25 mg, 50 mg, and 100 mg film-coated tablets
sitagliptin
What Sitagliptin Accord is and what it is used for
Sitagliptin Accord contains the active substance sitagliptin, which belongs to a group of medicines that lower blood sugar levels in adult patients with diabetes mellitus type 2. These are called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
This medicine helps to increase the insulin levels produced after a meal and reduces the amount of sugar that is formed in the body.
Your doctor has prescribed this medicine to help lower your blood sugar, which is too high due to your type 2 diabetes. This medicine can be used alone or in combination with certain other blood sugar-lowering medicines ( insulin, metformin, sulphonylureas, or glitazones) that you may already be taking for your diabetes and together with a diet and exercise program.
What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough insulin and the insulin the body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar ( glucose ) accumulates in the blood. This can lead to serious medical problems such as heart disease, kidney disease, blindness, and amputation.
What you need to know before you take Sitagliptin Accord
Do not use Sitagliptin Accord
- 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 Accord (see section 4).
If you get blisters on your skin, it could be a sign of a condition called bullous pemphigoid. Your doctor may tell you to stop taking Sitagliptin Accord.
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 type of fat) in the blood. These medical conditions may increase the risk of developing pancreatitis (see section 4).
- type 1‑ diabetes
- increased levels of ketones in the blood and urine (diabetic ketoacidosis; a complication of diabetes with high blood sugar, rapid weight loss, nausea, or vomiting)
- any past or present problems with the kidneys
- an allergic reaction to Sitagliptin Accord (see section 4).
This medicine does not work when blood sugar is low and is therefore unlikely to cause too low blood sugar. However, when this drug is used in combination with sulfonylurea or insulin, low blood sugar ( hypoglycemia ) may occur. Your doctor can then reduce the dose of one of your sulfonylurea or your insulin.
Children and young people
Children and adolescents under the age of 18 should not use this medicine. It is not effective in children and adolescents between 10 and 17 years of age. It is not known if this medicine is safe and effective when used in children and adolescents under 10 years of age.
Other medicines and Sitagliptin Accord
Tell your doctor or pharmacist if you 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 rhythms and other heart problems). The level of digoxin in the blood may need to be checked if it is taken together with Sitagliptin Accord.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
You should not use this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. You should not use this medicine if you are breastfeeding or plan to breastfeed.
Driving ability and use of machinery
This medicine has no or 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.
Concomitant use of this medicine with medicines called sulphonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive or use machines.
Sitagliptin Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to take Sitagliptin Accord
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The usual recommended dose is:
- a film-coated tablet of 100 mg
- once daily
- through the mouth.
If you have kidney problems, your doctor may prescribe you a lower dose (such as 25 mg or 50 mg).
You can take this medicine with or without food and drink.
Your doctor may prescribe this medicine alone or together with certain other medicines that lower blood sugar.
Diet and exercise can help your body make better use of blood sugar. It is important to continue with the diet and exercise recommended by the doctor while you are taking Sitagliptin Accord.
If you have taken too much Sitagliptin Accord
Contact your doctor immediately if you have taken more than the prescribed dose of one of these medicines.
If you forget to take Sitagliptin Accord
If you have forgotten to take a dose, take it as soon as you remember. If you do not remember it until it is time for the next dose, then do not take the missed dose and continue the usual dosing schedule. Do not take a double dose of this medicine on the same day.
If you stop taking Sitagliptin Accord
To keep your blood sugar under control, you should continue to take this medicine for as long as your doctor has prescribed the treatment. You should not stop taking the medicine without talking to your doctor first.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets 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) that may radiate to the back, with or without nausea and vomiting, as these may be signs of an inflamed pancreas ( pancreatitis ).
If you get a serious allergic reaction (frequency not known), such as rash, hives, skin blisters/scaly skin, and swelling of the face, lips, tongue, and throat which may cause breathing or swallowing difficulties, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe one medicine to treat your allergic reaction and another medicine for your diabetes.
Some patients have experienced the following side effects when adding sitagliptin to metformin:
Common (may affect up to 1 in 10 people): low blood sugar, feeling sick, feeling sick, being sick
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness
Some patients have experienced various types of stomach discomfort when starting combination therapy with sitagliptin and metformin together (reported frequency: common).
Some patients have experienced the following side effects when taking sitagliptin in combination with 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 when taking sitagliptin and pioglitazone:
Common: weather tension, swollen hands, and legs
Some patients have experienced the following side effects when taking sitagliptin in combination with pioglitazone and metformin:
Common: swollen hands and legs
Some patients have experienced the following side effects when taking sitagliptin in combination with insulin (with or without metformin ):
Common: influenza
Uncommon: dry mouth
Some patients have experienced the following side effects when taking sitagliptin alone in clinical trials or during post-approval follow-up when using sitagliptin alone and/or in combination with other diabetes medicines:
Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in arms or legs.
Uncommon: dizziness, constipation, itching
Rare: decreased number of blood platelets
Not known frequency: kidney problems (which sometimes require dialysis ), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a kind of blistering of the skin).
How to store Sitagliptin Accord
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the blister and carton after “EXP” and “Exp. date”. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is sitagliptin.
Sitagliptin Accord 25 mg film-coated tablets
Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.
Sitagliptin Accord 50 mg film-coated tablets
Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50 mg sitagliptin.
Sitagliptin Accord 100 mg film-coated tablets
Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.
Other ingredients are: In the tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, croscarmellose sodium (E468), and magnesium stearate (E470b). The film coating of the tablet contains poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
Appearance and package sizes of the medicine
Sitagliptin Accord 25 mg film-coated tablets: A pink, round, film-coated tablet with a smooth edge, debossed with “S3” on one side and plain on the other side. Diameter 6 mm to 6.40 mm.
Sitagliptin Accord 50 mg film-coated tablets: Light beige, round, film-coated tablet with a beveled edge, debossed with “S4” on one side and plain on the other side. Diameter 8 mm to 8.40 mm.
Sitagliptin Accord 100 mg film-coated tablets: Beige, round, film-coated tablets with a beveled edge, debossed with “S7” on one side and plain on the other side. Diameter 10 mm to 10.40 mm.
PVC/PE/PVDC aluminum blisters. Packs of 28, 30, 56, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6 a Planta,
08039 Barcelona, Spain
Manufacturer
Accord Healthcare Polska Sp. Zoo
ul.Lutomierska 50,
95-200, Pabianice, Poland
Paradox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare BV
Winthontlaan 200,
3526 KV Utrecht, The Netherlands