Sitagliptin 50 mg/2 ml oral solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or prescriber, 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 or prescriber, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Sitagliptin oral solution is and what it is used for
2. What you need to know before you take Sitagliptin oral solution
3. How to take Sitagliptin oral solution
4. Possible side effects
5. How to store Sitagliptin oral solution
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 oral solution (see section 4).

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

Tell your doctor or prescriber 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 oral solution (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 or prescriber 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 and adolescents under 10 years.

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

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

Sitagliptin oral solution can be taken with or without food.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or prescriber, 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 little or no effect 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.

Sitagliptin oral solution contains sodium methyl parahydroxybenzoate (E219):

This may cause allergic reactions (possibly delayed).

This medicine contains less than 1 mmol sodium (23mg) per 2 ml, that is to say essentially ‘sodium free’.

Please use the oral syringe provided to deliver your specific dose – see instructions below. The syringe can be used to measure your dose by drawing the liquid to the correct mark on the syringe.

1. Shake the bottle well, making sure the cap is firmly on the bottle.

2. Remove the cap.

Note: Keep the cap nearby to close the bottle after each use.

3. Make sure that the plastic adapter is into the neck of the bottle.

Note: The adapter must always stay in the bottle.

4. Take the syringe and check the plunger is fully down.

5. Keep the bottle upright and insert the oral syringe firmly into the plastic adapter.

6. Turn the whole bottle with the syringe upside down.

7. Slowly pull the plunger down fully so that the syringe fills with medicine. Push the plunger back up completely to expel any large air bubbles that may be trapped inside the oral syringe.

8. Then pull the plunger slowly back to the volume you need for your dose.

9. Turn the whole bottle with the syringe the right way up and take the syringe out of the bottle.

10. The dose of medicine can now be swallowed directly from the oral syringe. Please ensure that you are sitting upright, and the plunger must be pushed slowly to allow you to swallow the dose.

11. Replace the child resistant cap after use, leaving the adapter in place.

12. Cleaning: After use, dismantle the plunger and rinse both body and plunger with tap water and wipe with a dry, clean tissue or paper.

If you take more than the prescribed dosage of this medicine, contact your doctor or prescriber 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 or prescriber prescribes it so you can continue to help control your blood sugar. You should not stop taking this medicine without talking to your doctor or prescriber first.

If you get any side effects, talk to your doctor or prescriber, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: 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 2ml of oral solution contains sitagliptin hydrochloride monohydrate, equivalent to 50mg sitagliptin.

The other ingredients are:

Sodium methyl parahydroxybenzoate (E219), hydroxyethylcellulose (E1525), citric acid (E330), disodium edetate (E330), polysorbate 80 (E433), butyl hydroxy anisole (E320), sodium citrate (E331), polisucra 7477 (containing sucralose (E955), acesulfame), forest fruits flavor (consisting of maltodextrin (E1400), modified starch (E1400-E1500), lactic acid (E270), benzyl alcohol (E1519), ethyl alcohol (E1510), ethyl butyrate, frambinon crystal, propyleneglycol (E1520)), purified water.

The Sitagliptin oral solution appears as an amber glass bottle with cap.

Carton folded box contains one capped glass bottle with l00 ml oral solution, one 5ml medication syringe (applicator, CE marked CE 0459) with 0.5ml graduation.