Package Leaflet: Information for the User

Metformina Stada 850 mg Film-Coated Tablets EFG

Read this 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 is 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. Metformina helps to reduce your blood glucose to a level as normal as possible.

If you are an adult with overweight, taking metformina for a prolonged period also helps to reduce the risk of complications associated with diabetes. Metformina is associated with maintaining body weight or a slight decrease in it.

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

Adults can take metformina alone or with other medications for treating diabetes (oral medications or insulin).

Children aged 10 years and above, and adolescents can take metformina alone or with insulin.

- Do not take Metformina Stada:

• If you are allergic to the active ingredient or to 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, 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 disorder in which substances called "ketone bodies" accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor in your breath.

• If you have lost a lot of body water (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 below "Warnings and precautions").
• If you have a severe infection, for example, a lung, bronchial, or kidney infection. 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 have recently had a heart attack, if you have severe circulation problems (such as shock) or difficulty breathing. This can lead to tissue hypoxia, 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 the injection of contrast media containing iodine into your bloodstream.
• You need a major surgical intervention.

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 to follow your doctor's instructions precisely.

Warnings and precautions

Risk of lactic acidosis

Metformin can cause a rare but 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 "Warnings and precautions"), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart diseases).

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

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 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 that cause lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

• Vomiting
• Abdominal pain (stomach pain)
• Muscle cramps
• 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.

Consult your doctor quickly to find out what to do if:

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

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

Metformin alone does not cause hypoglycemia (low blood glucose). 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, vision disturbances, or difficulty concentrating, you can usually alleviate them by eating or drinking 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 medications and Metformina Stada

If you need to receive an injection of contrast media containing iodine into your bloodstream, for example, during an X-ray or scan, 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 medication. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the metformin dose. It is especially important to mention the following:

• Diuretics that increase urine production
• Medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• Certain medications 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)
• Medications that can 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, or olaparib).
• Other medications used to treat diabetes.

Taking Metformina Stada with alcohol

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, talk to your doctor about making changes to your treatment or monitoring your blood glucose levels.

This medication is not recommended for breastfeeding or if you plan to breastfeed your baby.

Driving and operating machinery

Metformin alone does not cause hypoglycemia (low blood glucose). This means it will not affect your ability to drive or operate machinery.

However, be cautious if you take metformin with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, or meglitinides). The symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, vision disturbances, or difficulty concentrating. Do not drive or operate machinery if you start to experience these symptoms.

Follow exactly the administration instructions of this medication as indicated by your doctor. If in 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

Children aged 10 years and older and adolescentsusually 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.

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 3 doses.

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 Stada

Take metformin 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.

• 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 noon (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 Stada than you should

If you have taken more metformin than you should, you may experience lactic acidosis. Symptoms of lactic acidosis are nonspecific such as vomiting, stomach pain (abdominal pain) with nausea, a general feeling of discomfort with intense 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 immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Metformin Stada

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 questions 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:

Metformin may cause a very rare but serious side effect called lactic acidosis (see the "Warnings and Precautions" section). If this occurs, you should stop taking metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.You should stop taking metformin and contact a doctor or the nearest hospital immediately.Lactic acidosis can lead to coma.

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

• 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 with metformin. Taking metformin during or immediately after a meal may help reduce these side effects.If symptoms persist, stop taking metformin and consult your doctor.

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

• changes in taste.
• low or decreased levels of vitamin B12 in the blood (symptoms may include extreme fatigue, red and painful tongue (glossitis), tingling (paresthesia) or yellow or pale skin). Your doctor may schedule some tests to find the cause of your symptoms, as some of them may be caused by diabetes or other unrelated health problems.

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

• 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 the "Warnings and Precautions" section).
• 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 redness of the skin (erythema), itching or a itchy rash (urticaria).

Children and adolescents

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

Reporting of 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://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

If a child is being treated with metformina, parents and caregivers are advised to supervise how this medication is used.

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 packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Metformina Stada

The active ingredient is hydrochloride of metformin. Each film-coated tablet contains 850 mg of metformin hydrochloride, corresponding to 662.9 mg of metformin base.

The other components (excipients) are: povidone, magnesium stearate, Opadry YS-1R-7006 (hypromellose/macrogol 400/macrogol 6000).

Appearance of the product and contents of the packaging

Metformina Stada 850 mg is presented in the form of film-coated tablets, white in color and biconvex.

Each package contains 50 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios STADA, S.L.

C/ Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Responsible for manufacturing:

GALENICUM HEALTH, S.L.U Sant Gabriel, 50

08950 Esplugues de LLobregat, Barcelona Spain

SAG MANUFACTURING S.L.U. National Highway I, Km. 36

San Agustin de Guadalix 28750 - Spain

Last review date of this leaflet:March 2025

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/