Colecalciferol 800unit tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Colecalciferol

Disponible depuis:

Consilient Health Ltd

Code ATC:

A11CC05

DCI (Dénomination commune internationale):

Colecalciferol

Dosage:

800unit

forme pharmaceutique:

Tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 09060400; GTIN: 5391512453701

Notice patient

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
ingredient

Résumé des caractéristiques du produit

OBJECT 1
COLECALCIFEROL 800 IU FILM-COATED TABLETS
Summary of Product Characteristics Updated 02-Feb-2017 | Consilient
Health Ltd
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 µg
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.
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
• 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
Colecalciferol 800 IU Film-coated Tablets are indicated in adults, the
elderly and adolescents.
4.2 Posology and method of administration
Posology
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.
_Osteoporosis: _For the adjunct therapy of osteoporosis a daily dose
of 800-1000 IU, or a correspondent
total weekly dose of 7000 IU, alternatively monthly dose of 30000 IU
vitamin D is recommended. A daily
dosis 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