SITAGLIPTIN GRINDEKS 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sitagliptina Grindeks 25mg film-coated tablets EFG

Sitagliptina Grindeks 50mg film-coated tablets EFG

Sitagliptina Grindeks 100mg film-coated tablets EFG

sitagliptin

Read all of this leaflet carefully before you start 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 signs of illness 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 pack

1. What is Sitagliptina Grindeks and what is it used for
2. What you need to know before you take Sitagliptina Grindeks
3. How to take Sitagliptina Grindeks
4. Possible side effects
5. Storage of Sitagliptina Grindeks
6. Contents of the pack and other information

1. What is Sitagliptina Grindeks and what is it used for

Sitagliptina 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 adult patients with type 2 diabetes mellitus.

This medicine helps to increase the amounts of insulin produced after a meal and decreases the amount of sugar produced by the body.

Your doctor has prescribed this medicine to help you reduce your blood sugar level, which is too high due to your type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas or glitazones) that reduce blood sugar levels, and which you may already be taking for your diabetes, together with diet and exercise.

What is type 2 diabetes?

Type 2 diabetes is a condition where your body does not produce enough insulin, and the insulin that your body produces does not work as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) builds up in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputations.

2. What you need to know before you take Sitagliptina Grindeks

Do not take Sitagliptina Grindeks

if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

There have been reports of pancreatitis (inflammation of the pancreas) in patients taking sitagliptin (see section 4).

If you notice blisters on your skin, it could be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptina Grindeks.

Tell your doctor if you have or have had:

• a disease of the pancreas (such as pancreatitis);
• gallstones, alcohol dependence or very high levels of triglycerides (a type of fat) in the blood. These conditions may increase the risk of developing pancreatitis (see section 4);
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes that causes high blood sugar levels, rapid weight loss, nausea or vomiting);
• any current or past kidney problems;
• an allergic reaction to Sitagliptina Grindeks (see section 4).

It is unlikely that this medicine will cause low blood sugar because it does not work when your blood sugar levels are low. However, when this medicine is used in combination with a sulfonylurea or insulin, low blood sugar (hypoglycemia) can occur. Your doctor may reduce the dose of sulfonylurea or insulin.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptina 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 heartbeats and other heart problems). It may be necessary to check the level of digoxin in your blood if you are taking Sitagliptina Grindeks.

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 if you are breastfeeding or plan to breastfeed.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.

Taking this medicine with the medicines called sulfonylureas or with insulin may cause low blood sugar, which may affect your ability to drive or use machines or work without a safe support.

Sitagliptina Grindeks contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet; this is essentially "sodium-free".

3. How to take Sitagliptina Grindeks

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is:

• one 100 mg film-coated tablet
• once a day
• by mouth

If you have kidney problems, your doctor may prescribe a lower dose (such as 25 mg or 50 mg).

You can take this medicine with or without food and drinks. The 50 mg and 100 mg film-coated tablets of Sitagliptina Grindeks have a score line on one side. The score line is only to help you break the tablet and make it easier to swallow; it does not divide the tablet into equal doses.

Your doctor may prescribe this medicine alone or with other medicines that also reduce blood sugar levels.

Diet and exercise may help your body use sugar better. It is important that you follow the diet and exercise recommended by your doctor while taking Sitagliptina Grindeks.

If you take more Sitagliptina Grindeks than you should

If you take more of this medicine than you should, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sitagliptina Grindeks

If you forget to take a dose, take it as soon as you remember. If you do not remember until the time of the next dose, then skip the missed dose and continue with your regular schedule. Do not take a double dose of this medicine.

If you stop taking Sitagliptina Grindeks

Continue to take this medicine as long as your doctor tells you to, so that you can continue to control your blood sugar level. Do not stop taking this medicine without first talking to your doctor.

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 Sitagliptina Grindeks and contact a doctor immediatelyif you notice any of the following serious side effects:

• Severe and persistent abdominal pain (in the stomach area) that may radiate to the back, with or without nausea and vomiting, as these may be signs of pancreatitis.

If you have a severe allergic reaction (frequency not known), including skin rash, urticaria, blisters on the skin/exfoliative skin conditions and swelling of the face, lips, tongue and throat that may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and change your treatment for diabetes.

