Scopoderm Factsheet

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.