Colecalciferol 800 IU capsules, soft

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Colecalciferol

Saatavilla:

Strides Pharma (Cyprus) Limited

ATC-koodi:

A11CC05

INN (Kansainvälinen yleisnimi):

Colecalciferol

Lääkemuoto:

Capsule, soft

Terapeuttinen alue:

colecalciferol

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2023-06-30

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
COLECALCIFEROL 800 IU CAPSULES, SOFT
COLECALCIFEROL
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
What Colecalciferol Capsules is and what it is used for
2. What you need to know before you take Colecalciferol Capsules
3. How to take Colecalciferol Capsules
4. Possible side effects
5. How to store Colecalciferol Capsules
6. Contents of the pack and other information
1. WHAT COLECALCIFEROL CAPSULES IS AND WHAT IT IS USED FOR
Colecalciferol capsules contains the active substance colecalciferol
(vitamin D 3).
Vitamin D is found in the diet and is also produced in the skin after
exposure to the sun. Vitamin D3
regulates the uptake and metabolism of calcium as well as the
incorporation of calcium in bone tissue.
Often vitamin D is given in combination with calcium.
Colecalciferol capsules may be prescribed by your doctor to treat or
prevent vitamin D deficiency.
Deficiency of vitamin D may occur when your diet or lifestyle does not
provide you enough vitamin D
or when your body requires more vitamin D (for instance when you are
pregnant). Colecalciferol
capsules may also be prescribed for certain bone conditions, such as
thinning of the bone
(osteoporosis) when it will be given to you with other medicines.
Colecalciferol capsules is used in adults, the elderly and
adolescents.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLECALCIFEROL CAPSULES
DO NOT TAKE COLECALCIFEROL CAPSULES:
•
if you are allergic to vitamin D or any of the other ingredients of
this med

Valmisteyhteenveto

Health Products Regulatory Authority
01 November 2023
CRN00DX5P
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colecalciferol 800 IU capsules, soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 800 IU colecalciferol (equivalent to 20
micrograms vitamin D
3
)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, soft (capsule)
Blue colored translucent oval shaped soft gelatin capsules containing
clear yellow oily liquid. Capsule dimensions: diameter: 6.7
+/-0.5 mm and length: 9.6 length +/-0.5 mm. 4.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D deficiency.
As an adjunct to specific therapy for osteoporosis in patients with
vitamin D deficiency or at risk of vitamin D insufficiency.
Colecalciferol is indicated in adults, the elderly and adolescents
from 12 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
_Vitamin D deficiency_
For vitamin D deficiency in adults and the elderly (serum levels <25
nmol/l (<10 ng/ml)), 1-4 capsules (800-3200 IU) daily for
up to 12 weeks dependent upon the severity of the disease and the
patient's response to treatment.
_Vitamin D insufficiency_
For vitamin D insufficiency in adults and the elderly (serum levels 25
– 50 nmol/l (10-20 ng/mL)), long term maintenance
therapy following treatment of deficiency in adults and the elderly
and prevention of vitamin D deficiency, 1- 2 Capsules
(800-1600 IU) daily.
_Osteoporosis_
As an adjunct to specific therapy for osteoporosis, 1 capsule daily.
_Dosage in hepatic impairment_
No dose adjustment is required.
_Dosage in renal impairment _
Colecalciferol should not be used in patients with severe renal
impairment (see section 4.3).
Health Products Regulatory Authority
01 November 2023
CRN00DX5P
Page 2 of 6
PAEDIATRIC POPULATION
_Vitamin D deficiency or insufficiency_
_ _
Vitamin D deficiency or insufficiency in children over 12 years – 1
capsule daily depending on the severity of the disease and
the pat