Sitagliptin Mylan
Italy
Table of Contents
Package leaflet: Information for the patient
Sitagliptin Mylan 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets
sitagliptin
Generic Medicine
Please read all of this leaflet carefully before 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, as 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
- What Sitagliptin Mylan is and what it is used for
- What you need to know before taking Sitagliptin Mylan
- How to take Sitagliptin Mylan
- Possible side effects
- How to store Sitagliptin Mylan
- Contents of the pack and other information
1. What is Sitagliptin Mylan and what is it used for?
Sitagliptin Mylan contains the active substance sitagliptin, which belongs to a class of medicines known as 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 may be used alone or in combination with other blood sugar-lowering medicines (such as insulin, metformin, sulphonylureas or glitazones) that you may already be taking to treat your diabetes, together 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 produced by the body does not work as effectively as it should. The body may also produce too much sugar. When this occurs, 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 Mylan
Do not take Sitagliptin Mylan
- 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 reported in patients treated with Sitagliptin Mylan (see section 4).
If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Sitagliptin Mylan.
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 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 Mylan (see section 4).
It is unlikely that this medicine will cause low blood sugar (hypoglycaemia) because it does not act when blood sugar levels are low. However, when this medicine is taken with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) may occur. Your doctor may reduce the dose of 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 Mylan
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 heartbeat and other heart-related problems). It may be necessary to monitor digoxin levels in your blood if taken together with Sitagliptin Mylan.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or 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 has no effect or has a negligible effect on the ability to drive and use machines. However, dizziness and somnolence 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 Mylan 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 Mylan
Take this medicine exactly as your doctor has told you. If you are not sure, 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 lower doses (such as 25 mg or 50 mg). You may take this medicine with or without food and beverages.
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. It is important to continue the diet and exercise programme recommended by your doctor while taking Sitagliptin Mylan.
If you take more Sitagliptin Mylan than you should
If you take more of this medicine than prescribed, contact your doctor immediately.
If you forget to take Sitagliptin Mylan
If you forget to take 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 the next dose at the regular time. Do not take a double dose to make up for the missed dose.
If you stop taking Sitagliptin Mylan
Keep taking this medicine for as long as your doctor prescribes it, so that you can continue to control your blood sugar level. 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 gets them.
STOP taking Sitagliptin Mylan and contact a doctor immediately if you experience any of the following serious side effects:
Severe and persistent pain in the abdomen (stomach area), possibly radiating to the back, with or without nausea and vomiting, as these could be signs of inflammation of the pancreas (pancreatitis).
If you have a severe allergic reaction (frequency not known), including rash, hives, blistering or peeling of the skin, and swelling of the face, lips, tongue, or throat which may cause difficulty breathing or swallowing, stop treatment with this medicine and contact a 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 after adding sitagliptin 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 reported 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 during post-approval use 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 at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Sitagliptin Mylan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, on the bottle label, and on the outer 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 Mylan contains
- The active substance is sitagliptin. Each film-coated tablet contains sitagliptin monohydrochloride monohydrate, equivalent to 25 mg of sitagliptin.
- The active substance is sitagliptin. Each film-coated tablet contains sitagliptin monohydrochloride monohydrate, equivalent to 50 mg of sitagliptin.
- The active substance is sitagliptin. Each film-coated tablet contains sitagliptin monohydrochloride monohydrate, equivalent to 100 mg of sitagliptin.
The other components are: in the tablet core: microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, calcium hydrogen phosphate, and magnesium stearate. The tablet coating contains: poly(vinyl alcohol), macrogol, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
Description of the appearance of Sitagliptin Mylan and package contents
Sitagliptin Mylan 25 mg film-coated tablets are round, biconvex, pink, film-coated, with "M" printed on one side and "SL1" on the other.
Sitagliptin Mylan 50 mg film-coated tablets are round, biconvex, light brown, film-coated, with "M" printed on one side and "SL2" on the other.
