Sitagliptin+metformin Hcl Medical Vallei

Leaflet accompanying the packaging: patient information

Sitagliptin+Metformin HCL Medical Valley, 50 mg + 850 mg, film-coated tablets

Sitagliptin+Metformin HCL Medical Valley, 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 that 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 as yours.
• 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 HCL Medical Valley and what is it used for
• 2. Important information before taking Sitagliptin+Metformin HCL Medical Valley
• 3. How to take Sitagliptin+Metformin HCL Medical Valley
• 4. Possible side effects
• 5. How to store Sitagliptin+Metformin HCL Medical Valley
• 6. Contents of the packaging and other information

1. What is Sitagliptin+Metformin HCL Medical Valley and what is it used for

Sitagliptin+Metformin HCL Medical Valley 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, used in conjunction with diet and exercise, helps to reduce blood sugar levels. This medicine can 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 as it should. 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 HCL Medical Valley

When not to take Sitagliptin+Metformin HCL Medical Valley

You should not take Sitagliptin+Metformin HCL Medical Valley if you have any of the above contraindications. You should consult a doctor to determine other methods of controlling diabetes. If in doubt, before taking Sitagliptin+Metformin HCL Medical Valley, you should discuss it with your doctor, pharmacist, or nurse.

Warnings and precautions

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

Risk of lactic acidosis

Sitagliptin+Metformin HCL Medical Valley 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 the case of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any conditions in which part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease). If any of the above situations apply to the patient, they should consult their doctor for more detailed instructions.

You should contact your doctor immediately for further instructions if:

• the patient has a genetically inherited disease affecting 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). If the patient experiences any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

You should temporarily stop taking Sitagliptin+Metformin HCL Medical Valley if

the patient has a condition that may be associated with dehydration(significant water loss from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. You should consult your doctor for more detailed instructions.

You should stop taking Sitagliptin+Metformin HCL Medical Valley and contact your doctor or the nearest hospital immediately 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 severe fatigue
• breathing difficulties
• decreased body temperature and slowed heart rate

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. Before taking Sitagliptin+Metformin HCL Medical Valley, you should discuss it with your doctor or pharmacist:

If the patient is to undergo major surgery, they should not take Sitagliptin+Metformin HCL Medical Valley during the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Sitagliptin+Metformin HCL Medical Valley. If in doubt, before taking Sitagliptin+Metformin HCL Medical Valley, you should discuss it with your doctor or pharmacist. During treatment with Sitagliptin+Metformin HCL Medical Valley, 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 between 10 and 17 years of age. It is not known whether this medicine is safe and effective when used in children under 10 years of age.

Sitagliptin+Metformin HCL Medical Valley and other medicines

If the patient is to be injected with a contrast medium containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Sitagliptin+Metformin HCL Medical Valley before or, at the latest, at the time of such injection. The doctor will decide when the patient should stop and resume treatment with Sitagliptin+Metformin HCL Medical Valley. You should tell your 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. The patient may need more frequent blood sugar checks and kidney function tests or dose adjustments of Sitagliptin+Metformin HCL Medical Valley by the doctor. It is especially important to inform about the following medicines:

• medicines (taken orally, by inhalation, or by injection) 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 media containing iodine or medicines containing alcohol
• certain medicines used to treat stomach disorders, 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 certain type of thyroid cancer (medullary thyroid cancer)
• digoxin (used to treat heart rhythm disorders and other heart conditions). When taking Sitagliptin+Metformin HCL Medical Valley with digoxin, the digoxin blood level should be monitored.

Sitagliptin+Metformin HCL Medical Valley with alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Sitagliptin+Metformin HCL Medical Valley, 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 taken during pregnancy or breastfeeding. See section 2, "When not to take Sitagliptin+Metformin HCL Medical Valley".

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, it should be taken into account that dizziness and drowsiness have been reported during sitagliptin treatment, 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. Sodium The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Sitagliptin+Metformin HCL Medical Valley

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

• You should take one tablet:
• twice a day, orally;
• with meals to reduce the likelihood of stomach upset.
• In order 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.

During treatment with this medicine, the patient should continue to follow the diet recommended by their doctor and pay attention to the uniform intake of carbohydrates throughout the day. It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Low blood sugar levels 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 HCL Medical Valley than recommended

If a higher dose of this medicine is taken than recommended, you should contact your doctor immediately. You should go to the hospital if symptoms of lactic acidosis occur, such as feeling cold or uncomfortable, severe nausea or vomiting, abdominal pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Sitagliptin+Metformin HCL Medical Valley

If a dose is missed, it should be taken as soon as possible. If it is almost time for the next dose, the missed dose should be skipped and the medicine should be continued according to the usual schedule. A double dose of this medicine should not be taken.

