SITAGLIPTIN/METFORMIN PHARMATHEN 50 mg/850 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the user

Sitagliptin/Metformin Pharmathen 50 mg/850 mg film-coated tablets EFG

Sitagliptin/Metformin Pharmathen 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, you may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Sitagliptin/Metformin Pharmathen is and what it is used for

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

• Sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• Metformin belongs to a class of medicines called 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 the amount of insulin produced after a meal and reduces the amount of sugar produced by your body.

Together with diet and exercise, this medicine helps lower your blood sugar levels. This medicine can be used alone or with certain other diabetes medicines (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?

Type 2 diabetes is a condition where your body does not produce enough insulin and the insulin it 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 (cardiac) problems, kidney (renal) problems, blindness, and amputations.

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

Do not take Sitagliptin/Metformin Pharmathen

• if you are allergic to sitagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney problems
• if you have uncontrolled diabetes, with 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 condition where substances called “ketone bodies” build up in the blood, which can lead to a pre-diabetic coma. 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 going to have an X-ray where you will be injected with a contrast medium. You will need to stop taking sitagliptin/metformin at the time of the X-ray and for 2 or more days after, as directed by your doctor, depending on your kidney function
• if you have recently had a heart attack or have severe circulatory problems, such as “shock” or breathing difficulties
• if you have liver problems (hepatic problems)
• if you drink excessive amounts of alcohol (either every day or only occasionally)
• if you are breast-feeding.

Do not take sitagliptin/metformin if any of the above applies to you and consult your doctor about other ways to control your diabetes. If you are not sure, consult your doctor, pharmacist, or nurse before taking Sitagliptin/Metformin Pharmathen.

Warnings and precautions

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

If you notice blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptin/Metformin Pharmathen.

Risk of lactic acidosis

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

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

Stop taking sitagliptin/metformin for a short period if you have a condition that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. Consult your doctor for further instructions.

Stop taking sitagliptin/metformin 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
• reduction in body temperature and heart rate

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

Consult your doctor promptly to find out how to proceed if:

• You know you have a genetic disorder that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, 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: seizure, cognitive impairment, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and deafness.

Consult your doctor or pharmacist before taking Sitagliptin/Metformin Pharmathen:

• if you have or have had pancreatitis (inflammation of the pancreas)
• if you have or have had gallstones, alcohol dependence, 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 is also known as insulin-dependent diabetes
• if you have had an allergic reaction to sitagliptin, metformin, or Sitagliptin/Metformin Pharmathen (see section 4)
• if you are taking a sulfonylurea or insulin, other diabetes medicines, as you may experience low blood sugar levels (hypoglycemia). Your doctor may consider it necessary to reduce the dose of the sulfonylurea or insulin you are taking

If you need to undergo major surgery, you should stop taking sitagliptin/metformin during the procedure and for some time after. Your doctor will decide when you should stop taking sitagliptin/metformin and when you can restart it.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking Sitagliptin/Metformin Pharmathen.

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

Children and adolescents

Children and adolescents under 18 years should not use this medicine. It is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective when used in children under 10 years.

Other medicines and Sitagliptin/Metformin Pharmathen

If you need to be given an injection of a contrast medium that contains iodine, for example, in the context of an X-ray or scan, you should stop taking sitagliptin/metformin before the injection or at the time of the injection. Your doctor will decide when you should stop taking sitagliptin/metformin and when you can restart it.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may need 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, inhaled, or injected) used to treat diseases that cause inflammation, 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)
• medicines used to treat bronchial asthma (beta-sympathomimetics)
• iodinated contrast agents or medicines that contain 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 (for treating irregular heartbeat and other heart problems). Your doctor may need to check your digoxin levels if you are taking Sitagliptin/Metformin Pharmathen.

Taking Sitagliptin/Metformin Pharmathen with alcohol

Avoid excessive alcohol intake while taking sitagliptin/metformin, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy. Do not take this medicine if you are breast-feeding. See section 2, Do not take Sitagliptin/Metformin Pharmathen.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible or non-existent. However, there have been reports of dizziness and drowsiness during treatment with sitagliptin, which may affect your ability to drive or use machines.

Taking this medicine with sulfonylureas or insulin may cause low blood sugar levels (hypoglycemia), which may affect your ability to drive or use machines or work without a safe support.

Sitagliptin/Metformin Pharmathen contains sodium

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

3. How to take Sitagliptin/Metformin Pharmathen

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• Take one tablet:
• • twice a day by mouth
  • with food to reduce the chance of stomach upset

• Your doctor may need to increase the dose to control your blood sugar levels.

