Tofranil 50mg: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TOFRANIL* has been prescribed by your doctor to relieve your symptoms of depression, (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pains).

What it does:

TOFRANIL*belongs to the group of medicines known as tricyclic antidepressants. TOFRANIL* is thought to work by making it difficult for chemical messages to get carried by specific brain neurons.

When it should not be used:

Do not take TOFRANIL* if you:

• Are allergic to any component of

  TOFRANIL*, including active and non‐active ingredients (see, ‘What the nonmedicinal ingredients are” section).

• Are allergic to other tricyclic antidepressants

• Are currently or have recently taken

  monoamine oxidase antidepressants (e.g. phenelzine sulphate, moclobemide).

• Have recently had a heart attack or if you

  suffer from severe heart disease

• have liver or kidney damage or any

  unspecified disorder of the blood

• have glaucoma

What the medicinal ingredient is:

imipramine hydrochloride

What the nonmedicinal ingredients are:

The tablets also contain the following non‐medicinal ingredients: cellulose compounds, colloidal silicon dioxide, corn starch, glycerin, iron oxides, lactose, magnesium stearate, polyethylene glycol, povidone, stearic acid, sucrose, talc, titanium dioxide.

What dosage forms it comes in:

TOFRANIL* is available in tablets of 25 mg, 50 mg or 75 mg. The tablets are reddish brown, round, biconvex, sugar‐coated. TOFRANIL* tablets 50mg and 75mg are branded GEIGY on one side and LB on the other side in white letters.

WARNINGS AND PRECAUTIONS

During treatment with these types of

medications, it is important that you and your doctor have good ongoing communication about how you are feeling.

Before you use TOFRANIL* talk to your doctor or pharmacist:

• if you are thinking about suicide,
• if you have history of convulsive disorders and other predisposing factors, (seizures)
• if you have irregular heart beat or history of heart problems,
• if you have schizophrenia,
• if you have blood disorder (fever, influenzal infection or sore thoat),
• if you are pregnant, breast‐feeding or trying to become pregnant
• if you have difficulty urinating or enlarged prostate,
• if you have overactive thyroid, or take thyroid medication

• if you take alcohol daily or in excess,

• if you have frequent constipation,
• if you have liver disease.

You should also inform your doctor if you are taking certain medicines used to treat depression (including medicines obtained without

prescription, such as St John’s Wort). Examples of prescription medicines are: fluoxetine, paroxetine, sertraline, citalopram, fluvoxamine, lithium and other tricyclic antidepressants.

TOFRANIL* coated tablets contain lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking TOFRANIL*.

Effects on Pregnancy, Newborns and Breast‐feeding

The safety of use in pregnant women has not been established. Therefore, TOFRANIL* should not be administered to women of childbearing potential or during pregnancy, unless your doctor thinks that the benefits to you outweigh the risk to the unborn baby. Some newborns whose mothers took TOFRANIL* during the last 3 months of pregnancy experienced withdrawl symptoms including: tremors, shortness of breath, lethargy, colic, irritability, tight or loose muscles, convulsions. To avoid such symptoms, TOFRANIL* should, if possible be withdrawn at least 7 weeks before the baby is due to be born. Your doctor will discuss with you the potential risk of taking TOFRANIL* during pregnancy. As TOFRANIL* passes into breast milk, TOFRANIL* should be gradually withdrawn from the mother or the infant should be weaned.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, including herbal and non‐prescription medicines.

Since many medicines interact with TOFRANIL*, it may be necessary to adjust the dosage or stop one of the medicines. TOFRANIL* should be stopped prior to elective surgery for as long as possible since little is known about its interaction with general anesthetics. It is especially important for your doctor and pharmacist to know if you drink alcohol every day or are taking any of the following: medicine for blood pressure or heart function, other antidepressants, sedatives, tranquillisers, barbiturates, antiepileptics, a medicine called terbinafine used

orally to treat skin, hair or nail infections due to fungus, medicine to prevent blood‐clotting (anticoagulants), medicine for asthma or allergies, medicine for Parkinson's disease, thyroid preparations, cimetidine, methylphenidate, birth control pills, estrogens.

PROPER USE OF THIS MEDICATION

Follow your doctor’s instructions carefully. Do not exceed the recommended dosage. Your doctor will decide on the most suitable dosage for your particular case.

Usual dose:

The recommended initial dosage is 25 mg three times daily. This should be increased gradually as required and tolerated, up to 150 mg/day. When your doctor has found the best dose for you, TOFRANIL* may be taken once a day at bedtime.

Overdose:

If you have accidentally taken more tablets than your doctor has prescribed, seek immediate emergency medical assistance. Take your medicine to show the doctor. You may require medical attention. You may be at risk for 4‐6 days.

Missed Dose:

If you forget to take a dose of TOFRANIL*, take the missed dose as soon as possible and then go back to your normal dosage schedule. If it is almost time for your next dose, skip the missed dose and continue with your normal dosage schedule. If you have any questions about this, ask your doctor. Do not double the dose to make up for the missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

TOFRANIL* can have some side effects in some people. These do not normally need medical

attention, and may go away during treatment as your body adjusts to the medicine. Ask your doctor if any side effects continue or are bothersome.

The most common side effects are drowsiness, fatigue, dry mouth, blurred vision, headache, shaking, palpitations, constipation, nausea, vomiting, dizziness, restlessness, hot flushes, sweating, fall in blood pressure associated with dizziness after abrupt standing or sitting up, weight gain. At the start of treatment TOFRANIL* may increase your feelings of anxiety, but this effect generally disappears within two weeks.

Other unwanted effects may also occur, such as dental caries, confusion, disorientation, agitation, sleep disturbances, over‐excitedness, irritability, aggressiveness, sexual difficulties, numbness or tingling of the extremities, involuntary movement, decreased production of tears, dilated pupils, ringing in the ears, increase in blood pressure, abdominal disorders, skin sensitivity to sunlight, darker areas of skin, skin rash, hair loss, swelling of the breasts and discharge of milk, swollen ankles,, hands and/or swelling of any other part of the body, fever.

Some patients may experience other side effects not listed above. If you notice any other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking TOFRANIL* contact your doctor or pharmacist.

HOW TO STORE IT

Protect from heat (store between 2 and 30^OC) and humidity.

Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll‐free at 1‐866‐234‐2345

• Complete a Canada Vigilance Reporting

  Form and:

  • Fax toll‐free to 1‐866‐678‐6789, or ‐ Mail to:

    Canada Vigilance Program Health Canada

    Postal Locator 0701C Ottawa, ON K1A 0K9 Postage paid labels, Canada Vigilance

Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TM Canada Web site at www.healthcanada.gc.ca/medeffect. NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice..

MORE INFORMATION

Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.

This document plus the full product monograph, prepared for health professionals can be found at: http://www.novartis.ca

or by contacting the sponsor, Novartis Pharmaceuticals Canada Inc., at:

1‐800‐363‐8883

385 Bouchard Blvd.

Dorval, Québec

H9S 1A9

Last revised: June 16, 2010.