Sitagliptina + Metformini hlorovodorek Reddi

Leaflet accompanying the packaging: patient information

Sitagliptin + Metformin hydrochloride Reddy, 50 mg + 850 mg, film-coated tablets

Sitagliptin + Metformin hydrochloride Reddy, 50 mg + 1000 mg, film-coated tablets

Sitagliptinum + Metformini hydrochloridum

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Sitagliptin + Metformin hydrochloride Reddy and what is it used for
• 2. Important information before taking Sitagliptin + Metformin hydrochloride Reddy
• 3. How to take Sitagliptin + Metformin hydrochloride Reddy
• 4. Possible side effects
• 5. How to store Sitagliptin + Metformin hydrochloride Reddy
• 6. Contents of the packaging and other information

1. What is Sitagliptin + Metformin hydrochloride Reddy and what is it used for

Sitagliptin + Metformin hydrochloride Reddy contains two different active substances called sitagliptin and metformin.

• Sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• Metformin belongs to a group of medicines called biguanides.

The combined action of these medicines leads to the normalization of blood sugar levels in adult patients with diabetes known as "type 2 diabetes". This medicine helps to increase the amount of insulin released after a meal and reduce the amount of sugar produced by the body. The medicine is used in combination with diet and exercise to reduce blood sugar levels. This medicine may be used as the only anti-diabetic medicine or in combination with certain other anti-diabetic medicines (insulin, sulfonylurea derivatives, or glitazones). What is type 2 diabetes? In type 2 diabetes, the body does not produce enough insulin, and the insulin produced does not work properly. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Sitagliptin + Metformin hydrochloride Reddy

When not to take Sitagliptin + Metformin hydrochloride Reddy

Lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis is a disease in which substances called ketone bodies accumulate in the blood and can lead to a diabetic pre-coma state. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odor from the mouth.

Do not take Sitagliptin + Metformin hydrochloride Reddy if any of the above contraindications occur. Consult a doctor to determine other methods of controlling diabetes. In case of doubts, before taking Sitagliptin + Metformin hydrochloride Reddy, consult a doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking Sitagliptin + Metformin hydrochloride Reddy, cases of pancreatitis (see section 4) have been reported. If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid blisters. The doctor may recommend that the patient stop taking Sitagliptin + Metformin hydrochloride Reddy.

Risk of lactic acidosis

Sitagliptin + Metformin hydrochloride Reddy may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney problems. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any conditions in which a part of the body is not adequately supplied with oxygen (e.g., severe heart disease). If any of the above situations apply to the patient, they should consult their doctor for more detailed instructions.

Temporarily discontinue use of Sitagliptin + Metformin hydrochloride Reddy,

(significant water loss), such as severe vomiting, diarrhea, fever, high temperature, or if the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

Stop taking Sitagliptin + Metformin hydrochloride Reddy and immediately contact a doctor or the nearest hospital if the patient experiences

any symptoms of lactic acidosis, as this condition can lead to coma. Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, along with extreme fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.

Immediately consult a doctor for further instructions if:

• the patient has a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• the patient experiences any of the following symptoms after starting metformin: seizures, worsening cognitive abilities, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Before taking Sitagliptin + Metformin hydrochloride Reddy, the patient should discuss the following with their doctor or pharmacist:

If the patient is to undergo major surgery, they should not take Sitagliptin + Metformin hydrochloride Reddy during the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Sitagliptin + Metformin hydrochloride Reddy. In case of doubts, before taking Sitagliptin + Metformin hydrochloride Reddy, the patient should consult their doctor or pharmacist. During treatment with Sitagliptin + Metformin hydrochloride Reddy, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and/or has worsening kidney function.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age. 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 when used in children under 10 years of age.

Sitagliptin + Metformin hydrochloride Reddy and other medicines

If the patient is to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Sitagliptin + Metformin hydrochloride Reddy before or at the latest at the time of injection. The doctor will decide when the patient should stop and resume treatment with Sitagliptin + Metformin hydrochloride Reddy. The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent blood sugar checks and kidney function tests or dose adjustments of Sitagliptin + Metformin hydrochloride Reddy by the doctor. It is especially important to inform about the following medicines:

• medicines (taken orally, inhaled, or injected) used to treat inflammatory diseases, such as asthma or 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 used to treat asthma (β-sympathomimetics),
• contrast agents containing iodine or medicines containing alcohol,
• certain medicines used to treat stomach disorders, such as cimetidine,
• ranolazine, a medicine used to treat angina,
• dolutegravir, a medicine used to treat HIV infection,
• vandetanib, a medicine used to treat a certain type of thyroid cancer (medullary thyroid cancer),
• digoxin (used to treat heart rhythm disorders and other heart diseases). When taking Sitagliptin + Metformin hydrochloride Reddy with digoxin, the patient's digoxin blood levels should be monitored.

