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CYMBALTA DRUG INFORMATION, ABOUT CYMBALTA

WHAT IS CYMBALTA?

Cymbalta antidepressant belongs to a group of drugs known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). These drugs are thought to work by increasing the activity of the chemicals serotonin and norepinephrine in the brain.

Cymbalta is available only with a doctor's prescription, in the following forms:

• Oral Delayed-release capsules ( U.S.A.)

USES

Cymbalta is used to treat mental depression. It is also used in the treatment of pain caused by nerve damage associated with diabetes.

PRECAUTIONS

Children: Cymbalta must be used with caution in children with depression. Studies have shown occurrences of children either thinking about suicide or attempting suicide in clinical trials for Cymbalta . More study is needed before duloxetine can be determined safe and effective in children.

Older Adults: Clinical test have not shown that Cymbalta causes different side effects or problems in older people than it does in younger adults. However, older patients are more likely to be sensitive to the effects of duloxetine than younger adults.

Allergies: Tell your physician if you have ever had any unusual or allergic reaction to duloxetine. Also tell your physician and pharmacist if you are allergic to any substances, such as foods, dyes or preservatives.

Other Medical Conditions: Inform your doctor about any other medical conditions you have, especially the following ones. The use of Cymbalta may cause the condition to worsen or cause side effects.

• Bipolar Disorder (a mood disorder with alternating manic and depressive episodes). Cymbalta may make the condition worse.
  
  
• Diabetes Mellitus (sugar diabetes) Cymbalta may increase your blood sugar.
  
  
• Severe Kidney Disease or Liver Disease. Cymbalta may occur at a higher level in the blood, which can increase the chance of side effects.
  
  
• A history of Mania. This condition may be activated.
  
  
• Narrow-angle Glaucoma. Cymbalta may increase your chance of developing blurred vision.
  
  
• A history of Seizures. The risk of seizures may be increased.

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

Do not suddenly stop taking your Cymbalta . If you have been instructed to stop taking it, ask you doctor how to slowly decrease the dose. This is to lower the chance of having discontinuation side effects such as

• dizziness
• nausea
• vomiting
• nightmares
• headache
• irritability
• prickling or tingling feelings.

CYMBALTA and PREGNANCY

Cymbalta has not been studied in pregnant women. Use Duloxetine during pregnancy only if the potential benefit outweighs the potential risk to the baby.

Before taking Cymbalta , be sure your doctor knows if you are pregnant (especially if it is the third trimester) or if you may become pregnant.

CYMBALTA and BREAST FEEDING

Test have shown that Cymbalta passes into the milk of rats. However, it is not known if it passes into human milk. Therefore, because the effects of this medicine in nursing babies is unknown and because there are potentially serious risks, Cymbalta is not recommended if you are breast-feeding.

NOTES

It is important that your doctor check your progress regularly, to monitor your dosage and to help reduce any side effects.

Cymbalta has not been shown to add to the effects of alcohol. However, alcohol use is not recommended in patients who are taking this drug.

It may require four weeks of use before your symptoms improve.

It is important to continue Cymbalta even after symptoms of depression are relieved.

Cymbalta may cause drowsiness or blurred vision. Make sure you know how you are reacting to this medicine before you drive, use machines or do anything else that could be dangerous if you are not alert or able to see clearly.

CYMBALTA DRUG INTERACTIONS

When taking Cymbalta , it is especially important that your doctor and pharmacist know if you are taking any of the following medications:

• Antidepressants - fluoxetine (e.g., Prozac), paroxetine (e.g., Paxil). Taken with Cymbalta may increase your chance for side effects.


• Antiarrhythmics - flecainide (e.g., Tambocor), propafenone (e.g., Rythmol), Quinidine (e.g., Quinaglute, Quinidex). Taken with Cymbalta may increase your chance for serious side effects.


