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PAROXETINE-ORAL (cont.)

PRECAUTIONS: Before taking paroxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, seizures, heart problems, stomach ulcers, glaucoma (narrow angle type), other mental/mood disorders (e.g., bipolar disorder), thyroid problems. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages. Though uncommon, depression can lead to thoughts or attempts of suicide. Tell your doctor immediately if you have any suicidal thoughts, worsening depression, or any other mental/mood changes (including new or worsening anxiety, agitation, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, rapid speech). Keep all medical appointments so your healthcare professional can monitor your progress closely and adjust/change your medication if needed. Caution is advised when using this product in the elderly because they may be more sensitive to its effects. The elderly are more likely to develop a type of electrolyte imbalance (hyponatremia), especially if they are also taking "water pills" or diuretics with this medication. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. If this medication is used during the last 3 months of pregnancy, infrequently your newborn may develop symptoms including feeding or breathing difficulties, seizures, muscle stiffness, jitteriness, or constant crying. However, do not stop taking this medication unless your doctor directs you to do so. Report any such symptoms to your doctor promptly. This drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Certain medications taken with this product could result in serious, even fatal, drug interactions. Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) within 2 weeks before or after treatment with this medication. Consult your doctor or pharmacist for additional information. This drug should not be used with the following medications because very serious (possibly fatal) interactions may occur: astemizole, terfenadine, thioridazine, weight loss drugs (e.g., sibutramine, phentermine). Ask your doctor or pharmacist for more details. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antiarrhythmics (e.g., propafenone, flecainide), cimetidine, clozapine, digoxin, herbal/natural products (e.g., melatonin, ayahuasca, St John's wort), lithium, nefazodone, procyclidine, other drugs which can cause bleeding/bruising (e.g., thrombolytic drugs such as TPA, anticoagulants such as heparin or warfarin, antiplatelet drugs including NSAIDs such as ibuprofen), other SSRI antidepressants (e.g., citalopram, fluoxetine), theophylline, tramadol, trazodone, tricyclic antidepressants (e.g., amitriptyline, nortriptyline), "triptan" migraine drugs (e.g., sumatriptan, zolmitriptan), tryptophan, venlafaxine. Low-dose aspirin (usually 81-325 mg per day) for heart attack or stroke prevention should be continued unless your doctor instructs you otherwise. Aspirin is similar to NSAID drugs, and can increase the risk of bleeding in combination with this medication (see above). Discuss the risks and benefits with your doctor. Tell your doctor if you take any drugs that cause drowsiness such as: anti-anxiety drugs (e.g., diazepam), certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep, muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine), sedatives, tranquilizers. Other drugs besides paroxetine which may affect the heart rhythm (QTc prolongation in the EKG) include dofetilide, pimozide, quinidine, sotalol, procainamide, and sparfloxacin among others. QTc prolongation can infrequently result in serious (rarely fatal) irregular heartbeats. Consult your doctor or pharmacist for details. Ask for instructions about whether you need to stop any other QTc-prolonging drugs you may be using in order to minimize the risk of this effect. Do not start or stop any medicine without doctor or pharmacist approval.




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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