Cevimeline

WHY is this medicine prescribed?

Cevimeline is used to treat the symptoms of dry mouth in patients with Sjogren's syndrome (a condition that affects the immune system and causes dryness of certain parts of the body such as the eyes and mouth). Cevimeline is in a class of medications called cholinergic agonists. It works by increasing the amount of saliva in the mouth.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Cevimeline comes as a capsule to take by mouth. It is usually taken 3 times a day. Take cevimeline at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cevimeline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking cevimeline,

• tell your doctor and pharmacist if you are allergic to cevimeline, or any other medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amiodarone (Pacerone, Cordarone); antifungal medications such as ketoconazole (Nizoral) and itraconazole (Sporanox); beta blockers such as acebutolol (Sectral), atenolol (Tenormin), betaxolol (Kerlone), bisoprolol (Zebeta, in Ziac), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), pindolol, propranolol (Inderal), sotalol (Betapace), and timolol (Blocadren); bethanechol (Urecholine); bupropion (Wellbutrin, Wellbutrin XL, Wellbutrin SR, Zyban); calcium channel blockers such as diltiazem (Cardizem, Dilacor, Tiazac, others) and verapamil (Calan, Covera, Isoptin, Verelan); chlorpheniramine (Chlor-Trimeton, Aller-Chlor, Teldrin Allergy, others); cimetidine (Tagamet); clarithromycin (Biaxin); clomipramine (Anafranil); duloxetine (Cymbalta); erythromycin (E.E.S., Erythrocin, E-Mycin); fluoxetine (Prozac, Sarafem); fluvoxamine; haloperidol (Haldol); ipratropium (Atrovent); certain medications for HIV such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir); medications for Alzheimer's disease, glaucoma, irritable bowel syndrome, motion sickness, Myastenia Gravis, Parkinson's disease, ulcers, or urinary problems; methadone (Dolophine); nefazodone; paroxetine (Paxil, Paxil CR, Pexeva); quinidine; and troleandomycin. Many other medications may also interact with cevimeline, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• tell your doctor if you have asthma, acute iritis (uveitis; swelling and irritation inside the eye), or glaucoma (an eye disease). Your doctor may tell you not to take cevimeline.

• tell your doctor if you have or have ever had chest pain or a heart attack, chronic bronchitis, chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema), kidney stones, gallstones or heart disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking cevimeline, call your doctor.

• you should know cevimeline may cause changes in vision, especially at night or when there is not enough light. Use caution when driving at night or performing hazardous activities in reduced lighting.

• you should know that cevimeline may cause you to sweat a great deal, which can cause dehydration. Be sure to drink plenty of water and talk to your doctor about ways to prevent dehydration while taking this medication.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Cevimeline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• sweating
• nausea
• runny nose

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• severe headache
• changes in vision
• tearing in eyes
• excessive sweating
• difficulty breathing
• abdominal cramping
• changes in heartbeat
• changes in blood pressure
• confusion
• shaking hands that you cannot control

Cevimeline may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.