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|Prosom

Prosom

Prosom is used for:

Treating insomnia (trouble sleeping). It may also be used for other conditions as determined by your doctor.

Prosom is a benzodiazepine. It works by depressing the central nervous system (brain), causing drowsiness to aid in falling asleep.

Do NOT use Prosom if:

• you are allergic to any ingredient in Prosom
• you are pregnant
• you have a severe mental disorder, acute angle-closure glaucoma, or severe liver disease
• you are taking clozapine, an HIV protease inhibitor (eg, ritonavir), or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prosom :

Some medical conditions may interact with Prosom . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have or have ever had alcoholism or substance abuse or dependence, or if you drink alcohol
• if you have depression, mental or mood problems, or a history of suicidal thoughts or behaviors
• if you have myasthenia gravis (a condition in which the muscles become progressively paralyzed)
• if you have liver or kidney problems, the blood disease porphyria, or glaucoma or you are at risk for glaucoma
• if you have chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, or other breathing problems

Some MEDICINES MAY INTERACT with Prosom . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carbamazepine or rifampin because the effectiveness of Prosom may be decreased
• Clozapine because dangerous side effects, such as confusion; sedation; excess salivation; unsteady movements; lightheadedness, especially upon standing; difficult or slow breathing; or drowsiness leading to unresponsiveness or coma, may occur
• Sodium oxybate (GHB) because an increase in sleep duration and decrease in the ability to breath are likely to occur
• Disulfiram, HIV protease inhibitors (eg, ritonavir), ketolides (eg telithromycin), macrolides (eg, erythromycin), nefazodone, omeprazole, or valproic acid because they may increase the actions and side effects of Prosom
• Hydantoins (eg, phenytoin) because the actions and side effects may be increased by Prosom ; also, the effectiveness of Prosom may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prosom may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prosom :

Use Prosom as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Prosom may be taken with or without food.
• Take Prosom at bedtime.
• If you miss a dose of Prosom , take it as soon as possible. If you no longer have time for a full night"s sleep or you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prosom .

Important safety information:

• Prosom may cause drowsiness, dizziness, lightheadedness, or difficulty with coordination. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Prosom . Using Prosom alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Prosom . Prosom will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Do not drink alcohol while you are using this medicine.
• Do NOT exceed the recommended dose or take Prosom for longer than prescribed without checking with your doctor.
• Prosom can cause memory loss. Take Prosom only when you are able to get a full night"s sleep (7 to 8 hours). Be sure to talk with your doctor if you are experiencing memory problems.
• If you notice any unusual or disturbing thoughts or behavior while taking Prosom , contact your doctor at once.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Prosom .
• Use Prosom with caution in the ELDERLY because they may be more sensitive to its effects, especially oversedation, dizziness, or confusion.
• Use Prosom with extreme caution in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Prosom if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Prosom is excreted in breast milk. Do not breast-feed while using Prosom .

When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as TOLERANCE. Sleep medicines should usually be used only for short periods of time, such as a few days and generally no longer than 1 or 2 weeks. If your sleep problems continue, contact your doctor.

Sleep medicines can cause dependence, especially when used regularly, for longer than a few weeks, or at high doses. Some people develop a need to continue taking Prosom . This is known as DEPENDENCE or "addiction."

WITHDRAWAL symptoms may occur when Prosom is stopped suddenly after being used daily for a long time. But these symptoms can occur even if Prosom has been used for only a week or two. In mild cases, WITHDRAWAL symptoms may include unpleasant feelings. Although uncommon, in more severe cases, abdominal and muscle cramps, vomiting, sweating, shakiness, and, rarely, seizures may occur. Another problem that may occur is "rebound insomnia," that is, more trouble sleeping the first few nights after the medicine is stopped than before starting the medicine. This usually goes away on its own after 1 or 2 nights. If you have been taking Prosom for more than 1 or 2 weeks, do not stop taking it on your own. Your doctor may give you special directions on how to gradually decrease your dose before stopping the medicine. Always follow your doctor"s directions.

Possible side effects of Prosom :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Clumsiness or unsteadiness; daytime drowsiness; dizziness; fatigue; feeling of hangover; headache; lightheadedness; nausea; nervousness; sluggishness; unusual weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); depression; chills, fever, or sore throat; fast or irregular heartbeat; hallucinations; mental or mood changes; memory loss; unusual bruising; urinary changes; unusual thoughts or behaviors; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include clumsiness; coma; confusion; difficult or slow breathing; dizziness; drowsiness leading to unresponsiveness or coma; lightheadedness especially upon standing; loss of consciousness.

Store Prosom at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prosom out of the reach of children and away from pets.

General information:

• If you have any questions about Prosom , please talk with your doctor, pharmacist, or other health care provider.
• Prosom is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Prosom . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.