Patient Information Leaflet

LAKTOMAG B
Magnesii hydroaspartas + Pyridoxini hydrochloridum
1000 mg (70 mg magnesium ions) + 5 mg, tablets
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a physician, pharmacist, or nurse.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If your symptoms do not improve or worsen, contact your doctor.

Table of Contents:

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

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

LAKTOMAG B is an oral mineral preparation. It contains magnesium in the form of a readily absorbable organic salt (magnesium hydroaspartate – 1000 mg, providing 70 mg of Mg²⁺ ions), supplemented with vitamin B₆ (5 mg), which enhances magnesium bioavailability and reduces its urinary excretion. The product is indicated for the prevention of complications associated with magnesium and/or vitamin B₆ deficiency, as well as for correcting diagnosed deficiencies. It is used in cases of chronic physical and mental fatigue, nervous system hyperexcitability, stress-related conditions, depression, sleep disorders, muscle pain, cardiac arrhythmias, prevention of atherosclerosis and myocardial infarction, and in the management of osteoporosis.

2. Important information before taking LAKTOMAG B

When not to take LAKTOMAG B:

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

Warnings and precautions

when using oral tetracycline preparations, a three-hour interval should be maintained between administration of the antibiotic and LAKTOMAG B due to reduced absorption of tetracyclines from the gastrointestinal tract;
in case of heart or kidney function disorders.

LAKTOMAG B and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Taking LAKTOMAG B with food, drink and alcohol:

do not take the product on an empty stomach, as it may cause diarrhea;
protein-rich foods facilitate magnesium absorption;
tablets should be taken with plenty of water.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before taking this medicine.
Driving and operating machinery
This medicine does not impair the ability to drive or operate machinery.
LAKTOMAG B contains aspartame – a source of phenylalanine. It may be harmful for patients with phenylketonuria.

3. How to take LAKTOMAG B

Prophylactic use:
For young children, tablets should be crushed and mixed with water before administration.
Children:
1–3 years of age: ½ tablet twice daily
4–6 years of age: ½ tablet three times daily
7–10 years of age: 1 tablet twice daily
Over 10 years of age: 1 tablet three times daily
Adults: 1 tablet three times daily.

Therapeutic use: as directed by the physician.
The recommended supplemental dose to correct deficiencies is 5 mg/kg body weight (calculated as Mg), divided into three doses.

The tablet should be taken with water.
The tablet may be split or crushed.

If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.

Overdose of LAKTOMAG B
If LAKTOMAG B is taken in doses exceeding the recommended amounts over a prolonged period, adverse effects may occur, including hypotension and muscle weakness, as described under "Undesirable effects".

Missed dose of LAKTOMAG B
Continue taking the medicine as prescribed without increasing the next dose.
Do not take a double dose to make up for a missed dose.

Discontinuation of LAKTOMAG B
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, LAKTOMAG B may cause adverse reactions, although not everyone experiences them.
Gastrointestinal disturbances, nausea, vomiting, loose stools or skin redness may occur sporadically.
Long-term regular administration of pyridoxine at a dose of 50 mg/day may lead to sensory peripheral neuropathy, whereas daily doses exceeding 200 mg may lead to folic acid deficiency, respiratory disorders and various types of dermatoses.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49-21-301, Fax: +48 22 49-21-309; e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicinal product can be collected.

5. How to store LAKTOMAG B

Keep LAKTOMAG B out of the sight and reach of children.
Store below 25°C. Keep in the original packaging.
Do not use LAKTOMAG B 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 dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What LAKTOMAG B contains
The active substances in the medicine are magnesium aspartate monohydrate in the amount of 1000 mg (70 mg of Mg++ ions)
and pyridoxine hydrochloride (vitamin B_) in the amount of 5 mg.
Other components of the medicine are: microcrystalline cellulose, povidone, colloidal silicon dioxide, banana flavour, aspartame, magnesium stearate.

What LAKTOMAG B looks like and contents of the pack
A polyethylene container with a snap-on cap in a cardboard box, containing 50 tablets with a patient leaflet.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Pharmaceutical Plant "Amara" Sp. z o.o.
Stacyjna Street 5
30-851 Kraków
Phone: 12 657 40 40
Fax: 12 657 40 40 ext. 34
e-mail: [email protected]

Manufacturer:
"CHANCE" Pharmaceutical Plant
Jerzy Jaworski, Maria Jaworska Spółka Jawna
Pieńków 11, 05-152 Czosnów
Phone: 22 751 13 35
Fax: 22 785 10 41
e-mail: [email protected]