STEGLUJAN 15/100 MG TAB 28's

STEGLUJAN®
Ertugliflozin pyroglutamic acid/Sitagliptin phosphate monohydrate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about STEGLUJAN.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking STEGLUJAN against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What STEGLUJAN is used for
STEGLUJAN is used to help lower your blood sugar (glucose), which is too high because of your type 2 diabetes. STEGLUJAN can be used alone or in combination with certain other medicines that lower blood sugar, along with a recommended diet and exercise program.
Type 2 diabetes mellitus
Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM. Type 2 diabetes mellitus is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar builds up in the blood. This can lead to serious medical problems.
High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.
Your doctor will do blood tests regularly to check your diabetes. These tests look to see if your blood sugar is normal at that moment (blood sugar levels) and how well you have managed your blood sugar over time (called haemoglobin A1c).
How STEGLUJAN works
STEGLUJAN contains two active ingredients – ertugliflozin and sitagliptin. Ertugliflozin belongs to a group of medicines you take by mouth called SGLT2 (sodium-glucose co-transporter 2) inhibitors and sitagliptin belongs to a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Both medicines work together to lower blood sugar levels in patients with type 2 diabetes mellitus.
STEGLUJAN helps remove sugar from the body through urination, helps to improve the levels of insulin after a meal and decreases the amount of sugar made by the body.
STEGLUJAN by itself is unlikely to cause low blood sugar (hypoglycaemia) because it does not work when your blood sugar is low.
Talk to your doctor about the symptoms of low blood sugar and high blood sugar.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Before you take STEGLUJAN
When you must not take it
Do not take STEGLUJAN if:
you have poorly functioning kidneys since ertugliflozin requires good functioning kidneys to work well.
you are allergic to any of the ingredients in STEGLUJAN listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin or you may feel faint.
the packaging is torn or shows signs of tampering.
the expiry date on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work.
If you are not sure whether you should start taking STEGLUJAN, talk to your doctor.
Before you start to take it
Tell your doctor if you:
have type 1 diabetes
have or have had diabetic ketoacidosis (increased ketones in the blood or urine)
are going to have surgery
are eating less due to illness, surgery, or a change in your diet
drink alcohol very often, or drink a lot of alcohol in the short term ("binge" drinking)
have kidney problems
have liver problems, because STEGLUJAN is not recommended for patients with severe liver disease.
take other diabetes medicines; you are more likely to get low blood sugar with certain medicines
have or have had yeast infections of the vagina or penis
You may obtain further information from your doctor or pharmacist, who has more detailed information.
Children:
It is not known if STEGLUJAN is safe and effective in children under 18 years of age.
Elderly:
In studies, ertugliflozin and sitagliptin worked well in and were generally well-tolerated by older adult patients. Patients 65 years or older were more likely to get dehydrated while taking ertugliflozin compared to younger patients. Elderly people are more likely to have kidney problems. If you are elderly, your doctor may do tests to see if your kidneys are working correctly. No dose adjustment is necessary based on age.
Tell your doctor if you are pregnant or planning to become pregnant. It is not known if STEGLUJAN may harm your unborn baby.
Do not use STEGLUJAN if you are pregnant. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known if STEGLUJAN passes into breast milk. Talk with your doctor about the best way to feed your baby if you take STEGLUJAN.
Do not use STEGLUJAN if you are breast-feeding or plan to breast-feed.
Tell your doctor if you have allergies to any other medicines or other substances such as foods, preservatives or dyes.
If you have not told your doctor about any of the above, tell him/her before you take any STEGLUJAN.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including medicines, vitamins and herbal supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
STEGLUJAN may be taken with most medicines.
Be sure to tell you doctor if you are taking water pills (diuretics), as you may be more likely to get dehydrated. See 'Side Effects'.
When you take STEGLUJAN with certain other diabetes medicines, you are more likely to get low blood sugar. See 'Side Effects'.
How to take STEGLUJAN
Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
It is important to eat right and exercise while you take STEGLUJAN.
How much to take
The recommended dose is one tablet once a day.
The strength of STEGLUJAN that you will take varies depending on your condition and the amount of ertugliflozin and sitagliptin needed to control your blood sugar.
Your doctor may do blood tests, including tests to monitor your kidney function, before you start STEGLUJAN and while you take it. Your doctor may change your dose of STEGLUJAN based on the results.
When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change.
Tell your doctor right away if you have any of these conditions and follow your doctor's instructions.
When to take it
Take STEGLUJAN at the same time every morning. Taking it at the same time each day will have the best eff
ect. It will also help you remember when to take it.
STEGLUJAN can be taken with or without food.
How long to take it
Continue to take STEGLUJAN for as long as your doctor prescribes it so you can continue to help control your blood sugar.
This medicine helps to control your condition, but will not cure it. It is important to keep taking your medicine even if you feel well.