SITAGLIPTIN/METFORMIN PHARMAZAC 50 mg / 1000 mg FILM-COATED TABLETS

2. What you need to know before you take Sitagliptin/Metformin Pharmazac 50mg/850mg, 50mg/1000mg film-coated tablets EFG

Do not take Sitagliptin/Metformin Pharmazac:

• If you are allergic to sitagliptin or 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, for example with 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 in which substances called ‘ketone bodies’ build up in the blood and can lead to diabetic precoma. The symptoms may include stomach pain, rapid and deep breathing, drowsiness, or your breath having an unusual fruity odor.
• If you have a severe infection or are dehydrated,
• If you have recently had a heart attack, or severe circulatory problems, such as cardiogenic shock or breathing difficulties,

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

Warnings and precautions

There have been cases of pancreatitis (inflammation of the pancreas) in patients taking Sitagliptin/Metformin (see section 4).

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

Risk of lactic acidosis

Taking Sitagliptin/Metformin can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of lactic acidosis also increases 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 oxygen supply (such as severe and acute heart disease).

If you notice any of these, consult your doctor for further guidance on what to do.

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

Stop taking Sitagliptin/Metformin Pharmazac 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.
• A general feeling of being unwell, with intense tiredness.
• 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 to take Sitagliptin/Metformin:

• If you have or have had a disease of the pancreas (such as pancreatitis).
• If you have or have had gallstones, alcohol addiction, or very high levels of triglycerides (a type of fat) in your blood. These medical conditions may increase the risk of 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 or metformin or Sitagliptin/Metformin (see section 4)
• If you are taking a sulfonylurea or insulin, other diabetes medicines, you may experience low blood sugar levels (hypoglycemia). Your doctor may consider it necessary to reduce the dose of sulfonylurea or insulin.

If you need to undergo major surgery, you should stop taking Sitagliptin/Metformin during the procedure and for a period after it. Your doctor will decide when to stop Sitagliptin/Metformin and when to resume treatment.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before starting to take Sitagliptin/Metformin.

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 worsening.

Children and adolescents

Children and adolescents under 18 years should not take this medicine. It is not effective for children and adolescents between 10 and 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 Pharmazac

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 to stop Sitagliptin/Metformin and when to resume treatment.

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 by injection) used to treat diseases that involve inflammation, such as asthma and arthritis (corticosteroids).
• Medicines that increase urine production (diuretics).
• Medicines used to treat pain and inflammation, such as non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 inhibitors (COX-2 inhibitors).
• Certain medicines used to treat high blood pressure (angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists).
• Medicines used to treat bronchial asthma (beta-sympathomimetics).
• Medicines that contain alcohol or iodinated contrast agents.
• 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: a medicine used to treat irregular heartbeat and other heart problems. Your doctor may need to check the level of digoxin in your blood if you are taking Sitagliptin/Metformin.

Sitagliptin/Metformin Pharmazac with alcohol

Avoid excessive alcohol intake while taking Sitagliptin/Metformin, as it may increase the risk of lactic acidosis (see ‘Warnings and precautions’ section).

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. You should not take this medicine if you are breast-feeding. See section 2, Do not take Sitagliptin/Metformin Pharmazac:

Driving and using machines

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

Taking this medicine in combination with a group of medicines called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive, use machines, or work without a secure support.

Sitagliptin/Metformin Pharmazac:

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially ‘sodium-free’.

3. How to take Sitagliptin/Metformin Pharmazac

Follow exactly the administration instructions of this medicine given by your doctor. If you are not sure, consult your doctor or pharmacist again.

• Take one tablet:
• • Twice a day by mouth
  • with food to reduce the chances of stomach upset.

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

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

You should 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 you to have low blood sugar (hypoglycemia). Low blood sugar may occur when this medicine is used with a medicine that contains a sulfonylurea or insulin, so your doctor may consider it necessary to reduce the dose of sulfonylurea or insulin.

If you take more Sitagliptin/Metformin Pharmazac than you should

If you take a dose of this medicine that is higher than prescribed, contact your doctor immediately. Go to the hospital if you have 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 ‘Warnings and precautions’ section).

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

If you forget to take Sitagliptin/Metformin Pharmazac

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 schedule. Do not take a double dose of this medicine.

If you stop taking Sitagliptin/Metformin Pharmazac

Continue to take this medicine for as long as your doctor tells you to, so 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 further questions on the use of this product, 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 and contact your doctor immediately if you notice any of the following serious adverse effects:

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

Sitagliptina/Metformina can cause a very serious but rare adverse effect (may affect up to 1 in 10,000 people) called lactic acidosis (see section "Warnings and Precautions"). If this happens, you must stop taking Sitagliptina/Metformina and contact your doctor or 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, blisters on the skin/peeling 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 a different medicine for 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.

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 sitagliptina and metformina (frequency classified as frequent).

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

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

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

Frequent: swelling of hands or feet.

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

Very frequent: low blood sugar.

Uncommon: dry mouth, headache.

Some patients have experienced the following adverse effects during clinical studies while taking sitagliptina alone or during post-approval use of Sitagliptina/Metformina or sitagliptina alone or with other diabetes medicines:

Frequent: low blood sugar, headache, upper respiratory tract infection, nasal congestion and runny nose, sore throat, arthrosis, pain in arms or legs.

Uncommon: dizziness, constipation, itching.

Rare: reduction in platelet count.

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

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

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

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does 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. Storage of Sitagliptina/Metformina Pharmazac

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 carton after "EXP." The expiration date is the last day of the month indicated.

Store below 30 °C.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

1. Composition of Sitagliptina/Metformina Pharmazac 50mg/850mg, 50mg/1000mg film-coated tablets EFG

• The active ingredients are sitagliptina and metformina.

• Each film-coated tablet of Sitagliptina/Metformina Pharmazac 50 mg/850 mg contains sitagliptina hydrochloride equivalent to 50 mg of sitagliptina and 850 mg of metformina hydrochloride.
• Each film-coated tablet of Sitagliptina/Metformina Pharmazac 50 mg/1000 mg contains sitagliptina hydrochloride equivalent to 50 mg of sitagliptina and 1000 mg of metformina hydrochloride.

• The other excipients are:

• Tablet core: microcrystalline cellulose 102 (E460), sodium croscarmellose, povidone (E1201), sodium lauryl sulfate, and sodium stearyl fumarate.

• Tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), red iron oxide (E172), and black iron oxide (E172).

Product Appearance and Package Contents

• Sitagliptina/Metformina Pharmazac 50 mg/850 mg are film-coated tablets, pink in color, and capsule-shaped, measuring 20.2 mm x 9.9 mm, with "L50" engraved on one side and smooth on the other side.
• Sitagliptina/Metformina Pharmazac 50 mg/1000 mg are film-coated tablets, red in color, and capsule-shaped, measuring 21.4 mm x 10.5 mm, with "H50" engraved on one side and smooth on the other side.

Blister packs (Aluminum-PVC/PE/PVDC). Packages of 14, 28, 56, 196 film-coated tablets. Multiple packages of 196 (2 packs of 98) and 168 (2 packs of 84) film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

PHARMAZAC S.A.

31 Naousis Str., 104 47

Athens, Greece

Tel.: +30 210 3418889-97

[email protected]

Manufacturer

Remedica Ltd.

Aharnon Street, Limassol Industrial Estate, 3056 Limassol

Cyprus

Tel.: +357 25553000

[email protected]

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

Date of the last revision of this prospectus:11/2024

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/)