Patient leaflet - Sitagliptin 100 mg/5 ml oral solution
1. What Sitagliptin is and what it is used for
Sitagliptin is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus. This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body.
Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan.
What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.
2. What you need to know before you take Sitagliptin
Do not take Sitagliptin:
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). Warnings and precautions
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).
an allergic reaction to Sitagliptin (see section 4) type 1 diabetes
any past or present kidney problems
3. How to take Sitagliptin
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The usual recommended dose is:
You can take this medicine with or without food and drink. 5ml (100mg)
once a day
by mouth
If you have kidney problems, your doctor may prescribe lower doses (such as 1.25ml (25mg) or 2.5ml (50 mg)).
Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar.
Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet and exercise recommended by your doctor while taking Sitagliptin.
Route and Method of administration
This medicine must be taken orally.
Use the measuring syringe provided in the pack to deliver the required dose.
Instructions for the use of syringe:
- 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).
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
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.
- 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).
7
Other medicines and Sitagliptin
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.
Alternative method of administration (with feeding tubes)
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.
Pregnancy and breast-feeding
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.
Driving and using machines
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.
Administering this medicine via NG or PEG tubes
- 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.
PIL/UK/MFG155/01/SMD/v3
The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sucralose (E955), mixed fruit flavor (contains propylene glycol (E1520)) and purified water. If you take more Sitagliptin than you should
If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
If you forget to take Sitagliptin
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.
If you stop taking Sitagliptin
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.
STOP taking Sitagliptin and contact a doctor immediately if you notice any of the following serious side effects: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).
If you have a serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, stop taking this medicine and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Some patients have experienced the following side effects after adding sitagliptin to metformin:
Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting
Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness
Some patients have experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency is common).
Common: flatulence, swelling of the hands or legs Some patients have experienced the following side effects while taking sitagliptin in combination with a sulphonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation
Some patients have experienced the following side effects while taking sitagliptin and pioglitazone:
Some patients have experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of the hands or legs
Some patients have experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister) Common: flu
Uncommon: dry mouth
Some patients have experienced the following side effects while taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other diabetes medicines: Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain
Uncommon: dizziness, constipation, itching
Rare: reduced number of platelets
Reporting of side effects
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.
5. How to store Sitagliptin
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle label and the carton after ‘EXP’. The expiry date refers to the last day of that month.
Do not store above 30°C.
Discard 60 days after first opening.
Do not use this medicine if you notice that the solution becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Sitagliptin contain
The active substance is sitagliptin (as hydrochloride).
Each 5ml of oral solution contains 100mg of sitagliptin (as hydrochloride).
PIL/UK/MFG155/01/SMD/v3
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. What Sitagliptin looks like and contents of the pack
Sitagliptin is supplied in a bottle containing 150ml oral solution.
Marketing Authorisation Holder and Manufacturer:
SyriMed
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK.
If this leaflet is hard to see or read, please call +44 208 515 3700 for help.
This leaflet was last revised in 11/2023.