Brotmin 1000 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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 the entire package 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, consult 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 Brotmin is and what it is used for
2. What you need to know before taking Brotmin
3. How to take Brotmin

4. Possible adverse effects

1. Storage of Brotmin

6. Contents of the pack and other information

1. What Brotmin is and what it is used for

This medicine contains metformin, a medication 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 absorb 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 lower 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.

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

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

Children aged 10 years and older, and adolescents, may take this medicine alone or together with insulin.

2. What you need to know before taking Brotmin

Do not take Brotmin

• If you are allergic (hypersensitive) to metformin hydrochloride 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, with severe hyperglycemia (high blood glucose), 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, fast and deep breathing, drowsiness, or a fruity odor on your breath.
• 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 repeatedly. Dehydration may trigger kidney problems, which could 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 may trigger kidney problems, which could put you at risk of developing lactic acidosis (see "Warnings and precautions").
• If you are being treated for acute heart failure or have recently had a heart attack, if you have serious circulation problems (such as shock), or if you have difficulty breathing. These conditions may lead to poor tissue oxygenation, which could put you at risk of developing lactic acidosis (see "Warnings and precautions" below).
• If you drink large amounts of alcohol.

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

Make sure to consult your doctor if

• You need a diagnostic procedure such as an X-ray or scan involving the injection into the bloodstream of iodine-containing contrast agents.
• You need major surgery.

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

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

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, severe infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems, and any medical condition in which part of the body receives reduced oxygen supply (such as acute and severe heart diseases).

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

Seek immediate medical advice on what to do 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 metformin treatment: seizures, cognitive decline, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or deafness.

Stop taking this medicine temporarily if you develop a condition 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 normal. Consult your doctor for further instructions.

Stop taking this medicine and contact a doctor or go to 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.
• Decreased 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 this medicine during the procedure and for a period afterward. Your doctor will decide when you should interrupt treatment with this medicine and when you should restart it.

Metformin alone does not cause hypoglycemia (blood glucose concentration too low). However, if you take metformin together with other antidiabetic medicines 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 Brotmin

If you need to receive an intravenous injection of an iodine-containing contrast agent, 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 you should interrupt treatment with this medicine and when you should restart it.

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. You may require more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of this medicine. 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 Brotmin with food, drinks, and alcohol

Avoid excessive alcohol consumption while taking metformin, as this may 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 determine if any changes to your treatment or blood glucose monitoring are needed.

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

Driving and operating machinery

This medicinal product by itself does not cause hypoglycaemia (a blood glucose concentration that is too low). This means it will not affect your ability to drive or operate machinery.

However, take special care if you are taking metformin together with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, increased heart rate, visual disturbances, or difficulty concentrating. Do not drive or operate machinery if you begin to experience these symptoms.

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

3. How to take Brotmin

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist.

This medicine 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

Adults usually start with 500 mg or 850 mg of this medicine twice 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 you a lower dose.

If insulin is also being administered, your doctor will instruct you on how to start taking this medicine.

Use in children and adolescents.

Children aged 10 years and older and adolescents usually start with 500 mg or 850 mg of this medicine 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 of age 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 will adjust your dose of this medicine according to your blood glucose levels. Make sure to speak with your doctor regularly. This is particularly important for children, adolescents, or if you are an elderly person.
• Your doctor will also check, at least once a year, how well 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 Brotmin

Take this medicine with or after meals. This will help prevent adverse effects on your digestion. Do not chew or crush the tablets. Swallow each tablet with a glass of water.

• 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 this medicine 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 develop lactic acidosis. The symptoms of lactic acidosis are nonspecific and include vomiting, stomach pain (abdominal pain) with cramps, a general feeling of discomfort accompanied by profound fatigue and difficulty breathing. Additional symptoms may include a decrease in body temperature and heart rate. If you experience any of these symptoms, seek immediate medical attention, as lactic acidosis can lead to coma. Stop taking this medicine immediately and contact your doctor or go to the nearest hospital right away.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Brotmin

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

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

4. Possible adverse effects

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 (may affect up to 1 in 10,000 people), but very serious, side effect called lactic acidosis (see section “Warnings and precautions”). If this happens to you, you must stop taking this medicine and contact a doctor or go to the nearest hospital immediately, as lactic acidosis can lead to coma.

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

• Gastrointestinal 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 metformin treatment. It may help to divide the daily doses throughout the day and to take this medicine during or immediately after meals. If symptoms persist, stop taking this medicine and consult your doctor.

Frequent adverse effects (affects less than 1 in 10 people)

• Changes in taste sensation.
• Low or decreased levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling (paresthesia), or pale or yellowish skin). Your doctor may schedule some tests to determine the cause of your symptoms, as some of these may also be caused by diabetes or other unrelated health conditions.

Very rare adverse effects (affecting fewer than 1 in 10,000 people)

• Lactic acidosis. This is a very rare but serious complication, especially if your kidneys are not functioning properly. The symptoms of lactic acidosis are nonspecific (see section “Warnings and precautions”).
• Changes 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 this medicine and consult your doctor.

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

Additional side effects in children and adolescents

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

Reporting of adverse reactions

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

5. Storage of Brotmin

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

Do not use this medicine after the expiry date stated on the label, following "EXP". The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

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 in doubt, please 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 Brotmin

• The active substance 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 components 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 of the product and contents of the container

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

Brotmin 850 mg film-coated tablets: yellow, oval-shaped film-coated tablets, marked 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: white, oval-shaped 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:

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

Only certain pack sizes may be marketed.

850 mg and 1,000 mg tablets:

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

Medochemie Iberia S.A.

Rua José Maria Nicolau, no 6 7°B,

1500-662, São Domingos de Benfica,

Lisboa, Portugal

Manufacturer Responsible

Medochemie LTD
1-10 Constantinoupoleos street,
3011 Limassol,
Cyprus

For further information about this medicinal product, please contact 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

For more information on this medicine, please contact the local representative of the marketing authorization holder.

Date of latest review of this leaflet: March 2025

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