Sitagliptin Lupin

Sitagliptin Lupin

Active ingredient(s): sitagliptin (as hydrochloride monohydrate)

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Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

1. Why am I using Sitagliptin Lupin?
2. What should I know before I use Sitagliptin Lupin?
3. What if I am taking other medicines?
4. How do I use Sitagliptin Lupin?
5. What should I know while using Sitagliptin Lupin?
6. Are there any side effects?
7. Product details

1. Why am I using Sitagliptin Lupin?

Sitagliptin Lupin contains the active ingredient sitagliptin. Sitagliptin Lupin is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adults with type 2 diabetes mellitus.

Sitagliptin Lupin is used to lower blood sugar levels in adults with type 2 diabetes mellitus. Sitagliptin Lupin can be used alone or in combination with certain other medicines that lower blood sugar along with a recommended diet and exercise program.

2. What should I know before I use Sitagliptin Lupin?

Warnings

Do not use Sitagliptin Lupin if:

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

Check with your doctor if you:

• have or have had type 1 diabetes mellitus;
• have or have had increased ketones in the blood or urine (diabetic ketoacidosis);
• have or have had any kidney problems or any past or present medical problems;
• take any medicines for any other condition.

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

Check with your doctor if you are pregnant or intend to become pregnant. Sitagliptin Lupin is not recommended for use during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed. You should not take Sitagliptin Lupin while breastfeeding or if planning to breastfeed.

Children

Children and adolescents below 18 years should not use this medicine. Sitagliptin Lupin is not effective in children and adolescents 10 to 17 years of age with type 2 diabetes. Sitagliptin Lupin has not been studied in children younger than 10 years of 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 supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Medicines that may cause low blood sugar when used in combination with Sitagliptin Lupin include:

• sulfonylureas;
• insulin.

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

4. How do I use Sitagliptin Lupin?

How much to use

• Take Sitagliptin Lupin once a day by mouth, with or without food.
• If you have kidney problems, your doctor may prescribe lower doses, and monitor your kidney function.
• Your doctor may prescribe Sitagliptin Lupin on its own, or with certain other medicines that lower blood sugar.

When to use Sitagliptin Lupin

• Take your Sitagliptin Lupin at about the same time each day.

If you forget to use Sitagliptin Lupin

Sitagliptin Lupin should be used 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 a double dose to make up for the dose you missed.

If you use too much Sitagliptin Lupin

If you think that you have used too much Sitagliptin Lupin, 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 using Sitagliptin Lupin?

Things you should do

Diet and exercise can help your body use its blood sugar better. It is important to stay on your doctor’s recommended diet, exercise and weight loss program while taking Sitagliptin Lupin.

Call your doctor straight away if you:

• become pregnant while taking Sitagliptin Lupin.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Sitagliptin Lupin.

Remind any doctor, dentist or pharmacist you visit that you are using Sitagliptin Lupin.

Things you should not do

• Do not stop using this medicine suddenly. Continue to take Sitagliptin Lupin as long as your doctor prescribes it so it can continue to help control your blood sugar.
• Do not give Sitagliptin Lupin to anyone else, even if they have the same condition as you.

Driving or using machines

There is no information to suggest that Sitagliptin Lupin affects your ability to drive a car or operate machinery.

Looking after your medicine

Keep your tablets in the blister pack until it is time to take them.

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 window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

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

Do not use 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
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, headache, flu-like symptoms. Stomach discomfort and vomiting, diarrhoea or constipation. Muscle aches or pain in the joints, back, arm, or leg. Itching, or blisters or the breakdown of your skin (erosion).	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Allergic reactions including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. Severe and persistent stomach pain, often with nausea and vomiting. These may be symptoms of pancreatitis. Pancreatitis can be a serious, potentially life-threatening medical condition. Low blood sugar when Sitagliptin Lupin is used in combination with a sulfonylurea medicine or with insulin. Severe blistering or the breakdown of your skin (erosion). Kidney problems (sometimes requiring dialysis).

Stop taking Sitagliptin Lupin. 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 Sitagliptin Lupin contains

Active ingredient (main ingredient)	Sitagliptin (as hydrochloride monohydrate)
Other ingredients (inactive ingredients)	Calcium hydrogen phosphate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate Hyprolose Polyvinyl alcohol Polyethylene glycol Purified talc Titanium dioxide Iron oxide red Iron oxide yellow
Potential allergens	Not applicable

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

What Sitagliptin Lupin looks like

Sitagliptin Lupin 25 mg: pink, round, biconvex, film-coated tablets debossed with “S25” on one side and plain on the other (AUST R 297342).

Sitagliptin Lupin 50 mg: light beige, round, biconvex, film-coated tablets debossed with “S50” on one side and plain on the other (AUST R 297343).

Sitagliptin Lupin 100 mg: beige, round, biconvex, film-coated tablets debossed with “STG” on one side and plain on the other (AUST R 297346).

Who distributes Sitagliptin Lupin

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia

  ghinfo@generichealth.com.au

  +61 3 9809 7900

  www.generichealth.com.au

This leaflet was prepared in May 2023.