| Available by prescription only
The information presented on this page is not meant
to take the place of your doctor's instructions. Read
this information carefully before you begin using Transderm
Scop®. Ask your doctor or pharmacist if you do not understand
any of this information or if you want to know more about
Transderm Scop®.
What Is the Transderm Scop® System?
Important Information When Using
Transderm Scop®
How the Transderm Scop® System Works
Precautions
Side Effects
How to Use Transderm Scop®
More Information
Transderm Scop®
Generic Name: scopolamine,
pronounced skoe-POL-a-meen
Transdermal Therapeutic System
What Is the Transderm
Scop® System?
The Transderm Scop® system helps to prevent the nausea
and vomiting of motion sickness for up to 3 days. It
is a round adhesive patch that you place behind your
ear several hours before you travel. It also helps to
prevent the nausea and vomiting associated with the
use of anesthesia and certain analgesics used during
or after many types of surgery. If the patch is to be
used in conjunction with scheduled surgery, it is applied
the evening before surgery. For cesarean section, the
patch is applied one hour prior to surgery to minimize
exposure of the unborn child to the drug. Wear only
one patch at any time.
Important
Information When Using Transderm Scop®
Be sure to wash your hands thoroughly with soap
and water immediately after handling the patch, so that
any drug that might get on your hands will not come
into contact with your eyes.
Avoid drinking alcohol while using Transderm Scop®.
Also, be careful about driving or operating any machinery
while using the system because the drug might make you
drowsy.
DO NOT USE Transderm Scop® IF YOU ARE ALLERGIC TO
SCOPOLAMINE.
Transderm Scop® SHOULD NOT BE USED IN CHILDREN AND
SHOULD BE USED WITH CAUTION IN THE ELDERLY.
How the Transderm
Scop® System Works
A group of nerve fibers deep inside the ear helps people
keep their balance. For some people, the motion of ships,
airplanes, trains, automobiles, and buses increases
the activity of these nerve fibers. This increased activity
causes the dizziness, nausea, and vomiting of motion
sickness. People may have one, some, or all of these
symptoms.
Transderm Scop® contains the drug scopolamine, which
helps reduce the activity of the nerve fibers in the
inner ear. When a Transderm Scop® patch is placed on
the skin behind one of the ears, scopolamine passes
through the skin and into the bloodstream. One patch
may be kept in place for 3 days if needed.
It has been suggested that Transderm Scop®, when used
to reduce nausea and vomiting associated with surgical
anesthesia or analgesia, acts on the same nerve fibers
that are affected when the product is taken for motion
sickness.
Precautions
Before using Transderm Scop®, be sure to tell your
doctor if you:
- Are pregnant or nursing (or plan to become pregnant)
- Have (or have had) glaucoma (increased pressure
in the eyeball) or a predisposition to glaucoma
- Have (or have had) any metabolic, heart, liver,
kidney, or other serious medical conditions
- Have any obstruction of the stomach or intestine
- Have any trouble urinating due to prostate enlargement
or any bladder obstruction
- Have any allergy or have had a reaction such as
a skin rash or redness to any drug, especially scopolamine,
or chemical or food substance
Any of these conditions could make Transderm Scop®
unsuitable for you. Also tell your doctor if you are
taking any other medicines.
In the unlikely event that you experience pain in the
eye and reddened whites of the eye while wearing the
patch, which may be accompanied by widening of the pupil
and blurred vision, remove the patch immediately and
consult your doctor. As indicated below under Side Effects,
widening of the pupils and blurred vision without pain
or reddened whites of the eye is usually temporary and
not serious.
Transderm Scop® should not be used in children. The
safety of its use in children has not been determined.
Children and the elderly may be particularly sensitive
to the effects of scopolamine.
Side Effects
The most common side effect experienced by people using
Transderm Scop® is dryness of the mouth. This occurs
in about two thirds of the people. A less frequent side
effect is drowsiness, which occurs in less than one
sixth of the people. Temporary blurring of vision and
dilation (widening) of the pupils may occur, especially
if the drug is on your hands and comes in contact with
the eyes. On infrequent occasions, disorientation, memory
disturbances, dizziness, restlessness, hallucinations,
confusion, difficulty urinating, skin rashes or redness,
temporary changes in heart rate such as palpitations,
dry itchy, or reddened whites of the eyes, and eye pain
have been reported. If these effects do occur, remove
the patch and call your doctor. Since drowsiness, disorientation,
and confusion may occur with the use of scopolamine,
be careful driving or operating any dangerous machinery,
especially when you first start using the drug system.
In addition, if you plan to participate in underwater
sports while wearing the patch, you should discuss with
your doctor the potentially disorienting effects of
scopolamine.
Eye Effects: Temporary blurring of vision and
dilation (widening) of the pupils may occur, especially
if the drug is on your fingers or hands and comes into
contact with the eyes. Dry, itchy, or reddened whites
of the eye and eye pain have been reported infrequently.
In the unlikely event that you experience pain in the
eye and reddened whites of the eye, which may be accompanied
by widening of the pupil and blurred vision, remove
the patch and consult your doctor promptly. Widening
of the pupils and blurred vision without pain, or reddened
whites of the eye, is usually temporary and not serious.
Drug Withdrawal/Post-Removal Symptoms: Symptoms
such as dizziness, nausea, vomiting, headache, and disturbances
of equilibrium have been reported by some people following
discontinuation of use of the Transderm Scop® patch.
These symptoms have occurred most often in people who
have used the patches for more than 3 days, and frequently
do not appear until 24 hours or more after the patch
has been removed. These symptoms may be associated with
adaptation from a motion environment to a motion-free
environment. It is recommended that you consult with
your doctor if these symptoms persist.
How to Use Transderm
Scop®
Transderm Scop® should be stored at controlled room
temperature between 20°C - 25° (68°F - 77°F) until you
are ready to use it.
- For the prevention of motion sickness, plan to apply
one Transderm Scop® patch at least 4 hours before
you need it. If the patch is to be used in conjunction
with scheduled surgery, it is applied the evening
before surgery. For cesarean section, the patch is
applied one hour prior to surgery to minimize exposure
of the unborn child to the drug. Wear only one patch
at any time. Do not cut the patch.
- Select a hairless area of skin behind one ear, taking
care to avoid any cuts or irritations. Wipe the area
with a clean, dry tissue.
- Peel the package open and remove the patch (Figure1).
Figure 1
- Remove the clear plastic six-sided backing from
the round patch. Try not to touch the adhesive surface
on the patch with your hands (Figure 2).
Figure 2
- Firmly apply the adhesive surface (metallic side)
to the dry area of skin behind the ear so that the
tan-colored side is showing (Figure 3). Make good
contact, especially around the edge. Once you have
placed the patch behind your ear, do not move it for
as long as you want to use it (e.g., up to 3 days
for prevention of motion sickness).
Figure 3
- Important: After
the patch is in place, be sure to wash your hands
thoroughly with soap and water to remove any scopolamine.
If this drug were to come into contact with your eyes,
it could cause temporary blurring of vision and dilation
(widening) of the pupils (the dark circles in the
center of your eyes). Unless accompanied by eye pain
and reddened whites of the eyes (see Precautions),
this is not serious and your pupils should return
to normal.
- If the patch is being used to prevent the nausea
and vomiting of motion sickness, remove the patch
after 3 days and throw it away. (You may remove it
sooner if you are no longer concerned about motion
sickness). If the patch is being used to prevent nausea
and vomiting associated with anesthesia or analgesia,
the patch should be kept in place for 24 hours following
surgery at which time it should be removed and discarded.
After removing the patch, be sure to wash your hands
and the area behind your ear thoroughly with soap
and water. Since the patch will still contain some
active ingredient after use, and to avoid accidental
contact or ingestion by children or pets, fold the
used patch in half with the sticky side together and
dispose in the trash out of the reach of children
and pets.
- If you wish to control the nausea and vomiting of
motion sickness for longer than 3 days, remove the
first patch after 3 days and place a new one behind
the other ear, repeating instructions 2 through 7.
- Keep the patch dry, if possible, to prevent it from
falling off. Limited contact with water, however,
as in bathing or swimming, will not affect the system.
In the unlikely event that the patch falls off, throw
it away and put a new one behind the other ear.
- Please inform your doctor if you are taking other
medications, including over-the-counter medications.
More Information
If you would like more information or if you have any
questions, ask your doctor or pharmacist. A more technical
leaflet is available, written for your doctor. If you
would like to read the leaflet, ask your pharmacist
to show you a copy. You may need the help of your doctor
or pharmacist to understand some of the information.
Mfd. by:
ALZA Corporation
Palo Alto, CA 94303-0802
Distributed by:
Novartis Consumer Health, Inc.
Parsippany, NJ 07504-0622
©2004
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