Vitamin D3 400 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:

400 international unit(s)

Pharmaceutical form:

Capsule, soft

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Vitamin D and analogues; colecalciferol

Authorization status:

Authorised

Authorization date:

2017-10-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VITAMIN D
3 400 IU CAPSULES, SOFT
COLECALCIFEROL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor
or pharmacist has told you.
− Keep this leaflet. You may need to read it again.
− Ask your pharmacist if you need more information or advice.
− 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.
− You must talk to a doctor if you do not feel better or if you feel
worse.
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:
• To prevent vitamin D deficiency in pregnant and breastfeeding
women when
there is a risk of deficiency.
Vitamin D
3
Capsules are used in adults 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 impairment)
• if you have high levels of vitamin D in your blood
(hypervitaminosis D)
• if you have kidney stones or calcium deposits in your kidneys.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Vitamin D
3
Capsules if:
• You have high tendency to kidney stone formation.
• You have canc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitamin D
3
400 IU Capsules, soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
400 IU Colecalciferol (equivalent to 10 micrograms Vitamin D
3
)
Excipients with known effect:
Each capsule also contains 16.5 milligrams of sorbitol and 40.5
micrograms of allura red.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft (Capsule)
Purple coloured clear transparent round shaped gelatin capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of Vitamin D deficiency in pregnant and breastfeeding women
with an identified risk.
Vitamin D
3
Capsules is indicated in adults and adolescents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents_
Dose should be established on an individual basis depending on the
extent of the necessary vitamin D supplementation.
_Pregnancy and breast-feeding_
- Prevention of deficiency: The usual dose is 400 IU/day (1 capsule)
Before starting the vitamin D therapy, the patient’s dietary habits
should be carefully evaluated by the doctor and
artificially added vitamin D content of certain food types should be
taken into consideration.
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Certain populations are at high risk of vitamin D deficiency, and may
require higher doses