Magnaspartate 243 mg powder for oral solution

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Magnesium aspartate dihydrate

थमां उपलब्ध:

Kora Corporation Limited trading as Kora Healthcare

ए.टी.सी कोड:

A12CC; A12CC05

INN (इंटरनेशनल नाम):

Magnesium aspartate dihydrate

डोज़:

243 milligram(s)

फार्मास्यूटिकल फॉर्म:

Powder for oral solution

प्रशासन का मार्ग:

Oral use

पैकेज में यूनिट:

Packs of 10 sachets.

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

द्वारा बनाया गया:

Lusomedicamenta Sociedade Tecnica Farmaceutica, S.A.

चिकित्सीय क्षेत्र:

Magnesium; magnesium aspartate

चिकित्सीय संकेत:

Treatment and prevention of magnesium deficiency

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2015-05-15

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MAGNASPARTATE 243 MG POWDER FOR ORAL SOLUTION
magnesium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor,or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What MAGNASPARTATE is and what it is used for
2.
What you need to know before you take MAGNASPARTATE
3.
How to take MAGNASPARTATE
4.
Possible side effects
5.
How to store MAGNASPARTATE
6.
Contents of the pack and other information
1.
WHAT MAGNASPARTATE IS AND WHAT IT IS USED FOR
Magnaspartate is a mineral preparation and contains the active
ingredient magnesium aspartate
dihydrate equivalent to 243 mg (10 mmol) of magnesium.
Magnaspartate is used in the treatment and prevention of magnesium
deficiency in adults and
children aged 2 years and above.
You must talk to a doctor if you do not feel better or if you feel
worse after taking this medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAGNASPARTATE
DO NOT TAKE MAGNASPARTATE:
•
if you are allergic to magnesium aspartate dihydrate or any of the
other ingredients of this
medicine (listed in section 6).
•
if you have severe kidney problems
•
if you have a very slow heart rhythm (called ‘bradycardia’)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Magnaspartate:
If you have switched from another magnesium medicine to ensure that
treatment with
Magnaspartate does not make you feel unwell and that you can continue
to receive the correct dose
of magnesium.
OTHER MEDICINES AND MAGNASPARTATE
Tell your doctor or pharmacist if you are taking, have recently taken
or might

उत्पाद विशेषताएं

Health Products Regulatory Authority
08 November 2022
CRN00D3WQ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Magnaspartate 243 mg powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 6.5 g sachet of powder contains magnesium aspartate dihydrate
equivalent to 243 mg (10 mmol) of magnesium.
Excipient(s) with known effect:
Each sachet contains 2.706g sucrose and 2mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution
White powder with a peach/apricot-like flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Magnaspartate is indicated for the treatment and prevention of
magnesium deficiency in adults and children aged 2 years and
above.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The duration of magnesium treatment required will depend on the
clinical circumstances of each patient.
It is recommended that serum magnesium levels should be monitored at
regular intervals e.g. every 3-6 months, particularly in
children and in patients with renal impairment.
Posology
ADULTS (> 18 YEARS)
1-2 sachets daily (243-486 mg magnesium or 10-20 mmol magnesium)
CHILDREN AND ADOLESCENTS: 10 TO 18 YEARS
One sachet daily (equal to 243 mg magnesium) dissolved in 50-200ml of
water, tea, or orange juice.
CHILDREN: 4-10 YEARS
One sachet daily (equal to 243 mg magnesium) dissolved in 50-200ml of
water, tea, or orange juice. Alternatively, for a half
dosage, use half the volume of 1 sachet dissolved in 50-200ml of water
(equal to 121.5 mg magnesium).
CHILDREN: 2 TO 4 YEARS
Half the volume of 1 sachet dissolved in 50-200ml water (equal to
121.5 mg magnesium).
The safety and efficacy of Magnaspartate in children below 2 years has
not been established
RENAL PATIENTS:
Magnaspartate 243 mg is contraindicated in patients with severe renal
impairment (see section 4.3).
There is no dose adjustment necessary in patients with mild to
moderate renal impairment.
ELDERLY:
No dose adjustment is necessary.
Method of administration
Health Products