Cevimeline

Cevimeline helps to increase the production of saliva and sweat in the body.

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

Cevimeline may also be used for reasons not mentioned in this medication guide.

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.

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

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.

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.

Usual Adult Dose for Sjogren's Syndrome:

30 mg orally three times a dayComments:-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.

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

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.

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.