Nature's Sunshine St. John's Wort with Passion Flower

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Passiflora incarnata, Quantity: 100 mg; Hypericum perforatum, Quantity: 300 mg (Equivalent: Hypericum perforatum, Qty 2.1 g)

Available from:

Nature's Sunshine Products of Australia Pty Ltd

INN (International Name):

Hypericum perforatum,Passiflora incarnata

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: magnesium stearate; maltodextrin; silicon dioxide; potable water; glacial acetic acid; Gelatin; sodium lauryl sulfate

Administration route:

Oral

Class:

Medicine Listed

Therapeutic indications:

Traditionally used in Western herbal medicine to Decrease/reduce/relieve restlessness/excess nervous energy ; Traditionally used in Western herbal medicine to Decrease/reduce/relieve nervous tension/unrest ; Traditionally used in Western herbal medicine to Decrease/reduce/relieve symptoms of mild anxiety ; Traditionally used in Western herbal medicine to Nervine/support nervous system ; Traditionally used in Western herbal medicine to Soporific/induces sleep ; Traditionally used in Western herbal medicine to Enhance/promote/increase healthy sleep patterns ; Traditionally used in Western herbal medicine to Enhance/improve/promote/increase sleep quality/deep sleep

Product summary:

Visual Identification: ;

Authorization status:

Listed

Authorization date:

2000-06-05

Patient Information leaflet

BETNOVATE cream and ointment - Consumer Medicine Information
Page 1 of 4
BETNOVATE
CREAM AND OINTMENT
_betamethasone valerate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BETNOVATE. It
does not contain all the available
information about this medicine.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using BETNOVATE against the
benefits this medicine is expected to
have for you.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT USING
THIS MEDICINE.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT IS BETNOVATE
USED FOR
BETNOVATE contains the active
ingredient betamethasone valerate (a
type of cortisone) and belongs to the
group of medicines called
corticosteroids.
BETNOVATE is available as a cream
and an ointment.
It is a topical corticosteroid, which is
applied to the body surface (skin).
It is used to help relieve the redness,
swelling, itching and discomfort of
various skin problems such as:
•
eczema
•
other types of dermatitis.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
BETNOVATE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor knows which skin
conditions BETNOVATE is helpful
for.
The cream and ointment are only
available with a doctor's prescription.
BEFORE YOU USE IT
_ _
_WHEN YOU MUST NOT USE IT _
DO NOT USE BETNOVATE IF YOU
HAVE EVER HAD AN ALLERGIC REACTION
TO:
•
betamethasone valerate or any
other corticosteroid
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction to BETNOVATE may
include red, itchy skin rashes or a
lumpy rash (“hives”).
It may also include some or all of the
following: wheezing, swelling of the
lips/mouth, difficulty in breathing, hay
fever or fainting.
DO NOT USE THIS MEDICINE IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT OR BREAST FEED.
Your doctor will discuss the risks and
benefits of using BETNOVATE
duri

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
BETNOVATE (BETAMETHASONE VALERATE)
CREAM, OINTMENT & SCALP APPLICATION
1
NAME OF THE MEDICINE
Betamethasone valerate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BETNOVATE cream and ointment contain 1.0 mg/g of betamethasone,
present as 1.21
mg/g of betamethasone-17
α
-valerate.
BETNOVATE 1/2 cream and ointment contain 0.5 mg/g of betamethasone,
present as
0.61 mg/g of betamethasone-17
α
-valerate.
BETNOVATE 1/5 cream contains 0.2 mg/g of betamethasone, present as
0.24 mg/g of
betamethasone-17
α
-valerate.
BETNOVATE scalp application contains 1.0 mg/g of betamethasone,
present as 1.21 mg/g
of betamethasone-17
α
-valerate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
BETNOVATE cream: A soft white cream with an odour faintly of
chlorocresol. Free from
visible foreign contamination.
BETNOVATE ointment: A smooth greyish-white translucent mass. Free from
undispersed
particles and visible foreign contamination.
BETNOVATE scalp application (1 mg/g): Colourless, hazy, slightly
viscous liquid with an
odour of isopropyl alcohol. Free from visible foreign contamination.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Eczema including: atopic, infantile, stasis and discoid eczemas.
Besnier's (flexural) prurigo.
Otitis externa. Neurodermatoses including lichen simplex, lichen
planus. Seborrheic
dermatitis, contact sensitivity reactions and allergies.
4.2
D
OSE AND METHOD OF ADMINISTRATION
A small quantity should be applied to the affected area once or twice
daily until improvement
occurs. If necessary, cover the area with a dry dressing.
BETNOVATE 1/5 may be applied up to four times daily.
2
Different presentations of topical corticosteroids may demonstrate
variable activity as
measured by skin blanching tests and treatment should be monitored for
efficacy and safety
in individual patients.
4.3
C
ONTRAINDICATIONS
•
Hypersensitivity to the preparations
•
Rosacea and acne vulgaris
•
Perioral dermatitis, perianal and genital pruritus
•