Slov-mag

Package Leaflet: Information for the Patient

Slow-Mag

(Magnesium Chloride Hexahydrate)

535 mg (64 mg of Magnesium Ions), Enteric-Coated Tablets

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 the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

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

The enteric-coated tablets of Slow-Mag contain magnesium in the form of magnesium chloride hexahydrate.
One tablet provides 64 mg of magnesium ions.
Slow-Mag is used for magnesium deficiencies, which are accompanied by:
muscle pain, muscle spasms, muscle tremors, headaches, fatigue, increased irritability,
reduced stress tolerance, sleep disorders, lipid metabolism disorders in the blood,
heart rhythm disorders, accelerated atherosclerotic changes in blood vessels, arterial hypertension,
accelerated osteoporosis.
Magnesium loss also increases during the use of diuretic medications.

2. Important information before taking Slow-Mag

When not to take 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 an elevated level of magnesium in the blood (hypermagnesemia);
• if there is significant arterial hypotension or cardiac conduction disorders;
• if the patient has severe renal impairment or myasthenia gravis (a disease characterized by muscle weakness and fatigue).

Warnings and precautions

Before starting to take Slow-Mag, the patient should discuss it with their doctor or pharmacist.
When taking Slow-Mag, caution should be exercised, as magnesium compounds have a laxative effect.
Chronic diarrhea caused by long-term use of magnesium-containing medications can lead to electrolyte imbalance (loss of water and minerals).
Administering the medicine to patients with renal impairment may lead to an excess of magnesium in the body and magnesium poisoning.
Taking Slow-Mag with other magnesium-containing products may lead to an excess of magnesium in the body.

Slow-Mag and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Calcium preparations used in high doses also reduce magnesium absorption.
Oral magnesium compounds reduce the absorption of tetracyclines, fluoroquinolones, iron preparations, fluoride compounds, and oral anticoagulant medications derived from warfarin.
Diuretic medications, aminoglycoside antibiotics, cisplatin, mitramycin, amphotericin B, and mineralocorticosteroids increase magnesium excretion in the urine.
Concomitant use of magnesium and amiodarone may cause cardiac conduction disorders.
Concomitant use of magnesium and dihydralazine may cause significant hypotension.

Slow-Mag with food and drink

The absorption of magnesium from enteric-coated tablets is limited by organic acids, phytin, oxalic acid, gallic acid (tannin), fatty acids, and phosphates.
The medicine should be taken during meals or immediately after meals, with a glass of water.

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 their doctor or pharmacist before taking this medicine.
In recommended doses, the medicine may be used during pregnancy and breastfeeding only on the advice of a doctor.
Excess magnesium in pregnant women may affect calcium metabolism in the fetus and newborn.

Driving and using machines

Slow-Mag does not affect the ability to drive and use machines.

3. How to take Slow-Mag

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose of the medicine is:
Prophylactically - 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 old: as directed by a doctor. The tablets should be swallowed whole, without chewing or dividing. After each use, the container should be closed tightly.

Overdose of Slow-Mag

In case of an overdose of Slow-Mag, the patient should immediately consult their doctor or pharmacist.

Missed dose of Slow-Mag

In case of a missed dose of Slow-Mag, the patient should take it as soon as possible, unless it is almost time for the next dose.
In this case, the missed dose should not be taken at all.
A double dose should not be taken to make up for a missed dose.

Stopping the use of Slow-Mag

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

4. Possible side effects

Like all medicines, Slow-Mag can cause side effects, although not everybody gets them.
It is possible to experience gastrointestinal disorders, including laxative effects.
Reporting side effects
If any side effects occur, including any possible side effects not listed in this leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
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 Slow-Mag

The medicine should be stored out of sight and reach of children.
Store in 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 given month.
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 pack and other information

What Slow-Mag contains

• The active substance of the medicine is magnesium chloride hexahydrate. One tablet contains 64 mg of magnesium ions.
• and excipients: calcium carbonate, povidone, talc, magnesium stearate. The composition of the coating: 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, and biconvex.
Available packs:

• A polypropylene container with a polyethylene lid equipped with a desiccant, in a cardboard box, with a patient information leaflet. 30 tablets, 60 tablets
• Blister packs of aluminum/PVC/PVdC foil in a cardboard box, with a patient information leaflet. 60 tablets

Not all pack sizes may be marketed.

Marketing authorization holder

ETHIFARM Sp. z o.o. Sp. komandytowa
ul. Hiacyntowa 39
60-175 Poznań
www.ethifarm.pl
Phone: +48 61 867 54 21
Fax: +48 61 867 50 67
Email: [email protected]

Manufacturer

ETHIFARM Sp. z o.o. Sp. komandytowa
ul. Żeromskiego 9
60-544 Poznań
To obtain more detailed information, the patient should contact the marketing authorization holder.

Date of the last revision of the leaflet: