• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Sitagliptin SUN is and what it is used for
2. What you need to know before you take Sitagliptin SUN
3. How to take Sitagliptin SUN
4. Possible side effects
5. How to store Sitagliptin SUN
6. Contents of the pack and other information

• if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving sitagliptin (see section 4).

If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Sitagliptin SUN.

Tell your doctor if you have or have had:

• a disease of the pancreas (such as pancreatitis)
• gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
  These medical conditions can increase your chance of getting pancreatitis (see section 4).
• type 1 diabetes
• diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting)
• any past or present kidney problems
• an allergic reaction to sitagliptin (see section 4)

This medicine is unlikely to cause low blood sugar because it does not work when your blood sugar is low. However, when this medicine is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur. Your doctor may reduce the dose of your sulphonylurea or insulin medicine.

Children and adolescents below 18 years should not use this medicine. It is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than 10 years.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). The level of digoxin in your blood may need to be checked if taking with sitagliptin.

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 take this medicine during pregnancy.

It is not known if this medicine passes into breast milk. You should not take this medicine if you are breast-feeding or plan to breast-feed.

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

Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

May cause stomach upset and diarrhea.

If you take more than the prescribed dose of this medicine, contact your doctor immediately.

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. Do not take a double dose of this medicine.

Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar. You should not stop taking this medicine without talking to your doctor first.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is sitagliptin:
  • Each Sitagliptin SUN 25 mg film-coated tablet contains sitagliptin fumarate, equivalent to 25 mg sitagliptin.
  • Each Sitagliptin SUN 50 mg film-coated tablet contains sitagliptin fumarate, equivalent to 50 mg sitagliptin.
  • Each Sitagliptin SUN 100 mg film-coated tablet contains sitagliptin fumarate, equivalent to 100 mg sitagliptin.
• The other ingredients are:
  • Tablet core: calcium hydrogen phosphate (E341), crospovidone type A (E1202), hydrogenated castor oil, glycerol dibehenate, and magnesium stearate (E470b).
  • Film-coating: hypromellose 2910/5 (E464), titanium dioxide (E171), macrogol 6000 (E1521), talc (E553b), red iron oxide (E172), and yellow iron oxide (E172).

• Sitagliptin SUN 25 mg film-coated tablets: Light pink colour, round film-coated tablets, dimensions approximately 6 mm x 3 mm, debossed with F1 on one side and plain on the other side.
• Sitagliptin SUN 50 mg film-coated tablets: Light beige colour, round film-coated tablets, dimensions approximately 8 mm x 4 mm, debossed with F2 on one side and plain on the other side.
• Sitagliptin SUN 100 mg film-coated tablets: Beige colour, round film-coated tablets, dimensions approximately 10 mm x 4.5 mm, debossed with F3 on one side and plain on the other side.

Sitagliptin SUN film-coated tablets are packed in PA/Alu/PE + desiccant/HDPE/Alu blisters. They are available in pack sizes of 28, 56 or 98 film-coated tablets.

Sitagliptin SUN film-coated tablets are also available in packs containing one HDPE bottle of 90 film-coated tablets with desiccant and child resistant closure.

Not all pack sizes may be marketed.

European Union

Great Britain