Colecalciferol Aristo 20,000 IU soft capsules

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Colecalciferol

Tilgængelig fra:

Aristo Pharma GmbH

ATC-kode:

A11CC; A11CC05

INN (International Name):

Colecalciferol

Dosering:

20,000 international unit(s)

Lægemiddelform:

Capsule, soft

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Vitamin D and analogues; colecalciferol

Autorisation status:

Not marketed

Autorisation dato:

2018-02-23

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
COLECALCIFEROL ARISTO 20,000 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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Colecalciferol Aristo Capsules are and what they are used for
2.
What you need to know before you take Colecalciferol Aristo Capsules
3.
How to take Colecalciferol Aristo Capsules
4.
Possible side effects
5.
How to store Colecalciferol Aristo Capsules
6.
Contents of the pack and other information
1.
WHAT COLECALCIFEROL ARISTO CAPSULES ARE AND WHAT THEY ARE USED FOR
Colecalciferol Aristo Capsules contains colecalciferol (vitamin D3).
Vitamin D is found in some foods and is also produced in the body when
skin is exposed to sunlight.
Vitamin D helps the kidneys and intestine absorb calcium and it helps
build bones.
Colecalciferol Aristo Capsules are used for initial treatment of
symptomatic vitamin D deficiency in
adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLECALCIFEROL ARISTO CAPSULES
DO NOT TAKE COLECALCIFEROL ARISTO CAPSULES:
•
if you are allergic to colecalciferol 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 a condition which means that your body is resistant to
parathyroid hormone
(pseudohypoparathyroidism)
•
if you have high levels of vitamin D in your blood (hypervitaminosis
D)
•
if you have kidney stones, calcification of the kidneys or serious
kidney problems.
WARNINGS AND PRECAUT

Produktets egenskaber

Health Products Regulatory Authority
11 July 2023
CRN00DLD9
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colecalciferol Aristo 20,000 IU soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
500 microgram colecalciferol (vitamin D
3
equivalent to 20,000 IU).
Excipients with known effect:
Each capsule contains 16.5 milligrams of sorbitol.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Soft capsule
Light yellow coloured clear transparent round shaped gelatin capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Initial treatment of symptomatic vitamin D deficiency in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dose: One capsule (20,000 IU) weekly.
After first month, lower doses may be considered, dependent upon
desirable serum levels of 25-hydroxycolecalciferol
(25(OH)D), the severity of the disease and/or the patient´s response
to treatment.
Alternatively, national posology recommendations in treatment of
vitamin D deficiency can be followed.
Special populations:
_Dosage in hepatic impairment_
No dose adjustment is required.
_Dosage in renal impairment_
Colecalciferol Aristo Capsulesmust not be used in patients with severe
renal impairment (see section 4.3).
_Paediatric population_
Colecalciferol Aristo Capsules are not recommended.
Method of administration
_Oral_
The capsules should be swallowed whole (not chewed) with water.
Patients should be advised to take Colecalciferol Aristo Capsules
preferably with meal (see section 5.2 Pharmacokinetic
properties -“Absorption”).
Health Products Regulatory Authority
11 July 2023
CRN00DLD9
Page 2 of 6
4.3 CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
- Diseases or conditions resulting in hypercalcemia and / or
hypercalciuria.
- Pseudohypoparathyroidism.
- Hypervitaminosis D.
- Nephrolithiasis.
- Nephrocalcinosis.
- Severe renal impairment.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Colec