Transderm Scop Patient, Information, Instructions - Scopolamine

Transderm Scop Patient, Information, Instructions - Scopolamine INFORMATION FOR PATIENTS

TRANSDERM SCOP®

Generic Name: scopolamine,

pronounced skoe-POL-a-meen

Transdermal Therapeutic 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 schedule 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.

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 acitivity 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 obstructions 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 or 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 and 25°C (68°F and 77°F) until you are ready to use it.

1. 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.
2. 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.
3. Peel the package open and remove the patch .
4. Remove the clear plastic six-sided backing from the round patch. Try not to touch the adhesive surface on the patch with your hands.
5. Firmly apply the adhesive surface (metallic side) to the dry area of skin behind the ear so that the tan-colored side is showing. 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).
6. 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.
7. 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.
8. 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.
9. 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.
10. Please inform your doctor if you are taking other medications, including over-the-counter medications.

This leaflet presents a summary of information about Transderm Scop. 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.

Since scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.

Patients should be advised to remove the patch immediately and promptly contact a physician in the unlikely event that they experience symptoms of acute narrow-angle glaucoma (pain and reddening of the eyes, accompanied by dilated pupils). Patients should also be instructed to remove the patch if they develop any difficulties in urinating.

Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of scopolamine. A patient brochure is available.