Sitagliptin 100mg/5ml Oral Solution

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

The name of your medicine is Sitagliptin 100mg/5ml Oral Solution but it will be referred to as ‘Sitagliptin’ throughout this leaflet.

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

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 heart beat 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.

Methyl parahydroxybenzoate (E 218) and Propyl parahydroxybenzoate (E 216): May cause allergic reactions (possibly delayed).

This medicine must be taken orally.

Use the measuring syringe provided in the pack to deliver the required dose.

a) Open the bottle: press the cap and turn it anticlockwise (figure 1).
b) Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).

c) Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (figure 5A) and then push the piston up in order to remove any possible air bubbles (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).

d) Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

e) Empty the contents of the syringe into the mouth by pushing the piston to the bottom of the syringe (figure 7). The contents of the syringe should be emptied into the side cheek of the patient's mouth to avoid a choking hazard. Close the bottle with the plastic screw cap. Wash the syringe with water (figure 8).

This medicine can also be administered via specific nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. There is further information in the SmPC, ask your doctor, pharmacist or nurse for this information.

1. Ensure that the enteral feeding tube is free from obstruction before administration.
2. Flush the enteral tube with water using a minimum 5ml of water.
3. Administer the required dose of Sitagliptin Oral Solution with a suitable measuring device. The oral syringe provided in the pack should not be used for administration via NG or PEG tubes, Healthcare Professionals must use another suitable device.
4. Flush the enteral tube with water again using the minimum flush volume (5 ml).

This product should be administered with silicone, PVC and polyurethane NG or PEG tubes only.

If you take more than the prescribed dosage 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website 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 (as hydrochloride).

Each 5ml of oral solution contains 100mg of sitagliptin (as hydrochloride).

The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sucralose (E955), mixed fruit flavor (contains propylene glycol (E1520)) and purified water.

Sitagliptin is clear, colourless solution supplied in amber glass bottles fitted with a tamper evident, child resistant plastic polypropylene plastic screw cap with EPE liner. The pack also contains 10ml oral syringe with 0.25ml graduation with an adaptor.

Sitagliptin is supplied in a bottle containing 150ml oral solution.