Colecalciferol 800 IU film-coated tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Cholecalciferol; Cholecalciferol concentrate (powder form)

Mevcut itibaren:

Consilient Health Limited

ATC kodu:

A11CC; A11CC05

INN (International Adı):

Cholecalciferol; Cholecalciferol concentrate (powder form)

Doz:

800 international unit(s)

Farmasötik formu:

Film-coated tablet

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Vitamin D and analogues; colecalciferol

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

2015-01-30

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
COLECALCIFEROL 800 IU FILM-COATED TABLETS
COLECALCIFEROL 1000 IU FILM-COATED TABLETS
COLECALCIFEROL 7000 IU FILM-COATED TABLETS
COLECALCIFEROL 30000 IU FILM-COATED TABLETS
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.
WHAT IS IN THIS LEAFLET
1.
What Colecalciferol Film-coated Tablets are and what they are used for
2.
What you need to know before you take Colecalciferol Film-coated
Tablets
3.
How to take Colecalciferol Film-coated Tablets
4.
Possible side effects
5.
How to store Colecalciferol Film-coated Tablets
6.
Contents of the pack and other information
1.
WHAT COLECALCIFEROL FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
The active substance of Colecalciferol Film-coated Tablets is vitamin
D
3
.
Vitamin D helps the body to absorb calcium and enhances bone formation
and decreases the level of
parathyroid hormone (PTH).
This medicine is recommended in the following cases:
•
For certain bone conditions, such as thinning of the bone
(osteoporosis), when it will be given to
you with other medicines.
•
To prevent or treat vitamin D deficiency. Vitamin D deficiency may
occur when your diet or
lifestyle does not provide you enough vitamin D or when your body
requires more vitamin D (e.g.
when you are pregnant).
Colecalciferol Film-coated Tablets are used in adults, the elderly and
adolescents
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLECALCIFEROL FILM-COATED
TABLETS
DO NOT TAKE COLECALCIFEROL FILM-COATED TABLETS IF:
•
if you are allergic to vitamin D or any of the other ingredients

Ürün özellikleri

Health Products Regulatory Authority
10 February 2020
CRN008XSF
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colecalciferol 800 IU film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 8 mg colecalciferol concentrate
(powder form) (equivalent to 20 microgram colecalciferol =
800 IU vitamin D
3
).
Excipients with known effect:
Each film-coated tablet contains 59.52 mg lactose monohydrate and 1.4
mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Colecalciferol 800 IU: yellow coloured, round, 6 mm diameter
film-coated tablet with smooth convex surface on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Treatment of Vitamin D deficiency (serum 25(OH)D < 25 nmol/l)
- Prevention of vitamin D deficiency in high-risk patients
- As an adjunct to specific therapy for osteoporosis in patients with
vitamin D deficiency or at risk of vitamin D insufficiency
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dose should be established on an individual basis depending on the
extent of the necessary vitamin D supplementation.
Colecalciferol 800 IU and 1000 IU Film-coated Tablets are suitable for
daily vitamin D supplementation, while the 7000 IU and
30000 IU doses contain amounts equal to the weekly and monthly vitamin
D doses respectively, which should be taken into
consideration and dosage should be established by a physician.
Please refer to the respective national guidelines.
Posology
Adults and elderly:
- Prevention of vitamin D deficiency (maintenance):
- for adults and elderly: 800-1600 IU/day or equivalent weekly or
monthly dose.
- for adults and elderly with osteoporosis: maximum 2000 IU/day or
equivalent weekly or monthly dose.
- Treatment of vitamin D deficiency (loading dose):
- 800-4000 IU/daily or equivalent weekly or monthly dose.
Patients should receive supplemental calcium if intake from diet is
inadequate.
_Hepatic impairment:_ no dose adjustment is necessary for patients
with