Cholecalciferol 20,000IU Capsules;Aviticol 20,000IU Capsules

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

COLECALCIFEROL

Disponible depuis:

Colonis Pharma Limited Quantum House, Hobson Industrial Estate, Burnopfield, Country, Durham NE16 6EA, United Kingdom

Code ATC:

A11CC05

DCI (Dénomination commune internationale):

COLECALCIFEROL 20,000 IU

forme pharmaceutique:

HARD CAPSULE

Composition:

COLECALCIFEROL 20,000 IU

Type d'ordonnance:

POM

Domaine thérapeutique:

VITAMINS

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2014-11-19

Notice patient

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CHOLECALCIFEROL 20 000 IU CAPSULES
CHOLECALCIFEROL
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What are Cholecalciferol Capsules and what are they used for?
2.
What you need to know before you take Cholecalciferol Capsules
3.
How to take Cholecalciferol Capsules
4.
Possible side effects
5.
How to store Cholecalciferol Capsules
6.
Contents of the pack and other information
1.
WHAT ARE CHOLECALCIFEROL CAPSULES AND WHAT THEY ARE USED FOR?
Cholecalciferol is a form of vitamin D used in the prevention and
treatment of vitamin D
deficiency
conditions.
Cholecalciferol 20 000 IU is the equivalent of 500 micrograms vitamin
D
3
which is involved
in bone formation. The active ingredient cholecalciferol is identical
to the cholecalciferol that
is found in the human body. It is found in the diet and is also
produced in the skin after
exposure to the sun.
Deficiency of vitamin D may occur when your diet or lifestyle does not
provide you with
enough vitamin D or when your body requires more vitamin D (for
instance when you are
pregnant).
IF YOU ARE PLANNING TO GET PREGNANT OR YOU ARE PREGNANT AND YOU
REQUIRE EXTRA
VITAMIN D DO NOT TAKE IT WITHOUT MEDICAL SUPERVISION.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHOLECALCIFEROL CAPSULES
DO NOT TAKE CHOLECALCIFEROL
•
If you are ALLERGIC
(hypersensitive) to cholecalciferol or any of the other ingredients in
the
capsules (these are listed in section 6, Contents of the pack and
other information)
•
if y

Résumé des caractéristiques du produit

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cholecalciferol 20 000 IU Capsules
Aviticol 20 000 IU Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
20 000 IU cholecalciferol (equivalent to 500
μg vitamin D
3
)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
3.
PHARMACEUTICAL FORM
Capsule, Hard
Ivory opaque, unprinted, hard gelatin capsule containing a clear,
slightly yellow oily liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The treatment and prevention of vitamin D deficiency.
Cholecalciferol is indicated in adolescents and adults
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
One capsule contains 20 000 IU cholecalciferol (vitamin D
3
).
•
ADULT POSOLOGY
-
Treatment of vitamin D deficiency: 40 000 IU/week (2 capsules) for 7
weeks,
followed by maintenance therapy of 2-3 capsules (equivalent to 1 400 -
2 000
IU/day) per month, as directed by your doctor.
Follow-up serum 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.
-
Prevention of vitamin D deficiency: 20 000 IU every 4 weeks (1
capsule),
higher doses may be required in certain populations, see below
CERTAIN POPULATIONS
are at high risk of vitamin D deficiency, and may require
higher doses and monitoring of serum 25(OH)D:
•
Institutionalised or hospitalised individuals
•
Dark skinned individuals
•
Individuals with limited effective sun exposure due to protective
clothing or consistent use of sun screens
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•
Patients being evaluated for osteoporosis
•
Obese individuals
•
Use of certain concomitant medications (e.g. anticonvulsant
medications glucocorticoids, anti-retrovirals)
•
Those recently treated for vitamin D deficiency, and requiring
maintenance therapy
•
Patients with liver or renal disease
•
Patients with malabsorption, including inflammatory bowel disease

and coeliac disease
•
PAEDIATRIC POSOLOGY
-
Prevention of vit