Sitagliptin 100 mg film-coated tablets

• 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 Tablets are and what they are used for
2. What you need to know before you take Sitagliptin Tablets
3. How to take Sitagliptin Tablets
4. Possible side effects
5. How to store Sitagliptin Tablets
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 Tablets (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 Tablets.

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 Tablets (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 Tablets.

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 (23mg) per tablet, that is to say essentially ‘sodium-free’.

• one 100mg film-coated tablet
• once a day
• by mouth

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

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 Tablets.

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.

• 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).

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

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)

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 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 Sitagliptin 25mg film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate, equivalent to 25mg sitagliptin.

Each Sitagliptin 50mg film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate, equivalent to 50mg sitagliptin.

Each Sitagliptin 100mg film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate, equivalent to 100mg sitagliptin.

The other ingredients in the tablet core are:

calcium phosphate dibasic anhydrous, microcrystalline cellulose (E460), croscarmellose sodium (E468), silica colloidal anhydrous, sodium stearyl fumarate, magnesium stearate (E470b)

The other ingredients in the film coating are:

25mg Tablets: polyvinyl alcohol partially hydrolized (E1203), titanium dioxide (E171), macrogol/PEG (E1521), talc (E553b), iron oxide yellow (E172), iron oxide red (E172) and iron oxide black (E172).

50mg and 100mg Tablets: polyvinyl alcohol partially hydrolized (E1203), titanium dioxide (E171), macrogol/PEG (E1521), talc (E553b), iron oxide yellow (E172) and iron oxide red (E172).

25mg tablets are round, pink film-coated tablets.

50mg tablets are round, light beige film-coated tablets, engraved with “S” on one side.

100mg tablets are round, beige film-coated tablets. They come in opaque blister packs of 28 film-coated tablets.

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