[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: [Web], [Web] and [Web].
Take this medicine by mouth in the morning. Follow the directions on the prescription label. Do not push the tablet through the foil backing. Peel back the foil with dry hands, gently remove the tablet, and immediately place the tablet on your tongue. It will dissolve in seconds. Do not swallow it. Wait about 5 minutes after taking your medicine before ingesting any food or liquid. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. It can take up to 4 weeks to see the full effects of this medicine. Do not suddenly stop taking your medicine. This may make your condition worse or give you withdrawal symptoms. Ask your doctor or health care professional for advice about gradually reducing your dosage. Even after you stop taking this medicine the effects can last for at least two weeks.
Patients and their families should watch out for depression or thoughts of suicide that get worse. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of antidepressant treatment or after a change in dose, call your health care professional.
If your doctor or health care professional increases the dose of this medicine to more than 10 mg a day, ask him/her about possible interactions with foods that contain tyramine. At higher doses, this medicine may interact with these foods to produce severe headaches, a rise in blood pressure, or irregular heart beat.
You may get drowsy, dizzy or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may increase dizziness or drowsiness. Do not drink alcoholic beverages while taking this medicine.
This medicine can make your mouth dry. Chewing sugarless gum, sucking hard candy and drinking plenty of water will help.
Do not treat yourself for coughs, colds, flu or allergies without asking your doctor or health care professional for advice. Do not take any medications for weight loss without advice either. Some ingredients in these products may increase possible side effects.
If you are diabetic there is a possibility that this medicine may affect your blood sugar. Ask your doctor or health care professional for advice if there is any change in your blood or urine sugar tests.
There have been reports of increased sexual urges or other strong urges such as gambling while taking some medicines for Parkinson's disease. If you experience any of these urges while taking this medicine, you should report it to your health care provider as soon as possible.
You should check your skin often for changes to moles and new growths while taking this medicine. Call your doctor if you notice any of these changes.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
agitation, excitability, restlessness, or nervousness
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
constipation or diarrhea
difficulty sleeping
increased appetite or weight increase
increased sensitivity to sunlight
muscle aches or pains, trembling
nausea or vomiting
sexual dysfunction
swelling of the feet or legs
tiredness or weakness
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Use within 3 months of opening the pouch and immediately after opening individual blister. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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