In the U.S.—

• Cholinergic enhancer:
• For treatment of dry mouth symptoms associated with Sjogren's syndrome.

Cevimeline (se-VIM-e-leen ) is used to treat the symptoms of dry mouth often experienced by patients with Sjogren's syndrome. It works by causing certain mouth glands to produce more saliva.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Capsules (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cevimeline, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to cevimeline. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Cevimeline has not been studied in women who are pregnant. However, in animal studies, cevimeline caused a reduction in the number of pregnancies. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether cevimeline passes into human breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of cevimeline in children with use in other age groups.

Older adults—Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of cevimeline in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking cevimeline, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Beta-adrenergic blocking agents (acebutolol, [e.g. Sectral], atenolol [e.g. Tenormin], betaxolol [e.g. Kerlone], carteolol [e.g. Cartrol], labetolol [e.g. Normodyne], metoprolol [e.g. Lopressor], nadolol [e.g. Corgard], oxprenolol [e.g. Trasicor], penbutolol [e.g. Levatol], pindolol [e.g. Visken], propranolol [e.g.Inderal], sotalol [e.g. Sotacor], timolol [e.g. Blocadren])—Disturbances in heart rhythms may occur if these medicines are taken with cevimeline.
• Anticholinergics (medicine for abdominal or stomach spasms or cramps)—Cevimeline may interfere with the effects of these medicines.
• Cholinergics (bethanechol [e.g.Duvoid], donepezil [e.g. Tacrine], physostigmine [e.g. Antilirium], pilocarpine [e.g. Pilocar], pyridostigmine [e.g. Mestinon]—These medicines can add to the effects of cevimeline.

. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.”

• Asthma, uncontrolled, or
• Cholelithiasis (gallstones), or
• Heart disease, or
• Nephrolithiasis (kidney stones), or
• Eye conditions in which contraction of the pupils is undesirable (e.g., acute iritis and narrow-angle glaucoma), or
• Pulmonary disease other than asthma

Dosing—

The dose of cevimeline will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of cevimeline. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking cevimeline

• For oral dosage form (capsules):
  • For the treatment of dry mouth in patients with Sjogren's syndrome:
    • Adults—30 milligrams three times a day
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for signs of your receiving too much medicine.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. This medicine may also cause a change in vision that could cause you to see less well at night. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are unable to see well, or if you are dizzy or are not alert.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Less common
  • Difficulty breathing;  fast heartbeat ;  itching 
  
  

• Rare
  • Chest pain;  fainting or light-headedness when getting up from a lying or a sitting position;  swelling of gums or tongue 
  
  

• Symptoms of Overdose

  Get emergency help immediately if any of the following symptoms of overdose occur:

  • Blurring or loss of vision;  chest pain ;  cold, clammy skin;  diarrhea, continuous and severe;  disturbed color vision;  dizziness, faintness, or light-headedness when getting up from a lying or sitting position;  difficult or labored breathing;  fast, pounding, slow, or irregular heartbeat ;  fast, weak pulse;  headache ;  mental confusion;  nausea ;  pounding in ears;  shaking or trembling of hands or feet;  shortness of breath ;  stomach cramps or pain;  sweating;  tearing of the eyes 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Bloody or cloudy urine;  blurred vision ;  chest pain;  cough;  cracks in skin;  difficult, burning , or painful urination;  dizziness;  dry or itching eyes;  earache;  feeling of constant movement of self or surroundings;  itching of vagina, genital, or other skin area;  lower back pain;  redness or pain in eye;  ringing or buzzing in the ears;  scaling of skin;  shortness of breath;  skin rash;  soreness or redness of skin;  sores, ulcers, or white spots on tongue, lips, or inside of mouth ;  stiffness of muscles;  swelling of hands, ankles, feet, or lower legs;  swelling on side of face and jaw, with or without pain;  tense muscles 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Excessive sweating;  nausea;  runny or stuffy nose 
  
  

• Less common
  • Abdominal pain;  belching;  bloating or swelling of face, hands, feet, or lower legs;  bloody nose;  bone or joint pain;  burning, dry, or itching feeling in eye;  change in vision;  chills;  constipation;  cough, mucus-producing;  decreased touch sensation;  depression ;  diarrhea;  dry mouth;  eye pain;  feelings of warmth in face, neck, arms, and occasionally, chest;  fever;  heartburn;  hiccups;  injury;  itching;  leg cramps ;  loss of appetite;  migraine headache;  mood or mental changes;  muscle aches, pain, or stiffness;  pain and swelling of eye, eyelid, or inner lining of eye;  pain on side of face and jaw;  pain, swelling, or redness of joints ;  postoperative pain;  rapid weight gain;  shortness of breath;  skin disorder;  tightness in chest;  tooth disorders or pain;  trembling or shaking of hands or feet;  trouble in sleeping;  unusual bleeding or bruising;  unusual tiredness or weakness;  vomiting;  watering of mouth;  weight loss 
  
  

• Rare
  • Abnormal crying;  deep, dark, purple bruise;  swelling or puffiness of face;  temperature sensation changes 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.