METFORMIN CINFA 850 mg FILM-COATED TABLETS

2. What you need to know before taking Metformin Cinfa

Do not take Metformin Cinfa

• If you are allergic to metformin or any of the other components of this medication (listed in section 6).
• If you have liver problems.
• If you have severe kidney function reduction.
• 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 disorder in which substances called "ketone bodies" accumulate in the blood, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor in your breath.
• If you have lost a lot of water from your body (dehydration), for example, due to prolonged or intense diarrhea, or if you have vomited several times in a row. Dehydration can trigger kidney problems, which can put you at risk of developing lactic acidosis (see "Warnings and precautions" below).
• If you have a severe infection, for example, an infection that affects your lungs, bronchi, or kidneys. Severe infections can trigger kidney problems, which can put you at risk of developing lactic acidosis (see "Warnings and precautions").
• If you are receiving treatment for acute heart failure or if you have recently had a heart attack, if you have severe circulation problems (such as shock), or if you have difficulty breathing. This can lead to a lack of oxygenation in the tissues, which can put you at risk of developing lactic acidosis (see "Warnings and precautions").
• If you drink a lot of alcohol.

If any of the above circumstances apply to you, consult your doctor before starting to take this medication.

Make sure to consult your doctor if:

• You need an examination, such as an X-ray or a scan, that involves injecting a contrast medium containing iodine into your bloodstream.
• You need major surgery.

You should stop taking metformin for a certain period before and after the examination or surgery. Your doctor will decide if you need any other treatment during this time. It is essential that you follow your doctor's instructions precisely.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Metformin Cinfa.

Risk of lactic acidosis

Metformin can cause a very rare but severe side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, 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 acute and severe heart disease).

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

Consult your doctor immediately 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 indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

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

The symptoms of lactic acidosis include:

• vomiting,
• stomach pain (abdominal pain),
• muscle cramps,
• a 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.

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

Metformin alone does not cause hypoglycemia (low blood sugar). However, if you take metformin with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, or meglitinides), there is a risk of hypoglycemia. If you experience symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, it is usually helpful to eat or drink something that contains sugar.

During treatment with metformin, your doctor will regularly 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.

Other medications and Metformin Cinfa

If you need to be administered a contrast medium containing iodine into your bloodstream, for example, during an X-ray or examination, you should stop taking metformin before or at the time of the injection. Your doctor will decide when you should stop and restart metformin treatment.

Tell your doctor if you are taking, have recently taken, or might 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 metformin. It is especially important to mention the following:

• 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 for treating high blood pressure (ACE inhibitors and angiotensin-II receptor antagonists).
• Beta-2 agonists such as salbutamol or terbutaline (used to treat asthma).
• Corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma).
• Medications that may alter the amount of metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

• Other medications used to treat diabetes.

Taking Metformin Cinfa with alcohol

Avoid excessive alcohol consumption while taking metformin, as this can increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

During pregnancy, you need insulin to treat your diabetes. Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, so that your treatment can be changed.

Breastfeeding

It is not recommended to take this medication if you are breastfeeding or plan to breastfeed your baby.

Driving and using machines

Treatment of diabetes with metformin as the only medication (monotherapy) does not produce hypoglycemia (low blood sugar) and therefore does not affect the ability to drive or use machines.

However, if you take metformin with other diabetes medications, hypoglycemia (symptoms of low blood sugar, such as fainting, confusion, increased sweating, vision disturbances, or difficulty concentrating) may occur, and you should be extremely cautious when driving or operating hazardous machinery.

3. How to take Metformin Cinfa

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Metformin cannot replace the benefits of a healthy lifestyle. Continue to follow any dietary advice your doctor has given you and exercise regularly.

Recommended dose:

Adults:Adultsusually start with 500 mg or 850 mg of metformin, two or three times a day. The maximum daily dose is 3,000 mg divided into three doses.

Use in children from 10 years and adolescents:Children10 years and older and adolescents usually start with 500 mg or 850 mg of metformin once a day. The maximum daily dose is 2,000 mg divided into 2 or 3 doses. Treatment of children between 10 and 12 years is only recommended under specific advice from your doctor, as clinical experience in this patient group is limited.

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

If you are also taking insulin, your doctor will tell you how to start taking metformin.

Monitoring:

• Your doctor will regularly perform blood glucose tests and adjust your metformin dose according to your blood glucose levels. Make sure to talk to your doctor regularly. This is especially important for children, adolescents, or if you are an elderly person.
• Your doctor will also check your kidney function at least once a year, or more frequently if you are an elderly person or if your kidney function is worsening.

How to take Metformin Cinfa

Take the tablets with meals or after meals. This will help prevent digestive side effects.

Do not chew or crush the tablets. Swallow each tablet with a glass of water. The tablet can be divided into equal doses.

• If you take one dose a day, take it in the morning (at breakfast).
• If you take two doses a day, take them in the morning (at breakfast) and at night (at dinner).
• If you take three doses a day, take them in the morning (at breakfast), at lunchtime, and at night (at dinner).

If, after some time, you think the effect of metformin is too strong or too weak, consult your doctor or pharmacist.

If you take more Metformin Cinfa than you should

If you have taken more metformin than you should, you may suffer from lactic acidosis. The symptoms of lactic acidosis are non-specific, such as vomiting, stomach pain (abdominal pain) with cramps, a general feeling of discomfort with intense fatigue, and difficulty breathing. Additional symptoms may include decreased body temperature and heart rate. If you experience any of these symptoms, seek medical attention immediately, as lactic acidosis can lead to a coma. Stop taking metformin immediately and contact your doctor or the nearest hospital as soon as possible.

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 medication and the amount ingested. It is recommended to bring the package and package leaflet to the healthcare professional.

If you forget to take Metformin Cinfa

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects may occur:

Metformin can cause a very rare but severe side effect called lactic acidosis (see section "Warnings and precautions"), which can lead to a coma. If this happens, stop taking metformin and contact a doctor or the nearest hospital immediately.

Very common side effects (may affect more than 1 in 10 patients):

• Digestive problems such as nausea, vomiting, diarrhea, stomach pain (abdominal pain), and loss of appetite. These side effects occur more frequently at the start of treatment. Spreading the doses throughout the day and taking the tablets during or immediately after a meal can help reduce side effects. If the symptoms persist, stop taking metformin and consult your doctor.

Common side effects (may affect up to 1 in 10 patients):

• Changes in taste.

Very rare side effects (may affect up to 1 in 10,000 patients):

• Lactic acidosis. This is a very rare but severe complication, especially if your kidneys do not function properly. The symptoms of lactic acidosis are non-specific (see "Warnings and precautions").
• Abnormal liver function tests or hepatitis (inflammation of the liver; this can cause fatigue, loss of appetite, weight loss, with or without a yellowish tint to the skin or the whites of the eyes). If this happens, stop taking metformin and talk to your doctor.
• Skin reactions such as redness of the skin (erythema), itching, or an itchy rash (urticaria).
• Low vitamin B12 levels in the blood.

Children and adolescents

Limited data in children and adolescents showed that the effects were similar in nature and severity to those observed in adults.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Metformin Cinfa

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the package after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Return the package and any unused medication to the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the package and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Metformina Cinfa

• The active ingredient is metformin hydrochloride. Each film-coated tablet contains 850 mg of metformin hydrochloride equivalent to 662.9 mg of metformin base.
• The other components are:

• Tablet core: povidone (E-1201) and magnesium stearate (E-470b).
• Tablet coating: hypromellose 5CP (E-464), macrogol 400, and macrogol 6000 (Opadry YS-1R-7006).

Product Appearance and Package Contents

Metformina Cinfa is presented in the form of film-coated tablets, white, oval, and scored.

It is presented in PVC-PVDC/Aluminum blisters.

Each package contains 50 or 500 (clinical package) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

Date of the Last Revision of this Prospectus:March 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68167/P_68167.html

QR code at: https://cima.aemps.es/cima/dochtml/p/68167/P_68167.html