Scopolamine Trandermal System (Page 4 of 5)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been conducted to evaluate the carcinogenic potential of scopolamine. The mutagenic potential of scopolamine has not been evaluated.

Fertility studies were performed in female rats and revealed no evidence of impaired fertility or harm to the fetus due to scopolamine hydrobromide administered by daily subcutaneous injection. Maternal body weights were reduced in the highest-dose group (plasma level approximately 500 times the level achieved in humans using a transdermal system). However, fertility studies in male animals were not performed.

14 CLINICAL STUDIES

14.1 Prevention of Motion Sickness

In 195 adult subjects of different racial origins who participated in clinical efficacy studies at sea or in a controlled motion environment, there was a 75% reduction in the incidence of motion-induced nausea and vomiting. Scopolamine transdermal system was applied from 4 to 16 hours prior to the onset of motion in these studies.

14.2 Prevention of Post-Operative Nausea and Vomiting

A clinical efficacy study evaluated 168 adult female patients undergoing gynecological surgery with anesthesia and opiate analgesia. Patients received scopolamine transdermal system or placebo applied approximately 11 hours before anesthesia/opiate analgesia. No retching/vomiting during the 24-hour post-operative period was reported in 79% of those treated with scopolamine transdermal system compared to 72% of those receiving placebo. When the need for additional antiemetic medication was assessed during the same period, there was no need for medication in 89% of patients treated with scopolamine transdermal system as compared to 72% of placebo-treated patients.

16 HOW SUPPLIED/STORAGE AND HANDLING

Scopolamine Transdermal System 1 mg/3 days is available as the following:

Carton of 4 transdermal systems, packaged into individual foil pouches. NDC 45802-580-84
Carton of 10 transdermal systems, packaged into individual foil pouches. NDC 45802-580-46
Carton of 24 transdermal systems, packaged into individual foil pouches. NDC 45802-580-62

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Store pouch(es) in an upright position.

Do not bend or roll pouch(es).

Wash hands thoroughly with soap and water immediately after handling the transdermal system. Upon removal, fold the used transdermal system in half with the sticky side together, and discard in household trash in a manner that prevents accidental contact or ingestion by children, pets or others [see Dosage and Administration (2.1), Warnings and Precautions (5.6)].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Administration Instructions

Counsel patients on how to apply and remove the transdermal system [see Dosage and Administration (2.1)]:

Only wear one transdermal system at any time.
Do not cut the transdermal system.
Apply the transdermal system to the skin in the postauricular (hairless area behind one ear) area.
After the transdermal system is applied on the dry skin behind the ear, wash hands thoroughly with soap and water and dry hands.
If the transdermal system becomes displaced, discard the transdermal system, and apply a new transdermal system on the hairless area behind the other ear.
Upon removal, fold the used transdermal system in half with the sticky side together, and discard in household trash in a manner that prevents accidental contact or ingestion by children, pets or others.

Patients with Open-Angle Glaucoma

Advise patients with open-angle glaucoma to remove the scopolamine transdermal system immediately and contact their healthcare provider if they experience symptoms of acute angle closure glaucoma, including pain and reddening of the eyes, accompanied by dilated pupils, blurred vision and/or seeing halos around lights [see Warnings and Precautions (5.1)].

Neuropsychiatric Adverse Reactions

Advise patients that psychiatric adverse reactions may occur, especially in patients with a past psychiatric history or in those receiving other drugs also associated with psychiatric effects, and to report to their healthcare provider any new or worsening psychiatric symptoms.
Advise patients to discontinue scopolamine transdermal system and contact a healthcare provider immediately if they experience a seizure.
Advise patients, especially elderly patients, that cognitive impairment may occur during treatment with scopolamine transdermal system, especially in those receiving other drugs also associated with CNS effects, and to report to their healthcare provider if they develop signs or symptoms of cognitive impairment such as hallucinations, confusion or dizziness.
Inform patients not to operate motor vehicles or other dangerous machinery or participate in underwater sports until they are reasonably certain that scopolamine transdermal system does not affect them adversely [see Warnings and Precautions (5.2)].

Decreased Gastrointestinal Motility and Urinary Retention

Instruct patients to remove the transdermal system if they develop symptoms of intestinal obstruction (abdominal pain, nausea or vomiting) or any difficulties in urinating [see Warnings and Precautions (5.4)].

Drug Withdrawal/Post-Removal Symptoms

Inform patients that if they remove the scopolamine transdermal system before treatment is complete, withdrawal symptoms may occur and to seek immediate medical care if they develop severe symptoms after removing scopolamine transdermal system [see Warnings and Precautions (5.5)].

Blurred Vision

Inform patients that temporary dilation of the pupils and blurred vision may occur if scopolamine transdermal system comes in contact with the eyes. Instruct patients to wash their hands thoroughly with soap and water immediately after handling the transdermal system [see Dosage and Administration (2.1), Warnings and Precautions (5.6)].

MRI Skin Burns

Instruct patients to remove the scopolamine transdermal system before undergoing an MRI [see Warnings and Precautions (5.7)].

Manufactured by:

AVEVA DRUG DELIVERY SYSTEMS

An APOTEX Company

Miramar, FL 33025

Distributed By

Perrigo®

Allegan, MI 49010 · www.perrigo.com

5A800 RC BR7

Medication Guide

MEDICATION GUIDE

Scopolamine (skoe pol’ a meen) Transdermal System

Read this Patient Information before you start using scopolamine transdermal system and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is scopolamine transdermal system?