• If you have reduced kidney function, your doctor may prescribe a lower dose.

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

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

If you take more Sitagliptin/Metformin Pharmathen than you should

If you take more than the prescribed dose of this medicine, contact your doctor immediately. Go to the hospital if you have symptoms of lactic acidosis such as feeling cold or unwell, 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sitagliptin/Metformin Pharmathen

If you miss 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 schedule. Do not take a double dose of this medicine.

If you stop taking Sitagliptin/Metformin Pharmathen

Keep taking this medicine for as long as your doctor tells you to, so that it can help control your blood sugar levels. Do not stop taking this medicine without talking to your doctor first. If you stop taking sitagliptin/metformin, your blood sugar levels may increase again.

If you have any other 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 all people suffer from them.

STOP taking Sitagliptina/Metformina Pharmathen and go to the doctor immediately if you notice any of the following serious adverse effects:

adverse effects:

• Severe and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting, as these can be signs of pancreatitis (inflammation of the pancreas).

Sitagliptina/metformina 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 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 (frequency not known), including skin rash, hives, blisters on the skin/desquamation of the skin 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 will prescribe a medicine to treat the allergic reaction and change the medicine for the treatment of diabetes.

Some patients who took metformin have experienced the following adverse 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 adverse effects when taking this medicine along with a sulfonylurea such as glimepiride:

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

Frequent: constipation

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

Frequent: swelling of hands or feet

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

Very Frequent: low blood sugar levels

Infrequent: dry mouth, headache

Some patients have experienced the following adverse effects during clinical studies while taking sitagliptina alone (one of the medicines that contains Sitagliptina/Metformina Pharmathen) or during use after the approval of sitagliptina/metformina or sitagliptina alone or with other diabetes medicines:

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

Infrequent: dizziness, constipation, itching

Rare: reduction of platelet count

Frequency not known: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

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 appear when you start taking metformin and usually disappear

Frequent: metallic taste, decrease or low levels of vitamin B12 in blood (symptoms may include extreme fatigue, pain and redness of the tongue, tingling, or pale or yellowish skin). Your doctor may request tests to determine the cause of your symptoms because some of them can 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Sitagliptina/Metformina Pharmathen

Keep this medicine out of sight and reach of children.

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

PVC/PE/PVDC-Aluminum blisters: Store below 30°C

PVC/PCTFE-Aluminum blisters: This medicine does not require special storage conditions

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Sitagliptina/Metformina Pharmathen

• The active ingredients are sitagliptina and metformina.

• Each film-coated tablet of Sitagliptina/Metformina Pharmathen 50 mg/850 mg (tablet) contains sitagliptina hydrochloride monohydrate equivalent to 50 mg of sitagliptina and 850 mg of metformina hydrochloride.
• Each film-coated tablet of Sitagliptina/Metformina Pharmathen 50 mg/1,000 mg (tablet) contains sitagliptina hydrochloride monohydrate equivalent to 50 mg of sitagliptina and 1,000 mg of metformina hydrochloride.

• The other components are:

• Core of the tablet: microcrystalline cellulose, povidone, sodium croscarmellose, and sodium stearyl fumarate.
• Film coating: partially hydrolyzed poly(vinyl alcohol), macrogol, talc, titanium dioxide (E171), red iron oxide (E172), and black iron oxide (E172).

Appearance of the Product and Package Contents

• The film-coated tablets of Sitagliptina/Metformina Pharmathen 50 mg/850 mg are capsule-shaped, pink in color, and engraved with a "50" on one side and "850" on the other, with approximate dimensions of 20.3 mm in length, 9.9 mm in width, and 6.8 mm in thickness.
• The film-coated tablets of Sitagliptina/Metformina Pharmathen 50 mg/1,000 mg are capsule-shaped, red in color, and engraved with a "50" on one side and "1000" on the other, with approximate dimensions of 21.5 mm in length, 10.5 mm in width, and 7.1 mm in thickness.

Box containing the appropriate number of white PVC/PE/PVDC-Aluminum blisters and transparent PVC/PCTFE-Aluminum blisters. Packages of 56, 60, 196 film-coated tablets

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pharmathen S.A.

Dervenakion 6

15351 Pallini, Attiki

Greece

Manufacturer

Pharmathen S.A.

Dervenakion 6

15351 Pallini, Attiki

Greece

Pharmathen International S.A.,

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

69300 Rodopi,

Greece

This medicine is authorized in the Member States of the European Economic Areawith the following names:

Date of the last revision of thisprospectus:April 2025

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