Metformin Bluefish

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Metformin Bluefish, 850 mg, coated tablets

Metformin hydrochloride

You should carefully read the contents of the leaflet before using 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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their 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 later 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 glucose level in the blood. Metformin Bluefish helps to reduce the glucose level 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 maintaining weight or moderate weight loss.
Metformin Bluefish is used to treat patients with type 2 diabetes mellitus (non-insulin-dependent diabetes), if diet and physical exercise alone do not achieve adequate blood glucose control. The medicine is used especially in patients with overweight.
Adults can take Metformin Bluefish alone or in combination with other anti-diabetic medicines (oral medicines or insulin).
Children aged 10 years and older and adolescents can take Metformin Bluefish alone or in combination with insulin.

2. Important information before taking Metformin Bluefish

When not to take Metformin Bluefish

• -if the patient is hypersensitive (allergic) to metformin or any of the other ingredients of this medicine (listed in section 6),
• -if the patient has liver function disorders,
• -if the patient has significantly reduced kidney function,
• -if the patient has uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden 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 which can lead to diabetic pre-coma. The symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity breath odor,
• -in case of excessive water loss from the body (dehydration), caused for example by prolonged or severe diarrhea or repeated vomiting. Dehydration can cause kidney function disorders, especially may 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 function disorders, especially may increase the risk of lactic acidosis (see "Warnings and precautions" below),
• -if the patient is being treated for acute heart failure, has recently had a heart attack, has severe circulatory disorders (such as shock) or breathing difficulties. These conditions can cause reduced tissue oxygen supply and may increase the risk of lactic acidosis (see "Warnings and precautions" below),
• -if the patient consumes large amounts of alcohol.

If the patient suspects that any of the above situations may apply to them, they should inform their doctor before taking this medicine.
You should consult a 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 while before and after the examination or surgical procedure. The doctor will decide whether another treatment is necessary during this time.
It is important to follow the 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 the patient has kidney function disorders. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver function disorders and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g. acute severe heart diseases).
If any of the above circumstances apply to the patient, they should consult their doctor for more detailed instructions.

You should temporarily stop taking Metformin Bluefish if the patient has

a condition that may be associated with dehydration(significant water loss from the body),
such as severe vomiting, diarrhea, fever, exposure to high temperature or if the patient drinks less fluid than usual. You should consult your doctor for more detailed instructions.

You should stop taking Metformin Bluefish and immediately contact your doctor or the nearest hospital if the patient experiences any symptoms of

lactic acidosis, as this condition 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,
• decreased body temperature and slowed heart rate.

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

• the patient has 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.
• the patient has experienced 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 the patient is to undergo a major surgical procedure, they should not take Metformin Bluefish during the procedure and for some time after it. The doctor will decide when the patient should stop and resume 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 sulfonylurea derivatives, insulin and meglitinides. In case of hypoglycemia symptoms, such as weakness, dizziness, excessive sweating, rapid heartbeat, vision disturbances or decreased concentration, it is usually helpful to consume food or a sugary drink.

Metformin Bluefish with other medicines

If the patient is to be injected with an iodine-containing contrast agent into the bloodstream, for example for an X-ray examination or computed tomography, they should stop taking Metformin Bluefish before or at the latest at the time of such injection. The doctor will decide when the patient should stop and resume treatment with Metformin Bluefish.
You should tell your doctor about all medicines you are currently 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 assessments or a dose adjustment of Metformin Bluefish by your doctor. It is especially important to inform 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 stimulants, 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 the patient has kidney function disorders (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 this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

During pregnancy, insulin should be used to treat diabetes. If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a baby, they should consult their doctor before taking this medicine: the doctor may decide to change the treatment.
It is not recommended to use this medicine if the woman is breastfeeding or plans 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 the ability to drive and use machines.
However, you should be especially careful if you take Metformin Bluefish in combination with other anti-diabetic medicines that can cause hypoglycemia, such as sulfonylurea derivatives, insulin and meglitinides.
The symptoms of hypoglycemia are: weakness, dizziness, excessive sweating, rapid heartbeat, vision disturbances or decreased concentration. You should not drive or operate machinery if you experience these symptoms.

3. How to take Metformin Bluefish

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Metformin Bluefish cannot replace the benefits of a healthy lifestyle. You should continue to follow the diet recommended by your doctor and regularly exercise.

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 a day. 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 special advice of a 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 taken in 3 divided doses.
If the patient has kidney function disorders, the doctor may prescribe a lower dose.
In case of concomitant use of insulin, the doctor will inform the patient how to start taking Metformin Bluefish.

Treatment monitoring

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

How to take Metformin Bluefish

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

• In case of once-daily dosing, it should be taken in the morning (during breakfast).
• In case of twice-daily dosing, the doses should be taken in the morning (during breakfast) and in the evening (during dinner).
• In case of three-times-daily dosing, the doses should be taken in the morning (during breakfast), at noon (during lunch) and in the evening (during dinner).

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

In case of taking a higher dose of Metformin Bluefish than recommended, lactic acidosis may occur. 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 decreased body temperature and slowed heart rate. If any of these symptoms occur, the patient should immediately seek medical help, as lactic acidosis can lead to coma. You should immediately stop taking Metformin Bluefish and contact your doctor or the nearest hospital.

Missing a dose of Metformin Bluefish

You should not take a double dose to make up for a missed dose. The next dose should be taken at the usual time.
If you have any further doubts about taking this medicine, you should consult 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 occur in up to 1 in 10,000 patients) a very serious side effect called lactic acidosis, especially if the kidneys are not working properly. The symptoms of lactic acidosis are non-specific (see "Warnings and precautions"). If it occurs in a patient, they should stop taking Metformin Bluefish and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.

Very common side effects (occurring in more than 1 in 10 patients)

• 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 dividing the doses throughout the day and taking Metformin Bluefish during or immediately after a meal. If the symptoms do not disappear, you should stop taking Metformin Bluefish and consult your doctor.

Common side effects (occurring in less than 1 in 10 patients)

• 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 pale or yellowish skin). The 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 (occurring in less than 1 in 10,000 patients)

• Liver function disorders with abnormal test results or hepatitis (may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin and whites of the eyes). If the patient experiences these symptoms, they should stop taking Metformin Bluefish and contact their 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 side effects occur, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported 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
Side effects can also be reported 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 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 850 mg of metformin hydrochloride, equivalent to 663 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, round, biconvex coated tablets with "A" embossed on one side and "61" on the other side.
Metformin Bluefish is available in blisters.
Each carton contains 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90, 98, 100, 120, 200, 300 or 400 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 850 mg Filmtabletten
Denmark
Metformin "Bluefish"
France
Metformine Cristers Pharma 850 mg, comprimés pelliculés
Spain
Metformina Bluefish 850 mg comprimidos recubiertos con película EFG
Iceland
Metformin Bluefish 850 mg filmuhúðaðar töflur
Ireland
Metformin Bluefish 850 mg film-coated tablets
Poland
Metformin Bluefish 850 mg tabletki powlekane
Portugal Metformina Bluefish 850 mg comprimidos revestidos por pelicula
Sweden
Metformin Bluefish

Date of last revision of the leaflet: 03/2025