Patient leaflet - SITAGLIPTIN GRINDEKS 25 MG FILM-COATED TABLETS
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Package leaflet: Information for the patient
Sitagliptin Grindeks 25 mg film-coated tablets Sitagliptin Grindeks 50 mg film-coated tablets Sitagliptin Grindeks 100 mg film-coated tablets
sitagliptin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, pharmacist or nurse.
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– 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.
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– 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.
What is in this leaflet
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1. What Sitagliptin Grindeks is and what it is used for
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2. What you need to know before you take Sitagliptin Grindeks
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3. How to take Sitagliptin Grindeks
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4. Possible side effects
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5. How to store Sitagliptin Grindeks
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6. Contents ofthe pack and other information
1. what sitagliptin grindeks is and what it is used for
Sitagliptin Grindeks contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body.
Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan.
What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart disease, kidney disease, blindness and amputation.
2. what you need to know before you take sitagliptin grindeksdo not take sitagliptin grindeks- 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 Grindeks (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 Grindeks.
Tell your doctor if you have or have had:
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– a disease of the pancreas (such as pancreatitis)
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– 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).
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– type 1 diabetes
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– diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting)
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– any past or present kidney problems
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– an allergic reaction to Sitagliptin Grindeks (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
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.
Other medicines and Sitagliptin Grindeks
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 Grindeks.
Pregnancy and breast-feeding
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.
Driving and using machines
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.
Sitagliptin Grindeks contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose that is to say essentially ‚sodium-free‘.
3. how to take sitagliptin grindeks
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual recommended dose is:
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– one 100 mg film-coated tablet
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– once a day
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– by mouth
If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
You can take this medicine with or without food and drink. Sitagliptin Grindeks 50 mg and 100 mg film-coated tablets have a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
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 Grindeks.
If you take more Sitagliptin Grindeks than you should
If you take more than the prescribed dosage of this medicine, 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 go back to your regular schedule. Do not take a double dose of this medicine.
If you stop taking Sitagliptin Grindeks
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.
If you have any further questions on the use of 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 a doctor immediately if you notice any ofthe following serious side effects:
- 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).
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 which is stated on the blister and the carton after ‚EXP‘.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other informationwhat sitagliptin grindeks containsthe active substance is sitagliptin. each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg, 50 mg or 100 mg sitagliptin.
The other ingredients are:
Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate (E341), croscarmellose sodium (E468), sodium stearyl fumarate (E485), magnesium stearate (E572).
Tablet film-coating:
25 mg tablets: Macrogolpoly(vinyl alcohol) grafted copolymer (El209) Talc(E553b)
Titanium dioxide (E171)
Glycerol monocaprylocaprate (type 1) (E471)
Poly(vinyl alcohol) (E1203)
Iron oxide yellow (E172)
Iron oxide black (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)
Iron oxide yellow (E172)
700 mg tablets: Macrogol poly(vinyl alcohol) grafted copolymer (E1209)
Talc(E553b)
Titanium dioxide(E171)
Glycerol monocaprylocaprate (type 1) (E471)
Poly(vinyl alcohol) (E1203)
Iron oxide yellow (E172)
What Sitagliptin Grindeks looks like and contents of the pack
Sitagliptin Grindeks 25 mg are light yellow, round, biconvex film-coated tablets, marked “25” on one side. Size of tablet is approximately 6.0 mm in diameter.
Sitagliptin Grindeks 50 mg are yellow, round, biconvex film-coated tablets, marked “50” on one side and breakline on other side. Size of tablet is approximately 8.0 mm in diameter.
Sitagliptin Grindeks 100 mg are yellow, round, biconvex film-coated tablets, marked “100” on one side and breakline on other side. Size of tablet is approximately 10.0 mm in diameter.
Sitagliptin Grindeks 25 mg, 50 mg and 100 mg are available in blisters of28,56 or 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
AS GRINDEKS.
Krustpils iela 53
Riga, LV-1057
Latvia
Phone:+371 67083205
Fax:+37167083505
E-mail:
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
| Sweden | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmdragerade tabletter |
| Austria | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg Filmtabletten |
| Belgium | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg comprimes pellicules |
| Bulgaria | CirrarjiHnTHH LpnH/ieKC 25 mg, 50 mg, 100 mg 4>HJMMpaHH Ta&ieTKH Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets |
| Croatia | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmom oblozene tablete |
| Czech Republic | Sitagliptin Grindeks |
| Denmark | Sitagliptin Grindeks |
| Estonia | Sitagliptin Grindeks |
| Finland | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg kalvopaallysteiset tabletit |
| France | SITAGLIPTINE GRINDEKS 25 mg, comprime pellicule SITAGLIPTINE GRINDEKS 50 mg, comprime pellicule SITAGLIPTINE GRINDEKS 100 mg, comprime pellicule |
| Germany | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg Filmtabletten |
| Greece | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg emKoXuppeva ps Xetcto vpsvio SiaKia |
| Hungary | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmtabletta |
| Ireland | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets |
| Italy | Sitagliptin Grindeks |
| Latvia | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg apvalkotas tabletes |
| Lithuania | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg plevele dengtos tabletes |
| Luxembourg | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmbeschichtete Pellen |
| The Netherlands | Sitagliptine Grindeks 25 mg filmomhulde tabletten |
| Sitagliptine Grindeks 50 mg filmomhulde tabletten | |
| Sitagliptine Grindeks 100 mg filmomhulde tabletten | |
| Norway | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmdrasjerte tabletter |
| Poland | Sitagliptin Grindeks |
| Portugal | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg comprimidos revestidos por pelfcula |
| Romania | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg comprimate filmate |
| Slovakia | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmom obalene tablety |
| Slovenia | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg fihnsko oblozene tablete |
| Spain | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg comprimidos recubiertos con pelfcula |
| United Kingdom | Sitagliptin Grindeks 25 mg, 50 mg, 100 mg |
| (Northern Ireland) | film-coated tablets |
This leaflet was last revised in 12/2021
01/03/2022 GB/T/0/1