Stopping treatment with Sitagliptin+Metformin HCL Medical Valley

In order to maintain control of blood sugar levels, the medicine should be taken for as long as prescribed by the doctor. The patient should not stop taking this medicine without consulting their doctor first. Stopping treatment with Sitagliptin+Metformin HCL Medical Valley may lead to increased blood sugar levels. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should STOPtaking Sitagliptin+Metformin HCL Medical Valley and contact your doctor immediately if you 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 HCL Medical Valley may very rarely cause (may occur in less than 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, you should stop taking Sitagliptin+Metformin HCL Medical Valley and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. In the 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, you should stop taking the medicine and contact your doctor immediately. The doctor may prescribe a medicine to treat the allergic reaction and another medicine (change the medicine) to treat diabetes. Some patients taking metformin after starting sitagliptin experienced the following side effects: Common (may occur in less than 1 in 10 people): low blood sugar, nausea, bloating, vomiting Uncommon (may occur in less than 1 in 100 people): abdominal pain, diarrhea, constipation, drowsiness Some patients experienced diarrhea, nausea, bloating, constipation, abdominal pain, or vomiting after starting sitagliptin treatment with metformin (common). Some patients taking this medicine with a sulfonylurea derivative, such as glimepiride, experienced the following side effects: Very common (may occur in more than 1 in 10 people): low blood sugar Common: constipation Some patients taking this medicine with pioglitazone experienced the following side effects: Common: swelling of the hands or feet Some patients taking this medicine with insulin experienced the following side effects: Very common: low blood sugar Uncommon: dry mouth, headache In clinical trials, some patients taking sitagliptin (one of the active substances of Sitagliptin+Metformin HCL Medical Valley) alone or in combination with metformin or other anti-diabetic medicines experienced the following side effects: Common: low blood sugar, headache, upper respiratory tract infection, stuffy nose or runny nose and sore throat, joint or muscle pain 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 (a type of blistering skin condition) Some patients taking metformin alone experienced the following side effects: Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear. Common: metallic taste, reduced or low vitamin B levels in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, or numbness or pale or yellowish skin). The doctor may order several tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other, non-diabetes-related health disorders. Very rare: liver inflammation (liver disease), hives, skin redness (rash), or itching

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products. Al. Jerozolimskie 181 C, 02-222 Warsaw Tel.: +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, you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin+Metformin HCL Medical Valley

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 and carton after "Expiry date (EXP)". The expiry date refers to the last day of the month. Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Sitagliptin+Metformin HCL Medical Valley contains

• The active substances are sitagliptin and metformin. Each film-coated tablet of Sitagliptin+Metformin HCL Medical Valley 50 mg + 850 mg contains sitagliptin phosphate, equivalent to 50 mg of sitagliptin, and 850 mg of metformin hydrochloride. Each film-coated tablet of Sitagliptin+Metformin HCL Medical Valley 50 mg + 1000 mg contains sitagliptin phosphate, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride.
• Other ingredients are: Tablet core:microcrystalline cellulose, povidone (K29/32), sodium lauryl sulfate, and magnesium stearate. Tablet coating(50 mg+850 mg): polyvinyl alcohol, partially hydrolyzed, copolymer of macrogol and polyvinyl alcohol, talc, titanium dioxide (E 171), mono- and diglycerides of fatty acids (GMDCC, GMCC), red iron oxide (E 172).

Tablet coating(50 mg+1000 mg): polyvinyl alcohol, partially hydrolyzed, copolymer of macrogol and polyvinyl alcohol, talc, titanium dioxide (E 171), mono- and diglycerides of fatty acids (GMDCC, GMCC), red iron oxide (E 172), and black iron oxide (E 172).

What Sitagliptin+Metformin HCL Medical Valley looks like and contents of the pack

Sitagliptin+Metformin HCL Medical Valley 50 mg + 850 mg is a pink, oval, biconvex film-coated tablet with dimensions of approximately 20.5 mm x 9.5 mm, with the inscription "S476" on one side and smooth on the other. Sitagliptin+Metformin HCL Medical Valley 50 mg + 1000 mg is a brown, oval, biconvex film-coated tablet with dimensions of approximately 21.5 mm x 10 mm, with the inscription "S477" on one side and smooth on the other. Sitagliptin+Metformin HCL Medical Valley is packaged in non-transparent PVC/PVdC-Aluminum blisters. The packaging contains 56 film-coated tablets in a cardboard box.

Marketing authorization holder

Medical Valley Invest AB Brädgårdsvägen 28 236 32 Höllviken Sweden email: [email protected]

Manufacturer/Importer

Laboratorios Liconsa, S.A. Polígono Industrial Miralcampo, Avda. Miralcampo, 7 19200 Azuqueca de Henares – Guadalajara Spain

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

Denmark: Sitagliptin/Metforminhydrochlorid Medical Valley Netherlands: Sitagliptine/Metformine Xiromed 50/850 mg filmomhulde tabletten Sitagliptine/Metformine Xiromed 50/1000 mg filmomhulde tabletten Iceland: Sitagliptin/Metformin Medical Valley 50 mg/850 mg filmuhúðaðar töflur Sitagliptin/Metformin Medical Valley 50 mg/1000 mg filmuhúðaðar töflur Germany: Sitagliptin/Metformin AXiromed 50 mg/850 mg Filmtabletten Sitagliptin/Metformin AXiromed 50 mg/1000 mg Filmtabletten Norway: Sitagliptin/Metformin Medical Valley Poland Sitagliptin+Metformin HCL Medical Valley Sweden: Sitagliptin/Metformin Medical Valley 50 mg/850 mg filmdragerade tabletter Sitagliptin/Metformin Medical Valley 50 mg/1000 mg filmdragerade tabletter Date of last revision of the leaflet:03/2025