Sitagliptin Accord

Package leaflet: Information for the patient

Sitagliptin Accord 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

sitagliptin
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Sitagliptin Accord is and what it is used for
2. What you need to know before taking Sitagliptin Accord
3. How to take Sitagliptin Accord
4. Possible side effects
5. How to store Sitagliptin Accord
6. Contents of the pack and other information

1. What is Sitagliptin Accord and what is it used for?

Sitagliptin Accord contains the active substance sitagliptin, which belongs to a class of medicines called dipeptidyl peptidase-4 (DPP-4) inhibitors that lower blood sugar levels in adult patients with type 2 diabetes mellitus.
This medicine helps increase the levels of insulin released after a meal and reduces the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help you lower your blood sugar level, which is too high due to type 2 diabetes. This medicine can be used alone or in combination with other blood sugar-lowering medicines (insulin, metformin, sulphonylureas, or glitazones) that you may already be taking to treat your diabetes, along with a diet and exercise programme.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, and the insulin the body produces does not work as well as it should. The body may also produce too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems such as heart disease, kidney disease, blindness, and amputations.

2. What you need to know before taking Sitagliptin Accord

Do not take Sitagliptin Accord

• if you are allergic to sitagliptin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been observed in patients treated with Sitagliptin Accord (see section 4).
If you develop blisters on the skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Sitagliptin Accord.
Tell your doctor if you have or have had:

• a pancreatic disease (such as pancreatitis)
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. These medical conditions may increase your risk of developing pancreatitis (see section 4)
• type 1 diabetes
• diabetic ketoacidosis (a diabetes complication with high blood sugar levels, rapid weight loss, nausea or vomiting)
• any kidney problems, past or present
• an allergic reaction to Sitagliptin Accord (see section 4)

It is unlikely that this medicine will cause low blood sugar levels (hypoglycaemia) because it does not act when blood sugar levels are low. However, when this medicine is taken together with a sulphonylurea or insulin, low blood sugar levels (hypoglycaemia) may occur. Your doctor may reduce the dose of the sulphonylurea or insulin.
Children and adolescents
Children and adolescents under 18 years of age must not use this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is not known whether this medicine is safe and effective when used in children under 10 years of age.
Other medicines and Sitagliptin Accord
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 heartbeats and other heart-related problems). It may be necessary to monitor digoxin levels in the blood when taken together with Sitagliptin Accord.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not use this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. You must not take this medicine if you are breastfeeding or think you may need to breastfeed.
Driving and using machines
This medicine does not affect or has a negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect your ability to drive and use machines.
Taking this medicine together with other medicines called sulphonylureas or with insulin may cause hypoglycaemia, which may affect your ability to drive, use machines, or work without protective barriers.
Sitagliptin Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Sitagliptin Accord

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your
doctor or pharmacist.
The usual recommended dose is:

• one 100 mg film-coated tablet
• once daily
• by mouth

If you have kidney problems, your doctor may prescribe a lower dose (such as 25 mg or 50 mg).
You may take this medicine with or without food and drinks.
Your doctor may prescribe this medicine alone or together with other medicines that lower blood sugar levels.
Diet and physical exercise can help your body use blood sugar more effectively.
While taking Sitagliptin Accord, it is important to continue following the diet and exercise plan recommended by your doctor.
If you take more Sitagliptin Accord than you should
If you take more of this medicine than prescribed, contact your doctor immediately.
If you forget to take Sitagliptin Accord
If you forget 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 take your next dose at the usual time.
Do not take a double dose of this medicine.
If you stop taking Sitagliptin Accord
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep your blood sugar levels under control. Do not stop taking this medicine without first talking to your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
STOP taking Sitagliptin Accord and contact your doctor immediately if you notice any of the following serious side effects:

• Severe and persistent pain in the abdomen (stomach area), which may extend to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

If you have a severe allergic reaction (frequency not known), including rash, hives, blistering and/or peeling of the skin, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

Some patients experienced the following side effects when sitagliptin was added to metformin:
Common (may affect up to 1 in 10 people): low blood sugar level, nausea, flatulence, vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness

Some patients experienced various types of stomach discomfort when starting sitagliptin and metformin together as part of combination therapy (frequency is common).

Some patients experienced the following side effects when taking sitagliptin in combination with a sulfonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar level
Common: constipation

Some patients experienced the following side effects when taking sitagliptin and pioglitazone:
Common: flatulence, swelling of the hands or legs

Some patients experienced the following side effects when taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of the hands or legs

Some patients experienced the following side effects when taking sitagliptin in combination with insulin (with or without metformin):
Common: influenza
Uncommon: dry mouth

Some patients experienced the following side effects when taking sitagliptin alone in clinical studies, or after approval, either alone and/or with other diabetes medicines:
Common: low blood sugar level, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in arms or legs
Uncommon: dizziness, constipation, itching
Rare: reduced platelet count
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 experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin Accord

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 blister and carton after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sitagliptin Accord contains

• The active substance is sitagliptin.
  Sitagliptin Accord 25 mg film-coated tablets: Each film-coated tablet (tablet) contains monohydrate sitagliptin hydrochloride, equivalent to 25 mg of sitagliptin.
  Sitagliptin Accord 50 mg film-coated tablets: Each film-coated tablet (tablet) contains monohydrate sitagliptin hydrochloride, equivalent to 50 mg of sitagliptin.
  Sitagliptin Accord 100 mg film-coated tablets: Each film-coated tablet (tablet) contains monohydrate sitagliptin hydrochloride, equivalent to 100 mg of sitagliptin.

• The other ingredients are:
  Tablet core: microcrystalline cellulose (E460), dicalcium phosphate, sodium croscarmellose (E468), and magnesium stearate (E470b).
  Tablet coating: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

Description of the appearance of Sitagliptin Accord and contents of the pack
Sitagliptin Accord 25 mg film-coated tablets: Pink, round, film-coated tablet with bevelled edges, marked with "S3" on one side and smooth on the other. Diameter between 6 mm and 6.40 mm.
Sitagliptin Accord 50 mg film-coated tablets: Light beige, round, film-coated tablet with bevelled edges, marked with "S4" on one side and smooth on the other. Diameter between 8 mm and 8.40 mm.
Sitagliptin Accord 100 mg film-coated tablets: Beige, round, film-coated tablet with bevelled edges, marked with "S7" on one side and smooth on the other. Diameter between 10 mm and 10.40 mm.
Packs of 28, 30, 56, 98 or 100 film-coated tablets in PVC/PE/PVDC-aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6th Floor,
08039 Barcelona, Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul. Lutomierska 50,
95-200 Pabianice, Poland
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht, The Netherlands

This Patient Information Leaflet was last approved on
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.