• Monoamine Oxidase (MAO) Inhibitor activity - isocarboxazid (e.g., Marplan), phenelzine (e.g., Nardil), procarbazine (e.g., Matulane), selegiline (e.g., Eldepryl), tranylcypromine (e.g., Parnate).
  • Do not take Cymbalta while you are taking an MAO inhibitor or within 2 weeks of taking an MAO inhibitor. Allow at least 14 days between stopping one medicine (duloxetine or the MAO inhibitor) and starting the other one. Otherwise, you may develop serious side effects such as:
  • sudden high body temperature
  • extremely high blood pressure
  • severe convulsions
  • serotonin syndrome
  • agitation
  • confusion
  • restlessness
  • stomach or intestinal symptoms

• Phenothiazines (e.g., Phenergan, Compazine, Thorazine). Taking phenothiazines together with Cymbalta may increase your risk of side effects.


• Tricyclic Antidepressants - amitriptyline (e.g., Elavil), desipramine (e.g., Norpramin), imipramine (e.g., Tofranil), nortriptyline (e.g., Aventyl). Taking certain tricyclic antidepressants together with Cymbalta may increase the risk of side effects.


• Thioridazine (e.g., Mellaril). Taking thioridazine with Cymbalta may cause serious heart problems.

PROPER USE OF CYMBALTA

Take Cymbalta only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer period than your doctor ordered.

The capsule should be swallowed whole. Do not chew, crush or sprinkle its contents on food or mix with it liquids before swallowing.

CYMBALTA DOSAGE

Different patients will need different doses of Cymbalta . Follow your physician's orders or the directions on the label. The following information includes only average doses. If your dose is different, do not change it unless your physician tells you to do so.

The number of capsules to be taken depends on the strength of the medicine.

Also, the reason you are taking Cymbalta determines how many doses you take per day, the time between each dose and the length of time you will take it.

• Oral dosage form:
  
  
• For treatment of depression:
  
  
• Adults - 40 mg a day (given as 20 mg, twice daily) to 60 mg a day (given either once a day or as 30 mg twice daily) with or without meals.
  
  
• Children - Use and dose must be determined by your physician.
  
  
• For treatment of pain which is associated with diabetic peripheral neuropathy:
  
  
• Adults - 60 mg a day with or without meals.
  
  
• Children - Dose must be determined by your physician.

CYMBALTA SIDE EFFECTS

Cymbalta medication side effects may occur that usually do not need medical attention. These side effects may go away as your body adjusts to the medication. However, check with your physician if any of the following side effects continue or become bothersome.

• More Common
  • cough
  • diarrhea
  • nausea
  • vomiting
  • muscle aches
  • difficulty having a bowel movement
  • dizziness
  • dry mouth
  • fever
  • frequent urination
  • headache
  • loss of strength
  • loss of appetite
  • sleepiness or drowsiness
  • sleeplessness
  • sore throat
  • runny or stuffy nose
  • increased sweating
  • difficulty sleeping
  • fatigue or weakness
  • weight loss


• Less common Cymbalta side affects
  • acidy or sour stomach
  • stomach discomfort upset or pain
  • belching
  • difficulty in moving
  • fear
  • feeling of warmth redness of the neck, face, arms and occasionally, upper chest
  • heartburn
  • indigestion
  • joint pain
  • swollen joints
  • loose stools
  • muscle aching or cramping
  • muscle pains or stiffness
  • nervousness
  • shakiness in legs, arms, hands, feet
  • sudden sweating
  • trembling or shaking of hands or feet
  • blurred vision
  • decreased interest in sexual intercourse
  • abnormal orgasm
  • change or problem with discharge of semen
  • inability to have or keep an erection
  • longer than usual time to ejaculation of semen
  • loss in sexual ability, drive, desire or performance


• If you notice any other side effects not listed above, check with your doctor.

MISSED DOSES

If you miss a dose of Cymbalta , take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not double doses.

STORAGE

Store away from heat and direct light. Keep out of the reach of children.

Heat or moisture may cause Cymbalta to break down. Do not store in the bathroom, near the kitchen sink or in any other damp place.

Do not keep outdated medicine or medicine which is no longer needed. Ask your doctor how you should dispose of any medicine you do not use. Be sure that any discarded drugs are out of the reach of children.

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