Sitagliptin/metformin Grindex 50 mg/850 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sitagliptina/Metformina Grindeks 50 mg/850 mg film-coated tablets EFG

Sitagliptina/Metformina Grindeks 50 mg/1,000 mg film-coated tablets EFG

sitagliptin/metformin hydrochloride

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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you get any side effects, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Sitagliptina/Metformina Grindeks and what is it used for?

Sitagliptina/Metformina Grindeks contains two different medicines called sitagliptin and metformin.

• Sitagliptin belongs to a class of medicines known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a class of medicines known as biguanides.

Together, they work to control blood sugar levels in adult patients with a form of diabetes called "type 2 diabetes mellitus." This medicine helps increase the levels of insulin produced after a meal and reduces the amount of sugar produced by your body.

Along with diet and exercise, this medicine helps lower your blood sugar level. It can be used alone or in combination with certain other diabetes medicines (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin, and the insulin your body does produce 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 lead to serious medical problems, such as heart disease, kidney disease, blindness, and amputations.

2. What you need to know before starting to take Sitagliptin/Metformin Grindeks

Do not take Sitagliptin/Metformin Grindeks

• if you are allergic to sitagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6).
• if you have severely reduced kidney function.
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood glucose), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below), or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” build up in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or a fruity-smelling breath.
• if you have a serious infection or are dehydrated.
• if you are undergoing an X-ray procedure requiring injection of a contrast agent. You will need to stop taking Sitagliptin/Metformin Grindeks at the time of the scan and for 2 or more days afterwards, as directed by your doctor, depending on how well your kidneys are functioning.
• if you have recently had a heart attack or have serious circulatory problems, such as “shock” or difficulty breathing.
• if you have liver problems (hepatic).
• if you drink excessive amounts of alcohol (either daily or occasionally).
• if you are breastfeeding.

Do not take this medicine if any of the above apply to you, and consult your doctor about other ways to manage your diabetes. If you are unsure, consult your doctor, pharmacist, or nurse before starting this medicine.

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with this medicine (see section 4).

If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptin/Metformin Grindeks.

Risk of lactic acidosis

This medicine may cause a very rare but serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, serious infections, prolonged fasting, alcohol consumption, dehydration (see further information below), liver problems, and any medical condition in which part of the body receives reduced oxygen supply (such as acute and severe heart conditions).

If any of the above apply to you, consult your doctor for further instructions.

Contact your doctor immediately for advice if:

• You are known to have a genetic mitochondrial disorder (components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: seizures, cognitive decline, movement difficulties, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Stop taking Sitagliptin/Metformin Grindeks temporarily if you develop an illness that could lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

Stop taking Sitagliptin/Metformin Grindeks and contact a doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort with severe fatigue
• difficulty breathing
• reduced body temperature and reduced heart rate

Lactic acidosis is a medical emergency and must be treated in a hospital.

Consult your doctor or pharmacist before starting this medicine:

• if you have or have had a pancreatic disease (such as pancreatitis).
• if you have or have had gallstones, alcohol addiction, or very high blood levels of triglycerides (a type of fat). These medical conditions may increase your risk of developing pancreatitis (see section 4).
• if you have type 1 diabetes. This condition may also be called insulin-dependent diabetes.
• if you have had or develop an allergic reaction to sitagliptin, metformin, or this medicine (see section 4).
• if you are taking a sulfonylurea or insulin, or other diabetes medicines along with this medicine, as you may experience low blood sugar levels (hypoglycemia). Your doctor may need to reduce the dose of the sulfonylurea or insulin you are taking.

If you need to undergo major surgery, you must stop taking this medicine during the procedure and for some time afterwards. Your doctor will decide when to interrupt and when to restart treatment with this medicine.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before starting this medicine.

During treatment with this medicine, your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function is worsening.

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 unknown whether this medicine is safe and effective in children under 10 years of age.

Other medicines and Sitagliptin/Metformin Grindeks

If you need to receive an injection of an iodine-containing contrast agent into your bloodstream, for example during an X-ray or scan, you must stop taking this medicine before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with this medicine.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of this medicine. It is especially important to mention the following:

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory conditions such as asthma and arthritis (corticosteroids)
• medicines that increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific medicines for bronchial asthma (β-sympathomimetics)
• iodinated contrast agents or medicines containing alcohol
• certain medicines used to treat stomach problems such as cimetidine
• ranolazine, a medicine used to treat angina pectoris
• dolutegravir, a medicine used to treat HIV infection
• vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid cancer)
• digoxin (to treat irregular heartbeat and other heart problems). Blood levels of digoxin may need to be monitored if you are taking this medicine.

Taking Sitagliptin/Metformin Grindeks with alcohol

Avoid excessive alcohol consumption while taking Sitagliptin/Metformin Grindeks, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Do not take this medicine during pregnancy or while breastfeeding. See section 2, Do not take Sitagliptin/Metformin Grindeks.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is negligible or minor. However, dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect your ability to drive and operate machinery.

Taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycemia, which may impair your ability to drive and use machines or work without secure support.

Sitagliptin/Metformin Grindeks contains sodium

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

3. How to take Sitagliptina/Metformina Grindeks

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

• Take one tablet:

  • twice daily, orally
  • with food to reduce the likelihood of stomach discomfort

• Your doctor may need to increase the dose to control your blood sugar levels.

• If you have reduced kidney function, your doctor may prescribe you a lower dose.

You should continue following the diet recommended by your doctor during treatment with this medicine and take care to evenly distribute carbohydrate intake throughout the day.

It is unlikely that treatment with this medicine alone will cause abnormally low blood sugar (hypoglycaemia). Low blood sugar may occur when this medicine is taken together with a medicine containing a sulphonylurea or with insulin; therefore, your doctor may consider it necessary to reduce the dose of your sulphonylurea or insulin.

If you take more Sitagliptina/Metformina Grindeks than you should

If you take more than the prescribed dose of this medicine, contact your doctor immediately. Go to the hospital if you experience symptoms of lactic acidosis such as feeling cold or unwell, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see section “Warnings and precautions”).

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

If you forget to take Sitagliptina/Metformina Grindeks

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

If you stop taking Sitagliptina/Metformina Grindeks

Keep taking this medicine for as long as your doctor prescribes it, to help control your blood sugar levels. You should not stop taking this medicine without first consulting your doctor. If you stop treatment with this medicine, your blood sugar levels may rise again.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

STOP taking this medicine and contact your doctor immediately if you notice any of the following serious adverse effects:

• Severe and persistent pain in the abdomen (stomach area), which may extend to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

This medicine may very rarely (may affect up to 1 in 10,000 people) cause a very serious adverse effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Sitagliptina/Metformina Grindeks and contact a doctor or go to the nearest hospital immediately, as lactic acidosis can lead to coma.

If you have a severe allergic reaction (frequency not known), including skin rash, hives, skin blistering/skin peeling, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor will prescribe treatment for the allergic reaction and switch you to another medicine for diabetes.

Some patients taking metformin have experienced the following adverse effects after starting treatment with sitagliptin:

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

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

Some patients have experienced diarrhoea, nausea, flatulence, constipation, stomach pain, or vomiting when starting treatment with the combination of sitagliptin and metformin (frequency classified as frequent).

Some patients have experienced the following adverse effects when taking this medicine in combination with a sulfonylurea such as glimepiride:

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

Some patients experienced the following adverse effects while taking this medicine in combination with pioglitazone:

Frequent: swelling of hands or legs

Some patients experienced the following adverse effects while taking this medicine in combination with insulin:

Very common: low blood sugar levels
Uncommon: dry mouth, headache

Some patients experienced the following adverse effects during clinical studies while taking sitagliptin alone (one of the medicines contained in this medicine) or during post-marketing use of this medicine or sitagliptin alone or in combination with other antidiabetic medicines:

Frequent: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or runny nose, sore throat, osteoarthritis, arm or leg pain
Uncommon: dizziness, constipation, itching
Rare: reduction in platelet count
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin rash)

Some patients have experienced the following adverse effects after taking metformin alone:

Very common: nausea, vomiting, diarrhoea, stomach pain, and loss of appetite. These symptoms may occur when you first start taking metformin and usually resolve over time.

Frequent: metallic taste, decreased or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling (paraesthesia), or pale or yellowish skin). Your doctor may order tests to determine the cause of your symptoms, as some of these may also be caused by diabetes or other unrelated health conditions.

Very rare: hepatitis (a liver problem), urticaria, skin redness (rash), or itching

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin/Metformin Grindeks

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the blister and on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly discard medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin/Metformin Grindeks

• The active substances are sitagliptin and metformin hydrochloride.

• Sitagliptin/Metformin Grindeks 50 mg/850 mg film-coated tablets:

Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.

• Sitagliptin/Metformin Grindeks 50 mg/1.000 mg film-coated tablets:

Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1.000 mg of metformin hydrochloride.

• Other components are:

Tablet core: povidone, sodium lauryl sulfate, microcrystalline cellulose, sodium fumarate stearate.

Film coating:

Tablets 50 mg/850 mg:

Glycol graft copolymer polyvinyl alcohol polyethylene (E-1209)

Talc (E-553b)

Titanium dioxide (E-171)

Mono- and diglycerides of fatty acids (E-471)

Polyvinyl alcohol (E-1203)

Yellow iron oxide (E-172)

Red iron oxide (E-172)

Tablets 50 mg/1.000 mg:

Glycol graft copolymer polyvinyl alcohol polyethylene (E-1209)

Talc (E-553b)

Titanium dioxide (E-171)

Mono- and diglycerides of fatty acids (E-471)

Polyvinyl alcohol (E-1203)

Red iron oxide (E-172)

Yellow iron oxide (E-172)

Black iron oxide (E-172)

Appearance of the product and contents of the pack

• Sitagliptin/Metformin Grindeks 50 mg/850 mg film-coated tablets are orange, oval-shaped, biconvex, film-coated tablets with the imprint «SM85» on one side. The tablet size is approximately 20 mm × 6.7 mm.
• Sitagliptin/Metformin Grindeks 50 mg/1.000 mg film-coated tablets are brown, oval-shaped, biconvex, film-coated tablets with the imprint «SM100» on one side. The tablet size is approximately 21 mm × 7.2 mm.

Sitagliptin/Metformin Grindeks is available in blister packs containing 28, 56, 98 film-coated tablets or in multiple packs containing 196 (2 packs of 98) film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS GRINDEKS
Krustpils iela 53
Riga, LV-1057
Latvia
Telephone: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

Further information about this medicinal product is available upon request to the local representative of the Marketing Authorization Holder

Grindeks Kalceks España, S.L.
C/ José Abascal, 58 – 2º Dcha.
Madrid, 28003, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: April 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)