METFORMIN 500 mg Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER
2. Metformin Bluefish, 500 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Metformin Bluefish and what is it used for
4. Important information before taking Metformin Bluefish
   1. When not to take Metformin Bluefish
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. You should temporarily stop taking Metformin Bluefish if you have
   5. You should stop taking Metformin Bluefish and contact your doctor or the nearest hospital immediately if you experience
   6. Metformin Bluefish with other medicines
   7. Metformin Bluefish with alcohol
   8. Pregnancy and breastfeeding
   9. Driving and using machines
5. How to take Metformin Bluefish
   1. Recommended dose:
   2. Treatment monitoring
   3. How to take Metformin Bluefish
   4. Taking a higher dose of Metformin Bluefish than recommended
   5. Missing a dose of Metformin Bluefish
6. Possible side effects
   1. Very common side effects (affect more than 1 in 10 people)
   2. Common side effects (affect less than 1 in 10 people)
   3. Very rare side effects (affect less than 1 in 10,000 people)
   4. Children and adolescents
   5. Reporting side effects
7. How to store Metformin Bluefish
8. Contents of the pack and other information
   1. What Metformin Bluefish contains
   2. What Metformin Bluefish looks like and contents of the pack
   3. Not all pack sizes may be marketed.
   4. Marketing authorization holder and manufacturer
   5. Marketing authorization holder
   6. Manufacturer
   7. This medicine is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet: 03/2025

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Metformin Bluefish, 500 mg, film-coated tablets

Metformin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Metformin Bluefish and what is it used for
• 2. Important information before taking Metformin Bluefish
• 3. How to take Metformin Bluefish
• 4. Possible side effects
• 5. How to store Metformin Bluefish
• 6. Contents of the pack and other information

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

Metformin Bluefish contains metformin, a medicine used to treat diabetes. The medicine belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that allows the body to take up glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for future use.
In diabetes, the pancreas does not produce enough insulin or the body is not able to use the produced insulin properly. This leads to an increased level of glucose in the blood. Metformin Bluefish helps to lower the level of glucose in the blood to a value as close to normal as possible.
In adults with overweight, long-term use of Metformin Bluefish also helps to reduce the risk of complications associated with diabetes. Taking Metformin Bluefish is associated with either maintaining body weight or a modest reduction in body weight.
Metformin Bluefish is used to treat patients with type 2 diabetes mellitus (non-insulin-dependent diabetes) when diet and exercise alone do not result in adequate blood glucose control. The medicine is particularly used in patients with overweight.
Adults can take Metformin Bluefish either alone or in combination with other anti-diabetic medicines (oral or insulin).
Children aged 10 years and older and adolescents can take Metformin Bluefish either alone or in combination with insulin.

2. Important information before taking Metformin Bluefish

When not to take Metformin Bluefish

• -if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (listed in section 6),
• -if you have liver disease,
• -if you have severely reduced 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 diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odor from the mouth,
• -in case of excessive loss of body water (dehydration), caused for example by prolonged or severe diarrhea or repeated vomiting. Dehydration can cause kidney problems, especially it can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• -in case of severe infection, such as pneumonia, bronchitis or pyelonephritis. Severe infection can cause kidney problems, especially it can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• -if you are being treated for acute heart failure, have recently had a heart attack, have severe circulatory problems (such as shock) or breathing difficulties. These conditions can cause tissue hypoxia and increase the risk of lactic acidosis (see "Warnings and precautions" below),
• -if you drink a lot of alcohol.

If you suspect that any of the above situations may apply to you, inform your doctor before taking this medicine.
You should consult your doctor if:

• a radiological examination or scintigraphy with intravenous administration of iodine-containing contrast agents is necessary,
• a major surgical procedure is necessary.

You should stop taking Metformin Bluefish for a while before and after the examination or surgery. Your doctor will decide whether you need to take another treatment during this time.
It is important to follow your doctor's instructions.

Warnings and precautions

Risk of lactic acidosis

Metformin Bluefish may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol intake, dehydration (see more information below), liver disease, and any conditions that cause tissue hypoxia (e.g. acute severe heart disease).
If any of the above conditions apply to you, consult your doctor for more detailed instructions.

You should temporarily stop taking Metformin Bluefish if you have

a condition that may cause dehydration(excessive loss of body water), such as severe vomiting, diarrhea, fever, exposure to high temperatures or if you drink less fluid than usual. Consult your doctor for more detailed instructions.

You should stop taking Metformin Bluefish and contact your doctor or the nearest hospital immediately if you experience

symptoms of lactic acidosis, as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell with severe fatigue,
• breathing difficulties,
• lowered body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate treatment in a hospital.
You should contact your doctor immediately for further instructions if:

• you have a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness.
• you experience any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, signs of nerve damage (e.g. pain or numbness), migraine, or hearing loss.

If you are going to have a major surgical procedure, you should not take Metformin Bluefish during the procedure and for some time after it. Your doctor will decide when you should stop and restart treatment with Metformin Bluefish.
Metformin Bluefish taken alone does not cause hypoglycemia (low blood sugar). However, the risk of hypoglycemia exists when Metformin Bluefish is taken with other anti-diabetic medicines that can cause hypoglycemia, such as sulfonylureas, insulin, and meglitinides.
Symptoms of hypoglycemia include weakness, dizziness, excessive sweating, rapid heartbeat, vision disturbances, or decreased concentration. Usually, consuming food or a sugary drink helps to relieve these symptoms.

