Altavita D3 50,000 IU oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cholecalciferol

Available from:

Consilient Health Limited

ATC code:

A11CC; A11CC05

INN (International Name):

Cholecalciferol

Dosage:

50,000 international unit(s)

Pharmaceutical form:

Oral solution

Administration route:

Oral use

Units in package:

pack with 1, 2, 3, 4, 5 or 6 single dose

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

SMB Technology S.A

Therapeutic group:

Vitamin D, colecalciferol

Therapeutic area:

Vitamin D and analogues; colecalciferol

Therapeutic indications:

For the treatment of vitamin D deficiency

Authorization status:

Not marketed

Authorization date:

2015-07-10

Patient Information leaflet

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, or
nurse.
•
This medicine has been prescribed for you only. Do not pass it onto
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 or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What altavitaD3 is and what it is used for
2. What you need to know before you use altavitaD3
3. How to use altavitaD3
4. Possible side effects
5. How to store altavitaD3
6. Contents of the pack and other information
1. WHAT ALTAVITAD3 IS AND WHAT IT IS USED FOR
altavitaD3 is a vitamin product containing colecalciferol (equivalent
to vitamin D
3
). Vitamin D
can be found in some foods and also produced by the body when skin is
exposed to sunlight.
Vitamin D helps the kidneys and intestine absorb calcium and it helps
build bones.
altavitaD3 50,000 IU is used to treat vitamin D deficiency that has
been confirmed by laboratory
tests.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALTAVITAD3
Do not use altavitaD3
•
if you are allergic to vitamin D or any of the other ingredients of
altavitaD3 (listed in section 6)
•
if you have hypercalcaemia (high levels of calcium in the blood)
•
if you have hypercalciuria (high levels of calcium in the urine)
•
if you have pseudohypoparathyroidism (disturbed parathyroid hormone
metabolism)
•
if you have renal calculi (kidney stones)
•
if you have hypervitaminosis D (high levels of vitamin D in the
blood).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using altavitaD3 if
you:
•
are undergoing treatment with certain medicines used to treat heart
disorders (e.g., cardiac
glycosides, such as digoxin)
•
have sarcoidosis (an immune system disorder which may cause

Summary of Product characteristics

Health Products Regulatory Authority
15 September 2023
CRN00DTS3
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Altavita D3 50,000 IU oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1mlsolution(1single-doseoralsolution)contains1.25mgcolecalciferol,equivalentto
50,000IUvitaminD3.
Forafulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Oralsolution.
Clear,slightlyyellow,oilyliquidwithanorangeodour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ThetreatmentofvitaminDdeficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Paediatricposology:
Duetoalackofclinicaldata,altavitaD3isnotrecommended.
Pregnancyandbreastfeeding:
Duetoalackofclinicaldata,altavitaD3isnotrecommended.
Adults:
TreatmentofvitaminDdeficiency(<25nmol/l)50,000IU/week(1single-doseoralsolution)for6-8
weeks,followedbymaintenancetherapy(equivalentto1400-2000IU/day,suchas1single-dose
50,000IUoralsolutionpermonth)mayberequired;follow-up25(OH)Dmeasurementsshouldbe
madeapproximatelythreetofourmonthsafterinitiatingmaintenancetherapy
toconfirmthatthetarget levelhasbeenachieved).
CertainpopulationsareathighriskofvitaminDdeficiency,andmayrequirehigherdoses
andmonitoringofserum25(OH)D:

Institutionalisedorhospitalisedindividuals

Darkskinnedindividuals

Individualswithlimitedeffectivesunexposureduetoprotectiveclothingorconsistentuseofsun
screens

Obeseindividuals

Patientsbeing evaluatedforosteoporosis

Useofcertain
concomitantmedications(e.g.,anticonvulsantmedications,glucocorticoids)

Patientswithmalabsorption,includinginflammatoryboweldiseaseandcoeliacdisease

ThoserecentlytreatedforvitaminDdeficiency,andrequiringmaintenancetherapy.
Health Products Regulatory Authority
15 September 2023
CRN00DTS3
Page 2 of 6
Specialpopulations
_Renalimpairment_
altavitaD3shouldnotbeusedincombinationwithcalciuminpatientswithsevererenalimpairment.
_Hepaticimpairment_
Noposologyadjustmentisrequiredinpatientswithhepaticimpairment.
Methodofadministration
PatientsshouldbeadvisedtotakealtavitaD3preferab