Prospecto:information for the user

Brotmin 500 mg film-coated tablets

Brotmin 850 mg film-coated tablets

Brotmin 1.000 mg film-coated tablets

Metformin hydrochloride

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospectus, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

4.Adverse effects

1. Storage of Brotmin

6.Contents of the pack and additional information

This medication 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 properly. This causes high levels of glucose in the blood. Metformin helps to reduce your blood glucose to a level as normal as possible.

If you are an adult with overweight, 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 decrease in it.

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

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

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

Do not take Brotmin

• If you are allergic (hypersensitive) to metformin hydrochloride, or to any of the other components of this medication (listed in section 6).
• If you have liver problems.
• If you have a severe reduction in 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 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 if your breath develops an unusual fruity odor.
• If you have lost a lot of fluid 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").
• If you have a severe infection, for example, an infection affecting 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 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 tissue hypoxia, which can put you at risk of developing lactic acidosis (see below "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

Consult your doctor or pharmacist before taking this medication.

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 "Warnings and precautions" 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 diseases).

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 know 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 hearing loss (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: convulsions, cognitive decline, difficulty with motor movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraines, and hearing loss.

Stop taking this medication 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 fluid than normal. Consult your doctor for further instructions.

Stop taking this medication and contact a doctor or the nearest hospital immediately if you experience any symptoms that produce 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 a major surgery, you should stop taking this medication while the procedure is being performed and for a period of time afterward. Your doctor will decide when to stop and when to restart treatment with this medication.

Metformin itself does not cause hypoglycemia (low blood sugar). However, if you take metformin with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, 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 treatment with metformin, 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 Brotmin

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 a scan, 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 treatment with this medication.

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 dose of this medication. 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 a reduction in kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
• Other medications used to treat diabetes.

Taking Brotmin with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor to determine if you need to make any changes to your treatment or blood glucose control.

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

Driving and operating machinery

This medication itself does not cause hypoglycemia (low blood sugar). 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, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, visual disturbances, or difficulty concentrating. Do not drive or operate machinery if you start to feel these symptoms.

This medication contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

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

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

The recommended dose is

Adultsusually start with 500 mg or 850 mg of this medication two to 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 this medication.

Use in children and adolescents.

Children aged 10 and over and adolescents usually start with 500 mg or 850 mg of this medication 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 old is only recommended under specific advice from your doctor, as experience in this age group is limited.

Monitoring

How to take Brotmin

Take this medication 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 this medication is too intense or too weak, consult your doctor or pharmacist.

If you take more Brotmin than you should

If you have taken more metformin than you should, you may experience lactic acidosis. The 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 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 this medication 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.

If you forgot to take Brotmin

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 can 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 (affecting up to 1 person in 10,000), called lactic acidosis (see section “Warnings and precautions”). If this happens to you,you must stop taking this medicine and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Very common side effects (affecting more than 1 person in 10)

Common side effects(affecting less than 1 person in 10)

Very rare side effects(affecting less than 1 person in 10,000)

Skin reactions such as redness of the skin (erythema), itching, or a pruritic rash (urticaria).

Additional side effects in 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 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 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.

Do not use this medication after the expiration date that appears on the label, after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and themedications that you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask yourpharmacist how to dispose of the containers and the medications that you no longer need. By doing so, you will help protect the environment.

Composition of Brotmin

Each film-coated tablet contains 500 mg of hydrochloride of metformin, corresponding to 390 mg of metformin base.

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

Each film-coated tablet contains 1,000 mg of hydrochloride of metformin, corresponding to 780 mg of metformin base.

- The other components are cellulose, microcrystalline, sodium croscarmellose, povidone, magnesium stearate.

Film coating:

500 mg and 1,000 mg:poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc

850 mg:yellow iron oxide (E172), poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc.

Appearance of the product and contents of the package

Brotmin 500 mg film-coated tablets: oval-shaped film-coated tablets, white in color, smooth on both sides, with dimensions of 16 mm x 8 mm.

Brotmin 850 mg film-coated tablets: oval-shaped film-coated tablets, yellow in color, engraved with "MC" on one side and smooth on the other, with dimensions of 20.1 mm x 9.8 mm.

Brotmin 1,000 mg film-coated tablets: oval-shaped film-coated tablets, white in color, with a groove on both sides, with dimensions of 21.2 mm x 10.2 mm. The tablet can be divided into equal doses.

500 mg tablets:

The tablets are presented in blisters of 9, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 200, 500, 600 or 1,000 tablets.

Only some package sizes may be commercially available.

850 mg and 1,000 mg tablets:

The tablets are presented in blisters of 8, 9, 10, 14, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 300, 600 or 1,000 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Medochemie Iberia S.A.

Rua José Maria Nicolau, no 6 7°B,

1500-662, São Domingos de Benfica,

Lisboa, Portugal

Responsible for manufacturing

Medochemie LTD

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; planta 5 office 6,

28044 Madrid

Spain

To obtain more information about this medication, please contact the local representative of the holder of the marketing authorization.

Date of the last review of this prospectus:March 2025

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