altavitaD3 1,000 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:

1000 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 1,000 IU SOFT CAPSULES
ALTAVITAD3 7,000 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, 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 D 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 high levels of vitamin D in your blood (hypervitaminosis
D)
If any of the above applies to you, talk to your doctor or pharmacist
before taking altavitaD

Summary of Product characteristics

Health Products Regulatory Authority
07 September 2023
CRN00DS0S
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
altavitaD3 1,000 IU soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 1,000 IU colecalciferol (equivalent to 0.025 mg
vitamin D3)
Excipients with known effect: each 1,000 IU capsule contains 0.11mg
Allura Red AC (E129)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soft capsule
Dark red, oval-shaped, soft capsule. It contains a slightly yellow
oily liquid. Each capsule has “1” 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,
adolescents and adults with an identified risk.
Prophylaxis of vitamin D deficiency in 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
Dose should be established on an individual basis depending on the
extent of the necessary vitamin D supplementation.
altavitaD3 1,000 IU soft capsules are suitable for daily
supplementation, while altavitaD3 7,000 IU soft capsules are suitable
for
weekly supplementation, which should be taken into consideration and
dosage should be established by a physician.
The dose of 1,000 IU/day is considered equivalent to 7,000 IU/week.
Paediatric posology
- Doses of up to 1,000 IU/day may be required to prevent deficiency in
some children.
- treatment of deficiency 1 0-18 years 2,000 IU/day for 6
weeks,followed by maintenance therapy of 400-1,000 IU/day (such as
one 1,000 IU soft capsule per day or one 7,000 IU soft capsule per
week).
Pregnancy and breastfeeding
- Doses of 1,000 – 2,000 IU/day 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 D