AltavitaD3 25,000IU oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Colecalciferol

Available from:

Consilient Health Limited

ATC code:

A11CC; A11CC05

INN (International Name):

Colecalciferol

Dosage:

25,000 international unit(s)

Pharmaceutical form:

Oral solution

Administration route:

oral use

Units in package:

Pack with 1, 2, 3 or 4 ampoules

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:

The prevention and treatment of vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency

Authorization status:

Marketed

Authorization date:

2015-09-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALTAVITAD3
25,000 IU ORAL SOLUTION
COLECALCIFEROL
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 quest ions, 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 informat ion
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 25,000 IU is used:
-
for the prevent ion of vitamin D deficiency when there is a
significant risk of deficiency or
an increased demand for vitamin D
-
with other medicines to treat certain bone condit ions, such as
thinning of the bone
(osteoporosis)
-
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 parathyro id hormone metabo lism)
-
if you have renal calculi (kidney stones)
-
if you have hypervitaminosis D (high levels of

Summary of Product characteristics

Health Products Regulatory Authority
25 August 2020
CRN009T9M
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AltavitaD3 25,000IU oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml solution (1 single-dose oral solution) contains 0.625mg
colecalciferol, equivalent to 25,000 IU vitamin D.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, slightly yellow, oily liquid with an orange odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The prevention and treatment of vitamin D deficiency.
As an adjunct to specific therapy for osteoporosis in patients with
vitamin D deficiency or at risk of vitamin D insufficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Paediatric posology:
- Prevention of deficiency 0-1 years 25,000 IU (1 single-dose oral
solution) every 8 weeks.
- Prevention of deficiency 1-18 years 25,000 IU (1 single-dose oral
solution) every 6 weeks.
- Treatment of deficiency 0-18 years 25,000 IU (1 single-dose oral
solution) once every 2 weeks for 6 weeks (followed by
maintenance therapy of 400-1000 IU/day, such as 1 25,000 IU
single-dose oral solution) per month.
Pregnancy and breastfeeding:
- The high strength formulation is not recommended.
Adults:
- Prevention of vitamin D deficiency 25,000 IU/month (1 single-dose
oral solution)
Higher doses may be required in certain situations, see below
- As an adjunct to specific therapy for osteoporosis: 25,000 IU/month
(1 single-dose oral solution.)
- Treatment of vitamin D deficiency (<25 nmol/l) 50,000 IU/week (2
single-dose oral solutions) for 6-8 weeks, followed by
maintenance therapy (1400-2000 IU /day may be required such as 50,000
IU (2 single-dose oral solutions) per month);
follow-up 25(OH)D measurements should be made approximately three to
four months after initiating maintenance therapy to
confirm that the target level has been achieved.
Certain populations are at high risk of vitamin D deficiency ,and may
require higher doses and monitoring of serum 25(OH)D:
-