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Cevimeline is used for:

Treating dry mouth in patients with Sjogren disease. It may also be used for other conditions as determined by your doctor.

Cevimeline is a cholinergic agent. It works by increasing the production of saliva.

Do NOT use Cevimeline if:

• you are allergic to any ingredient in Cevimeline
• you have uncontrolled asthma or certain eye problems (eg, inflammation of the iris, narrow-angle glaucoma)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cevimeline :

Some medical conditions may interact with Cevimeline . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have heart problems (eg, angina, heart attack), asthma, enzyme problems, lung problems (chronic bronchitis, chronic obstructive pulmonary disease [COPD]), gallstones, kidney stones, or kidney problems

Some MEDICINES MAY INTERACT with Cevimeline . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol) because risk of side effects such as heart problems may be increased
• Parasympathomimetics (eg, pilocarpine) because the risk of their side effects may be increased
• Anticholinergics (eg, ipratropium) because their effectiveness may be decreased by Cevimeline

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cevimeline may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cevimeline :

Use Cevimeline as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Cevimeline by mouth with or without food.
• Drinking extra fluids while you are taking Cevimeline is recommended. Check with your doctor for instructions.
• If you miss a dose of Cevimeline , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cevimeline .

Important safety information:

• Cevimeline may cause blurred vision, especially at night. This effect may be worse if you take it with alcohol or certain medicines. Use Cevimeline with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Use Cevimeline with caution in the ELDERLY; they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cevimeline while you are pregnant. It is not known if Cevimeline is found in breast milk. Do not breast-feed while taking Cevimeline .

Possible side effects of Cevimeline :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; coughing; hot flashes; joint pain; nausea; stuffy nose; sweating; tiredness; trouble sleeping.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal pain; breathing problems; chest pain; confusion; diarrhea; excessive saliva; excessive sweating; excessive tears; fast, slow, or irregular heartbeat; fever, chills, or sore throat; headache; increased or painful urination; severe nausea or vomiting; severe or persistent stomach pain; tremors; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Cevimeline at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cevimeline out of the reach of children and away from pets.

General information:

• If you have any questions about Cevimeline , please talk with your doctor, pharmacist, or other health care provider.
• Cevimeline is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Cevimeline . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.