Sitagliptin Grindeks
Italy
Table of Contents
Package leaflet: Information for the user
Sitagliptin Grindeks 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 you start using 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 or nurse.
- This medicine has been prescribed for you only. Do not give it to others, 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 or nurse. See section 4.
Contents of this leaflet:
- What Sitagliptin Grindeks is and what it is used for
- What you need to know before taking Sitagliptin Grindeks
- How Sitagliptin Grindeks is administered
- Possible side effects
- How to store Sitagliptin Grindeks
- Contents of the pack and other information
1. What is Sitagliptin Grindeks and what is it used for?
Sitagliptin Grindeks 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 insulin levels produced 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 (such as insulin, metformin, sulfonylureas or glitazones) that you may already be taking to treat your diabetes, along with a diet and exercise program.
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) accumulates 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 Grindeks
- Do not take Sitagliptin Grindeks
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 Grindeks (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 Grindeks.
Inform 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 Grindeks (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 with a sulphonylurea or with insulin, low blood sugar levels (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 Grindeks
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform 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 the blood if taken together with Sitagliptin Grindeks.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are 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 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 Grindeks contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, i.e. essentially 'sodium-free'.
3. How to take Sitagliptin Grindeks
Take this medicine exactly as instructed by your doctor. 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. Sitagliptin Grindeks 50 mg and 100 mg tablets have a breakline on one side. The breakline is only intended to facilitate tablet splitting for ease of ingestion and is not for dividing the tablet into equal doses.
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 Grindeks, it is important to continue the diet and exercise plan recommended by your doctor.
If you take more Sitagliptin Grindeks than you should
If you take more of this medicine than prescribed, contact your doctor immediately.
If you forget to take Sitagliptin Grindeks
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 take your next dose at the regular time. Do not take a double dose of this medicine.
If you stop taking Sitagliptin Grindeks
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep controlling your blood sugar level. Do not stop treatment with this medicine without first talking to your doctor.
If you have any questions about how to use this medicine, ask 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 Grindeks and contact your doctor immediately if you experience any of the following serious side effects:
- Severe and persistent pain in the abdomen (stomach area) which may spread 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 or peeling of the skin, swelling of the face, lips, tongue and 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 have 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 different types of stomach discomfort when starting sitagliptin and metformin together as combination therapy (frequency is common).
Some patients have 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 have experienced the following side effects when taking sitagliptin and pioglitazone:
Common: flatulence, swelling of the hands or legs
Some patients have experienced the following side effects when taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of the hands or 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 studies, or during post-approval use alone and/or with other antidiabetic 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. You can also report side effects directly via the national reporting system at the following 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 Grindeks
Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging after (Exp.). The expiry date refers to the last day of that month.
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 Grindeks contains
- The active substance is sitagliptin. Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg, 50 mg or 100 mg of sitagliptin.
- The other ingredients are: Tablet core: microcrystalline cellulose (E460), dibasic calcium phosphate (E341), croscarmellose sodium (E468), sodium stearate fumarate (E485), magnesium stearate (E572).
Tablet coating:
25 mg tablets: macrogol poly(vinyl alcohol) grafted copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1) (E471), poly(vinyl alcohol) (E1203), yellow iron oxide (E172), black iron oxide (E172).
50 mg tablets: macrogol poly(vinyl alcohol) grafted copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1) (E471), poly(vinyl alcohol) (E1203), yellow iron oxide (E172).
100 mg tablets: macrogol poly(vinyl alcohol) grafted copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1) (E471), poly(vinyl alcohol) (E1203), yellow iron oxide (E172).
Description of the appearance of Sitagliptin Grindeks and contents of the pack
Sitagliptin Grindeks 25 mg film-coated tablets are pale yellow, round, biconvex tablets with "25" engraved on one side. The tablet diameter is approximately 6.0 mm.
Sitagliptin Grindeks 50 mg film-coated tablets are pale yellow, round, biconvex tablets with "50" engraved on one side and a break line on the other side. The tablet diameter is approximately 8.0 mm.
Sitagliptin Grindeks 100 mg film-coated tablets are pale yellow, round, biconvex tablets with "100" engraved on one side and a break line on the other side. The tablet diameter is approximately 10.0 mm.
Sitagliptin Grindeks 25 mg, Sitagliptin Grindeks 50 mg and Sitagliptin Grindeks 100 mg are available in blisters containing 28, 56 or 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53
Rīga, LV-1057
Latvia
This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Sweden (SE): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmdragerade tabletter
Austria (AT): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg Filmtabletten
Belgium (BE): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg comprimés pelliculés
Bulgaria (BG): Ситаглиптин Гриндекс 25 mg, 50 mg, 100 mg филмирани таблетки
Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets
Croatia (HR): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmom obložene tablete
Czech Republic (CZ): Sitagliptin Grindeks
Denmark (DK): Sitagliptin Grindeks
Estonia (EE): Sitagliptin Grindeks
Finland (FI): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg kalvopäällysteiset tabletit
France (FR): SITAGLIPTINE GRINDEKS 25 mg, comprimé pelliculé
SITAGLIPTINE GRINDEKS 50 mg, comprimé pelliculé
SITAGLIPTINE GRINDEKS 100 mg, comprimé pelliculé
Germany (DE): Sitagliptin Ethypharm 25 mg, 50 mg, 100 mg Filmtabletten
Greece (EL): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg επικαλυμμένα με λεπτό υμένιο δισκία
Hungary (HU): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmtabletta
Ireland (IE): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets
Italy (IT): Sitagliptin Grindeks
Latvia (LV): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg apvalkotās tabletes
Lithuania (LT): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg plėvele dengtos tabletės
Luxembourg (LU): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmbeschichtete Pëllen
Netherlands (NL): Sitagliptine Grindeks 25 mg filmomhulde tabletten
Sitagliptine Grindeks 50 mg filmomhulde tabletten
Sitagliptine Grindeks 100 mg filmomhulde tabletten
Norway (NO): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmdrasjerte tabletter
Poland (PL): Sitagliptin Grindeks
Portugal (PT): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg comprimidos revestidos por película
Romania (RO): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg comprimate filmate
Slovakia (SK): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmom obalené tablety
Slovenia (SI): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmsko obložene tablete
Spain (ES): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg comprimidos recubiertos con película
United Kingdom (Northern Ireland): Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets