Vitamin D3 20,000 IU Capsules, soft

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Colecalciferol

Available from:

Alissa Healthcare Research Limited

ATC code:

A11CC; A11CC05

INN (International Name):

Colecalciferol

Dosage:

20,000 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:

Authorised

Authorization date:

2016-10-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VITAMIN D
3 20,000 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
20,000 IU Capsules are and what they are used for
2. What you need to know before you take Vitamin D
3
20,000 IU Capsules
3. How to take Vitamin D
3
20,000 IU Capsules
4. Possible side effects
5. How to store Vitamin D
3
20,000 IU Capsules
6. Contents of the pack and other information
1. WHAT VITAMIN D
3 20,000 IU CAPSULES
ARE AND WHAT THEY ARE USED FOR
Vitamin D
3
20,000 IU Capsules contains colecalciferol (vitamin D).
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.
Vitamin D
3
20,000 IU Capsules are used:
• To prevent vitamin D deficiency when there is a significant risk
of deficiency
or an increased demand for vitamin D.
• With other medicine to treat certain bone conditions, such as
thinning of the
bone (osteoporosis).
• To treat vitamin D deficiency that has been confirmed by
laboratory tests.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE VITAMIN D
3 20,000 IU CAPSULES
DO NOT TAKE VITAMIN D
3 20,000 IU 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
parathyroi

Summary of Product characteristics

Health Products Regulatory Authority
12 October 2018
CRN008JM1
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitamin D
3
20,000 IU Capsules, soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
20,000 IU Colecalciferol (equivalent to 500 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)
Light yellow coloured clear transparent round shaped gelatin capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The prevention and treatment of vitamin D deficiency. As an adjunct to
specific
therapy for osteoporosis in patients at risk of vitamin D
insufficiency or with vitamin
D deficiency.
Vitamin D
3
20,000 IU Capsules is indicated in adults.
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. The patient’s dietary habits
should be
carefully evaluated and artificially added vitamin D content of
certain food types
should be taken into consideration.
Prevention of Vitamin D deficiency:

Starting dose of 1 capsule (20,000 IU) once a month, higher doses may
be
required in certain situations, see below
Health Products Regulatory Authority
12 October 2018
CRN008JM1
Page 2 of 10

As an adjunct to specific therapy for osteoporosis: 1 capsule
(20,000IU)
once a month
Treatment of Vitamin D deficiency:

2 capsules (40,000 IU) once weekly for 7 weeks, followed by
maintenance
therapy (equivalent to 1400 - 2000 IU/day, such as 2-3 capsules per
month,
as directed by your doctor. Follow-up 25(OH)D measurements should be
made approximately three to four months after initiating maintenance
therapy to confirm that the target level has been achieved).
Medical supervision is necessary as dose requirements may vary
dependent on
patient response (see section 4.4).
Certain populations are at high risk of v