Metformin Bluefish with other medicines

If you are going to have an intravenous iodine-containing contrast agent, for example for an X-ray examination or computed tomography, you should stop taking Metformin Bluefish before or at the latest at the time of administration. Your doctor will decide when you should stop and restart treatment with Metformin Bluefish.
Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood glucose monitoring and kidney function tests or a dose adjustment of Metformin Bluefish by your doctor. It is especially important to inform your doctor about the following medicines:

• 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-adrenergic receptor agonists, such as salbutamol and terbutaline (used to treat asthma),
• corticosteroids (medicines used to treat many diseases, such as severe skin inflammation or asthma),
• medicines that may change the level of Metformin Bluefish in the blood, especially if you have kidney problems (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other anti-diabetic medicines.

Metformin Bluefish with alcohol

Avoid excessive alcohol consumption while taking Metformin Bluefish, as it may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

During pregnancy, insulin should be used to treat diabetes. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine: your doctor may decide to change your treatment.
This medicine is not recommended if you are breastfeeding or planning to breastfeed.

Driving and using machines

Metformin Bluefish taken alone does not cause hypoglycemia (low blood sugar). This means that the medicine will not affect your ability to drive or use machines.
However, be careful if you take Metformin Bluefish with other anti-diabetic medicines that can cause hypoglycemia, such as sulfonylureas, insulin, and meglitinides.
Symptoms of hypoglycemia include weakness, dizziness, excessive sweating, rapid heartbeat, vision disturbances, or decreased concentration. Do not drive or use machines if you experience these symptoms.

3. How to take Metformin Bluefish

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Metformin Bluefish cannot replace the benefits of a healthy lifestyle. You should continue to follow the diet and exercise plan recommended by your doctor.

Recommended dose:

For children aged 10 years and older and adolescents, the usual starting dose is 500 mg or 850 mg of Metformin Bluefish once daily. The maximum daily dose is 2000 mg in 2 or 3 divided doses. Treatment in children aged 10 to 12 years is only recommended on a special recommendation by the doctor, due to limited experience in this age group.
For adults, the usual starting dose is 500 mg or 850 mg of Metformin Bluefish 2 or 3 times a day. The maximum daily dose is 3000 mg taken in 3 divided doses.
If you have kidney problems, your doctor may prescribe a lower dose.
If you are taking insulin, your doctor will tell you how to start taking Metformin Bluefish.

Treatment monitoring

• Your doctor will recommend regular blood glucose tests and adjust the dose of Metformin Bluefish according to your blood glucose levels. You should regularly consult your doctor. This is especially important for children and adolescents and for older people.
• In addition, your doctor will assess your kidney function at least once a year. More frequent checks may be necessary for older people or patients with kidney problems.

How to take Metformin Bluefish

Take Metformin Bluefish with or after a meal. This will help avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablets with a glass of water.

• If you take one dose a day, take it in the morning (with breakfast).
• If you take two doses a day, take them in the morning (with breakfast) and evening (with dinner).
• If you take three doses a day, take them in the morning (with breakfast), at noon (with lunch), and evening (with dinner).

If you feel that the effect of Metformin Bluefish is too strong or too weak, ask your doctor or pharmacist.

Taking a higher dose of Metformin Bluefish than recommended

If you take more Metformin Bluefish than recommended, you may experience lactic acidosis. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain with muscle cramps, general feeling of being unwell with severe fatigue, and breathing difficulties. Other symptoms include lowered body temperature and slowed heart rate. If you experience any of these symptoms, you should immediately seek medical help, as lactic acidosis can lead to coma. You should stop taking Metformin Bluefish and contact your doctor or the nearest hospital immediately.

Missing a dose of Metformin Bluefish

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Metformin Bluefish may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis, especially if your kidneys are not working properly. Symptoms of lactic acidosis are non-specific (see "Warnings and precautions"). If you experience it, stop taking Metformin Bluefish and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

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

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. Such side effects usually occur at the beginning of treatment with Metformin Bluefish. They can be prevented by spreading the doses throughout the day and taking Metformin Bluefish with a meal or immediately after it. If the symptoms do not disappear, you should stop taking Metformin Bluefish and consult your doctor.

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

• Taste disorders.
• Decreased or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness or tingling, or pale or yellowish skin). Your doctor may order several tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

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

• Liver problems with abnormal blood test results or hepatitis (may cause fatigue, loss of appetite, weight loss, yellowing of the skin and whites of the eyes or without yellowing). If you experience these symptoms, stop taking Metformin Bluefish and contact your doctor.
• Skin reactions, such as redness, itching, or itchy rash (hives).

Children and adolescents

Limited data from studies in children and adolescents indicate that side effects have a similar nature and intensity as in adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metformin Bluefish

Keep this medicine out of the sight and reach of children. If a child is treated with Metformin Bluefish, parents and caregivers should control its use.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date which is stated on the carton or blister after "EXP" or "Expiry date". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Metformin Bluefish contains

The active substance of Metformin Bluefish is metformin hydrochloride.
Each film-coated tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
The other ingredients of the medicine are:
Core: povidone, magnesium stearate.
Coating: hypromellose, macrogol.

What Metformin Bluefish looks like and contents of the pack

Film-coated tablet.
White, round, biconvex film-coated tablets with "A" embossed on one side and "60" on the other side.
Metformin Bluefish is available in blisters.
Each cardboard box contains 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90, 98, 100, 120, 200, 300, or 400 film-coated tablets in blisters of 10 or 14 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden
phone: +46 8 51 91 16 00

Manufacturer

Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark
Metformin "Bluefish"
France
Metformine Cristers Pharma 500 mg, comprimés pelliculés
Iceland
Metformin Bluefish 500 mg filmuhúðaðar töflur
Ireland
Metformin Bluefish 500 mg film-coated tablets
Poland
Metformin Bluefish 500 mg tablets
Sweden
Metformin Bluefish

Date of last revision of the leaflet: 03/2025