Package leaflet: information for the patient

Slow-Mag B
(Magnesii chloridum hexahydricum + Pyridoxini hydrochloridum)
535 mg (64 mg magnesium ions) + 5 mg, enteric tablets
Please read this leaflet carefully before using the medicine, because
it contains important information for the patient.
This medicine should always be used exactly as described in this patient 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 there is no improvement or if you feel worse, consult your doctor.

Table of contents of the leaflet:

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

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

Slow-Mag B enteric tablets contain magnesium in the form of magnesium chloride
hexahydrate and vitamin B in the form of pyridoxine hydrochloride.
One tablet provides 64 mg of magnesium ions and 5 mg of vitamin B .
Slow-Mag B is used in magnesium and vitamin B deficiencies.
Magnesium deficiency may be associated with: muscle pain, tics, muscle tremors, headaches,
fatigue, increased irritability, reduced stress tolerance, sleep disturbances,
concentration disorders, lipid metabolism 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.
Vitamin B enhances magnesium absorption and reduces its urinary excretion.

2. Information before using Slow-Mag B

When not to use Slow-Mag B
Do not use the medicine:

if the patient is allergic to magnesium chloride, pyridoxine hydrochloride, 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 cardiac conduction disorders are present;
if the patient has severe renal insufficiency or myasthenia gravis (a disease characterized by muscle weakness and fatigue);
if levodopa is being used concurrently.

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

Slow-Mag B and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
Absorption of magnesium from enteric tablets is reduced by organic acids, phytates, oxalic acid, gallic acid (tannins), fatty acids, and phosphates.
Magnesium absorption is also reduced by calcium preparations used in high doses.
Oral magnesium compounds reduce the absorption of tetracyclines, fluoroquinolones, iron preparations, fluorides, and oral anticoagulants derived from warfarin.
Diuretics, aminoglycoside antibiotics, cisplatin, mitramycin, amphotericin B, and mineralocorticosteroids increase urinary excretion of magnesium.
Concurrent use of magnesium and amiodarone may cause cardiac conduction disturbances. Concurrent use of magnesium and dihydralazine may lead to significant hypotension.

Pregnancy, breastfeeding and fertility
Slow-Mag B may be used during pregnancy and breastfeeding only under medical supervision and on a doctor's recommendation.
Excess magnesium in pregnant women may affect calcium metabolism in the fetus and newborn.

Driving and operating machinery
Slow-Mag B does not impair the ability to drive or operate machinery.

3. How to use Slow-Mag B6

This medicine should always be used exactly as described in the patient leaflet or
as directed by a doctor. If in doubt, consult a doctor or pharmacist.
Adults:
For prophylaxis: 1 tablet in the morning and 1 tablet in the evening.
For magnesium and vitamin B6 deficiency: 5 tablets per day (2 tablets in the morning and 3 tablets
in the evening) for 3 weeks, then 3 tablets in the evening.
Children over 12 years – for short-term therapy, up to a maximum of 3 tablets per day
in divided doses.
Tablets should be swallowed whole, without chewing or dividing.
After each withdrawal of the medicine, the container must be closed tightly immediately.
Use of a higher than recommended dose of Slow-Mag B6
If a very large dose of Slow-Mag B6 has been taken, seek immediate advice from a doctor or pharmacist.
Missed dose of Slow-Mag B6
Take the missed dose as soon as possible.
Do not take a double dose to make up for a missed dose.
Stopping use of Slow-Mag B6
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 adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 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 B6

Keep this medicine out of the sight and reach of children.

Polypropylene container: Store below 25°C.
Aluminium/PVC/PVdC foil blisters: Store below 25°C. Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated 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. This will help protect the environment.

6. Contents of the pack and other information

What Slow-Mag B contains

The active substances are magnesium chloride hexahydrate and pyridoxine hydrochloride. Each tablet contains 64 mg of magnesium ions in the form of magnesium chloride hexahydrate and 5 mg of vitamin B(_6) in the form of pyridoxine hydrochloride.
The other components are: precipitated calcium carbonate, povidone, talc, magnesium stearate.
Coating composition: Eudragit L 100-55 (copolymer of methacrylic acid and ethyl acrylate 1:1), dibutyl sebacate, talc.

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

Polypropylene container closed with a polyethylene cap equipped with a moisture sorbent, in a cardboard box, with an enclosed patient information leaflet. 50 tablets
Aluminium/PVC/PVdC blisters in a cardboard box, with an enclosed patient information leaflet. 50 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder
ETHIFARM Sp. z o.o. Sp. komandytowa
Hiacyntowa 39 Street
60-175 Poznań
Poland
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 9 Street
60-544 Poznań
Poland

For further information about this medicinal product, please contact the Marketing Authorisation Holder.