Sitagliptin/metformin Viatris Pharmaceuticals 50 mg/1,000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sitagliptina/Metformina Viatris Pharmaceuticals 50mg/850mg film-coated tablets EFG

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

sitagliptin/metformin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Sitagliptina/Metformina Viatris Pharmaceuticals is and what it is used for

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

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

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

Together with diet and exercise, this medicine helps you lower your blood sugar level. This medicine may be used alone or in combination with certain 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 Viatris Pharmaceuticals

Do not take Sitagliptin/Metformin Viatris Pharmaceuticals

• 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 sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below), or ketoacidosis. Ketoacidosis is a disorder in which substances called “ketone bodies” accumulate in the blood, potentially leading to diabetic pre-coma. Symptoms include stomach pain, rapid deep breathing, drowsiness, or fruity-smelling breath

• if you have a serious infection or are dehydrated

• if you are undergoing a radiographic procedure requiring injection of contrast medium. You will need to stop taking Sitagliptin/Metformin Viatris Pharmaceuticals at the time of the scan and for 2 or more days afterwards, as directed by your doctor, depending on your kidney function

• 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 alcohol excessively (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 Sitagliptin/Metformin Viatris Pharmaceuticals.

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with sitagliptin/metformin (see section 4).

If you develop skin blisters, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking this medicine.

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 or alcohol intake, 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 serious heart conditions).

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

Stop taking Sitagliptin/Metformin Viatris Pharmaceuticals temporarily if you develop a condition that may be associated with 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 Viatris Pharmaceuticals 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 profound fatigue,
• difficulty breathing,
• decreased body temperature and 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 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 currently have an allergic reaction to sitagliptin, metformin, or Sitagliptin/Metformin Viatris Pharmaceuticals (see section 4),
• if you are taking a sulfonylurea or insulin, or other antidiabetic medicines along with this medicine, as you may experience low blood sugar levels (hypoglycemia). Your doctor may consider reducing the dose of your sulfonylurea or insulin.

If you require major surgery, you must stop taking this medicine during the procedure and for a period 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 conditions apply to you, consult your doctor or pharmacist before starting this medicine.

During treatment with Sitagliptin/Metformin Viatris Pharmaceuticals, 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 deteriorating.

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 when used in children under 10 years of age.

Other medicines and Sitagliptin/Metformin Viatris Pharmaceuticals

If you need to receive an intravenous injection of an iodine-containing contrast agent, 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 medicines. You may require more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Sitagliptin/Metformin Viatris Pharmaceuticals. It is especially important to mention the following:

• medicines (taken orally, inhaled, or injected) 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 Sitagliptin/Metformin Viatris Pharmaceuticals.

Taking Sitagliptin/Metformin Viatris Pharmaceuticals with alcohol

Avoid excessive alcohol consumption while taking this medicine, 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. You must not take this medicine during pregnancy. Do not take this medicine if you are breastfeeding. See section 2 “Do not take Sitagliptin/Metformin Viatris Pharmaceuticals”.

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 use machines.

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

Sitagliptin/Metformin Viatris Pharmaceuticals contains sodium

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

3. How to take Sitagliptina/Metformina Viatris Pharmaceuticals

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

• Take one tablet:

  • twice daily by mouth,
  • 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 must continue the diet recommended by your doctor during treatment with this medicine and ensure that carbohydrate intake is evenly distributed throughout the day.

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

If you take more Sitagliptina/Metformina Viatris Pharmaceuticals than you should

If you take more than the prescribed dose of this medicine, contact your doctor immediately. Go to 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”).

If you forget to take Sitagliptina/Metformina Viatris Pharmaceuticals

If you forget to take a dose, take it as soon as you remember. If you only remember at 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 Viatris Pharmaceuticals

Keep taking this medicine for as long as your doctor prescribes it, so that it can help you control your blood sugar levels. Do not stop taking this medicine without first consulting your doctor. If you stop treatment with Sitagliptina/Metformina Viatris Pharmaceuticals, your blood sugar levels may rise again.

