altavitaD3 25,000 IU soft capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cholecalciferol (02)

Available from:

Consilient Health Limited

ATC code:

A11CC; A11CC05

INN (International Name):

Cholecalciferol (02)

Dosage:

25,000 international unit(s)

Pharmaceutical form:

Capsule, soft

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Vitamin D and analogues; colecalciferol

Authorization status:

Marketed

Authorization date:

2016-09-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALTAVITAD3 25,000 IU SOFT CAPSULES
colecalciferol (vitamin D3)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
any 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 take altavitaD3
3.
How to take 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 contains colecalciferol (Vitamin D3). Vitamin D3, can be
found in some foods and is also
produced by the body when skin is exposed to sunlight. Vitamin D3
helps the kidneys and intestine
absorb calcium and it helps build bones.
altavitaD3 is used:
•
to prevent vitamin D deficiency when there is a significant risk of
deficiency or an increased
demand for vitamin D
•
with other medicine to treat certain bone conditions, 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 TAKE ALTAVITAD3
DO NOT TAKE ALTAVITAD3:
•
if you are allergic to vitamin D3 or any of the other ingredients of
this medicine (listed in
section 6);
•
if you have high levels of calcium in your blood (hypercalcaemia) or
urine (hypercalciuria);
•
if you have kidney stones (renal calculi);
•
if you have serious renal impairment
•
if you have high levels of vitamin D3 in your blood (hypervitaminosis
D)
•
if you have pseudohypoparathyroidism (disturbed parathyroid hormone
metaboli

Summary of Product characteristics

Health Products Regulatory Authority
08 February 2024
CRN00F3LG
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
altavitaD3 25,000 IU soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25,000 IU colecalciferol (equivalent to 0.625 mg
vitamin D3)
Excipients with known effect: each capsule contains 0.069 mg Allura
Red AC (E129).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soft capsule
Light red, oval-shaped, soft capsule. It contains a slightly yellow
oily liquid. Each capsule has “25” printed in white ink. Capsule
dimensions 12.8mm x 8.5mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis and treatment of Vitamin D deficiency in adolescents and
adults with an identified risk.
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
1 capsule contains 25,000 IU Vitamin D3.

Paediatric posology

preventionof deficiency 10-18 years 25,000 IU (1 capsule) every 6
weeks

treatmentof deficiency 10-18 years 25,000 IU (1 capsule) once every 2
weeks for 6 weeks (followed by maintenance
therapy of 400-1000 IU/day, such as 1 capsule per month.)
o
Pregnancy and breastfeeding

The high strength formulation is not recommended
o
Adults

prevention of Vitamin D deficiency 25,000 IU/month (1 capsule).Higher
doses may be required in certain situations,
see below.

as an adjunct to specific therapy for osteoporosis: 25,000 IU/month (1
capsule)

Treatment of Vitamin D deficiency (<25 nmol/l) 50,000 IU/week (2
capsules) for 6-8 weeks, followed by
maintenance therapy (1400-2000 IU/day may be required, such as 2
capsules 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 an