Sitagliptin Grindeks

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 the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Sitagliptin Grindeks and what is it used for
• 2. Important information before taking Sitagliptin Grindeks
• 3. How to take Sitagliptin Grindeks
• 4. Possible side effects
• 5. How to store Sitagliptin Grindeks
• 6. 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 DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adults with type 2 diabetes.
This medicine helps to increase the amount of insulin released after a meal and decrease the amount of sugar made by the body.
Your doctor has prescribed this medicine to reduce high blood sugar levels caused by type 2 diabetes. The medicine can be used alone or in combination with other medicines that reduce blood sugar levels (insulin, metformin, sulfonylurea derivatives, or glitazones) that you are already taking for diabetes, along with diet and exercise.
What is type 2 diabetes?
Type 2 diabetes is a condition where the body does not produce enough insulin and the insulin produced does not work as it should. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious diseases such as heart disease, kidney disease, loss of vision, and limb amputation.

2. Important information before taking Sitagliptin Grindeks

When not to 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

Patients taking Sitagliptin Grindeks have reported cases of pancreatitis (see section 4).
If you experience blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking Sitagliptin Grindeks.
Tell your doctor if you have or have had:

• pancreatic disease (e.g., pancreatitis);
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In these situations, the risk of pancreatitis (see section 4) may increase;
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting);
• any kidney disease that has occurred in the past or is currently present;
• an allergic reaction to Sitagliptin Grindeks (see section 4).

Since this medicine does not work when blood sugar levels are low, it is unlikely to cause low blood sugar levels. However, if this medicine is taken with a sulfonylurea derivative or insulin, it may cause low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea derivative or insulin.

Children and adolescents

Children and adolescents under 18 years of age should not take this medicine. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether this medicine is safe and effective in children under 10 years of age.

Sitagliptin Grindeks and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Sitagliptin Grindeks with digoxin, your doctor should monitor your digoxin blood levels.

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 taking this medicine.
Do not take this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. Do not take this medicine while breastfeeding or if you are planning to breastfeed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving or operating machinery, consider that dizziness and drowsiness have been reported.
Taking this medicine with sulfonylurea derivatives or insulin may cause low blood sugar levels (hypoglycemia), which can affect your ability to drive or operate machinery or work without safe foot support.

Sitagliptin Grindeks contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.

3. How to take Sitagliptin Grindeks

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual recommended dose is:

• one 100 mg film-coated tablet
• once a day
• taken orally.

If you have kidney problems, your doctor may prescribe a lower dose (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drink. Sitagliptin Grindeks 50 mg and 100 mg film-coated tablets have a break line on one side. The break line is only to help you break the tablet; it does not divide the tablet into equal doses.
Your doctor may advise you to take this medicine alone or with certain other medicines that reduce blood sugar levels.
Diet and exercise help your body use blood sugar better. When taking Sitagliptin Grindeks, it is important to follow the diet and exercise plan recommended by your doctor.

What to do if you take more Sitagliptin Grindeks than you should

If you have taken more than the recommended dose, contact your doctor immediately.

What to do if you miss a dose of Sitagliptin Grindeks

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose.

What to do if you stop taking Sitagliptin Grindeks

To maintain control of your blood sugar levels, you should continue to take this medicine for as long as your doctor recommends. Do not stop taking this medicine without first talking to your doctor.
If you have any further questions on the use of this product, 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 abdominal pain (in the stomach area), which may radiate to the back and is accompanied by nausea and vomiting or not - these may be symptoms of pancreatitis.

In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling of the skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking the medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
In some patients who added sitagliptin to metformin, the following side effects were reported:
Common (may affect up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness
In some patients who took sitagliptin in combination with metformin, various gastrointestinal symptoms were reported (commonly).
In some patients who took sitagliptin in combination with a sulfonylurea derivative and metformin, the following side effects were reported:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation
In some patients who took sitagliptin and pioglitazone, the following side effects were reported:
Common: bloating, swelling of the hands or feet
In some patients who took sitagliptin, pioglitazone, and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients who took sitagliptin and insulin (with or without metformin), the following side effects were reported:
Common: flu
Uncommon: dry mouth
In some patients who took sitagliptin alone in clinical trials or alone or with other anti-diabetic medicines after marketing authorization, the following side effects were reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy nose or sinusitis, and sore throat
Uncommon: dizziness, constipation, itching
Rare: reduced platelet count
Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Pharmacovigilance Department of the Medicinal Products Agency: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
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 in a temperature below 30 °C.
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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Sitagliptin Grindeks contains

