BROTMIN 850 MG FILM-COATED TABLETS

Introduction

Package Leaflet:information for the user

Brotmin 500 mg film-coated tablets EFG

Brotmin 850 mg film-coated tablets EFG

Brotmin 1,000 mg film-coated tablets EFG

Metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Brotmin and what is it used for
2. What you need to know before you take Brotmin
3. How to take Brotmin

4.

1. Storage of Brotmin

6.

1. What is Brotmin and what is it used for

This medication 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 makes your body take 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 blood glucose levels. Metformin helps reduce your blood glucose to as normal a level as possible.

If you are an adult with overweight, taking metformin for a long time also helps reduce the risk of complications associated with diabetes. Metformin is associated with maintaining body weight or a slight decrease in body weight.

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

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

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

2. What you need to know before you take Brotmin

Do not take Brotmin

• If you are allergic (hypersensitive) to metformin hydrochloride or any of the other ingredients of this medication (listed in section 6).
• If you have liver problems.
• If you have severe kidney function impairment.
• 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 severe 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 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 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 injecting a contrast medium into your blood that contains iodine.
• You need major surgery.

You should stop taking metformin for a certain period of time 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 taking this medication.

Risk of lactic acidosis

Metformin can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys do not work 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 disorder 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 indicate how to proceed if:

• You know you have a genetic inherited disease 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 present 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 this medication for a short period if you have a disorder 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 this medication and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that lactic acidosis produces, as this disorder 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.
• Decreased 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 this medication during the procedure and for a period after it. Your doctor will decide when you should stop taking this medication and when to restart it.

Metformin alone does not cause hypoglycemia (a blood glucose concentration that is too low). 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, 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 Brotmin

If you need to be given an injection of a contrast medium that contains 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 you should stop taking this medication and when to restart it.

Tell your doctor if you are taking, have recently taken, or might take any other medications. 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:

• 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 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, 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 section "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

This medication alone does not cause hypoglycemia (a blood glucose concentration that is too low). This means it will not affect your ability to drive or use machines.

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

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

3. How to take Brotmin

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

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

The recommended dose is

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

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

If insulin is also administered, your doctor will indicate how to start taking this medication.

Use in children and adolescents.

• Children aged 10 and older 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 is only recommended under specific advice from your doctor, as experience in this age group is limited.

Monitoring

• Your doctor will regularly perform blood glucose tests and adjust your dose of this medication according to your blood glucose levels. Make sure to talk to your doctor regularly. This is particularly important for children, adolescents, or if you are an elderly person.
• Your doctor will also check your kidney function at least once a year. You may need more frequent reviews if you are an elderly person or if your kidney function is not normal.

How to take Brotmin

Take this medication with meals or after meals. This will prevent you from suffering from side effects that affect your digestion. Do not chew or crush the tablets. Swallow each tablet with a glass of water.

• 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 noon (at lunch), and at night (at dinner).

If, after some time, you think the effect of this medication is too strong 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 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, you should seek medical attention immediately, as lactic acidosis can lead to a coma. Stop taking this medication 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.

If you forget to take Brotmin

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 on 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 gets them. The following side effects may occur:

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

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

• Digestive problems, such as discomfort (nausea), vomiting, diarrhea, stomach pain (abdominal pain), and loss of appetite. These side effects occur more frequently at the beginning of treatment with metformin. It may help to spread the doses throughout the day and take this medication during or immediately after a meal. If the symptoms continue, stop taking this medication and consult your doctor.

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

• Changes in taste.
• Low or decreased vitamin B12 levels in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness, or pale or yellowish skin). Your doctor may schedule some tests to discover the cause of your symptoms because some of them can also be caused by diabetes or other unrelated health problems.

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

• Lactic acidosis. It is a very rare but serious complication, especially if your kidneys do not work properly. The symptoms of lactic acidosis are non-specific (see section "Warnings and precautions").
• Abnormalities in 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 to you, stop taking this medication and talk to your doctor.

Skin reactions such as skin redness (erythema), itching, or an itchy rash (urticaria).

Additional side effects in children and adolescents

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Brotmin

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 "EXP". 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 wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This way, you will help protect the environment.

6. Contents of the pack and additional information

Composition of Brotmin

• The active ingredient is metformin hydrochloride.

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

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

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

• The other ingredients are microcrystalline cellulose, 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 and Packaging of the Product

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

Brotmin 850 mg film-coated tablets: oval, yellow, film-coated tablets, 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, white, film-coated tablets, with a score line 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 available in blisters of 9, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 200, 500, 600, or 1,000 tablets.

Only some pack sizes may be marketed.

850 mg and 1,000 mg tablets:

The tablets are available 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Medochemie Iberia S.A.

Rua José Maria Nicolau, no 6 7°B,

1500-662, São Domingos de Benfica,

Lisboa, Portugal

Manufacturer

Medochemie LTD

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

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

Medochemie Iberia S.A., Branch in Spain

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

28044 Madrid

Spain

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

Date of the Last Revision of this Leaflet:March 2025

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