METFORMIN BLUEFISH 850 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Metformin Bluefish 850 mg Film-Coated Tablets EFG

metformin hydrochloride

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Metformin Bluefish and what is it used for
2. What you need to know before taking Metformin Bluefish
3. How to take Metformin Bluefish
4. Possible side effects
5. Storage of Metformin Bluefish
6. Contents of the pack and further information

1. What is Metformin Bluefish and what is it used for

Metformin Bluefish contains metformin, a medication used to treat diabetes. It belongs to a group of medications called biguanides.

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

If you are an adult with overweight, taking Metformin Bluefish for a long time also helps reduce the risk of complications associated with diabetes.

Metformin Bluefish is associated with a stable body weight or modest weight loss

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

Adults can take Metformin Bluefish alone or in combination with other medications for treating diabetes (oral medications or insulin).

Children aged 10 years and older, and adolescents can take Metformin Bluefish alone or in combination with insulin

2. What you need to know before taking Metformin Bluefish

Do not take Metformin Bluefish

• if you are allergic (hypersensitive) to metformin or any of the other ingredients of the medication (listed in section 6)
• if you have liver problems
• if you have a severe reduction in kidney function
• 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 of the breath.
• if you have lost too much 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 below "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 below "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 breathing difficulties. This can make it difficult to supply oxygen to the tissues, which can put you at risk of developing lactic acidosis (see below "Warnings and precautions").
• if you drink a large amount of alcohol.

If any of the above circumstances apply to you, consult your doctor before taking 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 containing iodine into your blood.
• you need to undergo major surgery.

You should stop taking Metformin Bluefish for a certain period 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

Risk of lactic acidosis

Metformin Bluefish can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working 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 condition in which a part of the body has a reduced oxygen supply (such as severe and acute heart diseases).

Consult your doctor or pharmacist before starting to take Metformin Bluefish.

Stop taking Metformin Bluefish for a short period if you have a condition 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 Metformin Bluefish and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis, as this condition can lead to a coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with intense fatigue
• difficulty breathing
• reduction in body temperature and heart rate

Lactic acidosis is a medical emergency and should be treated in a hospital.

Consult your doctor quickly if:

• You know you have a genetic disorder 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 experience 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.

If you need to undergo major surgery, you should stop taking Metformin Bluefish during the procedure and for a period after it. Your doctor will decide when you should stop taking Metformin Bluefish and when you can restart it.

Metformin Bluefish alone does not cause hypoglycemia (a blood glucose level that is too low). However, if you take Metformin Bluefish 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 disorders, or difficulty concentrating, it is usually helpful to eat or drink something that contains sugar.

During treatment with Metformin Bluefish, your doctor will 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 Metformin Bluefish

If you need to be administered 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 Bluefish before the injection or at the time of the injection. Your doctor will decide when you should stop taking Metformin Bluefish and when you can restart it.

Tell your doctor if you are taking, have recently taken, or might 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 Metformin Bluefish. 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 may alter the amount of Metformin Bluefish 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 in the treatment of diabetes.

Taking Metformin Bluefish with alcohol

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

Pregnancy and breastfeeding

During pregnancy, you need insulin to treat the diabetes you have. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication, as changes may be needed in your treatment.

It is not recommended to take this medication if you are breastfeeding or plan to breastfeed your baby.

Driving and using machines

Metformin Bluefish alone does not cause hypoglycemia (a blood glucose level 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 Bluefish 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 disorders, or difficulty concentrating. Do not drive or use machines if you start to feel these symptoms.

3. How to take Metformin Bluefish

Follow the administration instructions of this medication indicated by your doctor precisely. If in doubt, consult your doctor or pharmacist again.

Metformin Bluefish cannot replace the benefits of a healthy lifestyle. Continue with the diet your doctor has indicated and exercise regularly.

The recommended dose is:

Children aged 10 years and older, and adolescents usually start with 500 mg or 850 mg of Metformin Bluefish once a day. The maximum daily dose is 2000 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.

Adults usually start with 500 mg or 850 mg of Metformin Bluefish, two or three times a day. The maximum daily dose is 3000 mg divided into 3 doses.

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

If you are also using insulin, your doctor will indicate how to start taking Metformin Bluefish.

Monitoring

• Your doctor will perform periodic blood glucose tests and adjust your dose of Metformin Bluefish 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 how well your kidneys are working at least once a year. You may need more frequent checks if you are an elderly person or if your kidneys are not working normally.

How to take Metformin Bluefish

Take Metformin Bluefish with meals or after meals. This will prevent you from experiencing side effects that affect your digestion.

Do not break or chew the tablets. Swallow each tablet with a glass of water.

If, after some time, you think the effect of Metformin Bluefish is too strong or too weak, consult your doctor or pharmacist.

If you take more Metformin Bluefish than you should

If you have taken more Metformin Bluefish than you should, you may experience lactic acidosis. The symptoms of lactic acidosis are non-specific, such as vomiting, abdominal pain with cramps, a 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 should seek medical attention immediately, as lactic acidosis can lead to a coma. Stop taking Metformin Bluefish immediately and contact your doctor or the nearest hospital right away.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 0420, indicating the medication and the amount taken.

Bring the remaining tablets or the package with you, so the doctor can identify what you have taken.

If you forget to take Metformin Bluefish

Do not take a double dose to make up for forgotten 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.

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 Bluefish can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The symptoms of lactic acidosis are non-specific (see section "Warnings and precautions"). If this happens to you, you should stop taking Metformin Bluefish and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to a coma.

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

• Digestive problems, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These side effects occur more frequently at the beginning of treatment with Metformin Bluefish. It helps to spread the doses throughout the day and if you take the tablets during or immediately after a meal. If the symptoms continue, stop taking Metformin Bluefish 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, numbness or tingling). Your doctor may schedule some tests to find the reason for your symptoms because 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):

• Abnormalities in liver function tests or hepatitis (inflammation of the liver, which can cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or the white part of the eyes). If this happens to you, stop taking Metformin Bluefish and talk to your doctor.
• Skin reactions such as skin redness, itching, or an itchy rash.

Children and adolescents

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package 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.

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5. Storage of Metformina Bluefish

Keep this medicine out of the sight and reach of children. If a child is treated with Metformina Bluefish, parents and caregivers are advised to supervise how this medicine is used.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the blister pack and on the packaging after "Cad". The expiration date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Metformina Bluefish

The active ingredient is metformin hydrochloride.

Each tablet contains 850 mg of metformin hydrochloride equivalent to 663 mg of metformin.

The other components (excipients) are:

Tablet core

Povidone, magnesium stearate.

Coating film

Hypromellose, Macrogol

Appearance of the Product and Package Contents

Film-coated tablet.

White, round, biconvex tablets, film-coated, with the letter "A" printed on one face and the number "61" on the other face.

Packaging with 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90, 98, 100, 120, 200, 300, or 400 film-coated tablets in blisters, with 10 or 14 film-coated tablets each.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bluefish Pharmaceuticals AB

P.O. Box 49013,

100 28 Stockholm

Sweden

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

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

Local Representative

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Branch 36

This medicine is authorized in the member states of the European Economic Area under the following names:

Austria Metformin Bluefish 850 mg Filmtabletten

Denmark Metformin "Bluefish"

Spain Metformina Bluefish 850 mg film-coated tablets EFG

France Metformine Cristers Pharma 850 mg film-coated tablets

Ireland Metformin Bluefish 850 mg film-coated tablets

Iceland Metformin Bluefish 850 mg film-coated tablets

Poland Metformin Bluefish 850 mg film-coated tablets

Portugal Metformina Bluefish 850 mg film-coated tablets

Sweden Metformin Bluefish

Date of the Last Revision of this Leaflet:May 2025

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