Vitamin D3 1,000 IU Capsules, soft

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Colecalciferol

Предлага се от:

Pharmafile Limited

АТС код:

A11CC; A11CC05

INN (Международно Name):

Colecalciferol

дозиране:

1000 international unit(s)

Лекарствена форма:

Capsule, soft

Терапевтична област:

Vitamin D and analogues; colecalciferol

Статус Оторизация:

Not marketed

Дата Оторизация:

2017-10-06

Листовка

Vitamin D 800/1000/10000 IU Capsules
IE/H/0444/002-004/IB/004
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Vitamin D
3
800 IU Capsules, soft
Vitamin D
3
1,000 IU Capsules, soft
Vitamin D
3
10,000 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
1.
What Vitamin D
3
Capsules are and what they are used for
2.
What you need to know before you take Vitamin D
3
Capsules
3.
How to take Vitamin D
3
Capsules
4.
Possible side effects
5.
How to store Vitamin D
3
Capsules
6.
Contents of the pack and other information
1.
WHAT VITAMIN D
3 CAPSULES ARE AND WHAT THEY ARE USED FOR
The active substance of Vitamin D
3
Capsules is vitamin D3. Vitamin D helps the body to absorb calcium
and enhances bone formation.
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.
Vitamin D
3
Capsules are used in adults, the elderly and adolescents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VITAMIN D
3 CAPSULES
DO NOT TAKE VITAMIN D
3 CAPSULES:
-
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 severe kidney problems (severe renal impairmen

Данни за продукта

Health Products Regulatory Authority
09 January 2020
CRN009750
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitamin D3 1,000 IU Capsules, soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
1,000 IU Colecalciferol (equivalent to 25 micrograms Vitamin D3)
Excipients with known effect:
Each capsule also contains 16.5 milligrams of sorbitol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft (Capsule)
Green coloured clear transparent round shaped gelatin capsule with a
clear, colourless liquid fill.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of Vitamin D deficiency
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.
Vitamin D
3
Capsulesis indicated in adults, the elderly and adolescents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Dose should be established on an individual basis depending on the
extent of the necessary vitamin D supplementation.
Vitamin D
3
800 IU and 1,000 IU capsules are suitable for daily vitamin D
supplementation, while the 10,000 IU dose is suitable
for weekly vitamin D dosing (equivalent to 1, 400 IU/day)
respectively, which should be taken into consideration and dosage
should be established by a physician.
_Osteoporosis: _For the adjunct therapy of osteoporosis a daily dose
of 800-1,000 IU. A daily doses equivalent of 2,000 IU vitamin
D should be considered in fragile elderly patients who are at
particular risk of falls and fractures. Patients should receive
supplemental calcium if intake from diet is inadequate.
_Vitamin D deficiency (serum levels < 25 nmol/l or < 10 ng/ml) in
adults and the elderly: _800 IU-4,000 IU daily for up to 12 weeks
depending upon the severity of the disease and the patient`s response
to treatment.
_Vitamin D insufficiency (serum levels 25-50 nmol/l or 10-20 ng/ml) in
adults and the elderly:_
_AND_
_Long term main