Product Information for the User

Metformin Cinfa 850 mg Film-Coated Tablets

Metformin Hydrochloride

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Metformina cinfa contains metformin, a medication for treating diabetes. It belongs to a group of medications called biguanides.

Insulin is a hormone produced by the pancreas that makes your body capture 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 use the insulin it produces effectively. This causes high levels of glucose in the blood. Metformin helps to reduce your blood glucose levels to as normal a level as possible.

If you are an adult with obesity, taking metformin for a prolonged period also helps to reduce the risk of complications associated with diabetes. Metformin is associated with maintaining body weight or a slight reduction in it.

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

Adults can take metformin alone or with other diabetes medications (oral medications or insulin).

Children aged 10 years and older, and adolescents, can take metformin alone or with insulin.

Do not take metformin cinfa

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

Make sure to consult your doctor if:

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

Advertencias and precautions

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

Risk of lactic acidosis

Metformin can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see below for more information), 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 to determine how to proceed if:

• You have a genetic disorder that affects the mitochondria (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternal diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: convulsions, cognitive impairment, difficulty with motor movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Stop taking metformin for a short period of time if you have a condition that may be associated with dehydration(significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less than normal. 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 that cause lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

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 while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to stop and when to restart metformin treatment.

Metformin alone does not cause hypoglycemia (low blood sugar levels). 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, increased heart rate, visual disturbances, or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.

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

Other medicines and metformin cinfa

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

Inform your doctor if you are taking, have taken recently, or may need to take any other medicine. 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:

• Diuretics that increase urine production.
• 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 can alter the amount of metformin in your blood, especially if you have a reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, or olaparib).

• Other diabetes medications.

Taking metformin cinfa with alcohol

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

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

This medicine is not recommended if you are breastfeeding or plan to breastfeed your baby.

Driving and operating machinery

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

However, if you take metformin with other diabetes medications that can cause hypoglycemia, there is a risk of hypoglycemia (symptoms of low blood sugar levels such as dizziness, confusion, increased sweating, increased heart rate, visual disturbances, or difficulty concentrating), and you should exercise extreme caution when driving and operating machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Metformin cannot replace the benefits of a healthy lifestyle. Continue following any dietary advice given by your doctor and practice regular exercise.

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 aged 10 and over and adolescents::Children aged 10 and over 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 renal function, your doctor may prescribe a lower dose.

If insulin is also administered:, your doctor will instruct you on how to start taking metformin.

Monitoring:

• Your doctor will perform regular blood glucose tests and adjust your metformin dose according to your blood glucose levels. Be sure to speak regularly with your doctor. This is particularly important for children, adolescents, or if you are elderly.
• Your doctor will also check, at least once a year, how your kidneys are functioning. 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 after meals. This will prevent you from experiencing adverse effects that affect your digestion.

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

• If you take a daily dose, take it in the morning (breakfast).
• If you take two doses a day, take them in the morning (breakfast) and in the evening (dinner).
• If you take three doses a day, take them in the morning (breakfast), at midday (lunch) and in the evening (dinner).

If, after some time, you believe the effect of metformin is too intense 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 experience lactic acidosis. The symptoms of lactic acidosis are non-specific such as vomiting, stomach pain (abdominal pain) with nausea, a general feeling of discomfort with intense fatigue and difficulty breathing. Additional symptoms may be 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 immediately.

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 packaging and the leaflet to the healthcare professional.

If you forgot to take metformin cinfa:

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects may occur:

Metforminmay cause a very rare but serious side effect, called lactic acidosis (see “Warnings and precautions”), If this occurs,you should stop taking metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

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 beginning of treatment. Taking the tablets during or immediately after a meal may help reduce the side effects.If symptoms persist, stop taking metformin and consult your doctor.

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

• Changes in taste.

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

• Lactic acidosis. This is a rare but serious complication, especially if your kidneys do not function properly. The symptoms of lactic acidosis are nonspecific (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 a yellowish tone of the skin or the white of the eyes). If this occurs,stop taking metformin and talk to your doctor.
• Skin reactions such as skin redness (erythema), itching or a pruritic rash (urticaria).
• Low blood levels 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 that appears on the packaging after “CAD.”The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Metformin cinfa composition

• The active ingredient is hydrochloride of metformin. Each film-coated tablet contains 850 mg of hydrochloride of metformin corresponding 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).

Appearance of the product and content of the packaging

Metformin 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 commercially marketed.

Marketing authorization holder

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

Last review date of this leaflet:March 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your 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 to:https://cima.aemps.es/cima/dochtml/p/68167/P_68167.html