Pronunciation:

se-VI-me-leen

Brand Names:

• Evoxac

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Central Nervous System Agent

Pharmacologic—

Cholinergic System

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

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. 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 of This Medicine:

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.

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 While Using This Medicine:

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 of This Medicine:

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.