Taking Sitagliptin + Metformin hydrochloride Reddy with alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Sitagliptin + Metformin hydrochloride Reddy, as it may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy. This medicine cannot be used during breastfeeding. See section 2, When not to take Sitagliptin + Metformin hydrochloride Reddy.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving and using machines, the patient should consider that dizziness and drowsiness have been reported when taking sitagliptin, which may affect the ability to drive and use machines. Taking this medicine with sulfonylurea derivatives or insulin may lead to hypoglycemia, which may affect the ability to drive and use machines or work without safe foot support.

Sitagliptin + Metformin hydrochloride Reddy contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially "sodium-free".

3. How to take Sitagliptin + Metformin hydrochloride Reddy

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

• The patient should take one tablet:
• twice a day, orally;
• with meals to reduce the likelihood of stomach upset.
• To control blood sugar levels, the doctor may increase the dose of the medicine.
• If the patient has kidney problems, the doctor may prescribe a lower dose.

While taking this medicine, the patient should continue to follow the diet recommended by their doctor and pay attention to evenly distributing carbohydrate intake throughout the day. It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Hypoglycemia may occur when taking this medicine with a sulfonylurea derivative or insulin - in such cases, the doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Sitagliptin + Metformin hydrochloride Reddy than recommended

In case of taking a higher dose of this medicine than recommended, the patient should immediately consult their doctor. The patient should go to the hospital if they experience symptoms of lactic acidosis, such as feeling cold or uncomfortable, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Sitagliptin + Metformin hydrochloride Reddy

If the patient misses a dose, they should take it as soon as possible. If it is almost time for the next dose, the patient should skip the missed dose and continue taking the medicine as usual. The patient should not take a double dose of this medicine.

Stopping treatment with Sitagliptin + Metformin hydrochloride Reddy

To maintain control of blood sugar levels, the patient should take the medicine for as long as prescribed by their doctor. The patient should not stop taking this medicine without consulting their doctor first. Stopping treatment with Sitagliptin + Metformin hydrochloride Reddy may lead to an increase in blood sugar levels. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The patient should STOPtaking Sitagliptin + Metformin hydrochloride Reddy and IMMEDIATELYconsult their doctor if they experience any of the following serious side effects:

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

Sitagliptin + Metformin hydrochloride Reddy may very rarely cause (may occur in up to 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should STOPtaking Sitagliptin + Metformin hydrochloride Reddy and IMMEDIATELYconsult their doctor or the nearest hospital, as lactic acidosis can lead to coma. 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, the patient should stop taking the medicine and immediately consult their doctor. The doctor may prescribe a medicine to treat the allergic reaction and another medicine (change the medicine) to treat diabetes. In some patients taking metformin after starting sitagliptin, the following side effects have occurred: Common (may occur in up to 1 in 10 patients): low blood sugar, nausea, bloating, vomiting Uncommon (may occur in up to 1 in 100 patients): stomach pain, diarrhea, constipation, drowsiness Some patients have experienced diarrhea, nausea, bloating, constipation, stomach pain, or vomiting after starting treatment with sitagliptin in combination with metformin (common). Some patients taking this medicine with a sulfonylurea derivative, such as glimepiride, have experienced the following side effects: Very common (may occur in more than 1 in 10 patients): low blood sugar Common: constipation Some patients taking this medicine with pioglitazone have experienced the following side effects: Common: swelling of the hands or feet Some patients taking this medicine with insulin have experienced the following side effects: Very common: low blood sugar Uncommon: dry mouth, headache In clinical trials, some patients taking only sitagliptin (one of the active substances of Sitagliptin + Metformin hydrochloride Reddy) or after marketing authorization of Sitagliptin + Metformin hydrochloride Reddy or sitagliptin alone or with other anti-diabetic medicines, have experienced the following side effects: Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose, and sore throat, osteoarthritis, pain in the arms or legs Uncommon: dizziness, constipation, itching Rare: decreased platelet count Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid blisters (a type of blisters on the skin) Some patients taking only metformin have experienced the following side effects: Very common: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear. Common: metallic taste, decreased or low vitamin B12 levels in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, or numbness or tingling). The doctor may order certain tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other unrelated health problems. Very rare: liver inflammation (liver disease), hives, skin redness (rash), or itching

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 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, more information can be collected on the safety of the medicine.

