Paroxetine, Oral (for Menopause)

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KEY POINTS

• This medicine is taken by mouth to treat hot flashes caused by menopause. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take this medicine with certain other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: selective serotonin reuptake inhibitor (SSRI)

Generic and brand names: paroxetine, oral; Brisdelle

What is this medicine used for?

This medicine is taken by mouth to treat hot flashes caused by menopause (when monthly menstrual periods stop).

Brisdelle does not treat mental health problems such as anxiety or depression.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Bleeding problems
• Glaucoma
• Heart disease or a heart attack
• High blood pressure
• Liver or kidney disease
• Low levels of sodium in the blood
• Mental health problems such as depression or bipolar disorder
• Seizures
• Thoughts of suicide

Do not take this medicine if you have taken an MAO inhibitor medicine in the last 2 weeks. Taking an MAO inhibitor medicine within 14 days of taking this medicine may cause serious side effects. Do not take pimozide (Orap), thioridazine, or linezolid (Zyvox) while taking this medicine. Tell your healthcare provider about ALL of the medicines you take.

Females of childbearing age: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or take it longer than prescribed. Taking too much can increase the risk of side effects. Do not stop taking this medicine without your healthcare provider's approval. You may need to reduce your dosage slowly to avoid withdrawal symptoms.

Do not use this medicine in children under age 18.

You may take this medicine with or without food. Take it at bedtime each day.

What if I miss a dose?

Do not miss a dose. If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, tremors, drowsiness, dizziness, sweating, decreased urination, blurred vision, fast or irregular heartbeat, confusion, fainting, aggression, seizures, coma.

What should I watch out for?

This medicine affects the brain the same way as some antidepressants. Antidepressant medicines may increase suicidal thoughts or actions within the first few months of treatment or at times of dose changes. Call your healthcare provider right away if you or your family notice:

• Changes in thoughts, mood, or behavior such as becoming irritable or anxious
• New or worsening depression or thoughts of suicide
• More outgoing or aggressive behavior than normal

This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as antidepressants, migraine medicines, pain medicines, some cough medicines, and St. John’s wort. Make sure that your providers know ALL of the medicines that you take. Contact your healthcare provider right away if you have:

• Restlessness
• Hallucinations
• Loss of coordination, tremors, or muscle twitching
• Stiff muscles
• Fast heart beat
• Rapid changes in blood pressure or dizziness
• Increased body temperature, sweating, or flushing
• Nausea
• Vomiting
• Diarrhea

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

This medicine may increase your risk for broken bones. Talk with your healthcare provider about this.

This medicine may increase the effects of alcohol and interact with many other medicines. Do not drink alcohol or take any other medicine, including nonprescription products or natural remedies, unless your healthcare provider approves.

Contact your healthcare provider if your hot flashes do not improve or if they get worse.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Seizures; thoughts of suicide; new or worsening depression; unusual changes in thoughts, mood, or behavior; trouble breathing; high fever, severe sweating or flushing, hallucinations, slurred speech, loss of coordination or unsteadiness; stiff muscles; confusion, severe dizziness or fainting, severe headache; chest pain; irregular or fast heartbeat; joint or muscle pain; unusual bruising or bleeding; unusual tiredness or weakness; black or tarry bowel movements; blistering, peeling, or severe skin rash; memory problems or trouble concentrating; severe nausea, vomiting, or diarrhea; vision problems; unexplained bone pain, swelling, or tenderness.

Other: Headache, mild nausea, dry mouth, constipation, diarrhea, decreased appetite, drowsiness, mild dizziness, shaking, sweating, change in sexual desire or ability, abnormal dreams, trouble sleeping, runny nose, sore throat, irregular menstrual periods, ringing in the ears, weight loss or gain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Alfuzosin (Uroxatral)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), moxifloxacin (Avelox), ofloxacin, pentamidine (NebuPent, Pentam), tedizolid (Sivextro), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), and vortioxetine (Trintellix)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), perphenazine, pimavanserin (Nuplazid), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and valproic acid (Depacon, Depakene, Depakote)
• Aspirin and other salicylates
• Atomoxetine (Strattera)
• Beta blockers such as carvedilol (Coreg) and metoprolol (Lopressor, Toprol)
• Bromocriptine (Cycloset, Parlodel)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cabergoline
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), nilotinib (Tasigna), procarbazine (Matulane), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cimetidine (Tagamet)
• Cinacalcet (Sensipar)
• Dextromethorphan, an ingredient in many allergy, cold, or cough medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), and tolbutamide
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), disopyramide (Norpace), dronedarone (Multaq), flecainide, mexiletine, procainamide, propafenone (Rythmol), and quinidine
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Lithium (Lithobid)
• Lorcaserin (Belviq)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), prasugrel (Effient), rivaroxaban (Xarelto), and warfarin (Coumadin)
• Metoclopramide (Metozolv, Reglan)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), ergotamine (Ergomar), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as alfalfa, anise, bilberry, cat’s claw, garlic, ginger, ginkgo biloba, ginseng, glucosamine, gotu kola, kava, SAMe, Syrian Rue, St. John's wort, tryptophan, turmeric, and valerian
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), prochlorperazine (Compro), promethazine, and ondansetron (Zofran)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Paxil, Pexeva)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rasagiline (Azilect)
• Sleeping pills such as butabarbital (Butisol), ramelteon (Rozerem), suvorexant (Belsomra), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants and diet pills such as dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), and methylphenidate (Concerta, Daytrana, Metadate, Ritalin)
• Tamoxifen
• Terbinafine (Lamisil)
• Tetrabenazine (Xenazine)
• Theophylline

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.