Patient information leaflet

Béres Magnesium 250 mg + B₆
30 and 60 film-coated tablets

Read the patient information leaflet carefully before taking the medicine.

• This is a non-prescription medicine. For the optimal effect, it is essential that this medicine.
• Please keep the patient information leaflet, because you might need the information in it later on as well.
• For further information or advice, consult your pharmacist.
• Urgently see your doctor if your symptoms do not ease within 3 days or get more severe.

Contents of the patient information leaflet:

• 1. What type of medicine is Béres Magnesium 250 mg + B₆ film-coated tablet, and what diseases can it be applied for?
• 2. Important notes before taking Béres Magnesium 250 mg + B₆ film-coated tablet
• 3. How to apply Béres Magnesium 250 mg + B₆ film-coated tablet?
• 4. Possible side effects
• 5. Storage

Active substance: 1.6 mg pyridoxine (in the form of 1.9448 mg pyridoxine hydrochloride), 250 mg magnesium (in the form of 352.92 mg heavy magnesium oxide, 463.93 mg magnesium citrate) per film-coated tablet.

Auxiliary materials: magnesium stearate, crospovidone, water-free dicalcium phosphate, microcrystalline cellulose.

Coating: "AquaPolish pink 048.15"

Hypromellose (E464), polydextrose (E1200), talc (E 553b), glycerine, titanium dioxide (E 171), yellow iron dioxide (E172), red iron dioxide (E172), black iron dioxide (E172).

Description: film-coated tablet: beige colour, with a bisecting line on each side of the film-coated tablet

Packaging: 30 and 60 film-coated tablets in white HDPE container, closed with an Alu/PE closing foil and a white PP screw cap. 1 container in a box.

Marketing authorisation holder and manufacturer: Béres Gyógyszergyár Rt., Budapest

1. WHAT TYPE OF MEDICINE IS BÉRES MAGNESIUM 250 MG + B₆ FILM-COATED TABLET AND WHAT DISEASES CAN IT BE APPLIED FOR?

2. IMPORTANT NOTES BEFORE TAKING BÉRES MAGNESIUM 250 MG + B₆ FILM-COATED TABLET

The preparation cannot be applied in the cases of:

• allergy to any of the active substances or auxiliary materials.
• severe kidney disorders

Important notes before starting the treatment:

The possible reasons for magnesium deficiency:

• increased physical activity,
• increased requirement during pregnancy and lactation
• inadequate, deficient nutrition (diet, slimming diet),
• digestion, absorption disorders (intestinal disease),
• increased loss of magnesium (diarrhoea, burns, taking particular diuretics)
• particular special pharmacotherapies (certain antibiotics, immune suppressive preparations, chemotherapeutics)

The possible symptoms of magnesium deficiency:

• neurological symptoms (concentration capacity disturbance)
• muscle shaking, muscle convulsion (e.g.: convulsion of the calf at night )

If you have hypertension, coronary disorders or particular heart rate disorders, consult your doctor by all means before starting the application!

Application of other medicines (interaction between medicines):
It can be applied together with medicines containing levodopa only under medical attention (its effect may decrease). Particular medicines (e.g. tetracyclines, calcium and iron preparations, biphosphonates) inhibit its absorption, so at least 3 hours should pass between taking these preparations and Béres Magnesium 250 mg + B₆!
Magnesium may interact also with other medicines (with particular diuretics and heart medicines) so consult your doctor before taking it!

Pregnancy and lactation:
It can be applied in the dose recommended for adults (1 film-coated tablet per day) during pregnancy and lactation. Taking other preparations containing magnesium is recommended only after the doctor’s approval.

The effects of the preparation on driving capabilities and capabilities of the operation of machines:
The recommended dose does not influence capabilities necessary for driving and the operation of machines.

3. TO APPLY BÉRES MAGNESIUM 250 MG + B₆ FILM-COATED TABLET?

Its recommended dose for adults is 1 film-coated tablet per day.

For children: 1/2 film-coated tablet per day between 4-10 years of age, 1 film-coated tablet per day above 11 years of age.

Take the preparation whole at least with half a decilitre of liquid (e.g. water, tea, fruit juice, etc.), at the end of a meal.
Take the preparation until the condition justifying the application persists, while in the case of the any disease, take the preparation until the doctor recommends it.

If you took more film-coated tablets than prescribed
Side effects may arise only when doses several times higher than the recommended daily dose are taken for a long period of time. Symptoms of possible overdose: weakness, nausea, vomiting, low heart rate (bradycardia), decreased reflexes (hyporeflexia), sensation problems (paraesthesias), or even disturbances of consciousness in a severe case. As an antibody i.v. 100-200 mg calcium can be applied lasting 5-10 minutes, and dialysis may also be applied.

f you missed taking a film-coated tablet:
Do not take a double dose the next administration time.

4. POSSIBLE SIDE EFFECTS

As every medicine Béres Magnesium 250 mg + B₆ film-coated tablet may also have side effects.
Rarely (when higher than recommended doses are taken) diarrhoea and abdominal pain may occur. In this case, stop taking the medicine!

For additional information about the medicine, consult your doctor or pharmacist!

5. STORAGE

Store below 25 ^oC.
Do not take the medicine after its expiry date printed on the packaging!
The medicine is to be stored out of reach of children!
OGYI-T-10 193/01 (30 db)
OGYI-T-10 193/02 (60 db)

OGYI approval number of the Patient information leaflet: 6512/40/2005

For risks and side effects, please read the patient information leaflet or consult your doctor, pharmacist!