Metformin CINFA 850 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

metformina cinfa 850 mg film-coated tablets EFG

metformine hydrochloride

Read the entire 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 or pharmacist.
• 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What metformina cinfa is and what it is used for

metformina cinfa contains metformin, a medicine used to treat diabetes. It belongs to a group of medicines called biguanides.

Insulin is a hormone produced by the pancreas that enables your body to take up glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for future use.

If you have diabetes, your pancreas does not produce enough insulin or your body cannot properly use the insulin it produces. This leads to high levels of glucose in the blood. Metformin helps reduce your blood glucose to as near normal levels as possible.

If you are an overweight adult, taking metformin over a long period of time also helps reduce the risk of diabetes-related complications. Metformin is associated with weight maintenance or a slight reduction in body weight.

Metformin is used to treat patients with type 2 diabetes (also called "non-insulin-dependent diabetes") when diet and physical exercise alone are not sufficient to control their blood glucose levels. It is especially used in overweight patients.

Adults may take metformin alone or together with other antidiabetic medicines (oral medications or insulin).

Children aged 10 years and older, and adolescents, may take metformin alone or in combination with insulin.

2. What you need to know before starting to take metformin cinfa

Do not take metformin cinfa

• If you are allergic to metformin or to any of the other ingredients of this medicine (listed in section 6).
• If you have liver problems.
• If you have severely reduced kidney function.
• If you have uncontrolled diabetes, 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 in which substances called “ketone bodies” accumulate in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid deep breathing, drowsiness, or your breath developing an unusual fruity odor.
• If you have lost a large amount of fluid from your body (dehydration), for example, due to prolonged or severe diarrhea, or if you have vomited several times in succession. Dehydration may trigger kidney problems, which could put you at risk of developing lactic acidosis (see below “Warnings and precautions ”).
• If you have a serious infection, for example, an infection affecting your lungs, bronchi, or kidneys. Serious infections may trigger kidney problems, which could put you at risk of developing lactic acidosis (see “Warnings and precautions ”).
• If you are receiving treatment for acute heart failure or have recently had a heart attack, if you have serious circulatory problems (such as shock), or if you have difficulty breathing. This may lead to inadequate oxygenation of tissues, which could put you at risk of developing lactic acidosis (see “Warnings and precautions ”).
• If you drink large amounts of alcohol.

If any of the above situations apply to you, consult your doctor before starting this medicine.

Make sure to consult your doctor if:

• You require an examination such as an X-ray or scan involving the injection into the bloodstream of iodine-containing contrast media.
• You require major surgery.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take metformin cinfa.

Risk of lactic acidosis

Metformin may cause a very rare but very 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 or alcohol consumption, dehydration (see further information below), liver problems, and any medical condition in which part of the body has a reduced oxygen supply (such as acute and severe heart diseases).

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

Contact your doctor immediately for advice if:

• You are known to have a genetic mitochondrial disease (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 deafness.

Stop taking metformin for a short period if you have an illness that may be associated with 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 metformin and contact a doctor or the nearest hospital immediately if you experience any of the 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,
• reduced body temperature and heart rate.

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

If you need to undergo major surgery, you must stop taking metformin during the procedure and for a period afterward. Your doctor will decide when to interrupt and when to restart treatment with metformin.

Metformin alone does not cause hypoglycemia (blood glucose level too low). However, if you take metformin together 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, increased heart rate, vision disturbances, or difficulty concentrating, it is generally helpful to eat or drink something containing sugar.

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

Other medicines and metformin cinfa

If you need to receive an injection of an iodine-containing contrast medium into your bloodstream, for example during an X-ray or scan, you must stop taking metformin before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with metformin.

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust your metformin dose. It is especially important to mention the following:

• 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).

• 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).

• Medicines 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 medicines used to treat diabetes.

Taking metformin cinfa with alcohol

Avoid excessive alcohol consumption while taking metformin, as this may increase the risk of lactic acidosis (see “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.

Pregnancy

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

Breastfeeding

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

Driving and use of machines

Diabetes treatment with metformin as the sole medication (monotherapy) does not cause hypoglycemia (low blood sugar) and therefore does not affect your ability to drive or operate machinery.

However, if you take metformin together with other diabetes medications, hypoglycemia may occur (symptoms of low blood sugar such as fainting, confusion, increased sweating, vision disturbances, or difficulty concentrating), and therefore you must exercise extreme caution when driving or operating dangerous machinery.

3. How to take metformin cinfa

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If you have any doubts, 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: Adults usually 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 of age and adolescents: Children aged 10 years and older and adolescents usually start with 500 mg or 850 mg of metformin once daily. The maximum daily dose is 2,000 mg, divided into 2 or 3 doses. Treatment of children between 10 and 12 years of age 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 insulin is also being administered, your doctor will instruct you on how to start taking metformin.

Monitoring:

• Your doctor will regularly perform blood glucose tests and adjust your dose of metformin according to your blood glucose levels. Make sure to speak regularly with your doctor. This is particularly important for children, adolescents, or if you are elderly.
• Your doctor will also check how well your kidneys are working at least once a year. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take metformin cinfa

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

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

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

If, after some time, you think that 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 develop lactic acidosis. Symptoms of lactic acidosis are nonspecific and may include vomiting, stomach pain (abdominal pain) with cramps, a general feeling of discomfort with severe fatigue and difficulty breathing. Additional symptoms may include a decrease in body temperature and heart rate. If you experience any of these symptoms, you must seek immediate medical attention, as lactic acidosis can lead to coma. Stop taking metformin immediately and contact your doctor or the nearest hospital right away.

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

If you forget to take metformin cinfa

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

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.

The following adverse effects may occur:

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

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

• Gastrointestinal problems such as nausea, vomiting, diarrhoea, stomach pain (abdominal pain), and loss of appetite. These adverse effects occur most frequently at the beginning of treatment. Spreading the doses throughout the day and taking the tablets during or immediately after a meal may help reduce these adverse effects. If symptoms persist, stop taking metformin and consult your doctor.

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

• Changes in taste sensation.

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

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

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 of adverse effects

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

5. Storage of metformin cinfa

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to 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 metformina cinfa

• The active substance 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).

• Film coating: hypromellose 5CP (E-464), macrogol 400 and macrogol 6000 (Opadry YS-1R-7006).

Appearance of the product and contents of the pack

metformina cinfa is presented as white, oval, film-coated tablets with a score line.

It is packaged in PVC-PVDC/Aluminum blisters.

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

Only certain pack 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 most recent review of this leaflet: March 2025

Detailed information on this medicinal product 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68167/P_68167.html

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