Filomag B6

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

FILOMAG B

40 mg of magnesium ions + 5 mg, tablets

Magnesium hydroaspartate + Pyridoxine hydrochloride
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient information leaflet or as directed by your doctor or pharmacist.

• You should keep this leafletso that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 30 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Filomag B and what is it used for.
• 2. Important information before taking Filomag B
• 3. How to take Filomag B
• 4. Possible side effects
• 5. How to store Filomag B
• 6. Contents of the pack and other information

1. What is Filomag B and what is it used for

Filomag B contains a well-absorbed magnesium compound (aspartate) and vitamin B.
Magnesiumacts as an enzyme activator and performs many metabolic functions in the human body's cells.
It is essential for heart muscle function, the nervous system, smooth muscle of blood vessels, and striated muscle.
A magnesium deficiency increases the risk of cardiovascular disease, heart attack, and heart rhythm disorders.
Symptoms of magnesium deficiency include: hyperexcitability, concentration difficulties, increased stress sensitivity, and skeletal muscle disorders (muscle cramps, tetany).
Vitamin Bincreases magnesium absorption from the gastrointestinal tract by 20 to 40%, facilitates the transport of this element into cells, and maintains its proper intracellular concentration.
It also reduces magnesium excretion in the urine.
The effectiveness of magnesium preparations containing vitamin B is greater than that of magnesium alone.
Vitamin B participates in protein metabolism (as a coenzyme in amino acid metabolism and protein synthesis).
Its deficiency can cause skin inflammation, mucous membrane inflammation, anemia, neurological disorders, and general weakness.

Indications for use

Filomag B is used:

• in confirmed magnesium and/or vitamin B deficiency, and
• in symptoms of functional magnesium deficiency.

2. Important information before taking Filomag B

When not to take Filomag B

• if you are allergic (hypersensitive) to the active substances or any of the other ingredients of the medicine (listed in section 6),
• if you have hypermagnesemia (excess magnesium in the blood),
• if you have severe renal impairment (creatinine clearance less than 30 ml/min),
• if you have atrioventricular conduction disorders (block), bradycardia (abnormally slow heart rate), or myasthenia gravis(a rare disease characterized by muscle weakness).

Warnings and precautions

You should be cautious if the medicine is administered for a long period.
During long-term use, magnesium levels in blood serum should be monitored (your doctor will prescribe the necessary tests).
The medicine contains sucrose (sugar). One tablet contains 29 mg of sucrose.
This should be taken into account in patients with diabetes.
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking the medicine.

Children and adolescents

The medicine is not intended for use in children under 4 years of age.

Other medicines and Filomag B

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The medicine should not be taken simultaneously with phosphates and calcium compounds, as they reduce magnesium absorption.
Magnesium salts reduce the absorption of certain antibiotics, such as tetracyclines;
a minimum 3-hour interval should be maintained between the administration of both medicines.
Magnesium reduces the absorption of iron compounds, fluoride, fluoroquinolones, and oral anticoagulants of the coumarin derivative type.
Vitamin B reduces the effectiveness of levodopa preparations without a peripheral decarboxylase inhibitor (medicines used in parkinsonism).

Filomag B with food and drink

The medicine should be taken after a meal, with a glass of water.
Magnesium absorption is reduced in the presence of phosphates, calcium, lipids, and phytates in the diet.

Pregnancy, breastfeeding, and fertility

In pregnancy, during breastfeeding, or if you suspect you are pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before taking any medicine.
In recommended doses, the medicine can be used during pregnancy and breastfeeding, but only in consultation with your doctor, who will determine the appropriate dose.

Driving and using machines

The medicine, when used as directed, does not affect the ability to drive vehicles, operate machinery, or psychophysical performance.

3. How to take Filomag B

The medicine should be used as directed by your doctor.
In case of doubt, you should consult your doctor again.
Usually, the medicine is used as described below.

Adults and adolescents over 12 years of age:

• therapeutically: usually 1 to 2 tablets 2 to 3 times a day (maximum 6 tablets per day), i.e., 80 mg to 240 mg of Mg per day (3.3 mmol to 9.9 mmol); 10 mg to 30 mg of vitamin B per day,
• prophylactically, in justified cases: usually 1 to 2 tablets 2 times a day (maximum 4 tablets per day), i.e., 80 mg to 160 mg of Mg per day (3.3 mmol to 6.6 mmol); 10 mg to 20 mg of vitamin B per day.

Children from 4 to 12 years of age:

according to confirmed magnesium deficiencies, age, and body weight of the child:
usually 1 to 2 tablets 2 times a day (maximum 4 tablets per day),
i.e., 80 mg to 160 mg of Mg per day (3.3 mmol to 6.6 mmol);
10 mg to 20 mg of vitamin B per day.
Patients with renal or hepatic impairment
Filomag B should not be used in patients with renal impairment.
Elderly patients
There is no need to change the way the medicine is administered or the dosage in patients over 65 years of age.
If you feel that the effect of Filomag B is too strong or too weak, you should consult your doctor.

In case of taking a higher dose of Filomag B than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately consult your doctor or pharmacist.
Symptoms of overdose: diarrhea, nausea, heart rhythm disorders (change in rhythm, atrioventricular conduction disorders).
Treatment: symptomatic.

Missing a dose of Filomag B

You should not take a double dose to make up for a missed dose.

Stopping treatment with Filomag B

In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Filomag B can cause side effects, although not everybody gets them.
Uncommon(symptoms occur less frequently than in 1 in 100 treated patients):
nausea and diarrhea, which usually resolve on their own
Rare(symptoms occur less frequently than in 1 in 1000 treated patients):
atrioventricular conduction disorders (e.g., changes in heart rhythm), skin redness, muscle weakness
Very rare(symptoms occur less frequently than in 1 in 10,000 treated patients):
insomnia
In some people, other side effects may occur during treatment with Filomag B.
If you experience any side effects, including any possible side effects not listed in this leaflet, you should consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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 49 21 309
e-mail: ndl@urpl.gov.pl
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Filomag B

The medicine should be stored in a place inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Store in a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
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 Filomag B contains

The active substances of the medicine are: magnesium aspartate and pyridoxine hydrochloride.
1 tablet contains: 40 mg of magnesium ions in the form of 600 mg of magnesium aspartate 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 oral tablets.
Available pack sizes:
Tablets in blisters, in a cardboard box:
25 tablets – 1 blister of 25 tablets
50 tablets – 2 blisters of 25 tablets
75 tablets – 3 blisters of 25 tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Pharmaceutical Cooperative FILOFARM
ul. Pułaskiego 39; 85-619 Bydgoszcz.
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
Pharmaceutical Cooperative FILOFARM
ul. Pułaskiego 39; 85-619 Bydgoszcz
phone: 52 342 67 88

Date of last revision of the leaflet: