Patient Medication Information: uses, side effects, how to take - Teva-Mexiletine
Serious Warnings and Precautions
- TEVA-MEXILETINE is intended for use only in patients with life-threatening irregular heartbeats (arrhythmias). Most anti-arrhythmic drugs have the potential to cause dangerous arrhythmias; some have been shown to be associated with an increase of sudden death. Your healthcare professional will tell you about the risk and benefits of anti-arrhythmic therapy.
- TEVA-MEXILETINE can cause liver problems including rare instances of death of liver cells. Your healthcare professional will monitor your health and may adjust your dose of TEVA-MEXILETINE.
What is TEVA-MEXILETINE used for?
TEVA-MEXILETINE is used in adults to treat certain types of irregular heartbeat conditions known as ventricular arrhythmias.
How does TEVA-MEXILETINE work?
TEVA-MEXILETINE is an antiarrhythmic agent. It works by blocking certain electrical signals in the heart that can cause an irregular heartbeat.
What are the ingredients in TEVA-MEXILETINE?
Medicinal ingredient: mexiletine hydrochloride
Non-medicinal ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and talc.
The capsule shell is made of:
100 mg: D&C Red#33, FD&C Blue#1, FD&C Red#3, FD&C Red#40, FD&C Yellow#6, gelatin and titanium dioxide
200 mg: D&C Red#33, FD&C Blue#1, FD&C Red#40, gelatin and titanium dioxide
TEVA-MEXILETINE comes in the following dosage forms:
Capsules: 100 mg and 200 mg
Do not use TEVA-MEXILETINE if:
- you are allergic to mexiletine hydrochloride or to any of the ingredients in TEVA-MEXILETINE.
- you are or have experienced allergic reactions to local anesthetics that are amide type such as lidocaine
- you have second or third degree atrioventricular block (a type heart rhythm disorder that causes the heart to beat slowly or skip beats) and do not have a pacemaker
- you have a heart condition called cardiogenic shock (heart is not able to pump enough blood to the body)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-MEXILETINE. Talk about any health conditions or problems you may have, including if you:
- have low blood pressure (hypotension)
have heart problems including:
- heart failure
- atrioventricular block
- heart conduction problems
- sinus node dysfunction, a heart rhythm disorder
- have low levels of potassium in your blood
- have liver problems
- have a seizure disorder
- are taking medicine or foods that change the acidity of your urine. Talk to your healthcare professional if you are not sure.
are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed. TEVA-MEXILETINE passes into breast milk. Talk to your healthcare professional about the best way to feed your baby during this time.
Other warnings you should know about:
Monitoring and Tests: Before you start treatment and during your treatment with TEVA-MEXILETINE, your healthcare professional may perform tests to monitor your:
- heart. TEVA-MEXILETINE and other antiarrhythmic drugs can cause new heart rhythm problems or worsen existing ones.
- liver.
- blood, bone marrow and lymph nodes.
Your healthcare professional will interpret your results and may adjust your dose or stop your treatment with TEVA-MEXILETINE.
Driving and using machines: TEVA-MEXILETINE can cause light headedness, dizziness, tremors and difficulty with coordination. Before you drive or do tasks that require special attention, wait until you know how TEVA-MEXILETINE affects you.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with TEVA-MEXILETINE:
- medicines known to affect the activity of CYP2D6 and CYP1A2 enzymes such as propafenone and fluvoxamine
- lidocaine, used to numb an area of the body and reduce pain
- other antiarrhythmic agents such as tocainide, quinidine, procainamide, and disopyramide
- medicines known as cardiac glycosides, used to treat heart failure and irregular heartbeats
- medicines known as diuretics (“water pills”), used to lower blood pressure
- medicines known as anticoagulants, used to prevent blood clotting
- medicines that increase the activity of liver enzymes, such as phenytoin, rifampin, and phenobarbital
- cimetidine, used to treat heartburn and stomach ulcers
- theophylline, used to treat asthma, bronchitis and other breathing problems
- metoclopramide, used to prevent nausea and vomiting
- narcotic analgesics, used to provide relief from pain
- magnesium hydroxide and aluminum hydroxide, used to relieve heartburn, acid indigestion and upset stomach
- anticholinergics medicines, used to treat incontinence, overactive bladder, respiratory disorders or Parkinson disease
How to take TEVA-MEXILETINE:
- Take TEVA-MEXILETINE exactly as your healthcare professional tells you. Do not increase or decrease your dose without talking to your healthcare professional.
