Steglujan

ertugliflozin with sitagliptin


STEGLUJAN®


Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist.


This medicine is new or being taken differently. Please report side effects. See the full CMI for further details.

1. Why am I taking STEGLUJAN?

STEGLUJAN contains the active ingredients ertugliflozin and sitagliptin. STEGLUJAN can be used to lower your blood sugar (glucose) alone or in combination with certain other medicines, along with a recommended diet and exercise program.

For more information, see Section 1. Why am I taking STEGLUJAN? in the full CMI.

2. What should I know before I take STEGLUJAN?

Do not use if you have ever had an allergic reaction to ertugliflozin or sitagliptin or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I take STEGLUJAN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with STEGLUJAN and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take STEGLUJAN?

  • Take one tablet once a day.

More instructions can be found in Section 4. How do I take STEGLUJAN? in the full CMI.

5. What should I know while taking STEGLUJAN?

Things you should do

  • Remind any doctor, dentist or pharmacist you visit that you are taking STEGLUJAN.

Things you should not do

  • Do not stop taking this medicine suddenly unless your doctor tells you.

Driving or using machines

  • Be careful before you drive or use any machines or tools until you know how STEGLUJAN affects you.

Looking after your medicine

  • Keep STEGLUJAN in its original packaging in a cool dry place where the temperature stays below 30°C.

For more information, see Section 5. What should I know while taking STEGLUJAN? in the full CMI.

6. Are there any side effects?

Less serious side effects include yeast infections of the vagina or penis, changes in urination, low blood sugar if you take STEGLUJAN with insulin or certain other diabetes medicines

Serious side effects include pancreatitis (severe and persistent stomach pain, often with nausea and vomiting), dehydration (losing too much water from your body), ketoacidosis (increased ketones in your blood or urine), genital infection, blisters and breakdown (erosion) of your skin, urinary tract infection

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

STEGLUJAN®

Active ingredients: Ertugliflozin pyroglutamic acid/Sitagliptin phosphate monohydrate


Consumer Medicine Information (CMI)

This leaflet provides important information about taking STEGLUJAN. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking STEGLUJAN.

Where to find information in this leaflet:

1. Why am I taking STEGLUJAN?

STEGLUJAN contains the active ingredients ertugliflozin and sitagliptin. Ertugliflozin is a medicine called a sodium-glucose co-transporter 2 (SGLT2) inhibitor and sitagliptin is a medicine called dipeptidyl peptidase-4 (DPP-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 because it does not work when your blood sugar is low.

STEGLUJAN can be used to lower your blood sugar (glucose) alone or in combination with certain other medicines, along with a recommended diet and exercise program.

2. What should I know before I take STEGLUJAN?

Warnings

Do not take STEGLUJAN if:

  • you are allergic to ertugliflozin or sitagliptin, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can take this medicine.

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.

  • you have poorly functioning kidneys since ertugliflozin requires good functioning kidneys to work well

Tell your doctor if you:

  • have type 1 diabetes
  • have or have had increased ketones in the blood or urine (diabetic ketoacidosis)
  • 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
  • take any medicines for any other condition
  • have allergies to any other medicines or other substances such as foods, preservatives or dyes.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Talk to your doctor if you are pregnant or intend to become pregnant. It is not known if STEGLUJAN may harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant. Do not use STEGLUJAN if you are pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed. 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.

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 patients. People 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. No dose adjustment is necessary based on age.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or herbal supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

STEGLUJAN may be taken with most medicines.

Some medicines may interfere with STEGLUJAN and affect how it works.

Be sure to tell your doctor if you are taking water pills (diuretics), as you may be more likely to get dehydrated. See Section 6. Are there any side effects?

When you take STEGLUJAN with certain other diabetes medicines, you are more likely to get low blood sugar. See Section 6. Are there any side effects?

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect STEGLUJAN.

4. How do I take STEGLUJAN?

How much to take

  • Take one tablet once a day. Your doctor will decide the dose of STEGLUJAN suitable for you.
  • Take STEGLUJAN until your doctor tells you to stop.

When to take STEGLUJAN

  • Take STEGLUJAN at the same time every morning. STEGLUJAN can be taken with or without food.

If you forget to take STEGLUJAN

STEGLUJAN should be taken regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take 2 doses of STEGLUJAN on the same day.

If you take too much STEGLUJAN

If you think that you have taken too much STEGLUJAN, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while taking STEGLUJAN?

Things you should do

  • If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking STEGLUJAN.
  • If you become pregnant while taking STEGLUJAN, tell your doctor immediately.
  • Continue to take STEGLUJAN for as long as your doctor prescribes it so that 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.

Call your doctor straight away if:

  • 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.

Remind any doctor, dentist or pharmacist you visit that you are taking STEGLUJAN.

Things you should not do

  • Do not stop taking this medicine suddenly or lower your dosage without checking with your doctor.
  • Do not take STEGLUJAN to treat any other complaints unless your doctor tells you to.
  • Do not give STEGLUJAN to anyone else, even if they have the same condition as you. Remember that your doctor has prescribed this medicine only for you.

