Egostar 22400 IU film-coated tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Cholecalciferol concentrate

Prieinama:

Jaba Recordati S.A.

ATC kodas:

A11CC05

INN (Tarptautinis Pavadinimas):

Cholecalciferol concentrate

Vaisto forma:

Film-coated tablet

Gydymo sritis:

colecalciferol

Leidimo data:

2022-04-08

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
EGOSTAR 22 400 IU FILM-COATED TABLETS
Cholecalciferol (Vitamin D3)
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 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, or pharmacist or
nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What
Egostar
is
and
what
it
is
used
for
2. What you need to know before you
take
Egostar
3.
How
to
take
Egostar
4. Possible side effects
5.
How
to
store
Egostar
6. Contents of the pack and other information
1.
WHAT EGOSTAR
IS
AND
WHAT
IT
IS
USED
FOR
Prevention of vitamin D deficiency in patients with an identified
risk.
Initial treatment of clinically relevant vitamin D deficiency.
As an adjunct to specific therapy for osteoporosis in patients with
vitamin D
deficiency or at risk of vitamin D insufficiency.
Egostar is indicated in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
EGOSTAR
DO NOT TAKE
EGOSTAR
if you are
allergic (hypersensitive
) to cholecalciferol (vitamin D3), or any of the
other ingredients of this medicine (listed in section 6);
if you have hypervitaminosis D (high levels of vitamin D in your
blood);
if you have renal calculi (kidney stones) (nephrolithiasis);
severe renal problems (severe renal impairment);
if you have a disorder or condition resulting from high levels of
calcium in your
blood (hypercalcaemia) and/or urine (hypercalciuria).
WARNINGS AND PRECAUTIONS
Talk to your doctor, or pharmacist or nurse before taking Egostar: if
you have
high levels of calcium in your blood (hypercalcaemia);
if you have renal impairment or renal calculi (kidney stones). Your
doctor shall
ask you to have regular blood

Prekės savybės

Health Products Regulatory Authority
08 April 2022
CRN009K3N
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Egostar 22400 IU film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of Egostar contains 560 micrograms (22 400 IU)
of cholecalciferol (vitamin D3).
Excipients with known effect:
Each tablet contains 429.60 mg of lactose monohydrate and 175 mg of
sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Egostar 22 400 IU tablets are white, convex oblong 18 mm x 8 mm, film
coated and engraved with a "V3" mark on one of the
sides of the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of vitamin D deficiency in patients with an identified
risk.
Initial treatment of clinically relevant vitamin D deficiency.
As an adjunct to specific therapy for osteoporosis in patients with
vitamin D deficiency or at risk of vitamin D insufficiency.
Egostar is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
Dose should be established on an individual basis depending on the
extent of the necessary vitamin D supplementation. The
patient's dietary habits should be carefully evaluated and
artificially added vitamin D content of certain food types should be
taken into consideration.
Prevention of Vitamin D deficiency:
One tablet (22 400 IU) once every 28 days.
Initial treatment of Vitamin D deficiency:
One tablet (22 400 IU) once a week for four weeks. After four weeks,
lower doses may be considered, dependent upon
desirable serum levels of 25 hydroxycolecalciferol (25(OH)D), the
severity of the disease and/or the patient´s response to
treatment.
As an adjunct to specific therapy for osteoporosis:
One tablet (22 400 IU) once every 28 days.
Medical supervision is necessary as dose requirements may vary
dependent on patient response (see section 4.4).
PAEDIATRIC POPULATION
This medicinal product should not be given to children (see section
4.4).
Health Products Regulatory A