).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not use Zytero Plus if you are pregnant.
Zytero Plus is not recommended during breast-feeding since metformin passes into breast milk.
Driving and using machines
Zytero Plus is not known to affect your ability to drive and use machines. Taking Zytero Plus in combination with medicines called pioglitazone or insulin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines.

 Take ZYTERO PLUS exactly as your doctor tells you to take it.
 Take ZYTERO PLUS 2 times each day.
 Take ZYTERO PLUS with food to lower your chances of having an upset stomach.
 Do not break or cut ZYTERO PLUS tablets before swallowing.
 Your doctor may need to change your dose of ZYTERO PLUS to control your blood glucose. Do not change your dose unless told to do so by your doctor.
 If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose, and take the next dose at your regular schedule. Do not take 2 doses of ZYTERO PLUS at the same time.
 If you take too much ZYTERO PLUS , call your doctor or go to the nearest hospital emergency room right away.
 If your body is under stress, such as from fever, infection, accident or surgery, the dose of your diabetes medicines may need to be changed. Call your doctor right away.
 Stay on your diet and exercise programs and check your blood sugar as your doctor tells you to.
 Your doctor may do certain blood tests before you start ZYTERO PLUS and during treatment as needed. Your doctor may ask you to stop taking ZYTERO PLUS based on the results of your blood tests due to how well your kidneys are working.

 Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
If you take more Zytero Plus than you should
If you take more tablets than you should, or if someone else or a child takes your medicine, contact or go to your nearest emergency centre straight away. Take this leaflet or some tablets with you so that your doctor knows exactly what you have taken.
If you forget to take Zytero Plus
If you forget to take a dose, take it as soon as you remember it. Do not take a double dose to make up for a forgotten dose.
If you stop taking Zytero Plus
Do not stop taking Zytero Plus without consulting your doctor first. Your blood sugar levels may increase when you stop taking Zytero Plus .
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Zytero Plus and contact a doctor immediately if you notice any of the following serious side effects:
Very rare (may affect less than 1 in 10,000 people):
 Lactic acidosis (a build-up of lactic acid in the blood). Lactic acidosis is a medical emergency and must be treated in a hospital. It can particularly affect patients whose kidneys are not working properly. Symptoms include some or all of the following: feeling cold or uncomfortable, severe nausea with or without vomiting, unexplained weight loss, or rapid breathing.
Not known (frequency cannot be estimated from the available data):
 An allergic reaction. The symptoms may include: a rash, hives, swallowing or breathing problems, swelling of your lips, face, throat or tongue and feeling faint.
 A severe allergic reaction: skin lesions or spots on your skin that can progress to a sore surrounded by pale or red rings, blistering and/or peeling of the skin possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores (Stevens-Johnson syndrome and Erythema multiforme).
 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 also discuss with your doctor if you experience the following side effects:
Very common (may affect more than 1 in 10 people):
 Stomach ache
 Diarrhoea

 Loss of appetite
 Feeling sick

 Being sick.
Common (may affect up to 1 in 10 people):
 Symptoms of low blood sugar (hypoglycaemia) may occur when Zytero Plus is taken in combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide). Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change or feeling confused. Your blood sugar could fall below the normal level, but can be increased again by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
 Cold symptoms such as sore throat, stuffy or blocked nose, feeling tired, fever, chills, dry cough
 Rash
 Itchy skin with or without hives
 Headache
 Indigestion, heartburn
 Vomiting and/or diarrhoea
Very rare:
 Decreased vitamin B12 levels or anaemia; symptoms include tiredness, lethargy, feeling faint, becoming breathless
 Liver problems (hepatitis).

Not known:
 Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness, loss of appetite, dark urine or yellowing of your skin or the whites of your eyes.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the National Pharmacovigilance and Drug Safety Centre (NPC) listed at the end of this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

Do not store above 30 °C.
Keep the container of ZYTERO PLUS tightly closed. 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 carton and blister after EXP. The expiry date refers to the last day of that month.
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 protect the environment.