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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sitagliptin/Metformin pensa 50 mg/1,000 mg film-coated tablets EFG

sitagliptin/metformin hydrochloride

Read all of this 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What is Sitagliptina/Metformina pensa and what is it used for?

Sitagliptina/Metformina pensa 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 levels. This medicine can 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 (cardiovascular) diseases, kidney (renal) diseases, blindness, and amputations.

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

Do not take Sitagliptin/Metformin pensa:

• if you are allergic to sitagliptin, to metformin, or to any of the other ingredients of this medicine (listed in section 6)
• if you have severely reduced kidney function
• if you have uncontrolled diabetes with, 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 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 a fruity odor on your breath
• if you have a serious infection or are dehydrated
• if you are scheduled for an X-ray where a contrast agent will be injected. You will need to stop taking sitagliptin/metformin at the time of the procedure and for 2 or more days afterward, as directed by your doctor, depending on how well your kidneys are functioning
• 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 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, speak with your doctor, pharmacist, or nurse before starting sitagliptin/metformin.

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 instruct you to stop taking this medicine.

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 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.

Contact your doctor immediately for guidance if:

• You are known to have a genetic mitochondrial disorder (components that produce energy inside 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, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Stop taking sitagliptin/metformin temporarily if you develop an illness that could lead to 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 and contact a doctor or go to 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 severe fatigue
• difficulty breathing
• lowered body temperature and reduced heart rate

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

Talk to your doctor or pharmacist before starting sitagliptin/metformin if:

• you have or have had a pancreatic disorder (such as pancreatitis)
• 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)
• you have type 1 diabetes. This condition may also be called insulin-dependent diabetes
• you have had or develop an allergic reaction to sitagliptin, metformin, or sitagliptin/metformin (see section 4)
• you are taking a sulfonylurea or insulin, other diabetes medications, along with sitagliptin/metformin, as you may experience low blood sugar levels (hypoglycemia). Your doctor may need to reduce the dose of your sulfonylurea or insulin.

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

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 declining.

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 pensa

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 sitagliptin/metformin.

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 your dose of sitagliptin/metformin. It is especially important to mention the following:

• medications (taken orally, by inhalation, or by injection) used to treat inflammatory conditions 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 for bronchial asthma (β-sympathomimetics)
• iodinated contrast agents 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). Blood levels of digoxin may need to be monitored if you are taking sitagliptin/metformin.

Taking Sitagliptin/Metformin pensa 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. You must not take this medicine during pregnancy or while breastfeeding. See section 2, Do not take Sitagliptin/Metformin pensa.

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 medications called sulfonylureas or with insulin may cause hypoglycemia, which could impair your ability to drive and use machines or work without secure support.

Sitagliptin/Metformin pensa contains sodium

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

3. How to take Sitagliptina/Metformina pensa

Follow exactly the dosage instructions given to you 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 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; therefore, your doctor may consider it necessary to reduce the dose of your sulphonylurea or insulin.

The tablet score line should not be used to split the tablet.

If you take more Sitagliptina/Metformina pensa 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").

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

If you forget to take Sitagliptina/Metformina pensa

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 of this medicine.

If you stop taking Sitagliptina/Metformina pensa

Keep taking this medicine for as long as your doctor prescribes it, to help control your blood sugar levels. Do not stop taking this medicine without first consulting your doctor. If you stop treatment with sitagliptina/metformina, your blood sugar levels 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), possibly radiating 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 (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 sitagliptin/metformin 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 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 will prescribe a medicine to treat the allergic reaction and switch you to 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 levels, nausea, flatulence, vomiting

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

Some patients have experienced diarrhoea, nausea, flatulence, 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

Common: constipation

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

Common: 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-approval use of sitagliptin/metformin 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, pain in the arm or leg

Uncommon: dizziness, constipation, itching

Rare (may affect up to 1 in 1,000 people): reduction in platelet count

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

Common: 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 these may also be caused by diabetes or other unrelated health conditions.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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. Conservation of Sitagliptin/Metformin pensa

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 after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are unsure, please 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 Sitagliptina/Metformina pensa

• The active substances are sitagliptin and metformin. Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.

• The other components (excipients) are: In the tablet core: povidone, microcrystalline cellulose PH 102, crospovidone, and stearoyl fumarate sodium. In addition, the film coating contains: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), red iron oxide (E172), and black iron oxide (E172).

Appearance of the product and contents of the pack

Sitagliptina/Metformina pensa 50 mg/1.000 mg film-coated tablets are oval-shaped, oblong, red to brown in colour, with a score mark in the middle showing the letters 'S' and 'B' on one side and a score mark on the other side.

The tablet has a diameter of 21.3 ± 0.5 mm.

PVC-PVDC/Aluminium blisters.

Pack sizes of 14 and 56 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

SAG MANUFACTURING S.L.U

Carretera Nacional I, Km 36

San Agustin de Guadalix 28750

Spain

OR

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona,

Spain

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

Spain: Sitagliptina/Metformina pensa 50 mg/1.000 mg film-coated tablets EFG

Portugal: Metformina + Sitagliptina toLife 1000 mg + 50 mg film-coated tablets

Italy: Sitagliptin e Metformina pensa 50 mg/1000 mg film-coated tablets

Malta: Sitagliptin/Metformin Galgenicum 50mg/1000mg film-coated tablets

Date of the most recent revision of this leaflet: 03/2025

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