altavitaD3 400 IU soft capsules

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:

400 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:

Not marketed

Authorization date:

2016-09-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALTAVITAD3 400 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 or 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, 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 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 D 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 D in your blood (hypervitaminosis
D)

if you have pseudohypoparathyroidism (disturbed parathyroid hormone
metabolism)

Summary of Product characteristics

Health Products Regulatory Authority
16 May 2022
CRN00C48D
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
altavitaD3 400 IU soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400 IU colecalciferol (equivalent to 0.01 mg
vitamin D3).
For thefulllistofexcipients,see section6.1.
3 PHARMACEUTICAL FORM
Soft capsule
Clear, oval-shaped, soft capsule. It contains a slightly yellow oily
liquid. Each capsule has “0.4” printed in white ink. Capsule
dimensions are 10.5mm x 7mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis and treatment of Vitamin D deficiency in children and
adolescents with an identified risk.
Prophylaxis of Vitamin D deficiency in adults, pregnant and
breast-feeding women with an identified risk.
As an adjunct to specific therapy for osteoporosis in patients with
Vitamin D deficiency or at risk of Vitamin D deficiency
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology

Paediatricposology
- prevention ofdeficiency10-18years800 IU/day (2 capsules).
- Doses of up to 1200 IU/day (3 capsules) may be required to prevent
deficiency in some children.
- treatment ofdeficiency 10-18years2000 IU/day (5 capsules) for 6
weeks,followed bymaintenancetherapyof 400-1200IU/day
(1-3 capsules)

Pregnancyand breastfeeding
- Prevention of deficiency 400 IU/day (1 capsule)
- Doses of up to 2000 IU/day (5 capsules) may be required to prevent
deficiency in some women (see below).
- Even higher doses may be required during breast-feeding if women
choose not to give the infant a vitamin D3 supplement.

Adults
- prevention ofVitamin D deficiency800 IU/day (2 capsules).
Higher doses may be required in certain situations, see below.
- as anadjunct tospecifictherapyforosteoporosis:800 IU/day (2
capsules)

Certainpopulationsareathigh riskof vitamin D3 deficiency, and may
requirehigherdosesand monitoringof
serum25(OH)D:
- Institutionalisedor hospitalisedindividuals
- Darkskinnedindividuals
- Individualswithlimitedeffective sun
exposureduetoprotec