Filomag b6
Poland
Table of Contents
FILOMAG B
40 mg of magnesium ions + 5 mg, tablets
Magnesii hydroaspartas + Pyridoxini hydrochloridum
PLEASE READ THIS LEAFLET CAREFULLY BEFORE USING THE MEDICINE, AS IT CONTAINS IMPORTANT INFORMATION FOR THE PATIENT.
This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 30 days, or if the patient feels worse, consult a doctor.
Contents of the leaflet
- What Filomag B is and what it is used for
- Important information before taking Filomag B
- How to take Filomag B
- Possible side effects
- How to store Filomag B
- Contents of the package and other information
1. What is Filomag B and what is it used for
Filomag B contains a well-absorbed magnesium compound (magnesium aspartate) and vitamin B₆.
Magnesium, as an enzyme activator, performs many metabolic functions in human body cells. It is essential for the proper function of the heart muscle, nervous system, smooth vascular muscle, and striated muscles. Magnesium deficiency increases the risk of coronary heart disease, myocardial infarction, and cardiac arrhythmias. Symptoms of magnesium deficiency include: hyperexcitability, difficulty concentrating, increased susceptibility to stress, and disorders of skeletal muscles (muscle cramps, tetany).
Vitamin B₆ increases the gastrointestinal absorption of magnesium by 20 to 40%, facilitates the transport of this element into cells, and maintains adequate intracellular magnesium concentration. It also reduces magnesium excretion in urine. The efficacy of magnesium preparations containing vitamin B₆ is higher than that of magnesium alone. Vitamin B₆ participates in protein metabolism (as a coenzyme in amino acid transformations and protein synthesis). Its deficiency may cause skin inflammation of the extremities, mucosal inflammation, anemia, neurological disorders, and general weakness.
Indications for use
Filomag B is indicated:
- In confirmed deficiency of magnesium and/or vitamin B₆, and
- In symptoms of functional magnesium deficiency.
2. Important information before taking Filomag B
When not to use Filomag B
- If the patient is allergic (hypersensitive) to the active substances or any of the other ingredients listed in section 6,
- If the patient has hypermagnesemia (excess magnesium in the blood),
- If the patient has severe renal insufficiency (creatinine clearance less than 30 mL/min),
- If the patient has atrioventricular conduction disturbances (block), bradycardia (abnormally slow heart rate), or myasthenia gravis (a rare disease characterized by muscle weakness).
Warnings and precautions
Exercise caution if Filomag B is to be used for a prolonged period.
During long-term treatment, serum magnesium levels should be monitored (your doctor will recommend appropriate blood tests).
This medicine contains sucrose (sugar). One tablet contains 29 mg of sucrose. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
Children and adolescents
Filomag B is not intended for use in children under 4 years of age.
Other medicines and Filomag B
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Do not take Filomag B simultaneously with phosphates or calcium compounds, as they reduce magnesium absorption. Magnesium salts reduce the absorption of certain antibiotics, e.g., tetracyclines; a minimum interval of 3 hours should be maintained between administration of both medicines. Magnesium reduces the absorption of iron, fluorine, fluoroquinolones, and oral anticoagulants of the coumarin derivatives. Vitamin B₆ reduces the effectiveness of levodopa preparations without a peripheral decarboxylase inhibitor (medicines used in Parkinson’s disease).
Filomag B with food and drink
Take the medicine after meals, with water.
Magnesium absorption is reduced in the presence of dietary phosphates, calcium, lipids, and phytates.
Pregnancy, breastfeeding, and fertility
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before taking any medicine.
Filomag B may be used during pregnancy and breastfeeding at recommended doses, but only under medical supervision and with dosage guidance from the attending physician.
Driving and operating machinery
When used as directed, Filomag B does not affect the ability to drive or operate machinery or psychomotor performance.
3. How to take Filomag B
Take Filomag B exactly as directed by your doctor. If in doubt, consult your doctor again.