• The active substance is sitagliptin. Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg, 50 mg, or 100 mg of sitagliptin.
• The other ingredients are: Tablet core: Microcrystalline cellulose (E 460), Calcium hydrogen phosphate (E 341), Sodium carmellose (E 468), Sodium stearyl fumarate (E 485), Magnesium stearate (E 572) Coating: 25 mg tablet:Macrogol (E 1209) - copolymer of macrogol and poly(vinyl alcohol) Talc (E 553b) Titanium dioxide (E 171) Glycerol monocaprylocaprate (type 1) (E 471) Poly(vinyl alcohol) (E 1203) Yellow iron oxide (E 172) Black iron oxide (E 172) 50 mg tablet:Macrogol (E 1209) - copolymer of macrogol and poly(vinyl alcohol) Talc (E 553b) Titanium dioxide (E 171) Glycerol monocaprylocaprate (type 1) (E 471) Poly(vinyl alcohol) (E 1203) Yellow iron oxide (E 172) 100 mg tablet:Macrogol (E 1209) - copolymer of macrogol and poly(vinyl alcohol) Talc (E 553b) Titanium dioxide (E 171) Glycerol monocaprylocaprate (type 1) (E 471) Poly(vinyl alcohol) (E 1203) Yellow iron oxide (E 172)

What Sitagliptin Grindeks looks like and contents of the pack

Sitagliptin Grindeks, 25 mg, film-coated tablets: light yellow, round, biconvex film-coated tablet, with engraving "25" on one side. The diameter of the tablet is about 6.0 mm.
Sitagliptin Grindeks, 50 mg, film-coated tablets: yellow, round, biconvex film-coated tablet, with engraving "50" on one side and a break line on the other side. The diameter of the tablet is about 8.0 mm.
Sitagliptin Grindeks, 100 mg, film-coated tablets: yellow, round, biconvex film-coated tablet, with engraving "100" on one side and a break line on the other side. The diameter of the tablet is about 10.0 mm.
Sitagliptin Grindeks 25 mg, 50 mg, and 100 mg are available in blisters of 28, 56, or 98 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS
Krustpils iela 53
Rīga, LV-1057
Latvia

This medicine is authorized 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, 50mg, 100 mg film-coated tablets
Austria
Sitagliptin Grindeks 25 mg, 50 mg,100 mg Filmtabletten
Belgium
Sitagliptin Grindeks 25 mg, 50 mg,100 mg film-coated tablets
Bulgaria
Ситаглиптин Гриндекс 25 mg, 50 mg,100 mg филмирани таблетки
Sitagliptin Grindeks 25 mg, 50 mg,100 mg film-coated tablets
Croatia
Sitagliptin Grindeks 25 mg, 50 mg,100 mg film-coated tablets
Czech Republic
Sitagliptin Grindeks
Denmark
Sitagliptin Grindeks
Estonia
Sitagliptin Grindeks
Finland
Sitagliptin Grindeks 25 mg, 50 mg,100 mg kalvopäällysteiset tabletit
France
SITAGLIPTINE GRINDEKS 25 mg, film-coated tablet
SITAGLIPTINE GRINDEKS 50 mg, film-coated tablet,
SITAGLIPTINE GRINDEKS 100 mg, film-coated tablet
Germany
Sitagliptin Ethypharm 25 mg, 50 mg,100 mg Filmtabletten
Greece
Sitagliptin Grindeks 25 mg, 50 mg,100 mg επικαλυμμένα με λεπτό υμένιο Δισκία
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 apvalkotās tablets
Lithuania
Sitagliptin Grindeks 25 mg, 50 mg,100 mg plėvele dengtos tabletės
Luxembourg
Sitagliptin Grindeks 25 mg, 50 mg,100 mg filmbeschichtete Pëllen
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
Sitagliptina Grindeks 25 mg, 50 mg,100 mg comprimidos revestidos por película
Romania
Sitagliptin Grindeks 25 mg, 50 mg,100 mg comprimate filmate
Slovakia
Sitagliptin Grindeks 25 mg, 50 mg,100 mg filmom obalené tablety
Slovenia
Sitagliptin Grindeks 25 mg, 50 mg,100 mg filmsko obložene tablete
Spain
Sitagliptina Grindeks 25 mg, 50 mg,100 mg comprimidos recubiertos con película
EFG
Ireland
Sitagliptin Grindeks 25 mg, 50 mg,100 mg film-coated tablets
Northern Ireland
Date of last revision of the leaflet:09/2022