Tofranil 25 mg

Generic Name: Imipramine 25 mg
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About Tofranil

What Tofranil 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 Tofranil 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 Tofranil 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 important nonmedicinal ingredients are:)

  • 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 important nonmedicinal ingredients for Tofranil are

The tablets also contain the following nonmedicinal 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 Tofranil 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 50 mg and 75 mg 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 throat),

  • 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.

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 withdrawal 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 Tofranil

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, tranquilizers, barbiturates, antiepileptics, medicine to prevent blood-clotting (anticoagulants), medicine for asthma or allergies, medicine for Parkinson's disease, thyroid preparations, cimetidine (e.g. Tagamet), methylphenidate (Ritalin), birth control pills, estrogens.


Proper Use of Tofranil

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, talk to your doctor straight away. 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.


Side Effects for Tofranil 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.

See your doctor as soon as possible if any of the following side effects occur, since they may need medical attention: seeing or hearing things that are not really there, eye pain, sudden contraction of the muscles, muscle stiffness, muscle spasms, fast or irregular heartbeat (racing, pounding), fits or seizures.

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.

Serious Side Effects, How Often They Happen and What to Do About Them
Symptom/Effect Talk with your doctor or pharmacist Stop taking drug and call your doctor or pharmacist
Only if severe In all cases
Common Allergic reactions Skin reactions (itching or reddening)    
Severe confusion or delirium, hallucinations    
Rare Seeing or hearing things that are not really there    
Fits or seizures    
Very rare Allergic reactions with/without coughing and difficulty in breathing    
Frequent infections with fever and sore throat (due to decreased number of white blood cells)    
Liver disorders Jaundice Severe abdominal pain with constipation, Severe loss of appetite    
Inability to coordinate movement, loss of balance Difficulty in speaking    
Difficulty in passing urine (signs of urinary retention)    
Eye pain    
Sudden contraction of the muscles, muscle stiffness, muscle spasms    
Fast or irregular heart beat (racing, pounding)    

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


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