The usual dosage recommendations are as follows:
Adults and adolescents over 12 years of age:
- Therapeutic use: usually 1 to 2 tablets, 2 to 3 times daily (maximum 6 tablets per day), i.e., 80 mg to 240 mg Mg/day (3.3 mmol to 9.9 mmol); 10 mg to 30 mg vitamin B₆/day.
- Prophylactic use, in justified cases: usually 1 to 2 tablets twice daily (maximum 4 tablets per day), i.e., 80 mg to 160 mg Mg/day (3.3 mmol to 6.6 mmol); 10 mg to 20 mg vitamin B₆/day.
Children aged 4 to 12 years:
Depending on the degree of magnesium deficiency, age, and body weight: usually 1 to 2 tablets twice daily (maximum 4 tablets per day), i.e., 80 mg to 160 mg Mg/day (3.3 mmol to 6.6 mmol); 10 mg to 20 mg vitamin B₆/day.
Patients with impaired kidney or liver function
Filomag B should not be used in patients with impaired kidney function.
Elderly patients
No dosage adjustment is required for patients over 65 years of age.
If you feel the effect of Filomag B is too strong or too weak, consult your doctor.
If you take more Filomag B than recommended
In case of overdose, contact your doctor or pharmacist immediately.
Symptoms of overdose: diarrhea, nausea, cardiac disturbances (rhythm changes, atrioventricular conduction disorders).
Treatment: symptomatic.
If you forget to take Filomag B
Do not take a double dose to make up for the missed dose.
Stopping Filomag B
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, Filomag B can cause side effects, although not everyone experiences them.
Uncommon (affects fewer than 1 in 100 patients):
Nausea and diarrhea, which usually resolve spontaneously.
Rare (affects fewer than 1 in 1,000 patients):
Atrioventricular conduction disturbances (e.g., changes in heart rhythm), skin redness, muscle weakness.
Very rare (affects fewer than 1 in 10,000 patients):
Insomnia.
Other side effects may occur in some individuals during treatment with Filomag B. If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Reporting of side effects
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring of 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 49 21 309
e-mail: [email protected]
Reporting side effects helps provide more information on the safety of this medicine.
5. How to store Filomag B
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from moisture.
Do not use after the expiry date stated on the package. The expiry date refers to the last day of the month indicated.
6. Contents of the package and other information
What is in Filomag B
- Active substances: magnesium hydroaspartate (providing 40 mg of magnesium ions) and pyridoxine hydrochloride (5 mg).
- Other ingredients: sucrose, microcrystalline cellulose, lactose monohydrate, magnesium stearate, colloidal anhydrous silica.
What the package contains
Filomag B tablets are available in blister packs of 30, 60, or 90 tablets, and in HDPE bottles of 100 tablets.
Marketing Authorization Holder:
[Company Name]
[Address]
Manufacturer:
[Manufacturer Name]
[Address]
For any further information about this medicine, please contact the local representative of the Marketing Authorization Holder.
Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: www.urpl.gov.pl
This leaflet was last reviewed in [Month, Year].
5. How to store Filomag B
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the indicated month.
Store below 25°C.
Keep in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.
6. Contents of the packaging and other information
What Filomag B contains
The active substances in this medicine are: magnesium hydroaspartate and pyridoxine hydrochloride.
Each tablet contains: 40 mg of magnesium ions in the form of 600 mg of magnesium hydroaspartate and 5 mg of pyridoxine hydrochloride.
Excipients: potato starch, sodium carboxymethyl starch, sucrose, talc, magnesium stearate.
What Filomag B looks like and contents of the pack
Filomag B is an oral tablet.
Available pack sizes:
Tablets in blisters, in a cardboard box:
25 tablets – 1 blister with 25 tablets
50 tablets – 2 blisters with 25 tablets each
75 tablets – 3 blisters with 25 tablets each
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39; 85-619 Bydgoszcz.
For further information, please contact the marketing authorisation holder:
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39; 85-619 Bydgoszcz
tel.: 52 342 67 88