Metformin Bluefish

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Metformin Bluefish, 1000 mg, coated tablets

Metformin hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should 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, you should tell 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. The use of Metformin Bluefish is associated with either weight loss or a modest weight gain.
Metformin Bluefish is used to treat patients with type 2 diabetes mellitus (non-insulin-dependent diabetes), if diet and exercise alone do not control blood glucose levels. 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 disease in which substances called ketone bodies accumulate in the blood and can lead to diabetic pre-coma. The 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 kidney infection. 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, you should inform your doctor before taking this medicine.
You should consult your doctor if:

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

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

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 heart failure).
If any of the above conditions apply to you, you should 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. You should 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 any symptoms of

lactic acidosis, as it can lead to coma.
The 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 hospital treatment.
You should contact your doctor immediately for further instructions if:

• you have a hereditary disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalomyopathy, 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 a certain period after it. Your doctor will decide when you should stop and restart treatment with Metformin Bluefish.
Metformin Bluefish used alone does not cause hypoglycemia (low blood sugar). However, the risk of hypoglycemia occurs when Metformin Bluefish is used in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, and meglitinides). In case of hypoglycemia, it is usually helpful to consume food or a drink containing sugar.
During treatment with Metformin Bluefish, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have impaired kidney function.

Metformin Bluefish with other medicines

If you are going to have an intravascular injection of a contrast agent containing iodine, 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 the injection. Your doctor will decide when you should stop and restart treatment with Metformin Bluefish.
You should 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 checks and kidney function tests, or your doctor may need to adjust the dose of Metformin Bluefish. 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 medicines used to treat diabetes.

Metformin Bluefish with alcohol

You should avoid consuming excessive amounts of alcohol 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, you should 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 used alone does not cause hypoglycemia (low blood sugar). This means that the medicine will not affect your ability to drive or use machines.
However, you should be careful if you take Metformin Bluefish in combination 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. You should not drive or use machines if you experience these symptoms.

3. How to take Metformin Bluefish

You should always take this medicine exactly as your doctor has told you. If you are not sure, you should 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:

In 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.
The usual starting dose in adults is 500 mg or 850 mg of Metformin Bluefish 2 or 3 times a day. The maximum daily dose is 3000 mg 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 people over 65 years of age.
• In addition, your doctor will assess your kidney function at least once a year. More frequent checks may be necessary for people over 65 years of age or for patients with kidney problems.

How to take Metformin Bluefish

Metformin Bluefish should be taken with or after a meal. This will help avoid gastrointestinal side effects.
Tablets should not be crushed or chewed. Tablets should be swallowed with a glass of water.

• If you are taking one dose a day, you should take it in the morning (with breakfast).
• If you are taking two divided doses a day, you should take them in the morning (with breakfast) and in the evening (with dinner).
• If you are taking three divided doses a day, you should take them in the morning (with breakfast), at noon (with lunch), and in the evening (with dinner). Metformin Bluefish 1000 mg contains a dividing line. The dividing line is not intended to break the tablet.

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

Taking a higher dose of Metformin Bluefish than recommended

If you take a higher dose of Metformin Bluefish than recommended, you may experience lactic acidosis. The 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 seek medical help immediately, 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

You should not take a double dose to make up for a forgotten dose. You should take the next dose at the usual time.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Metformin Bluefish 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. The symptoms of lactic acidosis are non-specific (see "Warnings and precautions"). If you experience it, you should stop taking Metformin Bluefish and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

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

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These side effects usually occur at the beginning of treatment with Metformin Bluefish. They can be prevented by dividing 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 (affecting 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, or numbness). 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 (affecting less than 1 in 10,000 people)

• Liver problems with abnormal 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, you should stop taking Metformin Bluefish and contact your doctor.
• Skin reactions, such as redness, itching, or itchy rash.

Children and adolescents

Limited data from studies in children and adolescents indicate that the 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, you should tell 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,
Al. 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

The medicine should be stored out of the sight and reach of children. If a child is being 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Metformin Bluefish contains

The active substance of the medicine is metformin hydrochloride.
Each coated tablet contains 1000 mg of metformin hydrochloride, which corresponds to 780 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

Coated tablet.
White, oval, biconvex coated tablets with the inscription "A" on one side and "62" on the other side and a dividing line between "6" and "2".
Metformin Bluefish is available in blisters.
Each carton contains 20, 30, 40, 50, 60, 70, 80, 90, 100, or 120 coated tablets in blisters of 10 or 14 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:

Austria
Metformin Bluefish 1000 mg Filmtabletten
Denmark
Metformin "Bluefish"
France
Metformine Cristers Pharma 1000 mg, comprimés pelliculés
Iceland
Metformin Bluefish 1000 mg filmuhúðaðar töflur
Ireland
Metformin Bluefish 1000 mg film-coated tablets
Poland
Metformin Bluefish 1000 mg tabletki powlekane
Portugal
Metformina Bluefish 1000 mg comprimidos revestidos por pelicula
Sweden
Metformin Bluefish

Date of last revision of the leaflet: 03/2025