Package leaflet: information for the patient

Filomag Uno
40 mg magnesium ions, tablets
Magnesii hydroaspartas
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 30 days, or if you feel worse, consult your doctor.

Contents of the leaflet

What Filomag Uno is and what it is used for
Important information before taking Filomag Uno
How to take Filomag Uno
Possible side effects
How to store Filomag Uno
Contents of the pack and other information

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

Magnesium, contained in the medicine in the form of magnesium hydroaspartate, plays many metabolic roles in human body cells. It acts as an activator of numerous enzymes and is involved in the production and transport of energy in the body. It is essential for the proper function of the heart muscle, nervous system, smooth muscle of blood vessels, and striated muscles. Magnesium deficiency increases the risk of coronary artery disease, myocardial infarction, and cardiac arrhythmias. Symptoms of magnesium deficiency include:
hyperexcitability, difficulty concentrating, increased susceptibility to stress, and skeletal muscle disturbances (tremors).
Indications
Filomag Uno is indicated for the treatment of magnesium deficiency.
If there is no improvement after 30 days, or if you feel worse, consult your doctor.

2. Important information before using Filomag Uno

When not to use Filomag Uno

if the patient is allergic to magnesium aspartate or any of the other ingredients of this medicine (listed in section 6);
if the patient has hypermagnesaemia (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 disorders (block), bradycardia (abnormally slow heart rate), or myasthenia gravis (a rare disease characterized by muscle weakness).

Warnings and precautions
Before starting treatment with Filomag Uno, please consult your doctor or pharmacist.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.
During prolonged use, serum magnesium levels should be monitored (your doctor will recommend appropriate blood tests).
Please consult your doctor, even if the above warnings refer to conditions that occurred in the past.

Children and adolescents
This medicine is intended for use in adults and children aged 4 years and older.

Filomag Uno with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Magnesium salts reduce the absorption of certain antibiotics, such as tetracyclines; a minimum interval of 3 hours should be maintained between administration of these drugs.
Magnesium reduces the absorption of iron, fluorides, fluoroquinolones, and oral anticoagulants of the cumarin derivatives.
This medicine should not be taken simultaneously with phosphates or calcium-containing compounds, as they reduce magnesium absorption.
Concomitant use of other magnesium-containing products (with laxative or gastric acid-neutralizing effects) may cause symptoms of magnesium poisoning, especially in patients with renal impairment.

Taking Filomag Uno with food, drink and alcohol
Take the medicine after meals, with water.
Do not drink alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
When used as directed, this medicine does not affect the ability to drive, operate machinery or impair psycho-motor performance.

Filomag Uno contains sucrose (sugar)
One tablet contains 32 mg of sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Filomag Uno contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose, meaning the medicine is considered "sodium-free".

3. How to take Filomag Uno

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is usually taken as described below.
Adults and adolescents over 12 years of age:

Therapeutic use: The recommended dose is 1 or 2 tablets 2 or 3 times daily,
i.e. 80 mg to 240 mg magnesium/day (3.3 mmol to 9.9 mmol)
Prophylactic use, in justified cases: The recommended dose is 1 or 2 tablets 2 times daily,
i.e. 80 mg to 160 mg magnesium/day (3.3 mmol to 6.6 mmol)

Children from 4 to 12 years of age:
Depending on the diagnosed magnesium deficiency, age and body weight:
usually 1 or 2 tablets 2 times daily,
i.e. 80 mg to 160 mg magnesium/day (3.3 mmol to 6.6 mmol)

The medicine should be taken orally, after meals, with water.
Patients with impaired kidney or liver function
Use of Filomag Uno is contraindicated in patients with renal insufficiency.
Filomag Uno must not be used in patients with impaired kidney function.
Elderly patients
There is no need to change the method of administration or dosage in elderly patients.
If you feel that the effect of Filomag Uno is too strong or too weak, consult your doctor.
Taking more Filomag Uno than recommended
If you take more than the recommended dose, contact your doctor or pharmacist immediately.
Symptoms of overdose: diarrhoea, nausea, cardiac disturbances (atrioventricular conduction disturbances).
Treatment: symptomatic.
Missing a dose of Filomag Uno
Do not take a double dose to make up for a missed dose.
Stopping Filomag Uno
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Uncommon (symptoms may occur in less than 1 in 100 patients): nausea and diarrhoea, which
usually resolve spontaneously.
Rare (symptoms may occur in less than 1 in 1,000 patients): atrioventricular conduction disorders (changes in heart rhythm), skin redness, muscle weakness.
Very rare (symptoms may occur in less than 1 in 10,000 patients): insomnia.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse 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
tel: 22 49 21 301
fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Filomag Uno

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Filomag Uno contains

The active substance is magnesium hydrogen aspartate. Each tablet contains 40 mg of magnesium ions.
The other ingredients (excipients) are: potato starch, sucrose, sodium carboxymethyl starch, magnesium stearate, talc.

What Filomag Uno looks like and contents of the pack
Filomag Uno is white, round, biconvex oral tablets.
Pack sizes available:
Tablets in blister packs, in a cardboard box:
50 tablets – 2 blisters containing 25 tablets each
75 tablets – 3 blisters containing 25 tablets each

Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39
85-619 Bydgoszcz

For further information about this medicinal product, please contact the Marketing Authorisation Holder:
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39; 85-619 Bydgoszcz
tel.: 52 342 67 88

Information for blind and partially sighted people: The package leaflet for Filomag Uno is available in the Audio Leaflet system via the national free-phone number 800 706 848.