Cholecalciferol mibe 1000 IE, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CHOLECALCIFEROL CONCENTRAAT, POEDERVORM 10 mg/stuk SAMENSTELLING overeenkomend met ; CHOLECALCIFEROL 25 µg/stuk

Beschikbaar vanaf:

Mibe GmbH Arzneimittel Münchener Strasse 15 06796 BREHNA (DUITSLAND)

ATC-code:

A11CC05

INN (Algemene Internationale Benaming):

CHOLECALCIFEROL CONCENTRAAT, POEDERVORM 10 mg/stuk SAMENSTELLING overeenkomend met ; CHOLECALCIFEROL 25 µg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND ; NATRIUMASCORBAAT (E 301) ; NATRIUMZETMEELGLYCOLAAT ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN, CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; NATRIUMASCORBAAT (E 301) ; NATRIUMZETMEELGLYCOLAAT ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN, CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; NATRIUMASCORBAAT (E 301) ; NATRIUMZETMEELGLYCOLAAT (E468) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Colecalciferol

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450); NATRIUMASCORBAAT (E 301); NATRIUMZETMEELGLYCOLAAT (E468); SACCHAROSE; SILICIUMDIOXIDE (E 551); TOCOFEROL, DL-ALFA (E 307); TRIGLYCERIDEN MIDDELLANGE KETEN;

Autorisatie datum:

1900-01-01

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CHOLECALCIFEROL MIBE 1000 IE, TABLETTEN
Cholecalciferol (vitamin D
3
)
For use in infants, children, adolescents and adults
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 Cholecalciferol mibe 1000 IE, tabletten is and what it is used
for
2.
What you need to know before you take Cholecalciferol mibe 1000 IE,
tabletten
3.
How to take Cholecalciferol mibe 1000 IE, tabletten
4.
Possible side effects
5.
How to store Cholecalciferol mibe 1000 IE, tabletten
6.
Contents of the pack and other information
1.
WHAT CHOLECALCIFEROL MIBE 1000 IE, TABLETTEN IS AND WHAT IT IS USED
FOR
Cholecalciferol mibe 1000 IE, tabletten contains vitamin D
3
(equivalent to cholecalciferol) for the
regulation of the absorption and metabolism of calcium and for the
integration of calcium into bone
tissue.
Cholecalciferol mibe 1000 IE, tabletten is used
-
for prophylaxis of rickets (impaired bone hardening during the growth
phase) and osteomalacia
(softening of bones) in children, adolescents and adults.
-
for prophylaxis of vitamin D deficiency in children, adolescents and
adults with an identified
risk.
-
for the supportive treatment of osteoporosis (thinning of bone tissue)
in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHOLECALCIFEROL MIBE 1000 IE,
TABLETTEN
DO NOT TAKE CHOLECALCIFEROL MIBE 1000 IE, TABLETTEN
-
if you are allergic to cholecalciferol or any of the other ingredients
of this medicine (listed in
section 6)
-
if you suffer from hype

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cholecalciferol mibe 500 IE, tabletten
Cholecalciferol mibe 1000 IE, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cholecalciferol mibe 500 IE, tabletten:
Each tablet contains 12.5 microgram of cholecalciferol (equivalent to
500 IU vitamin D
3
), as
cholecalciferol concentrate, powder form.
Cholecalciferol mibe 1000 IE, tabletten:
Each tablet contains 25 microgram of cholecalciferol (equivalent to
1000 IU vitamin D
3
), as
cholecalciferol concentrate, powder form.
Excipients with known effect:
One tablet Cholecalciferol mibe 500 IE, tabletten contains 34.47 mg
lactose monohydrate and 0.87 mg
sucrose.
One tablet Cholecalciferol mibe 1000 IE, tabletten contains 68.94 mg
lactose monohydrate and
1.73 mg sucrose.
Cholecalciferol mibe 500 IE, tabletten / 1000 IE, tabletten contains
less than 1 mmol sodium (23 mg)
per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Cholecalciferol mibe 500 IE, tabletten are round, biconvex, white to
yellowish tablets.
Cholecalciferol mibe 1000 IE, tabletten are oblong, biconvex, white to
yellowish tablets with score
line. The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Prophylaxis of rickets and osteomalacia in children, adolescents and
adults
-
Prophylaxis of vitamin D deficiency in children, adolescents and
adults with an identified risk
-
As an adjunct to specific therapy of osteoporosis in adults
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prophylaxis of rickets and osteomalacia in children, adolescents and
adults _
_ _
1 tablet Cholecalciferol mibe 500 IE, tabletten or ½ tablet
Cholecalciferol mibe 1000 IE, tabletten
daily (equivalent to 0.0125 mg or 500 IU vitamin D
3
) (see section 4.4).
2
The dosage should be established by the treating physician. Generally,
for the prophylaxis of rickets in
preterm newborn infants,
-
with a birth weight > 1500 g: 1 tablet Cholecalciferol mibe 500 IE,
tabletten or ½ tab