Sitagliptin 50 mg/2 ml oral solution – patient leaflet, side effects, dosage

1. What Sitagliptin oral solution is and what it is used for

Sitagliptin oral solution contains the active substance sitagliptin which 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 or prescriber 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 oral solution

Do not take Sitagliptin oral solution

• if you are allergic to sitagliptin or any of the

  other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

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.

Other medicines and Sitagliptin oral solution

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 with food and drink

Sitagliptin oral solution can be taken with or without food.

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 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. Driving and using machines

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).

Sitagliptin oral solution contains sodium

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

3. How to take Sitagliptin oral solution

Always take this medicine exactly as your doctor or prescriber has told you. Check with your doctor or prescriber, or pharmacist if you are not sure.

The usual recommended dose is:

• 100 mg (4 ml oral solution)
• once a day
• by mouth

If you have kidney problems, your doctor or prescriber may prescribe lower doses (such as 25 mg or 50 mg).

Your doctor or prescriber 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 or prescriber while taking Sitagliptin oral solution.

Method of administration

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.

How to use the oral syringe:

1. 1.

   Shake the bottle well,

   making sure the cap is

   firmly on the bottle.

2. 2.

   Remove the cap.

   Note: Keep the cap nearby

   to close the bottle after

   each use.

3. 3.

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

   Note: The adapter must always stay in the bottle.

4. 4.

   Take the syringe and check

   the plunger is fully down.

5. 5.

   Keep the bottle upright and

   insert the oral syringe firmly into the plastic adapter.

6. 6.

   Turn the whole bottle with

   the syringe upside down.

Package leaflet: Information for the patient Sitagliptin 50 mg/2 ml oral solution

sitagliptin

BEFORE AFTER

1

2

BEFORE AFTER

BEFORE AFTER BEFORE AFTER

BEFORE AFTER

1. 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.

1. 8.

   Then pull the plunger

   slowly back to the volume

   you need for your dose.

2. 9.

   Turn the whole bottle with

   the syringe the right way up

   and take the syringe out of

the bottle.

1. 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.

2. 11.

   Replace the child resistant cap after

   use, leaving the adapter in place.

3. 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 Sitagliptin oral solution than you should

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

If you forget to take Sitagliptin oral solution

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 oral solution

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 have any further questions on the use of this medicine, ask your doctor or prescriber, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP taking Sitagliptin oral solution and contact a doctor or prescriber immediately if you notice any of the following serious side effects:

• 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 or prescriber right away. Your doctor or prescriber 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).

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:

Common: flatulence, swelling of the hands or legs

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):

Common: flu-like symptoms

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

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)

Reporting of side effects

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.

5. How to store Sitagliptin oral solution

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 label and the carton after ‘EXP’.

The expiry date refers to the last day of that month.

Store in a refrigerator (2°C to 8°C).

After first opening of the bottle, the solution can be stored for 90 days.

Discard any remaining medicine 90 days after opening the bottle.

Do not throw away 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 oral solution contains

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.

What Sitagliptin oral solution looks like and contents of the pack

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.

Marketing Authorisation Holder

Glenmark Pharmaceuticals Europe Limited Laxmi House, 2-B Draycott Avenue

Kenton, Middlesex

HA3 0BU

United Kingdom

Manufacturer

Labomed Pharmaceutical Company SA Metaxa Ioanni 84

19441 Kropia

Greece

This leaflet was last revised in September 2024

BEFORE AFTER

BEFORE AFTER

BEFORE AFTER BEFORE AFTER

BEFORE AFTER

BEFORE AFTER

PRODUCT: Amends: Approval:

GM1615

Sitagliptin 50 mg/2 ml oral solution UK

9.4.21

150x400 mm

7

10.6.24

Leaflet (PIL)

N

Times New Roman ALL 9 pts body copy (min)

Internal proof approval

External proof approval Signed (digitally)

Signed (digitally)

off (digitally):