Scopoderm

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hyoscine 1.5mg (Supplied as Hyoscine (scopolamine) hydrobromide trihydrate);  

Available from:

Baxter Healthcare Ltd

INN (International Name):

Hyoscine 1.5 mg (Supplied as Hyoscine (scopolamine) hydrobromide trihydrate)

Dosage:

1mg/72 hours

Pharmaceutical form:

Transdermal patch

Composition:

Active: Hyoscine 1.5mg (Supplied as Hyoscine (scopolamine) hydrobromide trihydrate)  

Units in package:

Sachet, 2 patches

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Phytex Australia Pty Ltd

Therapeutic indications:

The prevention of symptoms of motion sickness, such as nausea, vomiting and vertigo, which can occur when traveling.

Product summary:

Package - Contents - Shelf Life: Sachet, - 2 patches - 48 months from date of manufacture stored at or below 25°C - Sachet, 25 x 2 carton pack - 50 patches - 48 months from date of manufacture stored at or below 25°C

Authorization date:

1982-11-18

Patient Information leaflet

New Zealand Consumer Medicine Information
SCOPODERM
_SCOPOLAMINE (HYOSCINE) 1.5MG TRANSDERMAL PATCH _
Average absorption rate 1mg/72 hours
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using SCOPODERM.
This leaflet answers some common questions about SCOPODERM. It does
not contain
all the available information. It does not take the place of talking
to your doctor or
pharmacist.
All medicines have risks and benefits.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT SCOPODERM IS USED FOR
SCOPODERM is used for the prevention of symptoms of motion sickness,
such as
nausea (feeling sick), vomiting (being sick) and vertigo (loss of
balance), which can
occur when traveling by boat, plane, train or car.
SCOPODERM contains the active substance scopolamine (hyoscine), which
belongs to
a group of medicines called anti-emetics or anti-nauseants.
Your doctor or pharmacist may have recommended SCOPODERM for another
reason.
Ask your doctor or pharmacist if you have any questions about why
SCOPODERM has
been recommended for you.
BEFORE YOU USE SCOPODERM
_WHEN YOU MUST NOT USE IT _
_ _
Do not use SCOPODERM if you:

are allergic (hypersensitive) to scopolamine or any of the ingredients
listed at
the end of this leaflet

have glaucoma (increased pressure inside the eye).
If you are not sure whether you should start using SCOPODERM, talk to
your doctor or
pharmacist.
_BEFORE YOU START TO USE IT _
_ _
Talk to your doctor or pharmacist before using SCOPODERM if you:

are elderly (65 years or older)

are pregnant or breastfeeding

have any liver or kidney disease, or metabolic conditions

have pyloric stenosis (a condition which affects your stomach)

have intestinal obstruction (partial or complete blockage of the small
or large
intestine)

have difficulties when passing urine (e.g. due to enlargement of the
prostate)

have or have had pain in the eyes, blurred vision, or s

Summary of Product characteristics

NEW ZEALAND DATA SHEET
SCOPODERM Data Sheet 8 November 2023
Baxter Healthcare Ltd
Page 1 of 10
1 PRODUCT NAME
SCOPODERM, 1.5mg transdermal patch.
_ _
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Hyoscine 1.5mg (supplied as Hyoscine (scopolamine) hydrobromide
trihydrate) per patch.
Dose delivered
Each transdermal therapeutic system (TTS) patch releases approximately
1mg of scopolamine over
72 hours.
Releasing surface
SCOPODERM is a flat, round transdermal patch approximately 1.8cm in
diameter, with a contact
surface area measuring 2.5cm
2
Excipients
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch.
Appearance
One side of the system is tan; the other side is silver and placed on
an oversized clear hexagonal film.
SCOPODERM is a film 0.2mm thick, with four layers.
Proceeding from the visible layer towards the layer attached to the
skin, these are:
1.
a backing
layer of tan‐coloured, aluminized, polyester film;
2.
a drug reservoir of scopolamine, light mineral oil, and
polyisobutylene;
3.
a microporous polypropylene membrane that controls the rate of
delivery of
4.
scopolamine from the system to the skin surface; and an adhesive
formulation of mineral oil,
polyisobutylene, and scopolamine. A protective peel strip of
siliconized polyester, which covers
the adhesive layer, is removed before the system is used.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
SCOPODERM is indicated to prevent symptoms of motion sickness, such as
nausea, vomiting, and
vertigo.
NEW ZEALAND DATA SHEET
SCOPODERM Data Sheet 8 November 2023
Baxter Healthcare Ltd
Page 2 of 10
4.2
Dosage and method of administration
Posology
To obtain an optimum protective effect, a single SCOPODERM transdermal
patch should be applied
about 5 ‐ 6 hours before embarking on a journey (or on the evening
before the journey) to a clean,
dry, hairless area of skin behind the ear (see section 6.6).
Application of one SCOPODERM transdermal
patch is sufficient to ensure protection over a period of 72 hours;