Metformin bluefish

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metformin Bluefish, 500 mg, coated tablets
Metformini hydrochloridum
Please read carefully all the information in this leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

Metformin Bluefish contains metformin, a medicine used in the treatment of diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas, which enables 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 cannot properly use the insulin it produces. This leads to increased glucose levels in the blood. Metformin Bluefish helps reduce blood glucose levels to values as close as possible to normal.
In overweight adults, long-term treatment with Metformin Bluefish also helps reduce the risk of diabetes-related complications. Treatment with Metformin Bluefish is associated with body weight maintenance or modest weight reduction.
Metformin Bluefish is used in the treatment of patients with type 2 diabetes (also known as insulin-independent diabetes), when diet and exercise alone have not achieved adequate blood glucose control. The medicine is particularly used in overweight patients.
Adults may take Metformin Bluefish as the sole therapy or in combination with other antidiabetic medicines (oral agents or insulin).
Children aged 10 years and older and adolescents may take Metformin Bluefish as monotherapy or in combination with insulin.

2. Important information before using Metformin Bluefish

When not to use Metformin Bluefish

• if the patient is allergic (hypersensitive) 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 hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden 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 and which may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odour of the breath,
• in case of excessive loss of body water (dehydration), caused for example by prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to kidney function disorders, especially increasing the risk of lactic acidosis (see section "Warnings and precautions" below),
• in case of severe infection, such as lung, bronchial or kidney infection. Severe infection may lead to kidney function disorders, especially increasing the risk of lactic acidosis (see section "Warnings and precautions" below),
• if the patient is being treated for acute heart failure, has recently suffered a heart attack, has severe circulatory disorders (such as shock) or breathing difficulties. These conditions may lead to reduced oxygen supply to tissues and may increase the risk of lactic acidosis (see section "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 using this medicine.
Consult a doctor if:

• a radiological or scintigraphic examination involving intravenous administration of iodine-containing contrast agents is required,
• a major surgical procedure is required.

The use of Metformin Bluefish must be temporarily discontinued for some time before and after the examination or surgical procedure.
The doctor will decide whether alternative treatment is necessary during this period.
It is important to strictly follow the doctor's instructions.

Warnings and precautions

Risk of lactic acidosis
Metformin Bluefish may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has kidney function disorders. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver function disorders, and any disease states in which a part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, they should consult their doctor for further instructions.

Temporarily discontinue the use of Metformin Bluefish if the patient develops a medical condition that may involve dehydration (significant loss of body water), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.

Discontinue the use of Metformin Bluefish and immediately contact a doctor or the nearest hospital if the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise associated with severe fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.

Contact a doctor immediately for further instructions if:

• the patient has a genetically inherited disease affecting mitochondria (cellular energy-producing structures), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD),
• after starting metformin treatment, the patient develops any of the following symptoms: seizures, worsening of cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.

If the patient is undergoing a major surgical procedure, they must not use Metformin Bluefish during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Metformin Bluefish.

Metformin Bluefish used alone does not cause hypoglycaemia (low blood sugar levels). However, the risk of hypoglycaemia exists when Metformin Bluefish is used concomitantly with other antidiabetic medicines that cause hypoglycaemia (such as sulfonylurea derivatives, insulin and meglitinides). If symptoms of hypoglycaemia occur, such as weakness, dizziness, excessive sweating, rapid heartbeat, blurred vision or reduced concentration, eating food or drinking a sugary beverage usually helps.

During treatment with Metformin Bluefish, the doctor will monitor the patient's kidney function at least once a year, or more frequently if the patient is elderly and/or has deteriorating kidney function.

Metformin Bluefish and other medicines

If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray or CT scan, they must stop taking Metformin Bluefish before or at the latest at the time of administration. The doctor will decide when the patient should stop and restart treatment with Metformin Bluefish.

Inform the doctor about all medicines currently taken, recently taken, or planned to be taken. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Metformin Bluefish by the doctor. It is especially important to inform about the following medicines:

• diuretics (medicines that increase urine production),
• 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 in the treatment of asthma),
• corticosteroids (medicines used to treat many conditions, such as severe skin inflammation or asthma),
• medicines that may alter the blood concentration of Metformin Bluefish, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used in the treatment of diabetes.

Metformin Bluefish and alcohol

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

Pregnancy and breastfeeding

During pregnancy, insulin should be used for the treatment of diabetes. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine: the doctor may decide that a change in treatment is necessary.

This medicine is not recommended if a woman is breastfeeding or planning to breastfeed.

Driving and operating machinery

Metformin Bluefish used alone does not cause hypoglycaemia (low blood sugar levels). This means that the medicine will not affect the ability to drive or operate machinery.

