Package Insert: Information for the User

Sitagliptin/Metformin Viso Pharmaceutical 50 mg/1,000 mg Film-Coated Tablets

sitagliptin/metformin hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Sitagliptina/Metformina Viso Farmacéutica contains two distinct medicines, called sitagliptin and metformin.

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

Along with a diet and exercise, this medicine helps to lower your blood sugar level. This medicine can be used alone or with certain diabetes medicines (insulin, sulfonylureas or thiazolidinediones).

What is type 2 diabetes?

Type 2 diabetes is a disease in which your body does not produce enough insulin and the insulin your body produces does not work as well as it should. Your body may also produce too much sugar.

When this occurs, sugar (glucose) accumulates in the blood. This can lead to serious medical problems, such as heart diseases (cardiac), kidney diseases (renal), blindness, and amputations.

Do not take Sitagliptina/Metformina Viso Farmacéutica

• if you are allergic to sitagliptin, metformin, or any of the other components of this medication (listed in section 6).
• if you have severe kidney function reduction.
• 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, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or if your breath develops an unusual fruity odor.
• if you have a severe infection or are dehydrated.
• if you are to undergo a radiography for which a contrast agent must be injected. You will need to stop taking Sitagliptina/Metformina at the time of the radiography and for 2 or more days afterwards, as instructed by your doctor, depending on the functioning of your kidneys.
• if you have recently had a heart attack or have severe circulatory problems, such as "shock" or difficulty breathing.
• if you have liver problems.
• if you drink excessive alcohol (whether daily or occasionally).
• if you are breastfeeding.

Do not take Sitagliptina/Metformina if any of the above circumstances apply to you and consult your doctor about other ways to control your diabetes. If you are unsure, consult your doctor, pharmacist, or nurse before starting to take this medication.

Warnings and precautions

Cases of pancreatitis have been reported in patients treated with Sitagliptina/Metformina (see section 4).

If you observe blisters on your skin, it may be a sign of a disease called bullous pemphigoid.

Your doctor may ask you to stop taking Sitagliptina/Metformina.

Risk of lactic acidosis

Sitagliptina/Metformina may cause a rare but serious side effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, alcohol consumption, dehydration (see below for more information), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart disease).

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

Stop taking Sitagliptina/Metformina Viso Farmacéutica for a short period of time if you have a condition that may be associated with dehydration(significant loss of body fluids) such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Consult your doctor for further instructions.

Stop taking sitagliptina/metformina viso farmacéutica and contact a doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

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

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

Consult your doctor or pharmacist before starting to take Sitagliptina/Metformina:

• if you have or have had pancreatitis
• if you have or have had gallstones, alcohol addiction, or have very high levels of triglycerides (a type of fat) in your blood. These medical conditions may increase your risk of developing pancreatitis (see section 4)
• if you have type 1 diabetes. This disease is also known as insulin-dependent diabetes
• if you have had an allergic reaction to sitagliptin, metformin, or Sitagliptina/Metformina: (see section 4)
• if you are taking a sulfonylurea or insulin at the same time as Sitagliptina/Metformina: because you may experience low blood sugar (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 should stop taking this medication while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment with Sitagliptina/Metformina and when to restart it.

If you are unsure whether you are affected by any of the above circumstances, consult your doctor or pharmacist before starting to take this medication.

During treatment with Sitagliptina/Metformina, your doctor will check your kidney function at least once a year or more frequently if you are an older person and/or if your kidney function is deteriorating.

Children and adolescents

Children and adolescents under 18 years old should not use this medication. It is not effective in children and adolescents aged 10 to 17 years. The safety and efficacy of this medication in children under 10 years old are unknown.

Other medications and Sitagliptina/Metformina Viso Farmacéutica

If you need to receive an injection of a contrast agent containing iodine, such as during a radiography or examination, you should stop taking Sitagliptina/Metformina before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with this medication and when to restart it.

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

• medications (taken orally, inhaled, or injected) used to treat inflammatory diseases, such as asthma and arthritis (corticosteroids)
• medications that increase urine production (diuretics)
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific medications used to treat asthma (β-adrenergic agonists)
• contrast agents containing iodine or medications containing alcohol
• certain medications used to treat stomach problems, such as cimetidine
• ranolazine, a medication used to treat angina pectoris
• dolutegravir, a medication used to treat HIV infection
• vandetanib, a medication used to treat a specific type of thyroid cancer (medullary thyroid cancer)
• digoxin (to treat irregular heartbeat and other heart problems). You may need to have your digoxin blood level checked if you are taking Sitagliptina/Metformina.

Taking Sitagliptina/Metformina Viso Farmacéutica with alcohol

Avoid excessive alcohol consumption while taking Sitagliptina/Metformina, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Do not take this medication during pregnancy. Do not take this medication if you are breastfeeding. See section 2, Do not take Sitagliptina/Metformina Viso Farmacéutica

Driving and operating machinery

The influence of this medication on your ability to drive and operate machinery is negligible or insignificant. However, cases of dizziness and somnolence with sitagliptin have been reported, which may affect your ability to drive and operate machinery.

