Filomag Uno

Package Leaflet: Information for the Patient

Filomag Uno

40 mg of magnesium ions, tablets

Magnesium hydroaspartate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 30 days, a doctor should be consulted.

Table of Contents of the Package Leaflet

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

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

The magnesium in Filomag Uno, in the form of magnesium hydroaspartate, performs many metabolic functions in the human body. It is an activator of many enzymes, mediates energy production and transport in the body, and is essential for the functioning of the heart, nervous system, smooth muscle of blood vessels, and striated muscles. A magnesium deficiency increases the risk of coronary heart disease, heart attack, and arrhythmias. Symptoms of magnesium deficiency include: hyperexcitability, difficulty concentrating, increased stress susceptibility, and skeletal muscle disorders (tremors).

Indications for Use

Filomag Uno is used in cases of magnesium deficiency.

If there is no improvement or the patient feels worse after 30 days, a doctor should be consulted.

2. Important Information Before Taking Filomag Uno

When Not to Take Filomag Uno

• if the patient is allergic to magnesium hydroaspartate or any other component of this medicine (listed in section 6);
• if the patient has hypermagnesemia (excessive magnesium in the blood);
• if the patient has severe renal impairment (creatinine clearance less than 30 ml/min);
• if the patient has atrioventricular conduction disorders (block), bradycardia (slow heart rate), or myasthenia gravis(a rare disease characterized by muscle weakness).

Warnings and Precautions

Before starting to take Filomag Uno, the patient should discuss it with a doctor or pharmacist.

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine.

During long-term use, the magnesium level in the blood serum should be monitored (the doctor will prescribe the necessary tests).

The patient should consult a doctor, even if the above warnings refer to past situations.

Children and Adolescents

The medicine is intended for adults and children over 4 years of age.

Filomag Uno and Other Medicines

The patient should inform the doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Magnesium salts reduce the absorption of certain antibiotics, such as tetracyclines; a minimum 3-hour interval should be maintained between the administration of these medicines.

Magnesium reduces the absorption of iron compounds, fluorine, fluoroquinolones, and oral anticoagulants derived from coumarin.

The medicine should not be taken simultaneously with phosphates and calcium compounds, as they reduce magnesium absorption.

Taking other products containing magnesium (with a laxative or antacid effect) may cause symptoms of magnesium poisoning, especially in patients with renal impairment.

Taking Filomag Uno with Food, Drink, and Alcohol

The medicine should be taken after a meal, with a glass of water.

Alcohol should not be consumed during treatment with the medicine.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Driving and Operating Machines

The medicine, when taken as directed, does not affect the ability to drive vehicles, operate machines, or perform psychophysical activities.

Filomag Uno Contains Sugar

One tablet contains 32 mg of sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine.

Filomag Uno Contains Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose, which means it is considered "sodium-free".

3. How to Take Filomag Uno

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

In case of doubt, the patient should consult a doctor or pharmacist.

Usually, the medicine is taken as described below.

Adults and Adolescents Over 12 Years Old:

• Therapeutically: The recommended dose is 1 or 2 tablets 2 or 3 times a day

i.e., 80 mg to 240 mg of magnesium per day (3.3 mmol to 9.9 mmol)

• Prophylactically, in justified cases: The recommended dose is 1 or 2 tablets 2 times a day, i.e., 80 mg to 160 mg of magnesium per day (3.3 mmol to 6.6 mmol)

Children from 4 to 12 Years Old:

Depending on the diagnosed magnesium deficiency, age, and body weight of the child:

usually, 1 or 2 tablets are taken 2 times a day

i.e., 80 mg to 160 mg of magnesium per day (3.3 mmol to 6.6 mmol)

The medicine should be taken orally, after a meal, with a glass of water.

Patients with Renal or Hepatic Impairment

Taking Filomag Uno in patients with renal impairment is contraindicated.

Filomag Uno should not be taken by patients with renal impairment.

Elderly Patients

There is no need to change the way the medicine is taken or the dosage in elderly patients.

If the patient feels that the effect of Filomag Uno is too strong or too weak, they should consult a doctor.

Taking a Higher Dose of Filomag Uno Than Recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist.

Symptoms of overdose: diarrhea, nausea, heart rhythm disorders (atrioventricular conduction disorders).

Treatment: symptomatic.

Missing a Dose of Filomag Uno

A double dose should not be taken to make up for a missed dose.

Stopping Treatment with Filomag Uno

In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Filomag Uno can cause side effects, although not everybody gets them.

Uncommon(may affect up to 1 in 100 people): nausea and diarrhea, which usually resolve on their own.

Rare(may affect up to 1 in 1,000 people): atrioventricular conduction disorders (changes in heart rhythm), skin redness, muscle weakness.

Very Rare(may affect up to 1 in 10,000 people): insomnia.

Reporting Side Effects

If any side effects occur, including those not listed in this package leaflet, the doctor or pharmacist should be informed.

Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C

02-222 Warsaw

tel: 22 49 21 301

fax: 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Filomag Uno

The medicine should be stored out of sight and reach of children.

The medicine should not be taken after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the specified month.

Store in a temperature below 25°C.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Filomag Uno Contains

• The active substance is magnesium hydroaspartate; one tablet contains 40 mg of magnesium ions.
• The excipients are: potato starch, sucrose, sodium carboxymethyl starch, magnesium stearate, talc.

What Filomag Uno Looks Like and Contents of the Package

Filomag Uno is a white, round, biconvex oral tablet.

Available packaging:

Tablets in blisters, in a cardboard box:

50 tablets - 2 blisters of 25 tablets each

75 tablets - 3 blisters of 25 tablets each

Marketing Authorization Holder and Manufacturer

Farmaceutyczna Spółdzielnia Pracy FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:

Farmaceutyczna Spółdzielnia Pracy FILOFARM

ul. Pułaskiego 39; 85-619 Bydgoszcz

tel.: 52 342 67 88

Information for the Blind and Visually Impaired: The content of the Filomag Uno package leaflet is available in the Ulotka Audio system under the national free phone number 800 706 848.

Date of Last Revision of the Package Leaflet: November 2024