Magne B6

Package Leaflet: Information for the User

MAGNE B48 mg Mg + 5 mg, coated tablets
Magnesium lactate dihydrate + Pyridoxine hydrochloride
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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 this package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package 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 Package Leaflet

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

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

Magne B tablets contain magnesium ions and pyridoxine hydrochloride (vitamin B6).
The medicine supplements magnesium and/or vitamin B6 deficiencies in the body.
Magnesium is an essential cation for the proper course of many biochemical processes in the body. Its biological role involves the activation of a series of enzymes. Magnesium plays a significant role in the heart muscle contraction process and affects the state of nervous and muscular excitability.
Magnesium is only partially absorbed from the gastrointestinal tract, mainly in the small intestine, and the amount of magnesium absorption depends on its content in food. Magnesium deficiency can cause disorders in the muscular and central nervous systems.
Vitamin B6 increases magnesium absorption from the gastrointestinal tract by 20-40%.
The product is indicated for use in magnesium deficiencies, which can occur in various physiological situations (e.g., insufficient magnesium intake, after intense physical exertion, or in cases of chronic stress or lack of sleep) as well as pathological situations (e.g., congenital absorption disorder).

The occurrence of the following symptoms may indicate a magnesium deficiency:

• nervousness, irritability, mood swings, mild anxiety, restlessness, transient fatigue, lethargy, sleep disturbances of mild severity;
• anxiety symptoms, such as intestinal cramps or heart palpitations (without heart disorders);
• muscle cramps, tingling, eyelid twitching.

Supplementing magnesium can alleviate the above symptoms.
If there is no improvement after a month of taking Magne B, continued treatment is not recommended.

2. Important information before taking Magne B

When not to take Magne B:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe renal impairment (creatinine clearance less than 30 ml/min).
• if the patient is taking levodopa.

Warnings and precautions

Before starting to take Magne B, the patient should discuss it with their doctor, pharmacist, or nurse.
Particular caution should be exercised in patients with moderate renal impairment due to the risk of high magnesium levels in the blood.
When taking high doses of the medicine for a long time, nerve problems may occur, such as tingling (see section 3).

Children and adolescents

The medicine is for use in adults and children aged 6 years or older
Other forms of the medicine are available for children under 6 years of age.
In case of any doubts, the patient should consult their doctor or pharmacist.

Magne B and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The patient should avoid taking products containing phosphates or calcium salts at the same time, as these substances inhibit magnesium absorption from the small intestine.
When taking the antibiotic tetracycline and Magne B orally at the same time, a 3-hour interval should be maintained between their administration.
Magne B should not be taken during treatment with levodopa, as pyridoxine weakens its effect.
Quinolone antibiotics (such as ciprofloxacin, levofloxacin) should be taken at least 2 hours before or 6 hours after Magne B administration.

Magne B with food and drink

The medicine should be taken during meals, with a glass of water.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.
Pregnancy
The medicine may be used during pregnancy only after consulting a doctor.
Clinical experience has not revealed any harmful effects of magnesium.
Breastfeeding
The decision to use Magne B during breastfeeding and the dose to be used should be made by a doctor.
Magne B may be used during breastfeeding at therapeutic doses; it is recommended that breastfeeding women take vitamin B6 at a maximum dose of 20 mg per day.
Fertility
Studies on vitamin B6 have shown an effect on male fertility. However, this effect is only observed at very high doses. The safety of Magne B is very high due to its low vitamin B6 content.

Driving and using machines

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

Magne B contains sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Magne B

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.
In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
Adults:
6 to 8 tablets per day, in 2 or 3 divided doses, during meals.

Use in children and adolescents

Children aged 6 years or older (with a body weight of approximately 20 kg):
4 to 6 tablets per day, in 2 or 3 divided doses, during meals.

Overdose of Magne B

In case of overdose, the patient should immediately consult their doctor or pharmacist.
Overdose of magnesium taken orally does not cause toxic reactions in patients with normal kidney function.
In patients with renal impairment, magnesium poisoning may occur.
When taking high doses of vitamin B6 (pyridoxine) for a long time (several months or, in other cases, several years), sensory nerve damage may occur.
Symptoms include tingling, numbness, and balance disturbances, limb tremors, and coordination problems (progressive sensory ataxia). Generally, these effects are reversible after discontinuation of the medicine.

Missed dose of Magne B

In case of a missed dose, the patient should take it as soon as possible, unless it is almost time for the next dose.
The patient should not take two doses of the medicine at the same time or at short intervals.

4. Possible side effects

Like all medicines, Magne B can cause side effects, although not everybody gets them.
Frequency not known(frequency cannot be estimated from the available data):
hypersensitivity,
diarrhea, abdominal pain,
skin reactions, including hives, itching, rash, redness.
Reporting side effects
If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. 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, 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 Magne B

The medicine should be stored out of sight and reach of children.
The medicine should be stored at a temperature below 25°C, in the original packaging to protect from light.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
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 package and other information

What Magne B contains

• The active substances are: magnesium ions (in the form of magnesium lactate dihydrate) 48 mg Mg (1.97 mmol) pyridoxine hydrochloride (vitamin B6) 5 mg
• The excipients are: sucrose, heavy kaolin, gum arabic, carbopol 934, talc, magnesium stearate. Coating: gum arabic, sucrose, titanium dioxide, talc, carnauba wax.

Available packaging

50, 60 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Manufacturer
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszow
ul. Lubelska 52
35-233 Rzeszow
Opella Healthcare Hungary Limited Liability Company
2112 Veresegyhaz, Levai utca 5
Hungary
Sanofi-Winthrop Industrie
1, rue de la Vierge
33440 Ambares
France
To obtain more detailed information, the patient should contact:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Phone: +48 22 280 00 00

Date of last revision of the package leaflet: April 2024