Decostriol 0.25 mcg capsule

Страна: Малайзія

мова: англійська

Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активний інгредієнт:

CALCITRIOL

Доступна з:

IDAMAN PHARMA SDN. BHD.

ІПН (Міжнародна Ім'я):

CALCITRIOL

Одиниць в упаковці:

100Capsule Capsules; 50Capsule Capsules; 30Capsule Capsules; 50 Capsule Capsules; 100 Capsule Capsules; 30 Capsule Capsules

Виробник:

mibe GmbH Arzneimittel

інформаційний буклет

_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DECOSTRIOL
®
0.25 ΜG CAPSULE
(
_Calcitriol_
)
WHAT IS IN THIS LEAFLET?
1.
What
_Decostriol_
_®_
_ _
is used for
2.
How
_Decostriol_
_®_
_ _
works
3.
Before you take
_Decostriol_
_®_
4.
How to take
_Decostriol_
_®_
5.
While you are using
_Decostriol_
_®_
6.
Possible side effects.
7.
After Using
_Decostriol_
_®_
8.
Product description.
9.
Marketing Authorization Holder &
Manufacturer.
•
Read this entire leaflet before you
start taking the medication.
•
Keep this leaflet. You may need to
read again.
•
Ask your doctor or pharmacist if you
need more information or advice.
•
This medicine has been prescribed
for you. Do not pass it on to others. It
may harm them, even if their
symptoms are the same as yours.
•
If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
1.
WHAT _DECOSTRIOL_
_® _
_ _IS USED FOR
_Decostriol_
_® _
_capsule_
contains the active
ingredient
_Calcitriol_
.
It is used in treatment of:
•
Osteoporosis (weaken bones) in
women after menopause.
•
Bone disease (osteodystrophy) in
patients with kidney problems and
undergoing dialysis.
•
Hypoparathyroidism (decreased
function of the parathyroid gland).
•
Vitamin D- resistant rickets.
2.
HOW _DECOSTRIOL_
_® _
WORKS
_Calcitriol_
is the active form of Vitamin
D. It works by helping the body to use
more of the calcium found in foods or
supplements. Low blood levels of
calcium may cause bone disease.
_3._
_ _
BEFORE YOU TAKE _DECOSTRIOL_
_®_
_ _
WHEN YOU MUST NOT TAKE IT
Do not take
_Decostriol_
_® _
_capsule_
if you:
•
Have any diseases associated with an
increase blood calcium level.
•
Have allergic reaction to the active
ingredient
_Calcitriol_
or to any other
ingredients in this product.
_If you are not sure whether you should _
_start taking this medicine, consult your _
_doctor. _
BEFORE YOU START TO TAKE IT
Tell your doctor if you are:
•
Taking any diuretic medicine from
_thiazide

Характеристики продукта

Dear Patient,
Please read this leaflet carefully. It gives you important information
about your medicine.
If you have any questions, ask your doctor or pharmacist.
I n f o r m a t i o n f o r P a t i e n t s
Active ingredient: calcitriol (1

,25-dihydroxycholecalciferol)
Composition
Each capsule contains:
– Pharmaceutically active ingredient:
– calcitriol (1

,25-dihydroxycholecalciferol) 0.25 μg
– Other ingredients:
– butylhydroxytoluene (Ph.Eur.) (E 321), butylhydroxyanisole
(Ph.Eur.) (E 320), ethanol 100 %, arachis oil,gelatin,
glycerol 85 %, sorbitol, liquid 70 % (non crystallising) (Ph.Eur.),
iron(III)oxide (E 172), titanium dioxide (E 171)
Pharmaceutical form and content
Pink (rose) soft capsule, oval. Each capsule contains yellow, clear,
oily solution.
Blister and bottle pack
Pack of 30 soft capsules
Pack of 50 soft capsules
Pack of 100 soft capsules
Product classification
Vitamin D
3
metabolite
Indications
-
Established postmenopausal osteoporosis
-
Renal osteodystrophy (bone changes) in patients with chronic renal
failure undergoing dialysis (e.g. artificial
kidney)
-
Hypofunction of the parathyroid gland (postoperative or idiopathic
hypoparathyroidism), hereditary disorder
of phosphate excretion (pseudohypoparathyroidism)
-
Hypophosphataemic rickets (so-called vitamin D-resistant rickets)
Contraindication
_When should you not use _Decostriol
®
0.25 μg_?_
Decostriol
®
0.25 μg must not be used in:
-
all diseases associated with an increased blood calcium level (e.g.
hyperactivity of the parathyroid gland).
-
Hypersensitivity to calcitriol or any other compound in this class of
substances or to any of the other ingre
dients in this medicinal product.
_What do you have to consider during pregnancy or while
breast-feeding?_
Decostriol
®
0.25 μg may only be administered during pregnancy after the possible
benefits have been carefully
weighed against the potential risks for the mother and the child. In
case of overdose (increased blood calcium
level, placental transfer of the active ingred