Dalmane

This medicine helps you get to sleep faster and sleep through the night .

Flurazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system .

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Capsule

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of flurazepam in the pediatric population. Safety and efficacy have not been established for children younger than 15 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of flurazepam in the elderly. However, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness are more likely to occur in the elderly, which may require an adjustment in the dose for patients receiving flurazepam.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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.

• Alfentanil


• Amobarbital


• Anileridine


• Aprobarbital


• Butabarbital


• Butalbital


• Carisoprodol


• Chloral Hydrate


• Chlorzoxazone


• Codeine


• Dantrolene


• Ethchlorvynol


• Fentanyl


• Hydrocodone


• Hydromorphone


• Levorphanol


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Morphine


• Morphine Sulfate Liposome


• Oxycodone


• Oxymorphone


• Pentobarbital


• Phenobarbital


• Primidone


• Propoxyphene


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Thiopental


• Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amprenavir


• St John`s Wort


• Theophylline

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:

• Alcohol abuse, or history of, or


• Drug abuse or dependence, or history ofa€”Dependence on flurazepam may develop.

• Breathing problems or lung disease, severe or


• Depression, or history ofa€”Use with caution. May make these conditions worse.

• Kidney disease or


• Liver diseasea€”Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use

Take this medicine only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take flurazepam just before going to bed, when you are ready to go to sleep.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  
  
  • For insomnia:
    
    
    
    • Adultsa€”30 milligrams (mg) at bedtime. Your doctor may adjust your dose if needed.
    
    
    • Older adultsa€”15 milligrams (mg) at bedtime. Your doctor may adjust your dose if needed.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby . Use an effective form of birth control to keep from getting pregnant . If you think you have become pregnant while using this medicine, tell your doctor right away.

Flurazepam may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention . Stop taking this medicine and call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than they are normally. Even though flurazepam is taken at bedtime, it may cause some people to feel drowsy or less alert the next morning . Also, this medicine may cause double vision or other vision problems . Make sure you know how you react to flurazepam before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well .

If you develop any unusual or strange thoughts and behavior while taking flurazepam, be sure to discuss it with your doctor . Some changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol . Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while you are asleep or not fully awake. If these behaviors occur, tell your doctor right away.

Do not stop taking this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), hallucinations, stomach or muscle cramps, tremors, or unusual behavior .

If your condition does not improve within 7 to 10 days, or if it becomes worse, check with your doctor .

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

Rare

• Black, tarry stools


• Blurred vision


• Chest pain


• Chills


• Confusion


• Cough


• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• Feeling like you will pass out


• Fever


• Painful or difficult urination


• Shortness of breath


• Slurred speech


• Sore throat


• Sores, ulcers, or white spots on the lips or in the mouth


• Sweating


• Swollen glands


• Unusual bleeding or bruising


• Unusual tiredness or weakness

Incidence not known

• Change in consciousness


• Clumsy movement, moving from side to side


• Confusion about identity, place, and time


• Falling


• Fast, irregular, pounding, or racing heartbeat or pulse


• Loss of consciousness


• Shakiness and unsteady walk


• Unsteadiness, trembling, or other problems with muscle control or coordination


• Unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

• Bitter taste


• Blurred vision


• Burning eyes


• Difficulty in focusing


• Discouragement


• Dry mouth


• False or unusual sense of well-being


• Feeling of warmth


• Feeling sad or empty


• Hallucinations


• Increased watering of the mouth


• Itching skin


• Loss of appetite


• Loss of interest or pleasure


• Mood or mental changes


• Nightmares


• Redness of the face, neck, arms and occasionally, upper chest


• Restlessness


• Skin rash


• Sweating


• Trouble concentrating


• Trouble sleeping


• Unusual excitement, nervousness, restlessness, or irritability


• Weight loss

Incidence not known

• Constipation


• Diarrhea


• Fear


• Headache


• Heartburn


• Joint pain


• Nausea


• Stomach upset


• Talkativeness


• Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

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