However, particular caution is required if Metformin Bluefish is used concomitantly with other antidiabetic medicines that may cause hypoglycaemia, such as sulfonylurea derivatives, insulin and meglitinides.

Symptoms of hypoglycaemia include: weakness, dizziness, excessive sweating, rapid heartbeat, blurred vision or reduced concentration. Do not drive or operate machinery if these symptoms occur.

3. How to use Metformin Bluefish

This medicine should always be taken exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Metformin Bluefish must not replace the benefits derived from a healthy lifestyle. You should continue the diet recommended by your doctor and regularly engage in physical exercise.
Recommended dose:
In children aged 10 years and older and in adolescents, the usual starting dose is 500 mg or 850 mg of Metformin Bluefish once daily. The maximum daily dose is 2000 mg, given in 2 or 3 divided doses. Treatment in children aged 10 to 12 years is indicated only on special medical advice due to limited experience in this age group.
The usual starting dose in adults is 500 mg or 850 mg of Metformin Bluefish two or three times daily. The maximum daily dose is 3000 mg, administered in three divided doses.
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
When insulin is used concomitantly, the doctor will inform the patient how to initiate treatment with Metformin Bluefish.

Monitoring of treatment

• Your doctor will recommend regular blood glucose monitoring and will adjust the dose of Metformin Bluefish according to blood glucose levels. You should consult your doctor regularly. This is particularly important for children and adolescents, as well as elderly patients.
• Additionally, your doctor will assess kidney function at least once a year. More frequent monitoring may be necessary in elderly patients or in patients with impaired kidney function.

How to use Metformin Bluefish
Metformin Bluefish should be taken during or after a meal. This helps to avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablets whole with a glass of water.

• If taking once daily, the dose should be taken in the morning (with breakfast).
• If taking two divided doses daily, they should be taken in the morning (with breakfast) and in the evening (with dinner).
• If taking three divided doses daily, they should be taken in the morning (with breakfast), at midday (with lunch), and in the evening (with dinner).

If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Taking more Metformin Bluefish than recommended
If you take more Metformin Bluefish than recommended, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain with muscle cramps, general malaise with severe fatigue, and breathing difficulties. Other symptoms include lowered body temperature and slowed heart rate. If any of these symptoms occur, the patient should immediately seek medical help, as lactic acidosis may lead to coma. Metformin Bluefish must be stopped immediately and the patient should contact a doctor or go to the nearest hospital.
Missing a dose of Metformin Bluefish
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur:
Metformin Bluefish may very rarely cause (in up to 1 in 10,000 patients) a very serious adverse reaction known as lactic acidosis, especially if the kidneys are not functioning properly. The symptoms of lactic acidosis are non-specific (see section “Warnings and precautions”). If it occurs in a patient, treatment with Metformin Bluefish must be discontinued and immediate contact must be made with a
doctor or the nearest hospital, as lactic acidosis can lead to coma.

Very common adverse reactions (occur in more than 1 in 10 patients)

• Gastrointestinal disturbances such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These adverse reactions most commonly occur at the beginning of treatment with Metformin Bluefish. They can be prevented by dividing the daily dose throughout the day and taking Metformin Bluefish during or immediately after meals. If symptoms do not resolve, treatment with Metformin Bluefish should be discontinued and medical advice sought.

Common adverse reactions (occur in less than 1 in 10 patients)

• Taste disturbances.
• Reduced or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellowish skin). Your doctor may order several tests to determine the cause of symptoms, as some of these may also be caused by diabetes or other health problems unrelated to diabetes.

Very rare adverse reactions (occur in less than 1 in 10,000 patients)

• Liver function abnormalities 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 a patient experiences these symptoms, treatment with Metformin Bluefish should be discontinued and a doctor contacted.
• Skin reactions such as skin redness (erythema), itching or itchy rash (urticaria).

Children and adolescents
Limited data from studies in children and adolescents indicate that adverse reactions are similar in nature and frequency to those in adults.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Metformin Bluefish

The medicine should be stored out of sight and reach of children. If a child is being treated with Metformin Bluefish, parents and caregivers should supervise 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 pack following “EXP” or “Expiry date”. The expiry date refers to the last day of the specified month.
Medicines must 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 is metformin hydrochloride.
Each coated tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of
metformin.
­ Other components of the medicine are:
Tablet core: povidone, magnesium stearate.
Coating: hypromellose, polyethylene glycol.

What Metformin Bluefish looks like and contents of the pack
Film-coated tablet.
White, round, biconvex film-coated tablets, embossed with "A" on one side and "60" on the other.
Metformin Bluefish is available in blister packs.
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, packed in blisters of 10 or 14 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden
Tel. +46 8 51 91 16 00

Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden

This medicinal product is authorised in 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 film-coated tablets
Sweden Metformin Bluefish