Description
Cevimeline is used to treat the symptoms of dry mouth often experienced by patients with Sjögren's syndrome. It works by causing certain glands in the mouth to produce more saliva.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of cevimeline in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cevimeline in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Acute iritis (swelling of the colored ring around your eye's pupil) or
- Asthma, uncontrolled, or
- Narrow-angle glaucoma—Should not be used in patients with these conditions.
- Angina (chest pain), history of or
- Heart attack, history of or
- Heart or blood vessel disease, history of—Use with caution. May cause side effects to become worse.
- Asthma, controlled or
- Bronchitis, chronic or
- Cholelithiasis (gallbladder stones), history of or
- Chronic obstructive pulmonary disease (COPD) or
- Eye problems or
- Nephrolithiasis (kidney stones), history of—Use with caution. May make these conditions worse.
Proper Use
Dosing
The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine 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 using the medicine.
- For oral dosage form (capsules):
- For dry mouth in patients with Sjögren's syndrome:
- Adults—30 milligrams 3 times a day.
- Children—Use and dose must be determined by your doctor.
- For dry mouth in patients with Sjögren's syndrome:
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
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
If your symptoms do not improve within a few days or if they become worse, check with your doctor.
This medicine may worsen the condition of patients with heart disease or heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain. You might also feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat.
Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.
This medicine may cause blurred or decreased vision, especially at night and in patients with eye problems. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine may cause kidney or gallbladder problems. Check with your doctor right away if you have severe nausea or vomiting, indigestion, stomach pain, itchy skin, light-colored stools, yellow eyes or skin, bloody or cloudy urine, or pain in the lower back or side.
Drink plenty of water, especially if you have excessive sweating, to prevent dehydration.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Check with your doctor or nurse immediately if any of the following side effects occur:
Check with your doctor immediately if any of the following side effects occur:
More common
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- chills
- cough
- difficult, burning, or painful urination
- difficulty in breathing
- dryness or soreness of the throat
- ear congestion
- frequent urge to urinate
- headache
- hoarseness
- loss of voice
- lower back or side pain
- runny or stuffy nose
- sneezing
- tender, swollen glands in the neck
- trouble in swallowing
- unusual tiredness or weakness
- voice changes
Less common
- Accumulation of pus
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision or other change in vision
- burning, dry, or itching eyes
- chest pain
- cough producing mucus
- diarrhea
- discharge, excessive tearing
- dizziness
- earache
- excessive muscle tone
- eye pain
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling unusually cold
- fever
- general feeling of discomfort or illness
- headache, severe and throbbing
- heartburn
- hives, skin rash
- joint pain
- loss of appetite
- muscle pain, stiffness, tension, or tightness
- nausea
- nosebleed
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- redness or swelling in the ear
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- sensitivity of the eye to light
- shivering
- sore throat
- swollen, red, tender area of the infection site
- tightness in the chest
- tingling of the hands or feet
- tremor
- trouble sleeping
- unusual bleeding or bruising
- unusual weight gain or loss
- vomiting
- weight loss
Rare
- Anxiety
- black, tarry stools
- bleeding after defecation
- bleeding gums
- blisters
- bloating
- blood in the urine or stools
- blood in vomit
- bloody nose
- blue or pale skin
- burning feeling in the chest or stomach
- burning feeling while urinating
- burning, numbness, pain, or tingling in all fingers, except the smallest finger
- burning, tingling, numbness or pain in the hands, arms, feet, or legs
- changes in skin color
- chest discomfort
- chest pain, possibly moving to the left arm, neck, or shoulder
- choking
- clumsiness or unsteadiness
- cold sweats
- collection of blood under the skin
- confusion
- constipation
- cool, pale skin
- coughing or spitting up blood
- cracked lips
- decreased urination
- deep, dark purple bruise
- depressed mood
- difficulty controlling your bladder or bowels
- difficulty walking
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- dry skin and hair
- dry, puffy skin
- extra heartbeat
- fainting
- feeling cold
- forgetfulness
- frequent urge to defecate
- fruit-like breath odor
- gaseous abdominal pain
- heart murmur
- heavier menstrual periods
- husky voice
- incoherent speech
- increase in heart rate
- increased hunger
- increased thirst
- increased volume of pale, dilute urine
- indigestion
- involuntary muscle contractions
- irregular heartbeat
- irritation or soreness of the mouth
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- joint stiffness or swelling
- lightheadedness
- loss of bladder control
- loss of consciousness
- lower back, side, or stomach pain
- metallic taste
- mood changes
- muscle cramps or weakness
- nerve pain
- nervousness
- nightmares
- noisy breathing
- numbness or tingling in the face, hands, feet, or lips
- pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
- pain or burning in the throat
- pain or discomfort in the arms, jaw, back, or neck pain, warmth, or burning in the fingers, toes, and legs
- painful blisters on the trunk of the body
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- pale, bluish-colored, or cold hands or feet
- pinpoint red spots on the skin
- pounding in the ears
- rapid, shallow breathing
- rectal bleeding
- recurrent fever
- redness and swelling of the gums
- redness, soreness, or itching skin
- redness, swelling, or soreness of the tongue
- seizures
- sensation of pins and needles
- severe constipation
- severe cramping
- severe or continuing stomach pain
- severe stomach pain
- severe vomiting
- shakiness
- slow heartbeat
- slurred speech
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- stabbing pain
- stomach bloating, burning, cramping, or pain
- stomach tenderness or discomfort
- stomach upset or fullness
- straining while passing stool
- sudden decrease in the amount of urine
- sunken eyes
- sweating
- swelling around the eyes
- swelling of the front part of the neck
- swelling or inflammation of the mouth
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- trouble in holding urine
- uncomfortable swelling around the anus
- unexplained weight loss
- voice changes
- vomiting of blood or material that looks like coffee grounds
- weak or absent pulses in the legs
- weight gain
- wrinkled skin
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of Overdose
- Blurred or loss of vision
- chest pain or discomfort
- cold, clammy skin
- confusion
- disturbed color perception
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- double vision
- fainting fast, pounding, or irregular heartbeat or pulse
- fast, weak pulse
- halos around lights
- nervousness
- night blindness
- overbright appearance of lights
- pounding in the ears
- pounding, slow heartbeat
- stomach cramps or pain
- tearing of the eyes
- tightness in the chest
- tremor
- troubled breathing
- tunnel vision
- unusual tiredness or weakness
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Back pain
- belching
- bloated, full feeling
- bone pain
- change in the color, amount, or odor of vaginal discharge
- difficulty in moving
- discouragement
- excess air or gas in stomach or bowels
- feeling of constant movement of self or surroundings
- feeling of warmth feeling sad or empty
- hiccup
- increased watering of the mouth
- irritability
- itching of the vagina or genital area
- leg cramps
- loss of interest or pleasure
- overactive reflexes, followed by underactive reflexes
- pain during sexual intercourse
- passing gas
- redness of the face, neck, arms, and occasionally, upper chest
- salivary gland enlargement or pain
- sensation of spinning
- thick, white vaginal discharge with no odor or with a mild odor
- tooth disorder
- toothache
- trouble concentrating
Rare
- Abnormal crying
- abnormal dreaming
- absence of menstruation
- acne
- agitation
- change in tongue color
- changes in menstrual periods
- decreased sexual ability in males
- difficulty in speaking
- discoloration of the fingernails or toenails
- false beliefs that cannot be changed by facts
- feeling of unreality
- hair loss or thinning of hair
- increase in body movements
- increased appetite
- increased sensitivity of skin to sunlight
- lack or loss of strength
- painful menstruation
- poor insight and judgment
- problems with memory or speech
- seeing, hearing, or feeling things that are not there
- sense of detachment from self or body
- severe sunburn
- sleepiness or unusual drowsiness
- trouble recognizing objects
- trouble thinking and planning
- trouble walking
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20062661
