Package leaflet: Information for the patient

MAGNE B6 Forte, 100 mg Mg + 10 mg, coated tablets
Magnesii citras + Pyridoxini hydrochloridum
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Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as your doctor, pharmacist, or nurse has advised.

Keep this leaflet so that you can read it again if necessary.
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 if you feel worse, you should contact your doctor.

Table of contents

What Magne B6 Forte is and what it is used for
What you need to know before taking Magne B6 Forte
How to take Magne B6 Forte
Possible side effects
How to store Magne B6 Forte
Contents of the pack and other information

1. What Magne B6 Forte is and what it is used for

Magne B6 Forte contains magnesium ions and pyridoxine hydrochloride (vitamin B6).
This medicine helps to correct deficiencies of magnesium and/or vitamin B6 in the body.
Magnesium is a cation essential for the proper functioning of many biochemical processes in the body. Its biological role involves the activation of numerous enzymes.
Magnesium plays an important role in myocardial contraction and affects neuromuscular excitability. Magnesium is only partially absorbed from the gastrointestinal tract, mainly in the small intestine, and the degree of absorption depends on its dietary content. Magnesium deficiency may lead to disorders in the muscular and central nervous systems.
Vitamin B6 increases gastrointestinal absorption of magnesium by 20–40%.
This product is indicated for use in magnesium deficiency, which may occur in various physiological (e.g. inadequate dietary intake, after intense physical exertion, or in cases of chronic stress or sleep deprivation) and pathological conditions (e.g. congenital malabsorption syndromes).
The presence of the following symptoms may indicate magnesium deficiency:

Nervousness, irritability, mood swings, mild anxiety, restlessness, transient fatigue, drowsiness, mild sleep disturbances;
Anxiety symptoms such as gastrointestinal cramps or palpitations (without cardiac disorders);
Muscle cramps, tingling sensations, eyelid twitching.

Supplementing magnesium may alleviate the above symptoms.
If no improvement occurs after one month of treatment with Magne B6 Forte, continued use is not recommended.

2. Important information before using Magne B6 Forte

When not to use Magne B6 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 kidney impairment (creatinine clearance less than 30 ml/min).
concomitant use of levodopa.

Warnings and precautions
Before starting treatment with Magne B6 Forte, discuss it with your doctor, pharmacist, or nurse.
Particular caution is advised in patients with moderate renal impairment due to the risk of developing high blood magnesium levels.
When high doses of the medicine are taken for a prolonged period, neurological problems such as tingling sensations may occur (see section 3).

Children and adolescents
This medicine is intended for use only in adults and children aged 6 years or older.
Other dosage forms appropriate for children under 6 years of age are available.
If in doubt, consult your doctor or pharmacist for advice.

Magne B6 Forte and other medicines
Tell your doctor or pharmacist if the patient is currently taking, has recently taken, or might take any other medicines.
Avoid concomitant use of products containing phosphates or calcium salts, as these compounds may inhibit magnesium absorption from the small intestine.
If an oral tetracycline antibiotic is taken at the same time as Magne B6 Forte, a 3-hour interval should be maintained between administrations.
Magne B6 Forte should not be used during treatment with levodopa, as pyridoxine reduces its effectiveness.
Quinolone antibiotics (such as ciprofloxacin, levofloxacin) must be taken at least 2 hours before or 6 hours after administration of Magne B6 Forte.

Magne B6 Forte with food and drink
Take the medicine during meals, with water.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
This 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 on whether to use Magne B6 Forte during breastfeeding and the appropriate dosage should be made by a physician.
Magne B6 Forte may be used during breastfeeding at therapeutic doses. It is recommended that breastfeeding women take vitamin B6 at a dose of 20 mg per day.

Fertility
Studies on vitamin B6 have shown effects on male fertility. However, this effect is observed only at very high doses. The safety profile of Magne B6 Forte is very high due to its low vitamin B6 content.

Driving and operating machinery
Magne B6 Forte has no influence on the ability to drive or operate machinery.

Magne B6 Forte contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Magne B6 Forte

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Adults:
3 to 4 tablets per day, divided into 2 or 3 doses taken with meals.

Use in children and adolescents
Aged 6 years and older (with body weight approximately 20 kg):
10 to 30 mg/kg body weight per day, i.e. 2 to 4 tablets per day, divided into 2 or 3 doses taken with meals.

If you feel that the effect of Magne B6 Forte is too strong or too weak, consult your doctor.

Taking more Magne B6 Forte than recommended
If you take more than the recommended dose of this medicine, contact your doctor or pharmacist immediately.

Oral magnesium overdose does not cause toxic reactions in patients with normal kidney function.
However, magnesium poisoning may occur in patients with renal impairment.

Prolonged use (for several months or, in some cases, several years) of high doses of vitamin B6 (pyridoxine) may cause damage to sensory nerves.
Symptoms include tingling, numbness, loss of balance, limb tremors, and coordination problems (progressive sensory ataxia). These effects are generally reversible upon discontinuation of the medicine.

If you forget to take a dose of Magne B6 Forte
If you miss a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for a missed tablet, and do not take doses too close together in time.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everyone experiences them.
Frequency unknown (frequency cannot be determined from the available data):
hypersensitivity,
diarrhea, abdominal pain,
skin reactions, including urticaria, pruritus, rash, erythema.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further collection of information on the safety of the medicine.

5. How to store Magne B6 Forte

Keep this medicine out of sight and reach of children.
Store the medicine at a temperature below 25°C.
Do not use this medicine 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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Magne B6 Forte contains

The active substances are: magnesium ions (as magnesium citrate) 100 mg, pyridoxine hydrochloride (vitamin B6) 10 mg
Other components (excipients): anhydrous lactose, macrogol 6000, magnesium stearate.
Coating composition: hypromellose, macrogol 6000, titanium dioxide (E 171), talc.

What Magne B6 Forte looks like and contents of the pack
The pack contains 60, 90, 100, 120 or 180 coated tablets of Magne B6 Forte,
packed in blisters made of PVC/PE/PVDC/Al foil, and placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Opella Healthcare Poland Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Poland

Manufacturers:
Opella Healthcare Hungary Limited Liability Company
2112 Veresegyhaz, Levai utca 5
Hungary
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France

For further information, please contact:
Opella Healthcare Poland Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Poland
Tel.: +48 22 280 00 00