Cholecalciferol Pharmemma 50.000 IE, zachte capsules

Land: Nederland

Språk: nederlandsk

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

Aktiv ingrediens:

CHOLECALCIFEROL 1250 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 50000 IE/stuk

Tilgjengelig fra:

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

INN (International Name):

CHOLECALCIFEROL 1250 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 50000 IE/stuk

Legemiddelform:

Capsule, zacht

Sammensetning:

CHINOLINEGEEL (E 104) ; GELATINE (E 441) ; GLYCEROL (E 422) ; SORBITOL VLOEIBAAR, GEDEELTELIJK GEDEHYDRATEERD ; TOCOFEROL, DL-ALFA ACETAAT ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD

Administreringsrute:

Oraal gebruik

Autorisasjon dato:

1900-01-01

Informasjon til brukeren

NL/H/5338/001-003/IA/001/G
1
PACKAGE LEAFLET
NL/H/5338/001-003/IA/001/G
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cholecalciferol Pharmemma 50.000 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

Preparatomtale

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 50.000 IE, zachte capsules
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each capsule contains:
1250 micrograms Cholecalciferol (vitamin D3), equivalent to 50,000 IU
Excipient(s) with known effect:
Each 50,000 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
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 50,000 IU soft
capsules: 1
capsule 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 50,000 IU soft capsules: 1 capsule 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 considered
depending on