IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
CEVIMELINE – ORAL
COMMON BRAND NAME(S): Evoxac
USES: This medication is used to treat symptoms of dry mouth due to a certain immune disease (Sjogren’s syndrome). Cevimeline belongs to a class of drugs known as cholinergic agonists. It works by stimulating certain nerves to increase the amount of saliva you produce, making it easier and more comfortable to speak and swallow.
HOW TO USE: Take this medication by mouth with or without food, usually 3 times daily or as directed by your doctor.
Dosage is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
You may continue to drink water or use saliva substitutes as needed for moisture in your mouth.
You may start to feel some benefit in 1 to 2 weeks. However, it may take up to 6 weeks to feel the full benefit. Tell your doctor if your condition persists or worsens.
SIDE EFFECTS: See also Precautions.
Sweating, nausea, runny nose, flushing, frequent urge to urinate, dizziness, weakness, diarrhea, and blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
This medication may cause an increase in tears. This can be helpful if you have dry eyes. Tell your doctor if runny eyes become a problem.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: slow/fast/irregular heartbeat, shakiness (tremor), fainting, lung problems (such as increased wheezing/cough/phlegm), mental/mood changes (such as confusion, agitation), severe stomach/abdominal pain.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US –
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking cevimeline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, chronic bronchitis, chronic obstructive pulmonary disease-COPD), certain eye conditions (such as night blindness, acute iritis, narrow-angle glaucoma), heart disease (such as chest pain, heart failure, heart attack, slow heartbeat), low or high blood pressure, liver problems, gallbladder disease (such as gallstones), kidney stones, mental/mood disorders (such as depression, psychoses, thinking/understanding problems like dementia, Alzheimer’s), stomach problems (such as chronic heartburn, ulcer).
Cevimeline may make you dizzy and cause vision problems, especially at night. Do not drive, use machinery, or do any activity that requires alertness or clear vision, especially at night, until you are sure you can perform such activities safely. Limit alcoholic beverages.
If cevimeline makes you sweat heavily, drink plenty of fluids so that you do not become dehydrated. If you are unable to drink enough fluids, talk with your doctor right away.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.
DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor’s approval.
Some products that may interact with this drug include: beta blockers (such as metoprolol, atenolol).
Other medications can affect the removal of cevimeline from your body, which may affect how cevimeline works. Examples include cimetidine, amiodarone, ritonavir, fluoxetine, and verapamil.
Cevimeline may cause drugs with “drying” effects (some antihistamines, anticholinergics such as certain drugs for asthma, over-active bladder, and Parkinson’s) to work less well. Examples of affected drugs include chlorpheniramine, diphenhydramine, atropine, belladonna alkaloids, benztropine, ipratropium, and tolterodine. These medications can also worsen dry mouth, causing cevimeline to work less well. Consult your doctor or pharmacist for more information.
Check the labels on all your medicines (such as cough-and-cold products) because they may contain ingredients that could have a drying effect. Ask your pharmacist for more details.
This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: extreme sweating, shakiness, slowed/irregular heartbeat, severe breathing problems, confusion, fainting, stomach/abdominal cramping.
NOTES: Do not share this medication with others.
Keep all regular medical and laboratory appointments so that your doctor can monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.