5. How to store Sitagliptin + Metformin hydrochloride Reddy

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister pack after "EXP" and on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the month stated. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sitagliptin + Metformin hydrochloride Reddy contains

• The active substances are sitagliptin and metformin.
• Sitagliptin + Metformin hydrochloride Reddy, 50 mg + 850 mg, film-coated tablets: Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
• Sitagliptin + Metformin hydrochloride Reddy, 50 mg + 1000 mg, film-coated tablets: Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
• Other ingredients are: Tablet core: povidone, sodium lauryl sulfate, microcrystalline cellulose, magnesium stearate Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171) Only for the 50 mg + 1000 mg dose, additionally: iron oxide red (E 172), iron oxide yellow (E 172).

What Sitagliptin + Metformin hydrochloride Reddy looks like and contents of the pack

Sitagliptin + Metformin hydrochloride Reddy, 50 mg + 850 mg, film-coated tablets are white, biconvex, oval tablets with the symbol "ǀ" embossed on one side and no embossing on the other side. Approximate tablet dimensions: 20 mm x 10 mm x 6 mm. Sitagliptin + Metformin hydrochloride Reddy, 50 mg + 1000 mg, film-coated tablets are brown, biconvex, oval tablets with the symbol "7" embossed on one side and no embossing on the other side. Approximate tablet dimensions: 21 mm x 10 mm x 7 mm. Packaging: blister pack with OPA/Aluminum/PVC/Aluminum foil in a cardboard box. Pack sizes: 56 and 196 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Reddy Holding GmbH Kobelweg 95 86156 Augsburg Germany Tel.: +49 821 74881 0

Manufacturer

Betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany Rual Laboratories SRL 313, Splaiul Unirii, Building H, 1st floor, sector 3 030138 Bucharest Romania Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park Paola PLA 3000 Malta

Importer:

Betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany Dr Reddy’s Laboratories Romania SRL 71-73 Nicolae Caramfil, 1st floor, sector 1, 014142 Bucharest Romania Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park Paola PLA 3000 Malta

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

Austria: Sitagliptin/Metforminhydrochlorid Reddy 50 mg/850 mg Filmtabletten Sitagliptin/Metforminhydrochlorid Reddy 50 mg/1000 mg Filmtabletten Czech Republic: Sitagliptin/Metformin Reddy Denmark: Sitagliptin/Metformin Reddy Finland: Sitagliptin/Metformin Reddy 50 mg/850 mg kalvopäällysteiset tabletit Sitagliptin/Metformin Reddy 50 mg/1000 mg kalvopäällysteiset tabletit France: SITAGLIPTINE/METFORMINE REDDY PHARMA 50 mg/850 mg, comprimé pelliculé SITAGLIPTINE/METFORMINE REDDY PHARMA 50 mg/1000 mg, comprimé pelliculé Spain: Sitagliptina/metformina Dr. Reddys 50 mg/850 mg comprimidos recubiertos con película EFG Sitagliptina/metformina Dr. Reddys 50 mg/1000 mg comprimidos recubiertos con película EFG Netherlands: Sitagliptine/Metformine hydrochloride Reddy 50 mg/850 mg filmomhulde tabletten Sitagliptine/Metformine hydrochloride Reddy 50 mg/1000 mg filmomhulde tabletten Germany: Sitagliptin/Metformin beta 50 mg/850 mg Filmtabletten Sitagliptin/Metformin beta 50 mg/1000 mg Filmtabletten Norway: Sitagliptin/Metformin Reddy Poland: Sytagliptyna + Metforminy chlorowodorek Reddy Romania: Sitagliptină/Metformin Dr. Reddy’s 50 mg/850 mg comprimate filmate Sitagliptină/Metformin Dr. Reddy’s 50 mg/1000 mg comprimate filmate Slovakia: Sitagliptin/Metformin Reddy 50 mg/850 mg filmom obalené tablety Sitagliptin/Metformin Reddy 50 mg/1000 mg filmom obalené tablety Sweden: Sitagliptin/Metformin Reddy 50 mg/850 mg filmdragerade tabletter Sitagliptin/Metformin Reddy 50 mg/1000 mg filmdragerade tabletter Italy: Sitagliptin e Metformina Dr. Reddy’s

Date of last revision of the leaflet: 02/2025