Ortho Evra

What you should know before using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatrics

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of norelgestromin/ethinyl estradiol in children with use in other age groups. This medicine should not be used before the start of menstruation. It may be used for birth control in teenage females and has not been shown to cause different side effects or problems than it does in adults. Some teenagers may need extra information on the importance of taking norelgestromin/ethinyl estradiol exactly as prescribed.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of norelgestromin/ethinyl estradiol in the elderly with use in other age groups.

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Felbamate
• Fosamprenavir
• Isotretinoin
• Paclitaxel
• Paclitaxel Protein-Bound
• Theophylline
• Tizanidine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Breast cancer—current or suspected diagnosis or
• Breast cancer—personal history or
• Cancer of the uterus or cervix—Use of hormonal contraceptives may make these conditions worse.

• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver cancer, disease or tumors—Use of hormonal contraceptives may increase the chance of liver problems or make liver conditions worse.

• Diabetes mellitus (sugar diabetes)—Use of hormonal contraceptives may cause an increase, usually only a small increase, in your blood sugar and usually does not affect the amount of diabetes medicine that you take. You or your doctor will want to test for any changes in your blood sugar.

• Depression or
• Gallbladder disease or
• Heart attack or
• Heart disease, now or in the past or
• High blood pressure or
• Stroke, now or in the past—Use of hormonal contraceptives may cause or worsen these conditions.
• Abnormal or unusual vaginal bleeding—This condition may sometimes be treated with hormone contraceptives, but may make this condition worse.
• Migraine headache, new or worse or a new kind of headache—Use of hormonal contraceptives may cause headaches to be worse.
• Obesity—Use of the transdermal patch may be less effective in women with body weight greater than or equal to 198 pounds (90 kilograms).
• Problems with circulation or blood clots, now or in the past or
• Problems with heart valves or
• Surgery with a long period of inactivity—Use of hormonal contraceptives may increase the chance of blood clots and worsen these conditions.