Foot care

Check your feet regularly and see your doctor if you notice any problems. Follow any other advice regarding foot care given by your doctor.

Blood tests

Your doctor may do blood tests before you start STEGLUJAN and while you take it. These tests look to see if your blood sugar level is normal at that moment and how well you have managed your blood sugar over time (called haemoglobin A1c). Blood tests may show changes related to kidney function or high levels of bad cholesterol. Your doctor may change your dose of STEGLUJAN based on the results.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how STEGLUJAN affects you.

STEGLUJAN has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive or use machines.

  • Do not drive or use any tools or machines if you feel dizzy while taking STEGLUJAN.

Taking this medicine in combination with insulin or medicines called insulin secretagogues can cause blood sugar levels to drop too low, which may cause symptoms such as shaking, sweating or changes in vision and may affect your ability to drive and use machines.

Drinking alcohol

Tell your doctor if you drink alcohol very often or drink a lot of alcohol in the short term ("binge" drinking).

Looking after your medicine

  • Keep your tablets in its original packaging in a cool dry place where the temperature stays below 30°C.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on windowsills.

Do not take STEGLUJAN if the packaging is torn or shows signs of tampering

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to take this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not take this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

Yeast infections of the vagina or penis

  • in women, symptoms include bad smell from your vagina, white or yellow discharge coming out of your vagina that may be lumpy or look like cottage cheese and itchiness.
  • in men, symptoms include swelling of the penis, red skin, itchiness or rash, bad smell and discharge coming out of your penis, pain in the skin around your penis. If you haven't been circumcised, it may be hard to pull back the skin around the tip of your penis.

Changes in urination

  • urgent need to urinate more often, in larger amounts, or at night, or thirst

Low blood sugar (hypoglycaemia)

If you take STEGLUJAN with insulin or certain other diabetes medicines, your blood sugar might get too low. Your doctor might need to lower the dose of your insulin or other diabetes medicine.

  • headache
  • drowsiness, dizziness or confusion, irritability or feeling jittery, sweating, weakness, fast heartbeat
  • hunger

Other side effects

  • Stomach discomfort, diarrhoea, vomiting, constipation
  • Back, arm, leg, or joint pain or muscle aches
  • Itching or blisters of the skin
  • signs of an infection of the breathing passages, including runny nose, sore throat, cough, soreness in the back of the nose and throat and discomfort when swallowing, flu-like symptoms
  • headache

Speak to your doctor if you have any of these side effects and they worry you.

Serious side effects

Serious side effects

What to do

Allergic reactions

  • rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing

Pancreatitis

  • severe and persistent stomach pain, often with nausea and vomiting

Stop taking STEGLUJAN and call your doctor right away if you experience these symptoms.

Dehydration (losing too much water from your body)

  • dry mouth, feeling dizzy, light-headed, or weak, especially when you stand up, fainting

You may be more likely to get dehydrated if you:

  • have kidney problems or take water tablets (diuretics) or
  • are 65 years or older

Ketoacidosis (increased ketones in your blood or urine)

  • nausea or vomiting
  • tiredness or trouble breathing
  • stomach-area (abdominal) pain
  • excessive thirst

If possible, check for ketones in your urine, even if your blood sugar is less than 14.0 mmol/L. You may need to be treated in a hospital.

Genital infection

These symptoms could be a sign of a rare but serious life-threatening infection called necrotising fasciitis of the perineum or Fournier's gangrene. This must be treated immediately.

  • pain or tenderness, redness, swelling of the genitals or the area between the genitals and the anus,
  • fever and feeling generally unwell.

Blisters and breakdown (erosion) of your skin:

Cases of a skin reaction called bullous pemphigoid that can require treatment in a hospital have been reported in patients receiving sitagliptin. Your doctor may tell you to stop taking STEGLUJAN.

Urinary tract infection

  • burning or pain when you pass urine, more frequent or urgent need to urinate
  • fever, chills, or blood in the urine

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What STEGLUJAN contains

Active ingredients

(main ingredients)

ertugliflozin pyroglutamic acid and sitagliptin phosphate monohydrate

Other ingredients

(inactive ingredients)

Microcrystalline cellulose

Calcium hydrogen phosphate

Croscarmellose sodium

Sodium stearyl fumarate

Magnesium stearate

Hypromellose

Hyprolose

Titanium dioxide

Iron oxide red

Iron oxide yellow

Iron oxide black

Carnauba wax

STEGLUJAN does not contain gluten, sucrose, tartrazine or any other azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What STEGLUJAN looks like

STEGLUJAN 5/100 is a beige, almond-shaped, film-coated tablet marked with '554' on one side and plain on the other side (AUST R 287630).

STEGLUJAN 15/100 is a brown, almond-shaped, film-coated tablet marked with '555' on one side and plain on the other side (AUST R 287626).

Who distributes STEGLUJAN

Merck Sharp & Dohme (Australia) Pty Limited

Level 1, Building A, 26 Talavera Road, Macquarie Park NSW 2113

This leaflet was prepared in April 2022.

RCN000018883-AU, RCN000022019-AU

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