Cholecalciferol Pharmemma 20.000 IE, zachte capsules

País: Holanda

Língua: holandês

Origem: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredientes ativos:

CHOLECALCIFEROL 500 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 20000 IE/stuk

Disponível em:

Pharmemma Limited Unit 2, Ashbourne Manufacturing Park A84 KH58 ASHBOURNE (IERLAND)

DCI (Denominação Comum Internacional):

CHOLECALCIFEROL 500 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 20000 IE/stuk

Forma farmacêutica:

Capsule, zacht

Composição:

GELATINE (E 441) ; GLYCEROL (E 422) ; SORBITOL VLOEIBAAR, GEDEELTELIJK GEDEHYDRATEERD ; TOCOFEROL, DL-ALFA ACETAAT ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD

Via de administração:

Oraal gebruik

Data de autorização:

1900-01-01

Folheto informativo - Bula

NL/H/5338/001-003/IA/002/G
1
PACKAGE LEAFLET
NL/H/5338/001-003/IA/002/G
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cholecalciferol Pharmemma 20.000 IE, zachte 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 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 Cholecalciferol Pharmemma Capsules are and what they are used for
2.
What you need to know before you take Cholecalciferol Pharmemma
Capsules
3.
How to take Cholecalciferol Pharmemma Capsules
4.
Possible side effects
5.
How to store Cholecalciferol Pharmemma Capsules
6.
Contents of the pack and other information
1.
WHAT CHOLECALCIFEROL PHARMEMMA CAPSULES ARE AND WHAT THEY ARE USED FOR
The active substance of Cholecalciferol Pharmemma 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 adults.
•
To treat vitamin D deficiency in adults.
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.
•
For certain bone conditions, such as conditions that affect bone
development (osteomalacia),
thinning of the bone (osteoporosis), when it will be given to you with
other medicines.
Cholecalciferol Pharmemma Capsules are used in adults and the elderly.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHOLECALCIFEROL PHARMEMMA
CAPSULES
DO NOT TAKE CHOLECALCIFEROL PHARMEMMA CAPSULES:
-
if you are allergic to cholecalciferol (vitamin D) or any of the other
ingredients

Características técnicas

NL/H/5338/001-003/IB/005
1
SUMMARY OF PRODUCT CHARACTERISTICS
NL/H/5338/001-003/IB/005
2
PRODUCT SUMMARY
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Cholecalciferol Pharmemma 20.000 IE, zachte capsules
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each capsule contains:
500 micrograms Cholecalciferol (vitamin D3), equivalent to 20,000 IU
Excipient(s) with known effect:
Each 20,000 IU capsule also contain 16.5 milligrams of sorbitol.
For the full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Soft capsule
Light Yellow coloured clear transparent round shaped gelatin capsule
with a clear, colourless liquid fill
with approximate dimensions 7.36 mm x 6.27 mm.
4.
C
LINICAL
P
ARTICULARS
4.1 THERAPEUTIC INDICATIONS
_ _
Treatment of Vitamin D deficiency (serum 25(OH)D < 25 nmol/l).
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.
Indicated for use in adults and the elderly.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be determined individually by the attending
physician, depending on the amount of
vitamin D supplementation required.
Adults and elderly:
•
Prevention of vitamin D deficiency (maintenance dose):
NL/H/5338/001-003/IB/005
3
-
for adults and the elderly: 800-1600 IU / day or a corresponding
weekly or monthly
dose. Recommended dose Cholecalciferol Pharmemma 20,000 IU soft
capsules: 1-2
capsules per month.
-
for adults and the elderly with osteoporosis: 800-1000 IU / day with a
maximum of
2000 IU / day or corresponding weekly or monthly dose in the case of
fragile elderly
people with osteoporosis who are at high risk of falls and fractures.
Recommended dose
Cholecalciferol Pharmemma 20,000 IU soft capsules: (1 to max 3
capsules per month).
•
Treatment of vitamin D deficiency (loading dose):
-
800-4000 IU / day or a corresponding weekly or monthly dose (max.
cumulative dose
of 120,000 IU / month). A lower dose may occur after the first month
be co