Cevimeline increases the secretions of the saliva and sweat glands in the body.

Cevimeline is used to treat dry mouth in people with Sjögren's Syndrome.

Cevimeline may also be used for purposes not listed in this medication guide.

You should not take cevimeline if you have uncontrolled asthma, glaucoma, or an eye condition called iritis or uveitis.

Follow all directions on your prescription label. Do not take cevimeline in larger or smaller amounts or for longer than recommended.

Drink plenty of liquids while you are taking cevimeline. This will help keep your kidneys working properly, and can also prevent dehydration.

Cevimeline is usually taken 3 times per day. Follow your doctor's dosing instructions.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Sjogren's Syndrome:

30 mg orally three times a day

Comments:
-There is insufficient safety information and insufficient evidence for additional efficacy to support doses greater than 30 mg three times a day.

Use: Treatment of symptoms of dry mouth in patients with Sjögren's Syndrome.

You should not take cevimeline if you are allergic to it, or if you have:

• untreated or uncontrolled asthma;

• narrow-angle glaucoma; or

• an eye condition called iritis or uveitis.

To make sure cevimeline is safe for you, tell your doctor if you have:

• asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD);

• heart disease, angina (chest pain), or a history of heart attack;

• a heart rhythm disorder;

• high blood pressure (hypertension);

• liver or kidney disease; or

• a history of kidney stones or gallstones.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether cevimeline passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Cevimeline is not approved for use by anyone younger than 18 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, vision problems, confusion, sweating, tremors, vomiting, diarrhea, feeling short of breath, and irregular heartbeats.

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

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

cevimeline may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Cevimeline can decrease sweating and you may be more prone to heat stroke.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cevimeline may cause serious side effects. Stop using cevimeline and call your doctor at once if you have:

• severe pain in your stomach, side, or lower back;

• vomiting;

• fast, slow, or uneven heart rate;

• painful or difficult urination;

• a light-headed feeling, like you might pass out; or

• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Common side effects of cevimeline may include:

• increased sweating;

• excessive salivation, drooling;

• nausea, diarrhea;

• dry mouth;

• headache; or

• stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• an antibiotic or antifungal medicine;

• an antidepressant;

• antiviral medicine to treat hepatitis C or HIV/AIDS; or

• heart or blood pressure medication.

This list is not complete. Other drugs may interact with cevimeline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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.