Rhuzdah: Uses, Side Effects and Dosage

DOSAGE AND ADMINISTRATION

HOW TO TAKE THE PILL

The instructions given in the COMBINATION DETAILED PATIENT LABELING AND BRIEF SUMMARY insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.

Instructions on how to use the blister card for the (28 Tablets) are included in the BRIEF SUMMARY PATIENT PACKAGE INSERT.

DETAILED PATIENT LABELING

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

INTRODUCTION

Any woman who considers using oral contraceptives (the “birth control pill” or the “pill”) should understand the benefits and risks of using this form of birth control.

Although the oral contraceptives have important advantages over other methods of contraception, they have certain risks that no other method has and some of these risks may continue after you have stopped using the oral contraceptive. This brochure will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this brochure is not a replacement for a careful discussion between you and your health care professional.

You should discuss the information provided in this brochure with him or her, both when you first start taking the pill and during your revisits. You should also follow your health care professional’s advice with regard to regular check-ups while you are on the pill.

EFFECTIVENESS OF ORAL CONTRACEPTIVES

Oral contraceptives or “birth control pills” or “the pill” are used to prevent pregnancy and are more effective than other nonsurgical methods of birth control. The chance of becoming pregnant is less than 1% (1 pregnancy per 100 women per year of use) when the pills are used correctly and no pills are missed. Typical failure rates are actually 3% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.

In comparison, typical accidental pregnancy rates for other nonsurgical methods of birth control during the first year of use are as follows:

IUD: 3%

Diaphragm with spermicides: 18%

Spermicides alone: 21%

Vaginal Sponge: 18% to 28%

Condom alone: 12%

Periodic abstinence: 20%

Injectable progestogen: 0.3% to 0.4%

Implants: 0.03% to 0.04%

No methods: 85%

WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES

Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You should also not use the pill if you have or have ever had any of the following conditions:

• A history of heart attack or stroke
• Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
• A history of blood clots in the deep veins of your legs
• Chest pain (angina pectoris)
• Known or suspected breast cancer or cancer of the lining of the uterus
• Unexplained vaginal bleeding (until a diagnosis is reached by your doctor)
• Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the pill
• Liver tumor (benign or cancerous)
• Take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.

Tell your health care professional if you have ever had any of these conditions. Your health care professional can recommend a safer method of birth control.

OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES

Tell your health care professional if you have:

• Breast nodules, fibrocystic disease of the breast or an abnormal breast x-ray or mammogram
• Diabetes
• Elevated cholesterol or triglycerides
• High blood pressure
• Migraine or other headaches or epilepsy
• Mental depression
• Gallbladder, heart or kidney disease
• History of scanty or irregular menstrual periods

Women with any of these conditions should be checked often by their health care professional if they choose to use oral contraceptives.

Also, be sure to inform your doctor or health care professional if you smoke or are on any medications.