Ezogabine (oral route)

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.

Appropriate studies have not been performed on the relationship of age to the effects of ezogabine in the pediatric population. Safety and efficacy have not been established.

Although appropriate studies on the relationship of age to the effects of ezogabine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related prostate and kidney problems, which may require caution and an adjustment in the dose for patients receiving ezogabine.

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.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Calcifediol
• Carbamazepine
• Fosphenytoin
• Lamotrigine
• Orlistat
• Phenytoin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

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:

• Congestive heart failure or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood)—Use with caution. May cause side effects to become worse.

• Depression or
• Hallucinations or
• Heart rhythm problems (eg, QT prolongation) or
• Mood disorder or
• Urinary retention (urinating problem)—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

More common

• Decrease in the frequency of urination
• decrease in the urine volume
• difficulty with passing urine (dribbling)
• painful urination
• shakiness in the legs, arms, hands, or feet

Less common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine
• burning while urinating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• difficult urination
• general feeling of discomfort or illness
• muscle twitching or jerking
• rapid weight gain
• rhythmic movement of the muscles
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss

Incidence not known

• Agitation
• back pain
• black, tarry stools
• bleeding gums
• blurred vision
• change in consciousness
• chest pain
• chills
• cloudy urine
• confusion
• cough
• difficult or labored breathing
• dizziness
• drowsiness
• fainting
• fever
• headache
• irritability
• loss of consciousness
• pain in the lower back or side
• pinpoint red spots on the skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stiff neck
• swollen glands
• tightness in the chest
• unusual bleeding or bruising
• vomiting

More common

• Being forgetful
• clumsiness or unsteadiness
• dizziness or lightheadedness
• double vision
• feeling of constant movement of self or surroundings
• seeing double
• sensation of spinning
• sleepiness or unusual drowsiness

Less common

• Absence of or decrease in the body movement
• acid or sour stomach
• belching
• changes in patterns and rhythms of speech
• confusion about identity, place, and time
• cough
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with swallowing
• dry mouth
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• feeling, seeing, or hearing things that are not there
• heartburn
• increased appetite
• increased sweating
• indigestion
• joint pain
• lack or loss of strength
• loss of appetite
• loss of memory
• muscle aches and pains
• problems with speech or speaking
• runny nose
• severe mood or mental changes
• shivering
• slurred speech
• stomach discomfort, upset, or pain
• sweating
• trouble sleeping
• trouble walking
• unusual behavior
• weight gain

Incidence not known

• False or unusual sense of wellbeing
• hair loss or thinning of the hair
• muscle spasms
• rash
• uncontrolled eye movements