SITAGLIPTIN SUN

SITAGLIPTIN SUN

Active ingredient(s): sitagliptin fumarate

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Sitagliptin SUN. 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 SUN.

Where to find information in this leaflet:

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

1. Why am I using Sitagliptin SUN?

Sitagliptin SUN contains the active ingredient sitagliptin fumarate. Sitagliptin SUN is a member of a class of oral anti‐hyperglycaemic agents which improve glycaemic control in patients with type 2 diabetes by enhancing the levels of active incretin hormones.

Sitagliptin SUN 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 patients with type 2 diabetes mellitus. Type 2 diabetes mellitus is also called non‐insulin‐dependent diabetes mellitus, or NIDDM.

• Sitagliptin SUN helps to improve the levels of insulin after a meal.
• Sitagliptin SUN decreases the amount of sugar made by the body.
• Sitagliptin SUN works when blood sugar is high, especially after a meal. This is when the body needs the greatest amount of help in lowering blood sugar. Sitagliptin SUN also lowers blood sugar between meals.
• Sitagliptin SUN by itself is unlikely to cause low blood sugar (hypoglycaemia) because it does not work when your blood sugar is low.

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

Warnings

Do not use Sitagliptin SUN if:

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

Check with your doctor if you:

• have any other medical conditions:
  – have or have had type 1 diabetes mellitus or a condition called diabetic ketoacidosis (increased ketones in the blood or urine)
  Sitagliptin SUN should not be used for the treatment of these conditions.
  – any kidney problems or any past or present medical problems
  If you have kidney problems, your doctor may prescribe lower doses.
  – an allergic reaction to Sitagliptin SUN or you have any allergies to any other medicines or other substances such as foods, preservatives or dyes
• take any medicines for any other condition

If you have not told your doctor about any of the above, tell him/ her before you take any Sitagliptin SUN.

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 SUN is not recommended for use during pregnancy.

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

Sitagliptin SUN should not be used while breastfeeding or if planning to breastfeed.

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.

Sitagliptin SUN can be taken with most other medicines.

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 SUN.

4. How do I use Sitagliptin SUN?

How much to take / use

• Take Sitagliptin SUN only when prescribed by your doctor.
• The recommended dose is to take is one 100 mg tablet, 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 SUN on its own, or with certain other medicines that lower blood sugar.
• Follow the instructions provided and use Sitagliptin SUN until your doctor tells you to stop.

When to take / use Sitagliptin SUN

• Sitagliptin SUN should be taken once a day, by mouth, with or without food.
• Continue to take Sitagliptin SUN as long as your doctor prescribes it so you can continue to help control your blood sugar.
• 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 SUN.

If you forget to use Sitagliptin SUN

Sitagliptin SUN should be used regularly at the same time each day. 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 go back to your regular schedule.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose you missed.

If you have trouble remembering to take your tablet, ask your pharmacist for some hints.

If you use too much Sitagliptin SUN

If you think that you have used too much Sitagliptin SUN, 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 SUN?

Things you should do

If you become pregnant while taking Sitagliptin SUN, tell your doctor immediately.

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

Things you should not do

• Do not stop using this medicine suddenly.
• Do not give Sitagliptin SUN to anyone else, even if they have the same condition as you.

Driving or using machines

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

Sitagliptin SUN is not expected to affect the ability to drive and use machines.

Looking after your medicine

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

If you take the tablets out of the blister pack they may not keep well.

Keep Sitagliptin SUN in a cool dry place where the temperature stays below 25°C. Do not store it or any other medicine in the bathroom or near a sink.

Follow the instructions in the carton on how to take care of your medicine properly.

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.

A locked cupboard at least one‐and‐a‐half metres above the ground is a good place to store medicines.

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
Infection related: 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 Nervous system related: headache Gastrointestinal system related: Sitagliptin may occasionally cause stomach discomfort and diarrhoea.	Speak to your doctor if you have any of these less serious side effects and they worry you.
Metabolism related: Low blood sugar (hypoglycaemia) when Sitagliptin is used in combination with a sulfonylurea medicine or with insulin. Due to the sulfonylurea or insulin, causing hypoglycaemia, the dose of your sulfonylurea medicine or insulin may need to be reduced while you use Sitagliptin. Skin related: Cases of a skin reaction called bullous pemphigoid that can require treatment in a hospital have been reported in patients receiving Sitagliptin. Tell your doctor if you develop blisters or the breakdown of your skin (erosion). Your doctor may tell you to stop taking Sitagliptin.	Tell your doctor immediately if you notice any of the following.

Serious side effects

Serious side effects

What to do

Allergic reactions Allergic reactions which may be serious including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have an allergic reaction, stop taking Sitagliptin and call your doctor right away. Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes. Gastrointestinal system related: 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. Stop taking Sitagliptin and call your doctor right away if you experience these symptoms.

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.

Additional side effects have been reported in general use with Sitagliptin SUN, by itself and/or with other diabetes medicines:

• Kidney problems (sometimes requiring dialysis)
• Constipation
• Diarrhoea
• Vomiting
• Joint pain
• Muscle aches
• Arm or leg pain
• Back pain
• Itching
• Blisters

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.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

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 Sun contains

Active ingredient (main ingredient)	Sitagliptin fumarate
Other ingredients (inactive ingredients)	The tablet contains the following inactive ingredients: calcium hydrogen phosphate crospovidone hydrogenated castor oil glycerol dibehenate magnesium stearate Opadry Pink 02F540038 (139708) Opadry Beige 02F570009 (139707) Opadry Beige 02F570006 (139717)
Potential allergens	none

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

What Sitagliptin SUN looks like

Sitagliptin SUN Tablet 25 mg ‐ Light pink colour, round film coated tablets debossed with F1 on one side and plain on the other side (Aust R 352533).

Sitagliptin SUN Tablet 50 mg ‐ Light beige colour, round film coated tablets debossed with F2 on one side and plain on the other side (Aust R 352532).

Sitagliptin SUN Tablet 100 mg ‐ Beige colour, round film coated tablets debossed with F3 on one side and plain on the other side (Aust R 352534).

Sitagliptin SUN tablets come in a blister strip. Each box contains 28 tablets.

Who distributes Sitagliptin SUN

Sun Pharma ANZ Pty Ltd
12 Waterloo Road
Macquarie Park NSW 2113
Australia
Tel No. 1800 726 229
Email: customerservice.aus@sunpharma.com

This leaflet was prepared in 07 Sept 2022.