Metformin bluefish

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metformin Bluefish, 1000 mg, film-coated tablets
Metformini hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, please 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 to treat diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that 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 that is produced. This leads to increased blood glucose levels. 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 maintenance of body weight or with moderate weight reduction.
Metformin Bluefish is used to treat patients with type 2 diabetes (also known as non-insulin-dependent diabetes) when diet and physical activity alone have not provided adequate control of blood glucose levels. It is particularly used in overweight patients.
Adults may take Metformin Bluefish as the only antidiabetic medicine 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 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 fluid loss from the body (dehydration), caused for example by prolonged or severe diarrhoea or repeated vomiting. Dehydration may cause 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 cause 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 had a heart attack, has severe circulatory disorders (such as shock) or breathing difficulties. These conditions may cause 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, 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 should be temporarily discontinued for some time before and after such an 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 reaction 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 medical conditions in which 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.
Metformin Bluefish should be temporarily discontinued if the patient develops a medical condition that may involve dehydration (significant loss of water from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult their doctor for further instructions.
Metformin Bluefish should be discontinued and the patient should immediately contact their doctor or the nearest hospital if any symptoms of lactic acidosis occur, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell combined 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 the doctor immediately for further instructions if:

• the patient has a genetically inherited disease affecting mitochondria (cellular structures producing energy), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD),
• the patient develops any of the following symptoms after starting metformin: seizures, worsening 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 take 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, when used alone, does not cause hypoglycaemia (low blood sugar levels). However, the risk of hypoglycaemia exists when Metformin Bluefish is used together 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, vision disturbances or reduced concentration, eating food or drinking a sugary drink is usually helpful.
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 worsening kidney function.

Metformin Bluefish and other medicines
If an iodine-containing contrast agent is administered intravenously, for example for an X-ray examination or computed tomography, the patient must 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.
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. 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 to treat asthma),
• corticosteroids (medicines used to treat many conditions, such as severe skin inflammation or asthma),
• medicines that may alter Metformin Bluefish blood levels, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used to treat 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 to treat diabetes. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans 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 her child.

Driving and operating machinery
Metformin Bluefish, when 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 together 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, vision disturbances or reduced concentration. Driving and operating machinery should be avoided if these symptoms occur.

3. How to use Metformin Bluefish

This medicine should always be taken exactly as directed by your doctor. 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 engage in regular 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 advice of 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 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

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

How to take 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). Metformin Bluefish 1000 mg contains a division line. The division line is not intended for breaking the tablet.

If you feel the effect of the medicine is too strong or too weak, consult your doctor or
pharmacist.
Use of more than the recommended dose of Metformin Bluefish
Taking more Metformin Bluefish than recommended may lead to lactic acidosis. Symptoms of
lactic acidosis are non-specific and include vomiting, abdominal pain with muscle cramps, general
malaise with severe fatigue, and difficulty breathing. Other symptoms include lowered body
temperature and slowed heart rate. If any of these symptoms occur, the patient must seek
immediate medical attention, 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.
Missed 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur:
Metformin Bluefish may very rarely (may affect up to 1 in 10,000 people) cause a very serious side effect 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 lactic acidosis occurs, treatment with Metformin Bluefish must be stopped and immediate contact must be made with a
doctor or the nearest hospital, as lactic acidosis may lead to coma.

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

• Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These side effects most commonly occur at the beginning of treatment with Metformin Bluefish. They can be prevented by spreading the doses 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 a doctor should be consulted.

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

• Taste disturbances.
• Reduced or low blood levels of vitamin B12 (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 them may also be caused by diabetes or other health problems unrelated to diabetes.

Very rare side effects (occur 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 these symptoms occur, treatment with Metformin Bluefish must be stopped and a doctor should be contacted.
• Skin reactions such as redness of the skin (erythema), itching or itchy rash (urticaria).

Children and adolescents
Limited data from studies in children and adolescents indicate that side effects are of a similar nature and severity as in adults.

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 authorisation holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Metformin Bluefish

Keep this medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin.
­ The other ingredients are:
Tablet core: povidone, magnesium stearate.
Coating: hypromellose, polyethylene glycol.

What Metformin Bluefish looks like and contents of the pack
Film-coated tablet.
White, oval, biconvex film-coated tablets, embossed with "A" on one side and "62" on the other side, with a break line between "6" and "2".
Metformin Bluefish is available in blister packs.
Each cardboard box contains 20, 30, 40, 50, 60, 70, 80, 90, 100 or 120 film-coated tablets 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 member states 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