Laktomag B6

Leaflet attached to the packaging: patient information

LAKTOMAG B

Magnesium hydroaspartate + Pyridoxine hydrochloride
1000 mg (70 mg of magnesium ions) + 5 mg, tablets

Please read the contents of the 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 patient leaflet or as advised by a doctor, pharmacist, or nurse.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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 LAKTOMAG B and what is it used for
• 2. Important information before taking LAKTOMAG B
• 3. How to take LAKTOMAG B
• 4. Possible side effects
• 5. How to store LAKTOMAG B
• 6. Package contents and other information

1. What is LAKTOMAG B and what is it used for

LAKTOMAG B is an oral mineral medicine. It contains magnesium in the form of an easily absorbable organic salt (magnesium hydroaspartate - 1000 mg, 70 mg of Mg ions) with the addition of vitamin B (5 mg), which increases the bioavailability of magnesium and also reduces its excretion in the urine. The medicine is used for the prevention of complications related to magnesium and/or vitamin B deficiency, as well as to supplement diagnosed deficiencies. In cases of chronic physical and mental fatigue, nervous irritability, stress, depression, sleep disorders, muscle pain, heart arrhythmia, to prevent atherosclerosis and heart attacks, and in the treatment of osteoporosis.

2. Important information before taking LAKTOMAG B

When not to take LAKTOMAG B:

• if the patient is allergic to magnesium hydroaspartate, vitamin B, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has:
• severe liver and kidney failure,
• hypermagnesemia,
• vitamin B overdose,
• significant hypotension,
• slow heart rate below 50 beats per minute,
• myasthenia gravis,
• Parkinson's disease treated with levodopa without a peripheral decarboxylase inhibitor.

Warnings and precautions

• when taking oral tetracycline preparations, a three-hour interval should be maintained between the administration of the antibiotic and LAKTOMAG B, due to the reduced absorption of tetracyclines from the gastrointestinal tract,

LAKTOMAG B 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.

Taking LAKTOMAG B with food, drink, and alcohol:

• the preparation should not be taken on an empty stomach, as it may cause diarrhea,
• protein products facilitate the absorption of magnesium,
• tablets should be taken with a large amount of water.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The medicine does not affect the ability to drive or operate machinery.
LAKTOMAG B contains aspartame- a source of phenylalanine. It may be harmful to patients with phenylketonuria.

3. How to take LAKTOMAG B

Prophylactically:
Small children can be given tablets only after crushing and mixing with water.
Children: 1-3 years old:
2 times a day, ½ tablet

• 4-6 years old: 3 times a day, ½ tablet
• 7-10 years old: 2 times a day, 1 tablet
  Above 10 years old: 3 times a day, 1 tablet
  Adults: 3 times a day, 1 tablet.

Therapeutically: as advised by a doctor.
The recommended supplementary dose for deficiency is 5 mg/kg body weight (in terms of Mg), in three divided doses.
The medicine should be taken with water.
The tablet can be halved or crushed.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of LAKTOMAG B than recommended

Prolonged use of the medicine in doses exceeding the recommended ones may cause symptoms described as side effects, as well as a decrease in blood pressure and muscle weakness.

Missing a dose of LAKTOMAG B

The patient should continue taking the medicine without increasing the next dose.
A double dose should not be taken to make up for a missed dose.

Stopping LAKTOMAG B treatment

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

4. Possible side effects

Like all medicines, LAKTOMAG B can cause side effects, although not everybody gets them.
Occasionally, gastrointestinal disorders, nausea, vomiting, loose stools, or skin redness may occur.
Prolonged systematic intake of pyridoxine in a dose of 50 mg/day may cause peripheral sensory neuropathy, while daily doses above 200 mg may lead to folic acid deficiency, respiratory disorders, and various types of dermatitis.
Reporting side effects
If any side effects occur, including any side effects not listed in the 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
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel: +48 22 49-21-301, Fax: +48 22 49-21-309; e-mail:
ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store LAKTOMAG B

LAKTOMAG B should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
The medicine should not be used 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 containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What LAKTOMAG B contains

The active substances of the medicine are magnesium hydroaspartate in the amount of 1000 mg (70 mg of Mg ions) and pyridoxine hydrochloride (vitamin B) in the amount of 5 mg.
Other ingredients of the medicine are: microcrystalline cellulose, povidone, colloidal silica, banana flavor, aspartame, magnesium stearate.

What LAKTOMAG B looks like and what the package contains

A polyethylene container with a snap-on cap in a cardboard box, 50 tablets with a patient leaflet.

Marketing authorization holder and manufacturer:

Marketing authorization holder:
Amara Pharmaceutical Plant Ltd.
Stacyjna Street 5
30-851 Krakow
Tel. 12 657 40 40
Fax 12 657 40 40 ext. 34
e-mail: amara@amara.pl
Manufacturer:
"CHANCE" Pharmaceutical Plant
Jerzy Jaworski, Maria Jaworska Spółka Jawna
Pieńków 11, 05-152 Czosnów
Tel.: 22 751 13 35
Fax.: 22 785 10 41
e-mail: amara.spj@amara.pl

Date of the last update of the leaflet: