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|Tofranil-PM

Tofranil-PM

Tofranil-PM is used for:

Treating depression. It may also be used for other conditions as determined by your doctor.

Tofranil-PM is a tricyclic antidepressant. It works by increasing the activity of certain chemicals in the brain that help elevate mood.

Do NOT use Tofranil-PM if:

• you are allergic to any ingredient in Tofranil-PM or to similar medicines
• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days or if you are taking astemizole, dofetilide, droperidol, terfenadine, or cisapride
• you are recovering from a recent heart attack

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

Before using Tofranil-PM :

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

• if you are pregnant, 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 drink alcohol-containing beverages daily or you have a history of alcohol abuse
• if you take thyroid medicine or you have a history of overactive thyroid, glaucoma, heart problems, kidney or liver problems, diabetes, seizures, the blood disease porphyria, or difficulty urinating
• if you have a history of suicidal thoughts or behavior, bipolar disorder, or any other mental disorders; you are undergoing electroshock therapy; or you are scheduled to have any surgery

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

• Azole antifungals (eg, fluconazole), cimetidine, duloxetine, flecainide, methylphenidate, mibefradil, phenothiazines (eg, chlorpromazine), propafenone, quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or terbinafine because the side effects of Tofranil-PM may be increased
• Arsenic, astemizole, cisapride, dofetilide, droperidol, furazolidone, MAO inhibitors (eg, phenelzine), pimozide, quinolone antibiotics (eg, ciprofloxacin), streptogramins (eg, dalfopristin), terfenadine, tramadol, or ziprasidone because the risk of high blood pressure, serious heart problems (eg, irregular heartbeat), or seizures may be increased
• Barbiturates (eg, phenobarbital) or phenytoin because the effectiveness of Tofranil-PM may be decreased
• Anticholinergics (eg, benztropine), carbamazepine, or sympathomimetics (eg, phenylephrine) because side effects may be increased by Tofranil-PM
• Clonidine, guanethidine, or guanfacine because effectiveness may be decreased by Tofranil-PM

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tofranil-PM 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 Tofranil-PM :

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

• Tofranil-PM comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Tofranil-PM refilled.
• Tofranil-PM may be taken with or without food.
• Taking Tofranil-PM at bedtime may help reduce side effects (eg, daytime drowsiness). Discuss this possibility with your doctor.
• It may take 1 to 3 weeks before you notice the effect of Tofranil-PM . Continue to use Tofranil-PM even if you feel well. Do not miss any doses.
• If you miss a dose of Tofranil-PM , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you take 1 dose daily at bedtime, do not take the missed dose the next morning.

Ask your health care provider any questions you may have about how to use Tofranil-PM .

Important safety information:

• Tofranil-PM may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tofranil-PM . Using Tofranil-PM alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Tofranil-PM . Tofranil-PM will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Alcohol, hot weather, exercise, and fever can increase dizziness. To prevent dizziness or fainting, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
• Do not become overheated in hot weather or during exercise or other activities; heatstroke may occur.
• Antidepressants can increase suicidal thoughts and behaviors in some children and teenagers. This risk may be higher in individuals with bipolar illness (also called manic-depressive illness), a family history of bipolar illness, or a history of attempting suicide. Pay close attention to changes in moods or actions, especially if changes occur suddenly. Contact your health care provider right away if any of the following effects occur or worsen: depression, anxiety, restlessness or irritability, panic attacks, thoughts or attempts of suicide, or other unusual changes in behavior or mood.
• Tofranil-PM may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Tofranil-PM . Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tofranil-PM .
• LAB TESTS, including blood counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Tofranil-PM with caution in the ELDERLY (especially those with cardiac disease) because they may be more sensitive to its effects.
• Use Tofranil-PM with extreme caution in CHILDREN. Safety and effectiveness have not been established.
• PREGNANCY and BREAST-FEEDING: It is unknown if Tofranil-PM can cause harm to the fetus. If you become pregnant while taking Tofranil-PM , discuss with your doctor the benefits and risks of using Tofranil-PM during pregnancy. It is unknown if Tofranil-PM is excreted in breast milk. Do not breast-feed while taking Tofranil-PM .

If you suddenly stop taking Tofranil-PM , you may experience WITHDRAWAL symptoms, including headache, nausea, and tiredness.

Possible side effects of Tofranil-PM :

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:

Dizziness; drowsiness; dry mouth; excitement; headache; impotence; nausea; nightmares; pupil dilation; sensitivity to sunlight; sweating; tiredness; upset stomach; vomiting; weakness; weight loss or gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; changes in sex drive; chest pain; confusion; constipation; fainting; fever; frequent or difficult urination; hallucinations; impulsive behavior or other unusual changes in behavior; fast, slow, or irregular heartbeat; jaw, neck, or muscle spasms; mental or mood changes (eg, increased anxiety, mood swings, agitation, irritability, nervousness, restlessness); panic attacks; ringing in the ears; seizures; severe dizziness or drowsiness; sore throat; stomach pain; suicidal thinking or behavior; swelling of the testicles; tremor; trouble sleeping; trouble walking or keeping your balance; twitching of the face or tongue; uncontrolled movements of arms and legs or stiffness; unusual bleeding or bruising; worsening of depression; yellowing of the skin or eyes.

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 agitation; bluish skin or mucous membranes; breathing problems; chest pain; coma; confusion; dry mouth; enlarged pupils; excess sweating; fainting; fast or irregular heartbeat; flushing; incoordination; involuntary movements; loss of consciousness; restlessness; rigid muscles; seizures; severe drowsiness; shock; stupor; vomiting.

Store Tofranil-PM at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly sealed container. Stored away from heat, moisture, and light. Do not store in the bathroom. Keep Tofranil-PM out of the reach of children and away from pets.

General information:

• If you have any questions about Tofranil-PM , please talk with your doctor, pharmacist, or other health care provider.
• Tofranil-PM 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 Tofranil-PM . 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.