Sitagliptin Mylan 100 mg film-coated tablets are round, biconvex, brown, film-coated, with "M" printed on one side and "SL3" on the other.
Sitagliptin Mylan 25 mg film-coated tablets are available in blisters (OPA/Al/PVC//Al) containing 14, 28, 30, 56 or 98 film-coated tablets, or in perforated unit dose blisters OPA/Al/PVC//Al containing 14 x 1, 28 x 1 or 30 x 1 film-coated tablets, or in calendar packs containing 28 film-coated tablets, and in white plastic bottles with white screw caps containing 98, 100 or 250 film-coated tablets.
Sitagliptin Mylan 50 mg film-coated tablets are available in blisters (OPA/Al/PVC//Al) containing 14, 28, 30, 56 or 98 film-coated tablets, or in perforated unit dose blisters OPA/Al/PVC//Al containing 14 x 1, 28 x 1, 30 x 1 or 56 x 1 film-coated tablets, or in calendar packs containing 28 film-coated tablets, and in white plastic bottles with white screw caps containing 98, 100 or 250 film-coated tablets.
Sitagliptin Mylan 100 mg film-coated tablets are available in blisters (OPA/Al/PVC//Al) containing 14, 28, 30, 56 or 98 film-coated tablets, or in perforated unit dose blisters OPA/Al/PVC//Al containing 14 x 1, 28 x 1, 30 x 1 or 56 x 1 film-coated tablets, or in calendar packs containing 28 or 56 film-coated tablets, and in white plastic bottles with white screw caps containing 98, 100 or 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy
Manufacturers
McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan Dublin
Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Medis International a.s.
Vyrobni zavod Bolatice, Prumyslova 961/16, Bolatice, 747 23, Czech Republic
Mylan Hungary Kft./Mylan Hungary Ltd.
Mylan utca 1., Komarom, 2900, Hungary
Mylan Germany GmbH,
Zweigniederlassung Bad Homburg v. d. Höhe, Benzstraße 1, Bad Homburg v.d. Höhe, 61352, Germany
This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Denmark Sitagliptin Viatris
Austria Sitagliptin Viatris 25 mg/50 mg/100 mg Filmtabletten
Cyprus Sitagliptin/Mylan 25 mg, 50 mg and 100 mg Film Coated tablets
Czech Republic Sitagliptin Viatris
Greece Sitagliptin/Mylan 25 mg, 50 mg and 100 mg Film Coated tablets
Spain Sitagliptina Viatris 25 mg, 50 mg, 100 mg comprimidos EFG
Finland Sitagliptin Viatris 25 mg, 50 mg, 100 mg tabletti, kalvopäällysteinen
France Sitagliptine Viatris 25 mg comprimé pelliculé,
Sitagliptine Viatris 50 mg comprimé pelliculé,
Sitagliptine Viatris 100 mg comprimé pelliculé
Germany Sitagliptin Mylan 25 mg Filmtabletten, Sitagliptin Mylan 50 mg Filmtabletten,
Sitagliptin Mylan 100 mg Filmtabletten
Ireland Sitagliptin Viatris 25 mg, 50 mg & 100 mg film-coated tablets
Iceland Sitagliptin Viatris 25 mg, 50 mg, 100 mg filmuhúðuð tafla
Italy Sitagliptin Mylan
Netherlands Sitagliptine Viatris 25 mg, 50 mg, 100 mg, filmomhulde tabletten
Norway Sitagliptin Viatris filmdrasjerte tabletter 25 mg, 50 mg, 100 mg
Portugal Sitagliptin Mylan
Slovakia Sitagliptin Viatris 50 mg, Sitagliptin Viatris 100 mg
Sweden Sitagliptin Viatris 25 mg, 50 mg, 100 mg filmdragerade tabletter
United Kingdom Sitagliptin Mylan 25 mg, 50 mg and 100 mg film-coated tablets