Sitagliptin/metformin Viso Farmaceutica 50 mg/850 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sitagliptina/Metformina Viso Farmacéutica 50 mg/850 mg film-coated tablets EFG

sitagliptin/metformin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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 effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What is Sitagliptin/Metformin Viso Farmacéutica and what is it used for?

Sitagliptin/Metformin Viso Farmacéutica contains two different medicines called sitagliptin and metformin.

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

They work together to control blood sugar levels in adult patients with a form 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.

Along with diet and exercise, this medicine helps lower your blood sugar level. This medicine may be used alone or in combination with certain other 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 (cardiovascular), kidney disease (renal), blindness, and amputations.

2. What you need to know before starting to take Sitagliptin/Metformin Viso Farmacéutica

Do not take Sitagliptin/Metformin Viso Farmacéutica

• 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 glucose), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below), or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” build up in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness, or unusual fruity odor on your breath.
• if you have a serious infection or are dehydrated.
• if you are undergoing an X-ray procedure requiring injection of a contrast agent. You will need to stop taking Sitagliptin/Metformin at the time of the scan and for 2 or more days afterward, as directed by your doctor, depending on how well your kidneys are functioning.
• if you recently had a heart attack or have serious circulatory problems, such as “shock” or difficulty breathing.
• if you have liver problems.
• if you drink alcohol excessively (either daily or occasionally).
• if you are breastfeeding.

Do not take Sitagliptin/Metformin 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 this medicine.

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 blisters on your skin, this may be a sign of a condition called bullous pemphigoid.

Your doctor may advise you to stop taking Sitagliptin/Metformin.

Risk of lactic acidosis

Sitagliptin/Metformin 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, alcohol consumption, dehydration (see further information below), liver problems, or any medical condition in which part of the body receives reduced oxygen supply (such as acute and serious heart diseases).

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

Contact your doctor immediately for guidance if:

• You are known to have a genetic mitochondrial disease (energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: seizures, cognitive decline, movement difficulties, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Temporarily stop taking Sitagliptin/Metformin Viso Farmacéutica if you develop an illness that may cause dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or reduced fluid intake. Consult your doctor for further instructions.

Stop taking Sitagliptin/Metformin Viso Farmacéutica and contact your doctor or 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 Sitagliptin/Metformin:

• if you have or have had a 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 develop an allergic reaction to sitagliptin, metformin, or Sitagliptin/Metformin (see section 4)
• if you are taking Sitagliptin/Metformin together with a sulfonylurea or insulin: because you may experience low blood sugar levels (hypoglycemia). Your doctor may consider reducing the dose of your sulfonylurea or insulin.

If you need to undergo major surgery, you must stop taking this medicine during the procedure and for some time afterward. Your doctor will decide when to interrupt and when to restart treatment with Sitagliptin/Metformin.

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, your doctor will monitor 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 must 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 in children under 10 years of age.

Other medicines and Sitagliptin/Metformin Viso Farmacéutica

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 Sitagliptin/Metformin 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. It is especially important to mention the following:

• medicines (taken orally, by inhalation, or injection) 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 (used to treat irregular heartbeat and other heart problems). Blood levels of digoxin may need to be monitored if you are taking Sitagliptin/Metformin.

Taking Sitagliptin/Metformin Viso Farmacéutica with alcohol

Avoid excessive alcohol consumption while taking Sitagliptin/Metformin, 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 are planning 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 Viso Farmacéutica.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is negligible or none. However, dizziness and drowsiness have been reported 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 impair your ability to drive and use machines or work at heights without secure support.

Sitagliptin/Metformin Viso Farmacéutica contains sodium

Sodium

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

3. How to take Sitagliptin/Metformin Viso Farmacéutica

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

• Take one tablet:
  • twice daily, 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 kidney function, your doctor may prescribe a lower dose.

You must continue the diet recommended by your doctor during treatment with this medicine and take care to evenly distribute carbohydrate intake throughout the day.

It is unlikely that treatment with this medicine alone will cause abnormally low blood sugar (hypoglycemia). Low blood sugar may occur when this medicine is taken together with a sulfonylurea or insulin; therefore, your doctor may consider it necessary to reduce the dose of your sulfonylurea or insulin.

If you take more Sitagliptin/Metformin Viso Farmacéutica than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Sitagliptin/Metformin Viso Farmacéutica

If you forget to take a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Sitagliptin/Metformin Viso Farmacéutica

Keep taking this medicine for as long as your doctor has instructed, so that it helps you control your blood sugar level. You should not stop taking this medicine without first consulting your doctor. If you stop treatment with Sitagliptin/Metformin, your blood sugar level may rise again.

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

4. Possible adverse effects

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

STOP taking Sitagliptin/Metformin 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).

Sitagliptin/Metformin may cause a very rare adverse effect (may affect up to 1 in 10,000 people), but very serious, called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Sitagliptin/Metformin and contact a doctor or go to the nearest hospital immediately, as lactic acidosis can lead to coma.

If you have a severe allergic reaction (frequency not known), including skin rash, hives, skin blisters/skin peeling, and swelling of the face, lips, tongue, and throat that may 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 the treatment of diabetes.

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 level, nausea, gas, vomiting

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

Some patients have experienced diarrhoea, 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 in combination with a sulfonylurea such as glimepiride:

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

Frequent: constipation

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

Frequent: swelling of hands or legs

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

Very common: 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 Sitagliptin/Metformin) or during post-marketing use of Sitagliptin/Metformin or sitagliptin alone or with other diabetes medicines:

Frequent: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or runny nose, sore throat, osteoarthritis, pain in arm or leg

Uncommon: dizziness, constipation, itching

Rare: reduction in the number of platelets

Frequency not known: kidney problems (which sometimes require 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 while taking metformin alone:

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

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

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

Reporting of adverse effects

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

5. Storage of Sitagliptin/Metformin Viso Farmacéutica

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 outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin/Metformin Viso Farmacéutica

• The active substances are sitagliptin and metformin.

Sitagliptin/Metformin Viso Farmacéutica 50 mg/850 mg film-coated tablets: Each tablet contains 50 mg of sitagliptin (as monohydrate hydrochloride) and 850 mg of metformin hydrochloride.

• The other components are:

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

Coating (50 mg/850 mg): PVA-PEG graft copolymer (E1209), talc, titanium dioxide, GMDCC (Glyceryl Mono and Dicapryl Caprate), GMCC (Glyceryl Monocapryl Caprate) Type 1, mono/diglycerides, glycerol, poly (vinyl alcohol), and red iron oxide.

Appearance of the product and pack contents

Sitagliptin/Metformin Viso Farmacéutica 50 mg/850 mg film-coated tablets: Oval-shaped, biconvex, film-coated tablets, approximately 20.5 mm x 9.5 mm, pink in colour, marked with "S476" on one side and smooth on the other.

Sitagliptin/Metformin Viso Farmacéutica 50 mg/850 mg film-coated tablets are packaged in:

• Opaque blisters composed of PVC/PVdC-Aluminum containing 14, 28, 30, 56, 60, 98, 196, and 210 tablets
• White HDPE bottles with silica gel desiccant in the cap containing 100 and 196 tablets

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturer:

LABORATORIOS LICONSA S.A.
Avda. Miralcampo, No. 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

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

Date of the most recent review of this leaflet: April 2025

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.