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

4. Possible adverse effects

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

STOP taking Sitagliptina/Metformina Viatris Pharmaceuticals and contact your doctor immediately if you notice any of the following serious adverse effects:

• Severe and persistent pain in the abdomen (stomach area) that 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 cause a very rare (may affect up to 1 in 10,000 people), but very serious adverse effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Sitagliptina/Metformina Viatris Pharmaceuticals and contact a doctor or go to the nearest hospital immediately, as lactic acidosis can lead to coma.

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

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, gas, vomiting

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

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

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

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

Frequent: constipation

Some patients have experienced the following adverse effects when taking this medicine together with pioglitazone:

Frequent: swelling of hands or legs

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

Very frequent: 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 Sitagliptina/Metformina Viatris Pharmaceuticals) or during post-marketing use of Sitagliptina/Metformina Viatris Pharmaceuticals or sitagliptin alone or in combination with other diabetes 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 the number of platelets

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 condition)

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

Very frequent: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may occur when you first start taking metformin and usually go away.

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

Very rare: hepatitis (a liver problem), hives, redness of the skin (rash), or itching.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin/Metformin Viatris Pharmaceuticals

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

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.

Do not store above 30 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Punto Sigre collection point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptina/Metformina Viatris Pharmaceuticals

• The active substances are sitagliptin and metformin.
• Each film-coated tablet of Sitagliptina/Metformina Viatris Pharmaceuticals 50 mg/850 mg contains sitagliptin monohydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
• The active substances are sitagliptin and metformin. Each film-coated tablet of Sitagliptina/Metformina Viatris Pharmaceuticals 50 mg/1.000 mg contains sitagliptin monohydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1.000 mg of metformin hydrochloride.
• The other components are:

Tablet core: microcrystalline cellulose (Avicel PH 102), povidone, sodium lauryl sulfate and magnesium stearate;

Film coating of Sitagliptina/Metformina Viatris Pharmaceuticals 50 mg/850 mg (Opadry QX pink (321A640002)): polyethylene glycol (PEG) graft copolymer of polyvinyl alcohol (E1209); talc (E553b); titanium dioxide (E171); mono- and diglycerides of fatty acids (E471); polyvinyl alcohol (E1203); red iron oxide (E172);

Film coating of Sitagliptina/Metformina Viatris Pharmaceuticals 50 mg/1.000 mg (Opadry QX brown (321A265038)): polyethylene glycol (PEG) graft copolymer of polyvinyl alcohol (E1209); talc (E553b); titanium dioxide (E171); red iron oxide (E172); mono- and diglycerides of fatty acids (E471); polyvinyl alcohol (E1203); black iron oxide (E172).

Nature and contents of the container

Film-coated tablets of Sitagliptina/Metformina Viatris Pharmaceuticals 50 mg/850 mg are oval-shaped, biconvex, approximately 20.5 mm x 9.5 mm in size, pink in colour, with the imprint “S476” on one side and no imprint on the other.

Film-coated tablets of Sitagliptina/Metformina Viatris Pharmaceuticals 50 mg/1.000 mg are oval-shaped, biconvex, approximately 21.5 mm x 10.0 mm in size, brown in colour, with the imprint “S477” on one side and no imprint on the other.

The product may be packaged in a cardboard box.

PVC/PVdC and aluminium blisters.

Pack sizes of 14, 28, 56, 60 and 196 film-coated tablets.

HDPE bottle with PP cap containing silica gel desiccant.

Pack size: 196 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Laboratorios Liconsa S.A.

Avenida Miralcampo 7, Poligono Industrial Miralcampo,

19200 Azuqueca De Henares, Guadalajara,

Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Austria, Croatia, Estonia, Greece, Hungary, Latvia, Lithuania, Poland, Czech Republic, Slovak Republic, Romania: Jamesi

Spain: Sitagliptina/Metformina Viatris Pharmaceuticals

Bulgaria: ???????/Jamesi

Date of the most recent review of this summary: June 2024

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