altavitaD3 5,600 IU soft capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Colecalciferol concentrate (oily form)

Available from:

Consilient Health Limited

ATC code:

A11CC; A11CC05

INN (International Name):

Colecalciferol concentrate (oily form)

Dosage:

5,600 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:

2016-10-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALTAVITAD3 5,600 IU SOFT CAPSULES
colecalciferol (vitamin D3)
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.
- 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 vitamin D3 which regulates the uptake and
metabolism of calcium as well as the
incorporation of calcium in bone tissue.
altavitaD3 is used to prevent and treat vitamin D3 deficiency in
adults and adolescents. Your
doctor may prescribe altavitaD3 as an adjunct to specific bone loss
medication.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALTAVITAD3
DO NOT TAKE ALTAVITAD3:
- if you are allergic to colecalciferol or any of the other
ingredients of this medicine (listed in section
6).
- if you have hypercalcaemia (increased levels of calcium in the
blood) or hypercalciuria (increased
levels of calcium in the urine).
- if you have hypervitaminosis D (increased levels of vitamin D in the
blood).
- if you have kidney stones.
If any of the above applies to you, talk to your doctor or pharmacist
before taking altavitaD3.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking altavitaD3:
- if you suffer from sarcoidosis (a special type of connective tissue
disease that affects the lungs, skin
and joints).
- when using other drugs containing vitamin D.
- if

Summary of Product characteristics

Health Products Regulatory Authority
17 January 2023
CRN00D4HG
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
altavitaD3 5,600 IU soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains colecalciferol (vitamin D3) 5,600 IU (equivalent
to 0.14 mg vitamin D3). Excipients with known effect:
Each capsule contains 0.03 mg Allura Red AC (E129). Each capsule
contains 0.1 mg Sunset Yellow FCF (E110).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soft capsule
Red, oval-shaped, soft capsule. It contains a slightly yellow oily
liquid. Each capsule has "5.6" 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 adults and
adolescents with an identified risk. In addition to specific
osteoporosis treatment of patients who are at risk of vitamin D
deficiency, preferably in combination with calcium.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dose: One capsule per week.
Higher doses can be necessary to achieve desirable serum levels of
25-hydroxycolecalciferol (25(OH)D).
The weekly dose should not exceed 5 capsules.
_Dosageinhepaticimpairment_
No dose adjustment is required.
_Dosageinrenalimpairment_
altavitaD3 should not be used in patients with severe renal
impairment.
_Paediatricpopulation_
altavitaD3 is not recommended in children under 12 years of age.
Method of administration
The capsules should be swallowed whole with water.
4.3 CONTRAINDICATIONS

Diseases and/or conditions resulting in hypercalcaemia or
hypercalciuria.

Nephrolithiasis.

Nephrocalcinosis

Hypervitaminosis D.

Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
17 January 2023
CRN00D4HG
Page 2 of 5
altavitaD3 should be prescribed with caution to patients suffering
from sarcoidosis due to risk of increased metabolism