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
Sitagliptinum
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 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 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.

Contents of the leaflet

1. What Sitagliptin Grindeks is and what it is used for
2. What you need to know before you take 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 Sitagliptin Grindeks is and what it is 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 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 lower high blood sugar caused by type 2 diabetes.
It may be used alone or together with other blood sugar-lowering medicines (such as insulin, metformin,
sulfonylureas, or glitazones) that you may already be taking, along with diet and an exercise program.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, the insulin produced
does not work properly, or the body produces too much sugar. When this happens, sugar (glucose) builds
up in the blood. This may lead to serious health problems such as heart disease, kidney disease, loss of
vision, and limb amputations.

2. Important information before using Sitagliptin Grindeks

When not to use Sitagliptin Grindeks

• if the patient is allergic to sitagliptin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Cases of pancreatitis (inflammation of the pancreas) have been reported in patients taking Sitagliptin Grindeks (see section 4).
If the patient develops blisters on the skin, this may be a sign of a condition called bullous pemphigoid. The doctor may advise the patient to stop taking Sitagliptin Grindeks.
Inform the doctor if the patient has or has had:

• pancreatic disease (e.g. pancreatitis);
• gallstones, alcohol addiction, or very high levels of triglycerides (a type of fat) in the blood. In such cases, the risk of pancreatitis may be increased (see section 4);
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea or vomiting);
• any kidney problems in the past or currently;
• an allergic reaction to Sitagliptin Grindeks (see section 4).

Since this medicine does not act when blood sugar levels are low, it is unlikely to cause excessively low blood sugar levels. However, if this medicine is used together with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur. The 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 whether this medicine is safe and effective for use in children under 10 years of age.
Sitagliptin Grindeks and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). Blood levels of digoxin should be monitored when Sitagliptin Grindeks is taken together with digoxin.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy.
It is not known whether this medicine passes into human breast milk. This medicine should not be used during breastfeeding or if breastfeeding is planned.
Driving and using machines
This medicine has no effect or has a negligible effect on the ability to drive and use machines. However, when driving and using machines, it should be taken into account that dizziness and somnolence have been reported.
Taking this medicine together with medicines called sulfonylureas or with insulin may lead to hypoglycaemia, which in turn may affect the ability to drive and use machines or to work without safe foot support.
Sitagliptin Grindeks contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to take Sitagliptin Grindeks

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

The usual recommended dose is:

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

If the patient has impaired kidney function, the doctor may prescribe a lower dose (e.g. 25 mg or 50 mg).

This medicine can be taken regardless of meals or drinks. Sitagliptin Grindeks 50 mg and 100 mg film-coated tablets have a score line on one side. The score line is intended only to facilitate breaking the tablet for easier swallowing and does not ensure an equal division into doses.

Your doctor may recommend taking this medicine alone or in combination with other medicines that lower blood sugar levels.

Diet and physical exercise help the body use blood sugar more effectively. While taking Sitagliptin Grindeks, it is important to follow the diet and exercise regimen recommended by your doctor.

Taking more Sitagliptin Grindeks than prescribed
If you take more of this medicine than prescribed, contact your doctor immediately.

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

Stopping Sitagliptin Grindeks
To maintain control of blood sugar levels, continue taking this medicine for as long as your doctor recommends. Do not stop taking this medicine without consulting your doctor first.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should STOP USING Sitagliptin Grindeks and contact your doctor immediately if any of the following serious adverse reactions occur:

• Severe and persistent pain in the abdomen (stomach area), possibly radiating to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis.

In case of a severe allergic reaction (frequency unknown), including rash, hives, blistering or peeling of the skin, and swelling of the face, lips, tongue, or throat, which may cause difficulty in breathing or swallowing, treatment with this medicine must be discontinued and immediate medical advice sought. Your doctor may prescribe medication to treat the allergic reaction and another medicine to manage diabetes.

In some patients, the following adverse reactions occurred when sitagliptin was added to metformin:

Frequent (may affect up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting
Not frequent (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness

In some patients, various gastrointestinal symptoms occurred after starting treatment with sitagliptin in combination with metformin (frequent).

In some patients, the following adverse reactions occurred during treatment with sitagliptin in combination with a sulfonylurea and metformin:

Very frequent (may affect more than 1 in 10 people): low blood sugar levels
Frequent: constipation

In some patients, the following adverse reactions occurred during treatment with sitagliptin and pioglitazone:

Frequent: bloating, swelling of hands or feet

In some patients, the following adverse reactions occurred during treatment with sitagliptin in combination with pioglitazone and metformin:

Frequent: swelling of hands or feet

In some patients, the following adverse reactions occurred during treatment with sitagliptin in combination with insulin (with or without metformin):

Frequent: influenza-like illness
Not frequent: dry mouth

In some patients, the following adverse reactions occurred during clinical trials with sitagliptin used alone, or after marketing authorization when used alone or in combination with other antidiabetic medicines:

Frequent: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion or runny nose and sore throat, bone and joint inflammation, pain in arms or legs
Not frequent: dizziness, constipation, itching
Rare: decreased platelet count
Frequency not known: kidney disorders (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sitagliptin Grindeks

Keep this medicine out of sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the blister and carton after:
"EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This 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 hydrochloride monohydrate equivalent to 25 mg, 50 mg or 100 mg of sitagliptin.
• Other ingredients:
  Tablet core: Microcrystalline cellulose (E 460), Calcium hydrogen phosphate (E 341), Sodium croscarmellose (E 468), Sodium stearyl fumarate (E 485), Magnesium stearate (E 572)
  Coating:
  Tablet 25 mg: Polyethylene glycol (E 1209) – grafted copolymer of polyethylene glycol and poly(vinyl alcohol), Talc (E 553b), Titanium dioxide (E 171), Glycerol monocaprylocaprate (type 1) (E 471), Polyvinyl alcohol (E 1203), Iron oxide yellow (E 172), Iron oxide black (E 172)
  Tablet 50 mg: Polyethylene glycol (E 1209) – grafted copolymer of polyethylene glycol and poly(vinyl alcohol), Talc (E 553b), Titanium dioxide (E 171), Glycerol monocaprylocaprate (type 1) (E 471), Polyvinyl alcohol (E 1203), Iron oxide yellow (E 172)
  Tablet 100 mg: Polyethylene glycol (E 1209) – grafted copolymer of polyethylene glycol and poly(vinyl alcohol), Talc (E 553b), Titanium dioxide (E 171), Glycerol monocaprylocaprate (type 1) (E 471), Polyvinyl alcohol (E 1203), Iron oxide yellow (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 the imprint “25” on one side. The tablet diameter is approximately 6.0 mm.
Sitagliptin Grindeks 50 mg, film-coated tablets: yellow, round, biconvex film-coated tablet with the imprint “50” on one side and a score line on the other side. The tablet diameter is approximately 8.0 mm.
Sitagliptin Grindeks 100 mg, film-coated tablets: yellow, round, biconvex film-coated tablet with the imprint “100” on one side and a score line on the other side. The tablet diameter is approximately 10.0 mm.
Sitagliptin Grindeks 25 mg, 50 mg and 100 mg are available in blister packs containing 28, 56 or 98 film-coated tablets in a cardboard carton.
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 countries 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 comprimés pelliculés
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 filmom obložene tablete
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, comprimé pelliculé / SITAGLIPTINE GRINDEKS 50 mg, comprimé pelliculé / SITAGLIPTINE GRINDEKS 100 mg, comprimé pelliculé
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
Northern Ireland: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets