FLECAINIDE

Though this medication often gives great benefits to people with irregular heartbeat, it may infrequently cause a serious new irregular heartbeat. Therefore, when starting treatment with this drug, your doctor may recommend that you stay in the hospital for proper monitoring. Flecainide should not be used to treat a certain type of irregular heartbeat (persistent atrial fibrillation/flutter). Talk with your doctor about the benefits and risks of taking this medication for your condition.

Pregnancy risk: Category C (Risk cannot be ruled out)

You should check with your doctor immediately if any of these side effects occur when taking flecainide:

More common

• Difficult or labored breathing
• dizziness, fainting, or lightheadedness
• fast, irregular, pounding, or racing heartbeat or pulse
• shortness of breath
• tightness in the chest
• wheezing

Less common

• Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• chest pain
• fainting
• feeling of warmth
• fever
• increased sweating
• partial or slight paralysis
• redness of the face, neck, arms, and occasionally, upper chest
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• swelling of the feet or lower legs
• trembling or shaking of the hands or feet
• unsteadiness, trembling, or other problems with muscle control or coordination

Rare

• Arm, back, or jaw pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• chest discomfort
• chest tightness or heaviness
• chills
• confusion
• convulsions
• cough
• decrease in the frequency of urination
• decrease in urine volume
• difficulty in passing urine (dribbling)
• difficulty with breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• frequent urination
• general feeling of discomfort or illness
• headache
• increased volume of pale, dilute urine
• nausea
• nervousness
• noisy breathing
• painful or difficult urination
• pinpoint red spots on the skin
• pounding in the ears
• sensation of pins and needles
• slow or fast heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stabbing pain
• sweating
• swollen glands
• thickening of bronchial secretions
• troubled breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

Some of the side effects that can occur with flecainide may not need medical attention:

More common

• Blurred vision or seeing spots

Less common

• Abdominal or stomach pain
• acid or sour stomach
• anxiety or mental depression
• belching
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• depression
• diarrhea
• feeling of constant movement of self or surroundings
• general feeling of discomfort or illness
• hearing loss
• heartburn
• indigestion
• lack or loss of strength
• loss of appetite
• sensation of spinning
• sleepiness or unusual drowsiness
• sleeplessness
• skin rash
• stomach discomfort, upset, or pain
• trouble with sleeping
• unable to sleep
• weight loss

Rare

• Bloated
• change in color vision
• change in taste
• cracks in the skin
• decreased awareness or responsiveness
• decreased interest in sexual intercourse
• difficulty seeing at night
• difficulty with moving
• dry mouth
• excess air or gas in the stomach or intestines
• eye pain or irritation
• false or unusual sense of well-being
• feeling of unreality
• full feeling
• hair loss or thinning of the hair
• hives or welts
• inability to have or keep an erection
• increased sensitivity of the eyes to sunlight
• itching skin
• joint pain
• lack of feeling or emotion
• loss in sexual ability, desire, drive, or performance
• loss of heat from the body
• loss of memory
• muscle aching or cramping
• muscle pain or stiffness
• passing gas
• problems with memory
• red, swollen skin
• scaly skin
• sense of detachment from self or body
• severe sleepiness
• swollen joints
• swollen lips, mouth, or tongue
• uncaring uncontrolled eye movements

Before taking flecainide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, other heart problems (such as previous heart attack, heart pacemaker).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Flecainide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using flecainide, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using flecainide safely.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Many drugs besides flecainide may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, and macrolide antibiotics (such as erythromycin), among others. (See also Precautions section.)

Other medications can affect the removal of flecainide from your body, which may affect how flecainide works. Examples include cimetidine, fluconazole, certain HIV protease inhibitors (such as ritonavir, tipranavir), anti-seizure drugs (such as carbamazepine, phenytoin, phenobarbital), among others.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact a poison control center or emergency room immediately. Symptoms of overdose may include: severe nausea/vomiting, seizures, very slow heartbeat, severe dizziness, fainting.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as EKG) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Brands

Available Brands

Tambocor [ iNova ]