MEDICATION GUIDE FLURAZEPAM HYDROCHLORIDE CAPSULES, USP

Flurazepam Hydrochloride Capsules USP, 15 mg and 30 mg are a Sedative-Hypnotic Indicated for Insomnia

Read this Medication Guide carefully before you start taking your medicine and each time you get more, since there may be new information. It does not contain all the information about your medicine that you may need to know, so please ask your doctor, nurse or pharmacist if you have any questions.

IMPORTANT

YOUR DOCTOR HAS PRESCRIBED THIS DRUG FOR YOUR USE ONLY. DO NOT LET ANYONE ELSE USE IT. KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN AND PETS. If a child puts a flurazepam hydrochloride capsule in his or her mouth or swallows it, call your local Poison Control Center or go immediately to the nearest emergency room.

What is the most important information I should know about sedative-hypnotic drugs?

After taking a sedative-hypnotic drug, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medications that make you sleepy with a sedative-hypnotic drug.

Reported activities include:

• driving a car ("sleep-driving")
• making and eating food
• talking on the phone
• having sex
• sleep-walking

Important:

1. Take a sedative-hypnotic drug exactly as prescribed:
   • Do not take more sedative-hypnotic drugs than prescribed.
   • Take the sedative-hypnotic drug right before you get in bed, not sooner.
2. Do not take a sedative-hypnotic drug if you:
   • drink alcohol
   • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take a sedative-hypnotic drug with your other medicines
   • cannot get a full night sleep
3. Call your doctor right away if you find out that you have done any of the above activities after taking a sedative-hypnotic drug.

What is flurazepam?

Flurazepam  is a sedative-hypnotic agent used to treat insomnia (difficulty falling asleep and staying asleep).

Who should not take flurazepam?

Do not use flurazepam  if you are:

• allergic to anything in flurazepam hydrochloride capsules. (Being allergic may include having a rash, itching, swelling or breathing difficulties.) See the end of this Medication Guide for a complete list of ingredients in flurazepam hydrochloride capsules. In rare cases patient have had additional symptoms such as shortness of breath, throat closing, or nausea and vomiting that suggest an allergic reaction. Some patients have required medical therapy in the emergency department as these rare complications could be fatal. Patients who experience these symptoms should seek medical attention and discontinue taking the sedative-hypnotic drug.
• pregnant or intending to become pregnant. If a woman becomes pregnant while taking flurazepam, she should discontinue use immediately.
• under 15 years of age. Flurazepam  has not been studied in children.

How should I take flurazepam?

Flurazepam comes as a capsule to take by mouth. You should take flurazepam, or other sedative-hypnotic medications, exactly as directed by your doctor. It usually is taken right before you get in bed, not sooner. If you forget to take flurazepam at bedtime, you are unable to fall asleep, and you will still be able to stay in bed for a full night’s sleep, you may take flurazepam at that time. Do not take a double dose of flurazepam to make up for a missed dose.

The smallest possible effective dose is suggested for elderly patients due to the risk of the development of oversedation, dizziness, confusion and/or loss of coordination.

Sleep problems are often temporary, requiring treatment for a very short time. You should not use flurazepam, or any other sedative-hypnotic medications, for long periods of time without talking to your doctor about the risks and benefits of prolonged use.

In the case of a suspected overdose, you should contact your local poison control center immediately.

What should I avoid while taking flurazepam?

Do not drink alcohol or take other medications that depress the central nervous system.

While taking flurazepam, do not engage in any hazardous occupations requiring complete mental alertness such as operating machinery or driving a car.

What are the possible or reasonably likely side effects of flurazepam?

Dizziness, drowsiness, light-headedness, staggering, loss of coordination and falling have occurred, particularly in elderly or debilitated persons. Severe sedation, lethargy, disorientation and coma, probably indicative of drug intolerance or overdosage, have been reported. Also reported are headache, heartburn, upset stomach, nausea, vomiting, diarrhea, constipation, nervousness, talking more than usual, anxiety, irritability, weakness, pounding heartbeat, chest pain, body and joint pains and difficulty urinating.

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 flurazepam hydrochloride capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any concerns about taking this, or any sedative-hypnotic medication, please ask your doctor. For detailed information regarding flurazepam hydrochloride capsules please consult the physician’s package insert. Do not use for conditions for which this medication was not prescribed. Do not give this medication to others.

What are the ingredients of flurazepam hydrochloride capsules, USP?

Active Ingredient: flurazepam hydrochloride, USP

Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, powdered cellulose and sodium lauryl sulfate. The empty gelatin capsule contains FD&C Blue No. 1, FD&C Red No. 3, gelatin and titanium dioxide. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.

How should I store flurazepam hydrochloride capsules?

• Store flurazepam hydrochloride capsules at room temperature, 20° to 25°C (68° to 77°F). 
• KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN. If a child accidentally takes flurazepam hydrochloride capsules, call your local Poison Control Center or go immediately to the nearest emergency room.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

REVISED MAY 2010
FLZ:R16mmt/MG:FLZ:R1

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK      74146