Doxepin Hydrochloride Oral capsule

What is this medicine?

DOXEPIN is used to treat depression and anxiety.

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:

• bipolar disorder or schizophrenia

• difficulty passing urine

• glaucoma

• kidney or liver disease

• thoughts or plans of suicide or a previous suicide attempt or family history of suicide attempt

• an unusual or allergic reaction to doxepin, sulfites, tartrazine dye, 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 with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. 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. While this drug may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

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?

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

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• 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.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. It can take several days before you feel the full effect of this medicine. If you have been taking this medicine regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or you may get severe side effects. Ask your doctor or health care professional for advice. Even after you stop taking this medicine it can still affect your body for several days.

Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden or severe 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 antidepressant treatment or after a change in dose, call your health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds, or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

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 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.

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:

• abnormal production of milk in females

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

• breast enlargement in both males and females

• breathing problems

• confusion, hallucinations

• excessive thirst and/or hunger

• fast, irregular or pounding heartbeat

• fever with sweating

• muscle stiffness, or spasms

• passing urine more times in a day

• seizures

• suicidal thoughts or other mood changes

• swelling of the testicles

• tingling, pain, or numbness in the feet or hands

• trouble passing urine or change in the amount of urine

• yellowing of the eyes or skin

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 sex drive or performance

• constipation, or diarrhea

• nausea, vomiting

• weight gain or loss

This list may not describe all possible side effects.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Doxepin Hydrochloride Oral solution

What is this medicine?

DOXEPIN is used to treat depression and anxiety.

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:

• bipolar disorder or schizophrenia

• difficulty passing urine

• glaucoma

• kidney or liver disease

• thoughts or plans of suicide or a previous suicide attempt or family history of suicide attempt

• an unusual or allergic reaction to doxepin, sulfites, tartrazine dye, 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. Follow the directions on the prescription label. Shake well before using. Measure the correct amount of medicine with the special dropper provided. Just before taking, dilute the solution with half a glass (4 oz.) of water, milk, or orange, grapefruit, tomato, prune or pineapple juice. Do not mix with a carbonated beverage or grape juice, they can stop the medicine from working properly. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not suddenly stop taking this medicine. You must gradually reduce the dose or you may get severe side effects. Ask your doctor or health care professional for advice. Even after you stop taking this medicine it can still affect your body for several days.

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. While this drug may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

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?

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

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• 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.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. It can take several days before you feel the full effect of this medicine.

Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden or severe 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 antidepressant treatment or after a change in dose, call your health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds, or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

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 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.

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:

• abnormal production of milk in females

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

• breast enlargement in both males and females

• breathing problems

• confusion, hallucinations

• fast, irregular or pounding heartbeat

• fever with sweating

• increased hunger or thirst

• muscle stiffness, or spasms

• passing urine more times in a day

• seizures

• suicidal thoughts or other mood changes

• swelling of the testicles

• tingling, pain, or numbness in the feet or hands

• trouble passing urine or change in the amount of urine

• yellowing of the eyes or skin

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 sex drive or performance

• constipation, or diarrhea

• nausea, vomiting

• weight gain or loss

This list may not describe all possible side effects.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Doxepin Hydrochloride Topical cream

What is this medicine?

DOXEPIN is used on the skin to treat itching caused by certain types of skin disorders.

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:

• asthma

• difficulty passing urine

• glaucoma

• if you frequently drink alcohol containing beverages

• liver disease

• prostate trouble

• schizophrenia

• seizure disorder

• an unusual or allergic reaction to doxepin, sulfites, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for external use only. Follow the direction on the prescription label. Apply a thin film of cream to the affected area as often as directed. Do not cover the area with a bandage or dressing. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. Use your doses at regular intervals. Do not use your medicine more often than directed.

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, use it as soon as you can. If it is almost time for your next dose, use only that dose. There should be at least 3 to 4 hours in between each dose. Do not use double or extra doses.

What may interact with this medicine?

• alcohol

• any medicine that makes you drowsy or helps you sleep, such as antihistamines, tranquilizers, barbiturates, seizure medicine, muscle relaxants and others

• cimetidine

• dextromethorphan (included in some cough medicines)

• medicines for correcting heart rhythm problems

• medicines for treating depression, especially MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

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 to check on your progress. Do not use this medicine for more than 8 days.

You may get drowsy or dizzy, especially if you are applying this medicine to large areas. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

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

• burning, tingling feeling on the skin

• changes in vision

• feeling faint or lightheaded, falls

• fast heartbeat

• muscle stiffness or problems with movement

• pain or difficulty passing urine

• seizures

• unusually weak or tired

• worsening of eczema

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

• changes in taste

• drowsiness or dizziness

• dry mouth or thirst

• dry, tight skin

• headache

• skin scaling and cracking

This list may not describe all possible side effects.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature below 27 degrees C (80 degrees F). Throw away any unused medicine after the expiration date.