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, 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 lower your high blood sugar levels, which are a result of type 2 diabetes. This medicine can be used alone or in combination with other medicines that lower blood sugar levels (such as insulin, metformin, sulfonylureas, or glitazones), which you may already be taking for your diabetes, along with diet and exercise.
What is type 2 diabetes?
Type 2 diabetes is a condition where the body does not make enough insulin, and the insulin that is made does not work properly. The body may also make 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, blindness, and 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 condition called bullous pemphigoid. Your doctor may advise you to stop taking Sitagliptin Grindeks.
Tell your doctor if you have or have had:

• pancreatic disease (such as 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, past or present;
• an allergic reaction to Sitagliptin Grindeks (see section 4).

Because 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 or insulin, low blood sugar levels (hypoglycemia) may occur. Your doctor may reduce the dose of the sulfonylurea 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 if 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 may need to check the level of digoxin in your blood.

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 if 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 using machines, consider that dizziness and drowsiness have been reported.

Sitagliptin Grindeks contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which 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 (such as 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 lower blood sugar levels.
Diet and exercise help your body use blood sugar better. While 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 take more Sitagliptin Grindeks than you should, 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 keep your blood sugar levels under control, you should keep taking this medicine as long as your doctor tells you to. Do not stop taking this medicine without talking to your doctor first.
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 area of the stomach), which may radiate to the back, with or without nausea and vomiting - these may be symptoms of pancreatitis.

In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, and peeling of the skin, as well as 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 the allergic reaction and another medicine to treat your diabetes.
In some patients, when sitagliptin was added 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, when sitagliptin was started in combination with metformin, various gastrointestinal symptoms were reported (commonly).
In some patients, when sitagliptin was taken in combination with a sulfonylurea 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, when sitagliptin and pioglitazone were taken, the following side effects were reported:
Common: bloating, swelling of the hands or feet
In some patients, when sitagliptin was taken in combination with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients, when sitagliptin was taken in combination with insulin (with or without metformin), the following side effects were reported:
Common: flu
Uncommon: dry mouth
In some patients, when sitagliptin was taken alone in clinical studies 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, sore throat, and arthralgia (joint pain)
Uncommon: dizziness, constipation, itching
Rare: reduced platelet count
Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, arthralgia, myalgia (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, tell your doctor or pharmacist. Side effects can be reported directly to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme (www.mhra.gov.uk/yellowcard). 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 “25” engraved on one side. The diameter of the tablet is approximately 6.0 mm.
Sitagliptin Grindeks 50 mg film-coated tablets: yellow, round, biconvex film-coated tablet, with “50” engraved on one side and a break line on the other side. The diameter of the tablet is approximately 8.0 mm.
Sitagliptin Grindeks 100 mg film-coated tablets: yellow, round, biconvex film-coated tablet, with “100” engraved on one side and a break line on the other side. The diameter of the tablet is approximately 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 25 mg, 50 mg,100 mg film-coated tablets
Denmark
Sitagliptin Grindeks 25 mg, 50 mg,100 mg film-coated tablets
Estonia
Sitagliptin Grindeks 25 mg, 50 mg,100 mg film-coated tablets
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 25 mg, 50 mg,100 mg film-coated tablets
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 filmomhulde tabletten
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 25 mg, 50 mg,100 mg film-coated tablets
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
United Kingdom
Sitagliptin Grindeks 25 mg, 50 mg,100 mg film-coated tablets
Date of last revision of the leaflet:09/2022