Scopolamine transdermal system is a prescription medicine used for adults to help prevent:

nausea and vomiting from motion sickness
nausea and vomiting from anesthesia or taking opioid pain medicines after surgery

It is not known if scopolamine transdermal system is safe or effective in children.

Who should not use scopolamine transdermal system?

Do not use Transderm Scōp if you:

have an eye problem called angle closure glaucoma.
are allergic to scopolamine, belladonna alkaloids or any of the ingredients in scopolamine transdermal system. See the end of this leaflet for a list of the ingredients in scopolamine transdermal system. Ask your doctor if you are not sure.

What should I tell my doctor before using scopolamine transdermal system?

Before you use scopolamine transdermal system, tell your doctor about all of your medical conditions, including if you:

have glaucoma (increased pressure in the eye).
have a history of seizures or psychosis.
have problems with your stomach or intestines.
have trouble urinating.
are scheduled to have a gastric secretion test.
have liver or kidney problems.
are pregnant or plan to become pregnant. It is not known if scopolamine transdermal system can harm your unborn baby.
are breastfeeding or plan to breastfeed. Scopolamine can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you use scopolamine transdermal system.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Scopolamine transdermal system may affect the way other medicines work, and other medicines may affect how scopolamine transdermal system works. Medicines that you take by mouth may not be absorbed well while you use scopolamine transdermal system.

Especially tell your doctor if you take:

a sedative, hypnotic, opioid or anxiolytic (medicines that make you sleepy)
an antidepressant medicine
an anticholinergic medicine, such as an allergy or cold medicine, a medicine to treat bladder or bowel spasms, certain asthma medicines, or other medicines for motion sickness

Ask your doctor if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine.

How should I use scopolamine transdermal system?

See the detailed Instructions for Use for information about how to use scopolamine transdermal system at the end of this Patient Information leaflet.
It is important that you apply scopolamine transdermal system exactly as your doctor tells you to.
Your doctor may change your scopolamine transdermal system dose. Do not change your scopolamine transdermal system dose without talking to your doctor.
Wear only one scopolamine transdermal system at any time.
If you use too much scopolamine transdermal system, call your doctor or Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away.

What should I avoid while using scopolamine transdermal system?

You should not drink alcohol while using scopolamine transdermal system. It can increase your chances of having serious side effects.
You should not drive, operate heavy machinery, or do other dangerous activities until you know how scopolamine transdermal system affects you.
You should not use scopolamine transdermal system during a Magnetic Resonance Imaging scan (MRI). Remove scopolamine transdermal system before undergoing an MRI. It can cause your skin to burn.
You should be careful if you use scopolamine transdermal system while you participate in watersports because you may feel lost or confused (disoriented).
Limit contact with water while swimming and bathing because scopolamine transdermal system may fall off. If scopolamine transdermal system falls off, throw it away and apply a new one on the hairless area behind your other ear.

What are the possible side effects of scopolamine transdermal system?

Scopolamine transdermal system may cause serious side effects, including:

angle closure glaucoma. If you have open angle glaucoma and use scopolamine transdermal system, remove scopolamine transdermal system and call a doctor right away if you feel pain or discomfort, have blurred vision, or see halos or colored images around lights and reddening of your eyes.
worsening of seizures. Tell your doctor about any worsening of seizures while using scopolamine transdermal system.
an unusual reaction called acute psychosis. Tell your doctor if you have any of these symptoms:
confusion
agitation
rambling speech
hallucinations (seeing or hearing things that are not there)
paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy. Some pregnant women with severe preeclampsia have had seizures after getting scopolamine by injection in the muscle (intramuscular) or injection in the vein (intravenous).
difficulty urinating.
difficulties in food passing from the stomach to the small intestines, which may cause abdominal pain, nausea or vomiting.
withdrawal symptoms after removing scopolamine transdermal system after using it for several days. Some people may have certain symptoms such as difficulty with balance, dizziness, nausea, vomiting, stomach cramps, sweating, confusion, muscle weakness, low heart rate or low blood pressure that could start 24 hours or more after removing scopolamine transdermal system. Call your doctor right away if your symptoms become severe.
temporary increase in the size of your pupil and blurry vision, especially if scopolamine transdermal system comes in contact with your eyes.
skin burns at the site of scopolamine transdermal system. This can happen during a medical test called a Magnetic Resonance Imaging scan (MRI). Scopolamine transdermal system contains aluminum and should be removed from your skin before you have an MRI.

The most common side effects of using scopolamine transdermal system include:

dry mouth
blurred vision or eye problems
feeling sleepy or drowsy
disorientation (confusion)
dizziness
feeling agitated or irritable
pharyngitis (sore throat)

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of scopolamine transdermal system.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of scopolamine transdermal system.

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use scopolamine transdermal system for a condition for which it was not prescribed. Do not give scopolamine transdermal system to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or doctor for information about scopolamine transdermal system that is written for health professionals.

What are the ingredients in scopolamine transdermal system?

Active ingredient: scopolamine

Inactive ingredients: crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, ethylene vinyl acetate copolymer and aluminized polyester film

Manufactured by: AVEVA DRUG DELIVERY SYSTEMS, an APOTEX Company
Miramar FL 33025

Distributed by: Perrigo
Allegan MI 49010
For more information, go to www.perrigo.com or call Perrigo at 1-866-634-9120.

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