Some patients experienced the following side effects after adding sitagliptin to their treatment with metformin:

Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting.

Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.

Some patients experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency classified as common).

Some patients experienced the following side effects while taking sitagliptin in combination with a sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar.

Common: constipation.

Some patients experienced the following side effects while taking sitagliptin and pioglitazone:

Common: flatulence, swelling of hands or feet.

Some patients experienced the following side effects while taking sitagliptin and pioglitazone and metformin:

Common: swelling of hands or feet.

Some patients experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):

Common: flu.

Uncommon: dry mouth.

Some patients experienced the following side effects while taking sitagliptin alone during clinical studies or after marketing authorization, alone and/or in combination with other diabetes medicines:

Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion and sore throat, arthrosis, pain in arms or legs.

Uncommon: dizziness, constipation, itching.

Rare: decreased number of platelets.

Frequency not known: kidney problems (which in some cases require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Vigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptina 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 carton after "EXP".

The expiry date is the last day of the month stated.

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

Composition of Sitagliptina Grindeks

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg, 50 mg or 100 mg of sitagliptin.

• The other ingredients are:

Core of the tablet: microcrystalline cellulose (E460), calcium hydrogen phosphate (E341), sodium croscarmellose (E468), sodium fumarate and stearate (E485), magnesium stearate (E572).

Coating of the tablet:

25 mg tablets:

graft copolymer of polyvinyl alcohol and polyethylene glycol (E1209)

talc (E553b)

titanium dioxide (E171)

glycerol monocaprylocaprate (type 1) (E471)

polyvinyl alcohol (E1203)

yellow iron oxide (E172)

black iron oxide (E172)

50 mg tablets:

graft copolymer of polyvinyl alcohol and polyethylene glycol (E1209)

talc (E553b)

titanium dioxide (E171)

glycerol monocaprylocaprate (type 1) (E471)

polyvinyl alcohol (E1203)

yellow iron oxide (E172)

100 mg tablets:

graft copolymer of polyvinyl alcohol and polyethylene glycol (E1209)

talc (E553b)

titanium dioxide (E171)

glycerol monocaprylocaprate (type 1) (E471)

polyvinyl alcohol (E1203)

yellow iron oxide (E172)

Appearance and packaging

Sitagliptina Grindeks 25 mg: the film-coated tablets are: round, biconvex, light yellow in color, with the marking "25" on one side. The tablet has a diameter of approximately 6.0 mm.

Sitagliptina Grindeks 50 mg: the film-coated tablets are: round, biconvex, yellow in color, with the marking "50" on one side and a score line on the other side. The tablet has a diameter of approximately 8.0 mm.

Sitagliptina Grindeks 100 mg: the film-coated tablets are: round, biconvex, yellow in color, with the marking "100" on one side and a score line on the other side. The tablet has a diameter of approximately 10.0 mm.

Sitagliptina Grindeks 25 mg, 50 mg and 100 mg are available in blister packs of 28, 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: +371 67083505

Email: grindeks@grindeks.lv

You can request more information about this medicine from the local representative of the marketing authorisation holder

Grindeks Kalceks España, S.L.

C/ José Abascal, 58 – 2º Dcha.

Madrid, 28003, Spain

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 film-coated tablets

Austria Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets

Belgium Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets

Bulgaria ??????????? ???????? 25 mg, 50 mg, 100 mg ????????? ????????

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 film-coated tablets

France SITAGLIPTINE GRINDEKS 25 mg, 50 mg, 100 mg film-coated tablets

Germany Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets

Greece Sitagliptin Grindeks 25 mg, 50 mg, 100 mg ???????????? ??????????? ????????

Hungary Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets

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 tablets

Lithuania Sitagliptin Grindeks 25 mg, 50 mg, 100 mg plevele dengtos tablets

Luxembourg Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets

Netherlands Sitagliptine Grindeks 25 mg, 50 mg, 100 mg film-coated tablets

Norway Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets

Poland Sitagliptin Grindeks

Portugal Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets

Romania Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets

Slovakia Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets

Slovenia Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets

Spain Sitagliptina Grindeks 25 mg, 50 mg, 100 mg film-coated tablets EFG

United Kingdom Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets

(Northern Ireland)

Date of last revision of this leaflet 12/2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)