Medication Guide

Doxepin Hydrochloride Tablets

(dox′ e pin)

Read this Medication Guide before you start taking doxepin hydrochloride tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about doxepin hydrochloride tablets? After taking doxepin hydrochloride tablets, 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 not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with doxepin hydrochloride tablets. Reported activities include: • driving a car (“sleep-driving”) • making and eating food • talking on the phone • having sex • sleep-walking Call your healthcare provider right away if you find out that you have done any of the above activities after taking doxepin hydrochloride tablets.   Important: 1. Take doxepin hydrochloride tablets exactly as prescribed • Do not take more doxepin hydrochloride tablets than prescribed. • Take doxepin hydrochloride tablets 30 minutes before bedtime. After taking doxepin hydrochloride tablets, you should only do activities needed to get ready for bed. 2. Do not take doxepin hydrochloride tablets: • with alcohol • if you take other medicines that can make you sleepy. Talk to your healthcare provider about all of your medicines. Your healthcare provider will tell you if you can take doxepin hydrochloride tablets with your other medicines • if you cannot get a full night of sleep before you must be active again

What are doxepin hydrochloride tablets?

Doxepin hydrochloride tablets are a hypnotic (sleep) medicine that is used to treat people who have trouble staying asleep.

Who should not take doxepin hydrochloride tablets?

Do not take doxepin hydrochloride tablets if you:

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take a monoamine oxidase inhibitor (MAOI) medicine or have taken an MAOI in the last 14 days (2 weeks). Ask your healthcare provider if you are not sure if your medicine is an MAOI.

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have an eye problem called narrow angle glaucoma that is not being treated

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have trouble urinating

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are allergic to any of the ingredients in doxepin hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in doxepin hydrochloride tablets.

Talk to your healthcare provider before taking this medicine if you have any of these conditions.

It is not known if doxepin hydrochloride tablets are safe and effective in children.

What should I tell my healthcare provider before taking doxepin hydrochloride tablets?

Before you take doxepin hydrochloride tablets, tell your healthcare provider if you:

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See “Who should not take doxepin hydrochloride tablets?”

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have a history of depression, mental illness, or suicidal thoughts

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have severe sleep apnea

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have kidney or liver problems

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have a history of drug or alcohol abuse or addiction

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have a history of glaucoma or urinary retention

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have any other medical conditions

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are pregnant or plan to become pregnant. It is not known if doxepin hydrochloride tablets will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

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are breast-feeding or plan to breast-feed. Doxepin hydrochloride can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take doxepin hydrochloride tablets. You should not breast-feed while taking doxepin hydrochloride tablets.

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Doxepin hydrochloride tablets and other medicines may affect each other causing side effects. Doxepin hydrochloride tablets may affect the way other medicines work, and other medicines may affect how doxepin hydrochloride tablets work. Especially tell your healthcare provider if you take:

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a monoamine oxidase inhibitor (MAOI). See “Who should not take doxepin hydrochloride tablets?”

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cimetidine (Tagamet) or other medicines that can affect certain liver enzymes

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certain allergy medicines (antihistamines) or other medicines that can make you sleepy or affect your breathing

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the diabetes medicine tolazamide

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take doxepin hydrochloride tablets?

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Take doxepin hydrochloride tablets exactly as your healthcare provider tells you to take them.

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Your doctor will tell you how many doxepin hydrochloride tablets to take and when to take them.

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Your doctor may change your dose if needed.

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Take doxepin hydrochloride tablets within 30 minutes of bedtime. After taking doxepin hydrochloride tablets, you should confine your activities to those necessary to prepare for bed.

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Do not take doxepin hydrochloride tablets within 3 hours of a meal. Doxepin hydrochloride tablets may not work as well, or may make you sleepy the next day if taken with or right after a meal.

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Do not take doxepin hydrochloride tablets unless you are able to get a full night of sleep before you must be active again.

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Call your doctor if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

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If you take too many doxepin hydrochloride tablets, call your doctor or get medical help right away.

What should I avoid while taking doxepin hydrochloride tablets?

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You should not drink alcohol while taking doxepin hydrochloride tablets. Alcohol can increase your chances of getting serious side effects with doxepin hydrochloride tablets.

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You should not drive, operate heavy machinery, or do other dangerous activities after doxepin hydrochloride tablets.

You may still feel drowsy the next day after taking doxepin hydrochloride tablets. Do not drive or do other dangerous activities after taking doxepin hydrochloride tablets until you feel fully awake.

What are the possible side effects of doxepin hydrochloride tablets?

Doxepin hydrochloride tablets can cause serious side effects including:

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See “What is the most important information I should know about doxepin hydrochloride tablets?”

The most common side effect of doxepin hydrochloride tablets is drowsiness or tiredness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of doxepin hydrochloride tablets. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store doxepin hydrochloride tablets?

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Store doxepin hydrochloride tablets between 68° and 77° F (20º to 25ºC).

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Keep doxepin hydrochloride tablets in a tightly closed container, and away from light. Safely throw away medicine that is out of date or no longer needed.

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Keep doxepin hydrochloride tablets and all medicines out of the reach of children.

General Information about doxepin hydrochloride tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use doxepin hydrochloride tablets for a condition for which they were not prescribed. Do not share doxepin hydrochloride tablets with other people, even if you think they have the same symptoms that you have. They may harm them.

This Medication Guide summarizes the most important information about doxepin hydrochloride tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about doxepin hydrochloride tablets that is written for healthcare professionals.

For more information, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

What are the ingredients in doxepin hydrochloride tablets?

Active Ingredient: doxepin hydrochloride

Inactive Ingredients: Microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The 3 mg tablet also contains FD&C Blue No. 1. The 6 mg tablet also contains FD&C Yellow No. 10 and FD&C Blue No. 1.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 10/2019
SP:SILEG:R1