Maprotiline Hydrochloride Oral tablet

What is this medicine?

MAPROTILINE (ma PROE ti leen) is used to treat depression. This medicine also helps to relieve anxiety associated with depression.

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

• blood disorders

• glaucoma

• heart disease

• liver disease

• previous heart attack

• seizures

• suicidal thoughts or family history of suicide

• an unusual or allergic reaction to maprotiline, 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 medicine at regular intervals. Do not take your medicine 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.

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:

• certain medicines for depression

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• certain medicines for irregular heart beat like dofetilide, dronedarone

• cisapride

• cocaine

• droperidol

• halofantrine

• linezolid

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

• methylene blue

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• pimozide

• sparfloxacin

• St. John's Wort

• ziprasidone

This medicine may also interact with the following medications:

• antihistamines for allergy, cough, and cold

• barbiturates like phenobarbital

• certain medicines for anxiety or sleep lilke diazepam, temazepam

• certain medicines for blood pressure

• certain medicines for breathing difficulties

• certain medicines for thyroid

• cimetidine

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• phenytoin

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?

Tell your doctor if your symptoms do not get better or if they get worse. Visit your doctor or health care professional for regular checks on your progress. Because it may take several weeks to see the full effects of this medicine, it is important to continue your treatment as prescribed by your doctor.

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.

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 interfere with the effect of this medicine. Avoid alcoholic drinks.

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.

Your mouth may get dry. Chewing sugarless gum, sucking hard candy and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

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

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.

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

• breathing problems

• confusion or nervousness

• fast or irregular heartbeat

• feeling faint or lightheaded, falls

• fever with increased sweating

• hallucinations

• muscle stiffness, twitches, or problems with movement

• pale skin

• seizures

• suicidal thoughts or other mood changes

• swelling or tenderness of breasts or testicles

• 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):

• blurred vision

• change in sex drive or performance

• constipation

• headache

• trouble sleeping

• unusually weak or tired

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.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.