"The U.S. Food and Drug Administration today approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart "...
(propafenone hydrochloride) Tablets
What is RYTHMOL?
RYTHMOL is a prescription medicine that is used:
- in certain people who have ventricular heart rhythm disorders
- to increase the amount of time between having symptoms of heart rhythm disorders called atrial fibrillation (AF) or paroxysmal supraventricular tachycardia (PSVT)
It is not known if RYTHMOL is safe and effective in children.
Who should not take RYTHMOL?
Do not take RYTHMOL if you have:
- heart failure (weak heart)
- had a recent heart attack
- a heart rate that is too slow, and you do not have a pacemaker
- a heart condition called Brugada Syndrome
- very low blood pressure
- certain breathing problems that make you short of breath or wheeze
- certain abnormal body salt (electrolyte) levels in your blood
Talk to your doctor before taking RYTHMOL if you think you have any of the conditions listed above.
What should I tell my doctor before taking RYTHMOL?
Before you take RYTHMOL, tell your doctor if you:
- have liver or kidney problems
- have breathing problems
- have symptoms including diarrhea, sweating, vomiting, or loss of appetite or thirst that are severe. These symptoms may be a sign of abnormal electrolyte levels in your blood.
- have myasthenia gravis
- have lupus erythematosis
- have been told you have or had an abnormal blood test called Antinuclear Antibody Test or ANA Test
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if RYTHMOL will harm your unborn baby.
- are breastfeeding or plan to breastfeed. RYTHMOL can pass into your milk and may harm your baby. You and your doctor should decide if you will breastfeed or take RYTHMOL. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYTHMOL and certain other medicines can affect (interact with) each other and cause serious side effects. You can ask your pharmacist for a list of medicines that interact with RYTHMOL.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take RYTHMOL?
- Take RYTHMOL exactly as prescribed. Your doctor will tell you how many tablets to take and how often to take them.
- To help reduce the chance of certain side effects, your doctor may start you with a low dose of RYTHMOL, and then slowly increase the dose.
- You should not drink grapefruit juice during treatment with RYTHMOL.
- If you miss a dose of RYTHMOL, take your next dose at the usual time. Do not take 2 doses at the same time.
- If you take too much RYTHMOL, call your doctor or go to the nearest hospital emergency room right away.
- Call your doctor if your heart problems get worse.
What are possible side effects of RYTHMOL?
RYTHMOL an cause serious side effects including:
- New or worsened abnormal heart beats, that can cause sudden death or be life-threatening. Your doctor may do an electrocardiogram (ECG or EKG) before and during treatment to check your heart for these problems.
- New or worsened heart failure. Tell your doctor about any changes in your heart symptoms, including:
- any new or increased swelling in your arms or legs
- trouble breathing
- sudden weight gain
- Effects on pacemaker function. RYTHMOL may affect how an implanted pacemaker or defibrillator works. Your doctor should check how your pacemaker or defibrillator is working during and after treatment with RYTHMOL. They may need to be re-programmed.
- Very low white blood cell levels in your blood
(agranulocytosis). Your bone marrow may not produce enough of a certain
type of white blood cells called neutrophils. If this happens, you are more
likely to get infections. Tell your doctor right away if you have any of these
symptoms, especially during the first 3 months of treatment:
- sore throat
- Worsening of myasthenia gravis in people who already have this condition. Tell your doctor about any change in your symptoms.
- RYTHMOL may cause lower sperm counts in men. This could affect the ability to father a child. Talk to your doctor if this is a concern for you.
Common side effects of RYTHMOL include:
- unusual taste
- irregular heart beats
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of RYTHMOL. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store RYTHMOL?
- Store RYTHMOL at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep the bottle tightly closed.
Keep RYTHMOL and all medicines out of the reach of children.
General information about RYTHMOL
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use RYTHMOL for a condition for which it was not prescribed. Do not give RYTHMOL to other people, even if they have the same symptoms you have. It may harm them.
If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about RYTHMOL that is written for health professionals. For more information about RYTHMOL, call 1-888-825-5249.
What are the ingredients in RYTHMOL?
Active ingredient: propafenone hydrochloride
Inactive ingredients: corn starch, hypromellose, magnesium stearate, polyethylene glycol, polysorbate, povidone, propylene glycol, sodium starch glycolate, and titanium dioxide.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 6/7/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Rythmol Information
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