Magne b6
Poland
Table of Contents
Package leaflet: Information for the user
MAGNE B 48 mg Mg + 5 mg, film-coated tablets
Magnesii lactas dihydricus + Pyridoxini hydrochloridum
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Please read all of 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, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
- If your symptoms persist or worsen, consult your doctor.
Contents of the leaflet
- What Magne B is and what it is used for
- Important information before taking Magne B
- How to take Magne B
- Possible side effects
- How to store Magne B
- Contents of the pack and other information
1. What Magne B is and what it is used for
Magne B tablets contain magnesium ions and pyridoxine hydrochloride (vitamin B ).
This medicine helps correct deficiencies of magnesium and/or vitamin B in the body.
Magnesium is a cation essential for the proper functioning of numerous biochemical processes in the body. Its biological role includes the activation of various enzymes. Magnesium plays an important role in myocardial contraction and influences neuromuscular excitability.
Magnesium is only partially absorbed from the gastrointestinal tract, mainly in the small intestine, and the extent of absorption depends on dietary magnesium content. Magnesium deficiency may lead to disturbances in the muscular and central nervous systems.
Vitamin B enhances 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-related symptoms such as gastrointestinal cramps or palpitations (in the absence of heart disorders);
- Muscle cramps, tingling sensations, eyelid twitching.
Supplementing magnesium may alleviate these symptoms.
If no improvement is observed after one month of treatment with Magne B, continued use is not recommended.
2. Important information before using Magne B
When not to use 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 concurrently using levodopa.
Warnings and precautions
Before starting treatment with Magne B, discuss it with your doctor, pharmacist, or
nurse.
Particular caution is advised in patients with moderate renal impairment due to the risk of elevated magnesium levels in the blood.
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 formulations of the medicine appropriate for children under 6 years of age are available.
If in doubt, consult a doctor or pharmacist for advice.
Magne B and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Avoid concomitant use of products containing phosphates or calcium salts, as these compounds inhibit magnesium absorption from the small intestine.
If a tetracycline antibiotic is taken orally together with Magne B, a 3-hour interval should be maintained between administrations.
Magne B 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 B.
Magne B 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 have a baby, she should consult her doctor 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 to use Magne B during breastfeeding and the dosage are determined by the doctor.
Magne B may be used during breastfeeding when therapeutic doses are observed; it is recommended that breastfeeding women take vitamin B in a maximum dose of 20 mg per day.
Fertility
Studies on vitamin B have shown effects on male fertility. However, such an effect is observed only at very high doses. The safety profile of Magne B is very good due to its low vitamin B content.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
Magne B contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
3. How to use Magne B
This medicine should always be used 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:
6 to 8 tablets per day, divided into 2 or 3 doses, taken with meals.
Use in children and adolescents
Children aged 6 years and older (with body weight approximately 20 kg):
4 to 6 tablets per day, divided into 2 or 3 doses, taken with meals.
Overdose of Magne B
If you take more than the recommended dose, seek immediate advice from your doctor or pharmacist.
Overdose of orally administered magnesium does not cause toxic reactions in patients with normal kidney function.
In patients with renal impairment, magnesium poisoning may occur.
When high doses of vitamin B6 (pyridoxine) are taken for a prolonged period (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
If you miss a dose, take it as soon as possible, unless it is almost time for the next dose.
Do not take two doses at the same time or within a short interval.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Frequency unknown (frequency cannot be determined from the available data):
hypersensitivity,
diarrhea, abdominal pain,
skin reactions, including urticaria, itching, rash, erythema.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. 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 181 C, 02-222 Warsaw.
Tel.: +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 continued monitoring of the medicine's safety.
5. How to store Magne B
Keep this medicine out of sight and reach of children.
Store the medicine at a temperature below 25°C and keep it in the original packaging to protect from light.
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 sewage systems or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Magne B contains
- The active substances are: magnesium ions (as magnesium lactate dihydrate) 48 mg Mg (1.97 mmol), pyridoxine hydrochloride (vitamin B_) 5 mg.
- The other ingredients are: sucrose, heavy kaolin, gum arabic, carbopol 934, talc, magnesium stearate.
Coating composition: gum arabic, sucrose, titanium dioxide, talc, carnauba wax.
Pack sizes available
50, 60 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Opella Healthcare Poland Sp. z o.o.
Marcina Kasprzaka 6
01-211 Warsaw
Poland
Manufacturers
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszów
Lubelska 52
35-233 Rzeszów
Poland
Opella Healthcare Hungary Limited Liability Company
Levai utca 5, Veresegyhaz 2112
Hungary
Sanofi-Winthrop Industrie
1, rue de la Vierge
33440 Ambares
France
For further information, please contact:
Opella Healthcare Poland Sp. z o.o.
Marcina Kasprzaka 6
01-211 Warsaw
Poland
Tel.: +48 22 280 00 00