Slov-mag B6

Package Leaflet: Information for the Patient

Slow-Mag B

(Magnesium Chloride Hexahydrate + Pyridoxine Hydrochloride)

535 mg (64 mg of magnesium ions) + 5 mg, enteric-coated tablets

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

Take this medicine always exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet:

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

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

Slow-Mag B enteric-coated 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 for magnesium and vitamin B deficiencies.
Magnesium deficiencies may be accompanied by: muscle cramps, spasms, muscle tremors, headaches,
fatigue, increased irritability, decreased stress tolerance, sleep disturbances,
lipid metabolism disorders in the blood, heart rhythm disorders, accelerated atherosclerotic changes in blood vessels, hypertension, accelerated osteoporosis.
Increased magnesium loss also occurs during the use of diuretics.
Vitamin B increases magnesium absorption and reduces its excretion in the urine.

2. Important information before taking Slow-Mag B

When not to take Slow-Mag B

Do not take the medicine:

• if you are allergic to magnesium chloride, pyridoxine hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
• if you have elevated magnesium levels in the blood (hypermagnesemia);
• if you have significant hypotension or cardiac conduction disorders;
• if you have severe renal impairment or myasthenia (a disease characterized by muscle weakness and fatigue);
• if you are taking levodopa at the same time.

Warnings and precautions

Before starting to take Slow-Mag B, discuss it with your doctor or pharmacist.
When taking Slow-Mag B, be cautious, as magnesium compounds have a laxative effect. Chronic diarrhea caused by prolonged use of magnesium-containing medicines 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 it with other medicines containing magnesium and vitamin B may lead to an excess of magnesium and vitamin B in the body.

Slow-Mag B and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as the medicines you plan to take.
The absorption of magnesium from enteric-coated tablets is limited by organic acids, phytin, oxalic acid, gallic acid (tannin), fatty acids, and phosphates.
Magnesium absorption is also reduced by high-dose calcium preparations.
Orally administered magnesium compounds reduce the absorption of tetracyclines, fluoroquinolones, iron preparations, fluoride compounds, and oral anticoagulant warfarin derivatives.
Diuretics, 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.

Pregnancy, breastfeeding, and fertility

In recommended doses, the medicine can be used during pregnancy and breastfeeding only on the doctor's advice.
Excessive magnesium in pregnant women may affect calcium metabolism in the fetus and newborn.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

3. How to take Slow-Mag B

Always take this medicine exactly as described in the package leaflet for the patient or as directed by your doctor. In case of doubt, consult your doctor or pharmacist.
Adults:
For prevention: 1 tablet in the morning and 1 tablet in the evening.
For magnesium and vitamin B 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 old – in short-term therapy, a maximum of 3 tablets per day in divided doses.
Swallow the tablets whole, without chewing or dividing them.
After each use, close the container tightly.

Taking a higher dose of Slow-Mag B than recommended

In case of taking a very high dose of Slow-Mag B, contact your doctor or pharmacist immediately.

Missing a dose of Slow-Mag B

Take the missed dose as soon as possible.
Do not take a double dose to make up for the missed dose.

Stopping the use of Slow-Mag B

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is possible to experience gastrointestinal disorders, including a laxative effect.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this package leaflet, tell your 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 181C
PL-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 this medicine.

5. How to store Slow-Mag B

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

• Polypropylene container: Store at a temperature below 25°C.
• Aluminium/PVC/PVdC blisters: Store at a temperature below 25°C. Store 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Slow-Mag B contains

• The active substances are magnesium chloride hexahydrate and pyridoxine hydrochloride. One tablet contains 64 mg of magnesium ions in the form of magnesium chloride hexahydrate and 5 mg of vitamin B in the form of pyridoxine hydrochloride.
• The excipients are calcium carbonate, povidone, talc, magnesium stearate. The coating composition is 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 package

Slow-Mag B tablets are white or almost white, round, biconvex.
Available packages:

• Polypropylene container with a polyethylene lid equipped with a desiccant, in a cardboard box, with a patient information leaflet. 50 tablets
• Aluminium/PVC/PVdC blisters in a cardboard box, with a patient information leaflet. 50 tablets

Not all package sizes may be marketed.

Marketing authorization holder

ETHIFARM Sp. z o.o. Sp. komandytowa
ul. Hiacyntowa 39
60-175 Poznań
Phone: +48 61 867 54 21
Fax: +48 61 867 50 67
Email: biuro@ethifarm.pl

Manufacturer

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

Date of the last revision of the package leaflet: