Magne B6 forte

Package Leaflet: Information for the Patient

MAGNE B6 Forte, 100 mg Mg + 10 mg, Film-Coated Tablets

Magnesium Citrate + Pyridoxine Hydrochloride
{Sanofi logo}

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 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.

Package Leaflet Contents

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

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

Magne B Forte contains 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 crucial role in the contraction of the heart muscle 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 degree of 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) and pathological situations (e.g., congenital absorption disorders).
The occurrence of the following symptoms may indicate a magnesium deficiency:

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

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

2. Important information before taking Magne B Forte

When not to take Magne B Forte

• 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).
• concomitant use of levodopa.

Warnings and precautions

Before starting treatment with Magne B Forte, the patient should discuss it with their doctor, pharmacist, or nurse.
Particular caution is advised in patients with moderate renal impairment due to the risk of high magnesium levels in the blood.
Long-term administration of high doses of the medicine may cause nerve problems, 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 doubt, the patient should consult their doctor or pharmacist.

Magne B Forte 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.
The patient should avoid concomitant use of products containing phosphates or calcium salts, as these substances inhibit magnesium absorption from the small intestine.
In case of concomitant oral administration of a tetracycline antibiotic and Magne B Forte, a 3-hour interval should be maintained between their administration.
Magne B Forte should not be used 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 Forte administration.

Magne B Forte 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 or pharmacist before taking this medicine.
Pregnancy
The medicine may be used during pregnancy only after consultation with a doctor.
Clinical experience has not revealed any harmful effects of magnesium.
Breastfeeding
The decision to use Magne B Forte during breastfeeding and the dose to be used should be made by a doctor.
Magne B Forte may be used during breastfeeding, provided that therapeutic doses are used; it is recommended that breastfeeding women take vitamin B6 at a 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 Forte is very high due to its low vitamin B6 content.

Driving and using machines

Magne B Forte does not affect the ability to drive or operate machinery.

Magne B Forte contains lactose

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

3. How to take Magne B Forte

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.
Adults:
3 to 4 tablets per day, in 2 or 3 divided doses, taken during meals.

Use in children and adolescents

for children aged 6 years or older (with a body weight of approximately 20 kg):
10 to 30 mg/kg body weight per day, i.e., 2 to 4 tablets per day, in 2 or 3 divided doses, taken during meals.
If the patient feels that the effect of Magne B Forte is too strong or too weak, they should consult their doctor.

Overdose of Magne B Forte

In case of overdose, the patient should immediately consult their doctor or pharmacist.
Overdose of orally administered magnesium does not cause toxic reactions in patients with normal renal function.
In patients with renal impairment, magnesium poisoning may occur.
Long-term administration of high doses of vitamin B6 (pyridoxine) (for several months or, in some cases, several years) may cause sensory nerve damage.
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 Forte

In case of a missed dose, the patient should take it as soon as possible, unless it is close to the time of the next dose. The patient should not take a double dose to make up for the missed tablet or take it in a short period.

4. Possible side effects

Like all medicines, Magne B Forte 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 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
Al. Jerozolimskie 181C
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 Forte

The medicine should be stored out of sight and reach of children.
The medicine should be stored at a temperature below 25°C.
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. Package contents and other information

What Magne B Forte contains

• The active substances are: magnesium ions (in the form of magnesium citrate) 100 mg pyridoxine hydrochloride (vitamin B6) 10 mg
• The excipients are: lactose anhydrous, macrogol 6000, magnesium stearate. Coating:hypromellose, macrogol 6000, titanium dioxide (E 171), talc.

What Magne B Forte looks like and contents of the pack

Packagingcontains 60, 90, 100, 120, or 180 film-coated tablets of Magne B Forte,
packed in PVC/PE/PVDC/Al blisters in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Opella Healthcare Poland Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Manufacturer
Opella Healthcare Hungary Limited Liability Company
2112 Veresegyhaz, Levai utca 5
Hungary
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France
To obtain more detailed information, the patient should contact:
Opella Healthcare Poland Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Phone: +48 22 280 00 00

Date of last revision of the package leaflet: