Package leaflet: Information for the user

Slow-Mag
(Magnesii chloridum hexahydricum)
535 mg (64 mg magnesium ions), enteric-coated tablets
Please read all of this leaflet carefully before taking this medicine, because
it contains important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by a 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 possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your symptoms do not improve or if you feel worse, consult your doctor.

Contents of the leaflet:

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

1. What Slow-Mag is and what it is used for

Slow-Mag enteric-coated tablets contain magnesium in the form of magnesium chloride hexahydrate.
One tablet provides 64 mg of magnesium ions.
Slow-Mag is used in magnesium deficiency states associated with:
muscle pain, tics, muscle tremors, headaches, fatigue, increased irritability, reduced stress tolerance, sleep disturbances, lipid concentration disorders in blood serum, cardiac arrhythmias, accelerated atherosclerotic vascular changes, arterial hypertension, and accelerated osteoporosis.
Increased magnesium loss may also occur during treatment with diuretic drugs.

2. Important information before using Slow-Mag

When not to use Slow-Mag

if the patient is allergic to magnesium chloride or any of the other ingredients of this medicine (listed in section 6);
if there is elevated magnesium concentration in blood serum (hypermagnesemia);
if significant arterial hypotension or disturbances in cardiac conduction are present;
if the patient has severe renal failure or myasthenia gravis (miastenia gravis – a disease characterized by muscle weakness and fatigue).

Warnings and precautions
Before starting treatment with Slow-Mag, consult your doctor or pharmacist.
Use Slow-Mag with caution, as magnesium compounds have a laxative effect.
Chronic diarrhea caused by long-term use of magnesium-containing medicines may lead to electrolyte imbalance (loss of water and minerals). Administration of this medicine to patients with renal impairment may result in excess magnesium in the body and magnesium poisoning.
Concurrent use with other products containing magnesium may lead to excess magnesium in the body.

Slow-Mag and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines planned for use.
Calcium preparations given in high doses reduce magnesium absorption.
Oral magnesium compounds reduce the absorption of tetracyclines, fluoroquinolones, iron preparations, fluoride compounds, and oral anticoagulants of the warfarin type.
Diuretics, aminoglycoside antibiotics, cisplatin, mitramycin, amphotericin B, and mineralocorticosteroids increase urinary excretion of magnesium.
Concomitant use of magnesium and amiodarone may cause disturbances in cardiac conduction. Concurrent use of magnesium and dihydralazine may lead to significant hypotension.

Food and drink
Organic acids, phytates, oxalic acid, gallic acid (tannins), fatty acids, and phosphates reduce intestinal absorption of magnesium from enteric tablets.
This medicine should be taken during or immediately after meals, with water.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Slow-Mag may be used during pregnancy and breastfeeding only under medical supervision and at doses recommended by a physician.
Excess magnesium in pregnant women may affect calcium metabolism in the fetus and newborn.

Driving and operating machinery
Slow-Mag has no influence on the ability to drive vehicles or operate machinery.

3. How to use Slow-Mag

This medicine should always be taken exactly as described in the patient leaflet, or
as directed by a doctor or pharmacist. If in doubt, consult a doctor or
pharmacist.
The recommended dose is:
For prevention – usually 2 tablets per day (1 tablet in the morning and 1 tablet in the evening).
In confirmed magnesium deficiency:

Adults: 6 tablets per day (2 tablets in the morning and 4 tablets in the evening) for 3 weeks, then 3 tablets in the evening;
Children over 6 years of age: as directed by a doctor.

The tablets should be swallowed whole, without chewing or dividing. After each withdrawal of the medicine, the container should be immediately closed tightly.

Taking more than the recommended dose of Slow-Mag
If more than the recommended dose of Slow-Mag has been taken, seek immediate advice from a doctor or pharmacist.
Missing a dose of Slow-Mag
If a dose of Slow-Mag is missed, take it as soon as possible, unless it is almost time for the next dose. In that case, do not take the missed dose at all.
Do not take a double dose to make up for a missed dose.
Stopping the use of Slow-Mag
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Gastrointestinal disturbances, including laxative effects, may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Slow-Mag

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

6. Contents of the pack and other information

What Slow-Mag contains

The active substance is magnesium chloride hexahydrate. Each tablet contains 64 mg of magnesium ions.
Other ingredients: precipitated calcium carbonate, povidone, talc, magnesium stearate.
Coating composition: Eudragit L100-55 (copolymer of methacrylic acid and ethyl acrylate 1:1), dibutyl sebacate, talc.

What Slow-Mag looks like and contents of the pack
Slow-Mag tablets are white or almost white, round, biconvex.
Available pack sizes:

Polypropylene container closed with a polyethylene cap equipped with a moisture sorbent, placed in a cardboard box, with an enclosed patient information leaflet. 30 tablets, 60 tablets
Blister packs made of aluminium/PVC/PVdC foil in a cardboard box, with an enclosed patient information leaflet. 60 tablets

Not all pack types may be marketed.

Marketing Authorisation Holder
ETHIFARM Sp. z o.o. Sp. komandytowa
Hiacyntowa Street 39
60-175 Poznań
www.ethifarm.pl
Tel.: +48 61 867 54 21
Fax: +48 61 867 50 67
E-mail: [email protected]

Manufacturer
ETHIFARM Sp. z o.o. Sp. komandytowa
Żeromskiego Street 9
60-544 Poznań

For further information, please contact the Marketing Authorisation Holder.