Abidec Multivitamin Oral Drops Solution

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Vitamin a palmitate; Ergocalciferolci; Thiamine hydrochloride; Riboflavin sodium phosphate; Pyridoxine hydrochloride; Nicotinamide; Ascorbic acid

Commercializzato da:

Chefaro Ireland DAC

Codice ATC:

A11BA

INN (Nome Internazionale):

Vitamin a palmitate; Ergocalciferolci; Thiamine hydrochloride; Riboflavin sodium phosphate; Pyridoxine hydrochloride; Nicotinamide; Ascorbic acid

Dosaggio:

25 millilitre(s)

Forma farmaceutica:

Oral drops, solution

Tipo di ricetta:

Product not subject to medical prescription

Area terapeutica:

Multivitamins, plain

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2000-09-01

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
ABIDEC
MULTIVITAMIN
ORAL DROPS SOLUTION
READ THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION.
THIS MEDICINE IS FOR YOUR CHILD.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If your child gets 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 Abidec Multivitamin Drops are and what they are used for
_2._
_ _
What you need to know before you use Abidec Multivitamin Drops
_3._
_ _
How to use Abidec Multivitamin Drops
_4._
_ _
Possible side effects
_5._
_ _
How to store Abidec Multivitamin Drops
_6._
_ _
Contents of the pack and other information
1.
WHAT ABIDEC MULTIVITAMIN DROPS ARE AND WHAT THEY ARE USED FOR
Abidec Multivitamin Drops contains 1333 IU retinol (as vitamin A
palmitate), 400 IU
ergocalciferol, 0.4 mg thiamine hydrochloride, 0.8 mg riboflavin
sodium phosphate, 0.8 mg
pyridoxine hydrochloride, 8 mg nicotinamide, and 40 mg ascorbic acid
in each 0.6 ml dose.
Abidec Multivitamin Drops are used to prevent vitamin deficiencies in
babies and children up to 12
years old. It is not designed for adults. This medicine contains seven
essential vitamins that a child
or baby needs to grow and keep healthy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ABIDEC MULTIVITAMIN DROPS
DO NOT USE ABIDEC MULTIVITAMIN DROPS
if your child is allergic to peanut oil because Abidec Multivitamin
Drops contain arachis oil
(peanut oil).
-
if your child is allergic to soya.
-
if your child is allergic to any of the active substances (listed
above in section 1) or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Abidec Multivitamin
Drops.
When prescribing Abidec

Scheda tecnica

Health Products Regulatory Authority
25 March 2021
CRN009ZWS
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Abidec Multivitamin Oral Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Abidec
Multivitamin
Drops
contains
1333
IU
retinol
(as
vitamin
A
palmitate),
400
IU
ergocalciferol,
0.4
mg
thiamine
hydrochloride, 0.8 mg riboflavin sodium phosphate, 0.8 mg pyridoxine
hydrochloride, 8 mg nicotinamide, and 40 mg ascorbic
acid in each 0.6 ml dose.
Excipient(s) with known effect
Contains sucrose 45 mg per 0.6 ml dose and arachis oil (peanut oil)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution
A clear yellow/brown solution with a characteristic odour and taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Abidec Multivitamin Drops is indicated for the prevention of vitamin
deficiencies and for the maintenance of normal growth
and health during the early years of infancy and childhood;
multivitamin supplement.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS AND CHILDREN OVER 12 YEARS:
Not appropriate.
CHILDREN AGED 1 TO 12 YEARS: Oral.
One 0.6ml dose taken daily.
Maximum daily dose: 0.6ml.
CHILDREN UNDER 1 YEAR:
Oral.
One 0.3ml dose taken daily.
Maximum daily dose: 0.3ml.
THE ELDERLY:
Not appropriate.
HEPATIC/RENAL DYSFUNCTION:
Normal dosage is appropriate.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Health Products Regulatory Authority
25 March 2021
CRN009ZWS
Page 2 of 7
Vitamin A palmitate contains refined peanut oil (Arachis oil) and
should not be taken by patients known to be allergic to
peanut. As there is a possible relationship between allergy to peanut
and allergy to soya, patients with soya allergy should also
avoid Abidec Multivitamin Drops.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
When prescribing Abidec Multivitamin Drops, as with all multivitamin
preparations, allowance should be made for vitamins
obtained from other sources.
While chi