Sinequan (Doxepin Hydrochloride)

They need to know if you have any of these conditions: -bipolar disorder -depression -difficulty passing urine -glaucoma -heart disease -history of a drug or alcohol abuse problem -liver disease -lung or breathing disease, like asthma or sleep apnea -prostate trouble -schizophrenia -suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member -an unusual or allergic reaction to doxepin, other medicines, foods, dyes, or preservatives -pregnant or trying to get pregnant -breast-feeding

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, and not within 3 hours of a meal. This medicine should be taken within 30 minutes of going to sleep and only when you are able to get a full night of sleep before you must be active again. Do not take it more often than directed. Do not stop taking this medicine suddenly except upon the advice of your doctor. Stopping this medicine too quickly may cause serious side effects or your condition may worsen. 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.

This does not apply. This medicine should only be taken before going to sleep. Do not take double or extra doses.

Do not take this medicine with any of the following medications: -arsenic trioxide -certain medicines used to regulate abnormal heartbeat or to treat other heart conditions -cisapride -halofantrine -levomethadyl -linezolid -MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate -methylene blue -other medicines for mental depression -phenothiazines like perphenazine, thioridazine and chlorpromazine -pimozide -procarbazine -sparfloxacin -St. John's Wort -ziprasidone This medicine may also interact with the following medications: -cimetidine -tolazamide

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.

Visit your doctor or health care professional for regular checks on your progress. Keep a regular sleep schedule by going to bed at about the same time each night. 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. Do not take this medicine unless you are able to get a full night of sleep before you must be active again. After taking this medicine, do not drive, use machinery, or do anything that needs mental alertness. Take this medicine only within 30 minutes of going to bed and then confine your activities to those needed to get ready for sleep. You may still feel drowsy the next day after taking this medicine. If this happens, do not drive, use machinery, or do anything that needs mental alertness until you feel fully awake. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. 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. Patients and their families should watch out for new or worsening thoughts of suicide or depression. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your health care professional. Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe. This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe. This medicine can cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional. This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

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 -breathing problems -changes in vision -confusion -eye pain -fast, irregular heartbeat -feeling faint or lightheaded, falls -fever with increased sweating -seizures -stiff muscles -suicidal thoughts or other mood changes -trouble passing urine or change in the amount of urine -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): -change in appetite or weight -constipation -daytime drowsiness -dry mouth -upset stomach

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.

Keep out of the reach of children. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.