It is very important that your doctor check your progress at regular visits to allow dosage adjustments and to help reduce side effects.

AMITRIPTYLINE will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking AMITRIPTYLINE .

Antidepressants may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

AMITRIPTYLINE may cause some people to become drowsy. If this occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

AMITRIPTYLINE may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Tricyclic antidepressants may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking AMITRIPTYLINE:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking AMITRIPTYLINE. The results of the metyrapone test may be affected by AMITRIPTYLINE.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using AMITRIPTYLINE. Taking tricyclic antidepressants together with medicines used during surgery or dental or emergency treatments may increase the risk of side effects.

For diabetic patients:

• AMITRIPTYLINE may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Do not stop taking AMITRIPTYLINE without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are using before stopping completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as headache, nausea, and/or an overall feeling of discomfort.

The effects of AMITRIPTYLINE may last for 3 to 7 days after you have stopped taking it. Therefore, all the precautions stated here must be observed during this time.

For patients taking protriptyline:

• If taken late in the day, protriptyline may interfere with nighttime sleep.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking AMITRIPTYLINE and get emergency help immediately if any of the following side effects occur:

• Reported for amoxapine only--rare
  • Convulsions (seizures);  difficult or fast breathing;  fever with increased sweating;  high or low (irregular) blood pressure;  loss of bladder control;  muscle stiffness (severe);  pale skin;  unusual tiredness or weakness  
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Blurred vision;  confusion or delirium ;  constipation (especially in the elderly);  decreased sexual ability (more common with amoxapine and clomipramine) ;  difficulty in speaking or swallowing;  eye pain;  fainting;  fast or irregular heartbeat (pounding, racing, skipping);  hallucinations;  loss of balance control;  mask-like face;  nervousness or restlessness ;  problems in urinating;  shakiness or trembling;  shuffling walk;  slowed movements;  stiffness of arms and legs 
  
  

• Reported for amoxapine only (in addition to the above)--less common
  • Lip smacking or puckering;  puffing of cheeks;  rapid or worm-like movements of tongue;  uncontrolled chewing movements;  uncontrolled movements of hands, arms, or legs 
  
  

• Rare
  • Anxiety;  breast enlargement in both males and females;  hair loss;  inappropriate secretion of milk—in females;  increased sensitivity to sunlight;  irritability;  muscle twitching;  red or brownish spots on skin;  ringing, buzzing, or other unexplained sounds in the ears;  seizures (more common with clomipramine) ;  skin rash and itching;  sore throat and fever;  swelling of face and tongue ;  swelling of testicles (more common with amoxapine) ;  trouble with teeth or gums (more common with clomipramine) ;  weakness;  yellow eyes or skin 
  
  

• Symptoms of acute overdose
  • Confusion;  convulsions (seizures);  disturbed concentration;  drowsiness (severe);  enlarged pupils;  fast, slow, or irregular heartbeat;  fever;  hallucinations (seeing, hearing, or feeling things that are not there);  restlessness and agitation;  shortness of breath or troubled breathing;  unusual tiredness or weakness (severe);  vomiting  
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Dizziness;  drowsiness;  dryness of mouth;  headache;  increased appetite (may include craving for sweets);  nausea;  tiredness or weakness (mild) ;  unpleasant taste;  weight gain 
  
  

• Less common
  • Diarrhea;  heartburn;  increased sweating;  trouble in sleeping (more common with protriptyline, especially when taken late in the day);  vomiting 
  
  

Certain side effects of AMITRIPTYLINE may occur after you have stopped taking it. Check with your doctor if you notice any of the following effects:

• Headache;  irritability;  nausea, vomiting, or diarrhea;  restlessness;  trouble in sleeping, with vivid dreams;  unusual excitement 

• Reported for amoxapine only (in addition to the above)
  • Lip smacking or puckering;  puffing of cheeks;  rapid or worm-like movements of the tongue ;  uncontrolled chewing movements;  uncontrolled movements of arms or legs 
  
  

Other side effects not listed above also may occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, tricyclic antidepressants are used in certain patients with the following medical conditions:

• Attention deficit hyperactivity disorder (hyperactivity in children) (desipramine, imipramine, and protriptyline)
• Bulimia (uncontrolled eating, followed by vomiting) (amitriptyline, clomipramine, desipramine, and imipramine)
• Cocaine withdrawal (desipramine and imipramine)
• Headache prevention (for certain types of frequent or continuing headaches) (most tricyclic antidepressants)
• Itching with hives due to cold temperature exposure (doxepin)
• Narcolepsy (extreme tendency to fall asleep suddenly) (clomipramine, desipramine, imipramine, and protriptyline)
• Neurogenic pain (a type of continuing pain) (amitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, and trimipramine)
• Nicotine dependence (as an aid to other smoking cessationn therapy) (nortriptyline)
• Panic disorder (clomipramine, desipramine, doxepin, nortriptyline, and trimipramine)
• Stomach ulcer (amitriptyline, doxepin, and trimipramine)
• Urinary incontinence (imipramine)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.