ALKINDI hydrocortisone 2 mg granules (in capsule) bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrocortisone, Quantity: 2 mg

Available from:

Chiesi Australia Pty Ltd

Pharmaceutical form:

Granules

Composition:

Excipient Ingredients: microcrystalline cellulose; hypromellose; magnesium stearate; ethylcellulose

Administration route:

Oral

Units in package:

50 capsules per bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Replacement therapy of adrenal insufficiency

Product summary:

Visual Identification: The granules are white to off-white and contained in a transparent colourless size 00el hard capsule. The capsule is printed with INF-2.0 in green ink.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-08-18

Patient Information leaflet

ALKINDI CMI v3.0
1
ALKINDI
®
_Hydrocortisone (0.5 mg, 1 mg, 2 mg or 5 mg) granules in capsules for
opening_
Consumer Medicine Information
WARNING
ALKINDI granules come in a capsule that must be opened before use,
discard the empty
capsule after use out of reach of children. Do NOT swallow the capsule
– small children
may choke.
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about
ALKINDI.
It does not contain all of the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of your child being
given this medicine against the
benefits this medicine is
expected to have for your child.
IF YOU HAVE ANY CONCERNS
ABOUT GIVING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET, YOU MAY
NEED TO READ IT AGAIN.
WHAT ALKINDI IS
USED FOR
ALKINDI contains a medicine
called hydrocortisone.
Hydrocortisone belongs to a
group of medicines known as
corticosteroids.
Hydrocortisone is a synthetic
version of the hormone cortisol.
Cortisol is made naturally by the
adrenal glands in the body.
ALKINDI is used when the
body is not making enough
cortisol, because part of the
adrenal gland is not working
(adrenal insufficiency, often
caused by an inherited condition
called congenital adrenal
hyperplasia).
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
ALKINDI HAS BEEN PRESCRIBED
FOR YOUR CHILD.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU GIVE
ALKINDI
_WHEN YOU MUST NOT GIVE IT _
DO NOT GIVE ALKINDI:
If your child is allergic to
hydrocortisone or any of the
other ingredients of this
medicine.
If your child has difficulties
swallowing food, or is a
premature baby who cannot yet
be fed by mouth.
_BEFORE YOU GIVE ALKINDI _
TALK TO YOUR DOCTOR OR
PHARMACIST BEFORE GIVING
ALKINDI IF YOUR CHILD IS:
-
unwell or has an infection.
The endocrinologist may
need to increase the dose of
ALKINDI temporarily; talk
to your endocrinologist if your
child is unwell. If y

Summary of Product characteristics

ALKINDI Product Information
ALKINDI PI v3.3
1
AUSTRALIAN PRODUCT INFORMATION
ALKINDI
®
(HYDROCORTISONE) – GRANULES (IN CAPSULE)
1.
NAME OF THE MEDICINE
Hydrocortisone.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alkindi 0.5 mg granules in capsules for opening
Each capsule contains 0.5 mg hydrocortisone
Alkindi 1 mg granules in capsules for opening
Each capsule contains 1 mg hydrocortisone
Alkindi 2 mg granules in capsules for opening
Each capsule contains 2 mg hydrocortisone
Alkindi 5 mg granules in capsules for opening
Each capsule contains 5 mg hydrocortisone
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Granules in capsules for opening.
The granules are white to off-white and contained in a transparent
colourless (size 00el) hard
capsule.
Alkindi 0.5 mg granules in capsules for opening
The capsule is printed with "INF-0.5" in red ink.
Alkindi 1 mg granules in capsules for opening
The capsule is printed with "INF-1.0" in blue ink.
Alkindi 2 mg granules in capsules for opening
The capsule is printed with "INF-2.0" in green ink.
Alkindi 5 mg granules in capsules for opening
The capsule is printed with "INF-5.0" in grey ink
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Replacement therapy of adrenal insufficiency.
ALKINDI Product Information
ALKINDI PI v3.3
2
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Dosage must be individualised according to the response of the
individual patient. The lowest
possible dosage should be used.
Alkindi was developed for use in patients requiring smaller doses.
Alternative formulations of
hydrocortisone should be considered for patients requiring larger
doses.
Monitoring of the clinical response is necessary and patients should
be observed closely for signs
that might require dosage adjustment, including changes in clinical
status resulting from remissions
or exacerbations of the disease, individual responsiveness to the
medicinal product, and the effect
of stress (e.g. surgery, infection, trauma). During stress it may be
necessa