Renson 10mg Tablet

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

HYDROCORTISONE

Dostopno od:

Vitamode Sdn.bhd

INN (mednarodno ime):

HYDROCORTISONE

Enote v paketu:

3 x 10 Tablets

Izdeluje:

RENATA LIMITED

Navodilo za uporabo

RENSON TABLET
Hydrocortisone (10mg and 20mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Renson_
is used for
2.
How
_Renson _
works
3.
Before you use
_Renson_
4.
How to use
_Renson_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Renson_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _RENSON _IS USED FOR
_Renson _
is used:
- to treat low hydrocortisone levels
caused
by
diseases
of
the adrenal
gland
(such
as
Addison’s
disease,
adrenocortical insufficiency);
- in the treatment of hypopituitarism
(a condition in which the pituitary
gland
does
not
produce
normal
amounts
of
some
or
all
of
its
hormones);
-
to
treat
congenital
adrenal
hyperplasia
which
affects
your
body’s
natural
production
of
steroids;
- in conditions where systemic (oral
or injectable) glucocorticoid therapy
is needed
Your doctor will tell you for which
disease
or
symptom
(s)he
has
prescribed
_Renson_
for you.
HOW _RENSON_
WORKS
Hydrocortisone or cortisol is a natural
glucocorticoid (corticosteroid hormone).
It acts by binding to steroid receptors in
the cytoplasm. It acts mainly by reducing
the local inflammation reaction. It e.g.
alleviates inflammation symptoms and
eliminates allergic symptoms.
BEFORE YOU USE _RENSON _
_ _
Some medicines may increase the effects
of
_Renson_
and your doctor may wish to
monitor you carefully if you are taking
these medicines (including some
medicines for HIV such as cobicistat).
_- When you must not use it _
Do not use
_Renson_
tablet if:
•
you are allergic to hydrocortisone or
any of the other ingredients in this
medicine.
•
you
have
thrush,
Candida
or
any
other fungal infection.
•
you have any other infection.
•
you have been vaccinated recently
or
are
going
to
have
any
vaccinations.
_ _
_Pregnancy and lactation _
If
you
are
pregnant
or
breast-feeding,
think
you
may
be
pregnant
or
are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine. Your doctor wi

Lastnosti izdelka

RENSON 10MG TABLET
(HYDROCORTISONE 10 MG TABLETS)
RENSON 20MG TABLET
(HYDROCORTISONE 20 MG TABLETS)
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S):
RENSON 10MG TABLET
Name of Active Substance(s): Hydrocortisone BP/Ph. Eur.
Strength of Active Substance(s): 10 mg Hydrocortisone BP/Ph. Eur.
RENSON 20MG TABLET
Name of Active Substance(s): Hydrocortisone BP/Ph. Eur.
Strength of Active Substance(s): 20 mg Hydrocortisone BP/Ph. Eur.
PRODUCT DESCRIPTION:
RENSON 10MG TABLET
8 x 5.25 mm, white, oval, flat, bevelled with imprinted “H” on one
side and
plain on the other side.
RENSON 20MG TABLET
10.9 x 7.1 mm, white, oval, flat, bevelled single breakline on one
side and
imprinted “H” on the other side.
Breakline is to break the tablet in half if needed.
PHARMACODYNAMICS
Hydrocortisone
or
cortisol
is
a
natural
glucocorticoid
(corticosteroid
hormone). It acts by binding to steroid receptors in the cytoplasm. It
acts
mainly by reducing the local inflammation reaction. It e.g. alleviates
inflammation symptoms and eliminates allergic symptoms.
PHARMACOKINETICS
Hydrocortisone is absorbed rapidly and completely from the alimentary
tract. Because of first-pass metabolism, its bioavailability varies
between
25% and 90%. In plasma, the peak concentration of hydrocortisone is
reached in 1-2 hours after dosing. It is bound to plasma transcortin
and
albumin. At low concentrations, 10% of hydrocortisone is free; at
higher
concentrations, the binding capacity of transcortin is saturated and
the
proportion of free drug can increase to 40-50%. Its volume of
distribution is
0.4-0.7 l/kg. The pharmacological half life of hydrocortisone averages
1.5
hours, but the half life of biological effect is considerably longer,
approx.
10 hours. Hydrocortisone penetrates the placenta and is excreted in
small
amounts
in
breast
milk.
The
elimination
of
hydrocortisone
may
be
prolonged in liver diseases and shortened in thyrotoxicosis.
INDICATION
Adrenocortical insufficiency (Addison’s disease), diminution of
anterior
pituitary
function
(hypopituitarism),