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Scopolamine
long-acting transdermal therapeutlc system 1.5 mg.
Properties and scope of use
Scopoderm TTS constitutes a new method of using scopolamine in the form
of a patch which is applied behind the ear and which provides for programmed
release of the active substance through the intact skin into the bloodstream
over a prolonged period of up to 3 days. This so-called transdermal
therapeutic system containing scopolamine is designed for the prevention
of motion sickness, such as can occur when travelling by boat, plane,
train, or car, and which gives rise to nausea, dizziness, and vomiting.
Restrictions
on use
Scopoderm TTS must not be used by persons hypersensitive to scopolamine
or by those suffering from glaucoma (increased pressure within the eye).
Since little experience has yet been obtained in children, those under
10 years of age should not be treated with Scopoderm TTS. Pregnant and
nursing mothers should use Scopoderm TTS only after having consulted
their doctor.
Precautions
Before using Scopoderm TTS, please ask your doctor or pharmacist for
advice:
- if you are
suffering from any form of gastro-intestinal obstruction
- if you have
difficulties when passing water (e.g. due to enlargement of the prostate)
- if you have
(or have had) any metabolic, liver, or kidney disease
- if you have
suffered in the past or are now suffering from pain in the eyes, blurred
vision, or rainbow-coloured halos around lights
- if you have
had epileptic seizures in the past or are now suffering from epilepsy.
Under these circumstances,
Scopoderm TTS may be unsuitable for you. Also elderly patients should
consult their doctor before using Scopoderm TTS. Since Scopoderm TTS
can occasionally cause drowsiness and other side effects, you should
not drive a vehicle or operate machinery while under treatment with
it. In rare cases confusional states and/or visual hallucinations may
occur. Should this happen, remove the Scopoderm TTS at once and notify
a doctor. Hypersensitivity reactions may occur with ordinary therapeutic
doses of scopolamine. Scopoderm TTS should not be used together with
other products for the prevention of travel sickness. If you are undergoing
medical treatment or taking other medicines, please ask your doctor
whether Scopoderm TTS is suitable for you. Avoid drinking alcohol while
using Scopoderm TTS.
Side effects
During use of Scopoderm TTS the following side effects may occur:
- frequently
temporary dryness of the mouth
- frequently blurring
of (near) vision and enlargement of the pupils (sometimes in one eye
only), especially if traces of active substance on the hands enter
the eyes; occasionally irritation of the eye lids
- occasionally
drowsiness
- rarely difficulty
in passing water
- occasionally
localised skin irritation; in isolated cases generalised skin rash
- in isolated
cases impairment of memory or concentration, restlessness, dizziness,
disorientation, confusion, and hallucinations.
Should you find
such effects very troublesome, please remove the Scopoderm TTS and,
if necessary, consult a doctor.
Unwanted effects
after discontinuation of Scopoderm TTS
In rare cases - usually after several days of use - symptoms such as
dizziness, nausea, vomiting, headache, and disturbances of balance have
been reported after discontinuation of the treatment. If this happens,
please consult a doctor.
Instructions
for use
Scopoderm TTS is suitable for use by adults and children as from
the age of 10 years.
- One Scopoderm
TTS should be applied about 5-6 hours before embarking on a journey
(or already on the evening before the journey) to a dry, hairless
area of intact skin behind the ear.
- Tear open the
sachet at the top and take out the flesh-coloured system complete
with its transparent hexagonal protective foil
- Holding the
system only by its edge - and taking care if possible not to touch
the silvery adhesive side peel off the hexagonal foil.
- Press the system
[silvery adhesive side downwards) firmly on to a dry area of skin
behind the ear. Make sure that the system is firmly attached. Once
it is fixed in position, it must not be shifted.
- If the Scopoderm
TTS, which normally adheres well to the skin, becomes accidentally
detached, it should be replaced by a fresh one.
- Once the system
has been affixed, it should not be touched again while it is being
worn, since pressure exerted on it might possibly cause scopolamine
to ooze out at the edge.
- After the system
has been applied, as well as after it has been removed, the hands
(and, after its removal, also the site of application) should be thoroughly
washed. This is in order to prevent traces of the active substance
from entering the eyes as a result of finger contact, since this might
temporarily cause blurring of (near) vision and enlargement of the
pupils (some- times in one eye only).
- Application
of one Scopoderm TTS is quite sufficient to ensure protection for
up to 3 days; but, if the journey is of shorter duration, you should
remove it earlier. If you need more prolonged protection, remove the
Scopoderm TTS after 3 days and apply a fresh patch behind the other
ear.
- If you swim,
take a shower, or wash your hair, this will not adversely affect the
adhesiveness or the action of Scopoderm TTS, provided you do not spend
too long exposed to the water.
Safety note
concerning children
Scopoderrn TTS patches should be kept out of the reach of children at
all times and should be disposed of in such a way that nobody can touch
them.
Precautions
for storage
Store below 25C.
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