- TEVA-MEXILETINE should be taken with liquid, food and/or an antacid.
Usual dose:
Your healthcare professional will determine the right dose of TEVA-MEXILETINE for you. The usual initial dose is 200 mg three times a day. Your healthcare professional may decide on a different dose depending on:
- your response and tolerance to TEVA-MEXILETINE
- if you have liver problems
- if you have heart problems
Overdose:
Some of the signs of an overdose include:
- nausea
- low blood pressure
- slow heart rhythm
- sensation of tingling, pain or numbness in hands, fingers and toes
- heart conduction problems
| If you think you, or a person you are caring for, have taken too much TEVA-MEXILETINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you miss taking your dose, take it as soon as you remember. But if it is almost time for you to take the next dose, skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.
What are possible side effects from using TEVA-MEXILETINE?
These are not all the possible side effects you may have when taking TEVA-MEXILETINE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- feeling lightheaded, weak, fatigued or nervous
- tremor
- difficulty with coordination
- changes in sleep habits
- having trouble thinking clearly or concentrating
- sensation of tingling, pain or numbness in hands, fingers and toes
- changes in appetite
- constipation
- stomach pain, cramps, or discomfort
- diarrhea
- dry mouth
- shortness of breath
- vision problems
- rash
- headache
- excessive sweating
- loss of hair
- dry skin
- changes in libido
- changes in taste
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Upper gastrointestinal problems: heartburn, nausea, vomiting, stomach pain, or difficulty swallowing | √ | ||
| COMMON | |||
| Arrhythmia (abnormal heart rhythms): rapid, slow or irregular heartbeat | √ | ||
| Congestive Heart Failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise | √ | ||
| Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive) and thoughts of death or suicide. If you have a history of depression, your depression may become worse | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Palpitation (fast-beating, fluttering or pounding heart): skipping beats, beating too fast, pounding, fluttering rapidly | √ | ||
| UNCOMMON | |||
| Angina: (not enough oxygen to the heart muscle): discomfort in the shoulder, arm, back, throat, jaw or teeth; pain or pressure in the chest | √ | ||
| Bradycardia (abnormally slow heartbeat) | √ | ||
| Cardiogenic shock (heart is not able unable to pump enough blood to the organs of the body): breathe fast, fast heartbeat, loss of consciousness, sweating, pale skin, cold hands or feet | √ | ||
| Edema: unusual swelling of the arms, hands, legs, feet and ankles, face or airway passages | √ | ||
| Hallucinations: seeing or hearing things that are not there | √ | ||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse or heart palpitations | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Seizures (fits): uncontrollable shaking with or without loss of consciousness | √ | ||
| Syncope (fainting): a temporary loss of consciousness due to a sudden drop in blood pressure | √ | ||
| Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness | √ | ||
| Neutropenia (decreased white blood cells): infections, fatigue, fever, aches, pains and flu-like symptoms | √ | ||
| RARE | |||
| Hepatic necrosis (death of liver cells): abdominal pain and dark urine, fever, light-colored stool, and jaundice (a yellow appearance of the skin and white portion of the eyes) | √ | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heart beat, nausea, vomiting, tenderness when touching the abdomen | √ | ||
| Stevens-Johnson syndrome (SJS) (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | √ | ||
| UNKNOWN FREQUENCY | |||
| Drug reaction with eosinophilia and systemic symptoms (DRESS) (serious skin reaction that may affect one or more | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| organs): fever, severe rash, peeling skin, swelling of the face, swollen lymph glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feel thirsty, urinating less often, less urine | ||
| Kidney failure (severe kidney problems): confusion; itchiness or rashes; puffiness in your face and hands; swelling in your feet or ankles; urinating less or not at all; weight gain. | ||
| √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at 15° - 30°C.
Keep out of reach and sight of children.
If you want more information about TEVA-MEXILETINE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.tevacanada.com, or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.