Taking this medication with medications called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work without a secure support.

Sitagliptina/Metformina Viso Farmacéutica contains sodium

Sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• Take one tablet:
• • twice a day orally
  • with food to reduce the likelihood of stomach discomfort
• Your doctor may need to increase the dose to control blood sugar levels.
• If you have reduced renal function, your doctor may prescribe a lower dose.

You must continue with the diet recommended by your doctor during treatment with this medication and be careful to distribute carbohydrate intake evenly throughout the day.

It is unlikely that treatment with this medication alone will cause an abnormal drop in blood sugar (hypoglycemia). A drop in blood sugar may occur when this medication is taken with a sulfonylurea or insulin, so it is likely that your doctor will consider reducing the dose of your sulfonylurea or insulin.

If you take more Sitagliptina/Metformina Viso Farmacéutica than you should

If you take more than the prescribed dose of this medication, contact your doctor immediately. Go to the hospital if you have symptoms of lactic acidosis such as feeling cold or unwell, intense nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or agitated breathing (see "Warnings and precautions").

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sitagliptina/Metformina Viso Farmacéutica

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 treatment. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Sitagliptina/Metformina Viso Farmacéutica

Continue taking this medication as long as your doctor tells you to, to help control your blood sugar levels. Do not stop taking this medication without first consulting your doctor. If you stop treatment with Sitagliptina/Metformina, your blood sugar levels may increase again.

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

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

STOP taking Sitagliptina/Metformina and see your doctor immediately if you notice any of the following serious side effects:

Sitagliptina/Metformina can cause a rare but very serious side effect (affects up to 1 in 10,000 people), called lactic acidosis (see "Warnings and precautions"). If this happens to you,you must stop taking Sitagliptina/Metformina and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

If you have a severe allergic reaction (unknown frequency), including skin rash, urticaria, blisters on the skin/skin peeling, and swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and a different medicine for diabetes treatment.

Some patients taking metformin have experienced the following side effects after starting treatment with sitagliptina:

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

Infrequent (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 sitagliptina and metformina (frequency classified as frequent).

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

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

Frequent: constipation

Some patients presented the following side effects while taking this medicine in combination with pioglitazone:

Frequent: swelling of hands or feet

Some patients presented the following side effects while taking this medicine in combination with insulin:

Very frequent: low blood sugar

Infrequent: dry mouth, headache

Some patients have experienced the following side effects during clinical studies while taking sitagliptina alone (one of the medicines contained in Sitagliptina/Metformina) or during use after approval of Sitagliptina/Metformina or sitagliptina alone or with other diabetes medicines:

Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity, and throat pain, arthritis, arm or leg pain

Infrequent: dizziness, constipation, itching

Rare: platelet reduction

Unknown frequency: kidney problems (which sometimes require dialysis), vomiting, joint pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

Some patients have experienced the following side effects while taking metformin alone:

Very frequent: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may appear when you start taking metformin and usually disappear.

Frequent: metallic taste, decrease or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue (glossitis), tingling (paresthesia), or pale or yellowish skin). Your doctor may request tests to determine the cause of your symptoms because some of them may be caused by diabetes or other unrelated health problems.

Rare: hepatitis (liver problem), urticaria, skin redness (rash) or itching

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Sitagliptin/Metformin Viso Pharmaceutical

• The active principles are sitagliptin and metformin.

Sitagliptin/Metformin Viso Pharmaceutical 50 mg/1,000 mg film-coated tablets:Each tablet contains 50 mg of sitagliptin (as hydrochloride monohydrate) and 1,000 mg of metformin hydrochloride.

• The other components are:

Tablet core: microcrystalline cellulose, povidone (K29/32), sodium lauryl sulfate, and magnesium stearate.

Coating (50 mg/1000 mg):polyvinyl alcohol-polyethylene glycol graft copolymer,talc, titanium dioxide, iron oxide red, GMDCC (Glycerol Mono and dicapryl caprate), GMCC (Glycerol Monocapryl Caprate) Type 1, mono/diglycerides, glycerol, poly(vinyl alcohol), and iron oxide/iron oxide black.

Appearance of the product and contents of the package

Sitagliptin/Metformin Viso Pharmaceutical 50 mg/1,000 mg film-coated tablets: Film-coated, oval-shaped, biconvex tablets, approximately 21.5 mm x 10.0 mm, brown, with "S477" on one face and smooth on the other.

Sitagliptin/Metformin Viso Pharmaceutical 50 mg/1,000 mg film-coated tablets are packaged in

- Blister packs made of opaque PVC/PVdC-Aluminum in 14, 28, 30, 56, 60, 98, 196, and 210 tablets

- HDPE bottles with silica gel desiccant in the cap in 100 and 196 tablets

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible manufacturer:

LABORATORIOS LICONSA S.A.

Avda. Miralcampo, Nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Further information about this medicinal product can be obtained by contacting the local representative of the holder of the marketing authorization:

Viso Farmacéutica, S.L.U

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:August 2024

Further 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/.