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

• if the patient is allergic to sitagliptin or metformin, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has significantly reduced kidney function
• if the patient has uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odor from the mouth.
• if the patient has a severe infection or dehydration
• if the patient is scheduled to undergo a radiological examination with intravenous administration of a contrast agent. The patient should discontinue Sitagliptin+Metformin HCL Medical Valley during the radiological examination and for a period of 2 or more days, as recommended by the doctor, depending on the patient's kidney function
• if the patient has recently had a heart attack or has experienced severe circulatory disorders, such as shock or breathing difficulties
• if the patient has liver disease
• if the patient consumes excessive amounts of alcohol (either daily or from time to time),
• if the patient is breastfeeding

Do not take Sitagliptin+Metformin HCL Medical Valley if any of the above contraindications are present. Consult a doctor to determine other methods of controlling diabetes. In case of doubts, before taking Sitagliptin+Metformin HCL Medical Valley, discuss it with a doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking Sitagliptin+Metformin HCL Medical Valley, 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 discontinue 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 disease, and any conditions in which a part of the body is not adequately supplied with oxygen (e.g., acute severe heart disease). If any of the above situations apply to the patient, they should consult a doctor for more detailed instructions.

You should contact your doctor immediately 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, maternal inherited diabetes and deafness).

• the patient has experienced any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

You should temporarily discontinue Sitagliptin+Metformin HCL Medical Valley if

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

You should discontinue Sitagliptin+Metformin HCL Medical Valley and immediately contact a doctor or the nearest hospital if the patient experiences any of the following

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, accompanied by 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, the patient should discuss it with a doctor or pharmacist:

• if the patient has or has had pancreatitis (e.g., pancreatitis)
• if the patient has or has had gallstones, alcohol dependence, or very high triglyceride levels in the blood. In such cases, the risk of pancreatitis (see section 4) may increase
• if the patient has type 1 diabetes. It is sometimes called insulin-dependent diabetes
• if the patient has currently or has had allergic reactions to sitagliptin, metformin, or Sitagliptin+Metformin HCL Medical Valley (see section 4)
• if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Sitagliptin+Metformin HCL Medical Valley, as it may lead to excessively low blood sugar levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

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 must discontinue and resume treatment with Sitagliptin+Metformin HCL Medical Valley. In case of doubts, before taking Sitagliptin+Metformin HCL Medical Valley, the patient should discuss it with a 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 deteriorating kidney function.

Children and adolescents

This medicine should not be used in children and adolescents under the age of 18. This medicine is not effective in children and adolescents between 10 and 17 years old. It is not known whether this medicine is safe and effective when used in children under the age of 10.

Sitagliptin+Metformin HCL Medical Valley 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 discontinue Sitagliptin+Metformin HCL Medical Valley before or, at the latest, at the time of such injection. The doctor will decide when the patient must discontinue and resume treatment with Sitagliptin+Metformin HCL Medical Valley. 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 glucose monitoring and kidney function assessment or dose adjustment 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 diseases related to inflammation, 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 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 diseases). When taking Sitagliptin+Metformin HCL Medical Valley with digoxin, the patient's digoxin levels 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 a doctor or pharmacist before taking this medicine. This medicine should not be used 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, while driving and using machines, the patient should take 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 as directed by the doctor. In case of doubts, the patient should consult a 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 the diet recommended by the doctor and pay attention to the uniform intake of carbohydrates throughout the day. It is unlikely that the use of this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Low blood sugar levels may occur when this medicine is used 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

In case of taking a higher dose of this medicine than recommended, the patient should immediately contact a 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, abdominal pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Sitagliptin+Metformin HCL Medical Valley

In case of missing a dose, the patient 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 according to the usual schedule. The patient should not take a double dose of this medicine.

Discontinuing Sitagliptin+Metformin HCL Medical Valley

To maintain control of blood sugar levels, the medicine should be taken for as long as the doctor recommends. The patient should not stop taking this medicine without consulting a doctor first. Stopping Sitagliptin+Metformin HCL Medical Valley may lead to increased blood sugar levels. In case of any further doubts about taking this medicine, the patient should consult a 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 HCL Medical Valley and IMMEDIATELYcontact a 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 HCL Medical Valley may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to the patient, they should STOPtaking Sitagliptin+Metformin HCL Medical Valley and IMMEDIATELYcontact a 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 contact a doctor. 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 affect up to 1 in 10 people): low blood sugar, nausea, bloating, vomiting Uncommon (may affect up to 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 affect 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 after marketing authorization, when taking sitagliptin in combination with metformin or other anti-diabetic medicines, experienced the following side effects: Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose, 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 blisters (a type of blisters on the skin) 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, decreased or low vitamin B levels in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, or numbness). The doctor may order some 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 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 Drug Safety Monitoring of the 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, more information can be collected on the safety of the 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 stated. Do not store above 30°C. 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 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), iron oxide red (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), iron oxide red (E 172), and iron oxide black (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 imprint "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 imprint "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: safety@medicalvalley.se

  Manufacturer/Importer

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

  This medicine is authorized for use 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