Temazepam Oral capsule

What is this medicine?

TEMAZEPAM (te MAZ e pam) is a benzodiazepine. It is used to help you to fall asleep and sleep through the night.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an alcohol or drug abuse problem

• bipolar disorder, depression, psychosis or other mental health condition

• kidney disease

• liver disease

• lung or breathing disease

• myasthenia gravis

• Parkinson's disease

• porphyria

• seizures or a history of seizures

• suicidal thoughts

• an unusual or allergic reaction to temazepam, other benzodiazepines, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. It is only for use at bedtime. Follow the directions on the prescription label. Swallow the tablets or capsules with a drink of water. If it upsets your stomach, take it with food or milk. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• barbiturate medicines for inducing sleep or treating seizures, like phenobarbital

• herbal or dietary supplements, like kava kava, melatonin, or valerian

• medicines for anxiety or sleeping problems, like alprazolam, diazepam, lorazepam or triazolam

• medicines for depression, mental problems or psychiatric disturbances

• phenytoin

• prescription pain medicines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. This medicine is for short-term periods of use. If sleep medicine is taken every night for a long time it may no longer help you to sleep. Also, your body can become dependent on this medicine. If you have been taking it regularly for some time, do not stop suddenly or you may get severe side effects. Ask your doctor or health care professional for advice. Keep a regular sleep schedule by going to bed at about the same time nightly. Avoid caffeine-containing drinks in the evening hours. Talk to your doctor if you still have trouble sleeping within 7 to 10 days of using this medicine. This may mean there is another cause for your sleep problems.

After taking this medicine for sleep, 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 have no memory of the event. Activities such as driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking have been reported. Call your doctor right away if you find out you have done any of these activities. Do not take this medicine if you drink alcohol or have taken another medicine for sleep, since your risk of doing these sleep-related activities will be increased.

Do not take this medicine unless you are able to stay in bed for a full night (7 to 8 hours) before you must be active again. You may have a decrease in mental alertness the day after use, even if you feel that you are fully awake. Tell your doctor if you will need to perform activities requiring full alertness, such as driving, the next day. Do not stand or sit up quickly after taking this medicine, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your doctor right away.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• confusion

• depression

• feeling faint or lightheaded

• hallucinations

• memory loss

• mood changes, excitability or aggressive behavior

• muscle cramps

• problems with balance, speaking, walking

• suicidal thoughts

• tremors

• unusually weak or tired

• unusual activities while asleep like driving, eating, making phone calls

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness, drowsiness

• headache

• increased dreaming

• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature below 30 degrees C (86 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date.