Cevimeline Hydrochloride, Oral

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KEY POINTS

• This medicine is taken by mouth to relieve the symptoms of dry mouth in people with Sjögren’s syndrome. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause vision problems, affect your gallbladder, or make breathing problems worse. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• 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: cholinergic agonist (treats dry mouth)

Generic and brand names: cevimeline hydrochloride, oral; Evoxac

What is this medicine used for?

This medicine is taken by mouth to relieve the symptoms of dry mouth in people with Sjögren’s syndrome.

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 allergy to any medicine
• Acute iritis (eye inflammation)
• Asthma, COPD, or other breathing problems
• Chest pain, an irregular heartbeat, or a heart attack
• Gallbladder disease
• Glaucoma or iritis (inflammation of the colored part of the eye)
• Kidney stones

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

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 or for a longer period than directed by your healthcare provider.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. You may need to drink extra water. Talk to your healthcare provider about this.

What if I 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: headache, blurred vision, watery eyes, confusion, sweating, tremors shaking, nausea, vomiting, diarrhea, stomach pain, trouble breathing, fast, slow, or irregular heartbeat.

What should I watch out for?

This medicine may make lung disease and breathing problems worse. Talk to your healthcare provider about this.

This medicine may affect your gallbladder. The main symptoms are a steady sharp or dull pain on the right side of your belly that may spread to your back around your shoulder blade. Talk to your healthcare provider about this.

This medicine may cause vision problems. Do not drive or perform other hazardous tasks if your vision is not clear. Be especially careful at night. Talk to your healthcare provider about this.

This medicine may cause you to sweat too much and lose too much fluid from your body. Be careful when exercising, especially in hot weather.

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.): Vision problems; heavy sweating or eye watering; trouble breathing; slow, fast, or irregular heartbeat; chest pain; severe dizziness or fainting; sudden confusion; severe headache; shaking; sharp or dull pain on the right side of your belly that may spread to your back around your shoulder blade; yellowing of skin or eyes; severe nausea or vomiting; light colored bowel movements; trouble urinating; pain when urinating.

Other: Sinus infection, runny nose, cough, stomach pain, nausea, vomiting, diarrhea, mild dizziness, muscle pain, tiredness, rash, heaving drooling, hot flashes.

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:

• Abiraterone (Zytiga)
• Alzheimer’s disease medicines such as donepezil (Aricept), galantamine (Razadyne), and rivastigmine (Exelon)
• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, and telithromycin (Ketek)
• Anticholinergic medicines such as aclidinium (Tudorza), glycopyrrolate (Cuvposa, Robinul), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), and propantheline
• Antidepressants such as clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac), imipramine (Tofranil), and sertraline (Zoloft)
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Monistat, Oravig), posaconazole (Noxafil), terbinafine (Lamisil), and voriconazole (Vfend)
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), and thioridazine
• Aprepitant (Emend)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), betaxolol, bisoprolol (Zebeta), carteolol, esmolol (Brevibloc), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, sotalol (Betapace, Sorine), and timolol
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cimetidine (Tagamet)
• Cinacalcet (Sensipar)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Imatinib (Gleevec)
• Methadone (Dolophine, Methadose)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

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 it 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.