Rythmol

Rythmol is a Class IC anti-arrhythmic that influences how your heart beats.

Rythmol is used in specific cases to stop serious heart rhythm problems.

Rythmol may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take Rythmol with or without food.

You may have very low blood pressure while taking this medication. Call your doctor if you are sick with vomiting or diarrhea, extreme thirst, loss of appetite, or if you are sweating more than usual.

You may need frequent blood tests. Your heart function may also need to be checked with an electrocardiograph or ECG (sometimes called an EKG), before and during treatment with Rythmol.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

You should not use Rythmol if you have heart failure, Brugada syndrome, sick sinus syndrome, AV block (without a pacemaker), severe low blood pressure, very slow heartbeats, a severe electrolyte imbalance, shortness of breath, or if you recently had a heart attack.

Rythmol may cause a new or worsening heartbeat pattern. Call your doctor right away if you experience fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness.

You should not use Rythmol if you are allergic to it, or if you have:

• heart failure, or if you have recently had a heart attack;
• a genetic heart condition called Brugada syndrome;
• a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker);
• severe low blood pressure, or a history of slow heartbeats that have caused you to faint;
• a severe or uncontrolled electrolyte imbalance; or
• wheezing or shortness of breath.

Tell your doctor if you have ever had:

• a breathing disorder;
• liver or kidney disease;
• lupus;
• myasthenia gravis; or
• an abnormal blood test called Antinuclear Antibody Test or ANA.

Tell your doctor if you have a pacemaker or defibrillator. These devices may need to be reprogrammed while you are taking Rythmol.

Tell your doctor if you are pregnant or breastfeeding.

Rythmol may affect fertility (ability to have children) in men. Talk with your doctor if you have concerns about this risk.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Rythmol may cause a new or worsening heartbeat pattern. Call your doctor right away if you have fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out).

Also call your doctor right away if you have:

• shortness of breath (even with mild exertion);
• swelling in your arms or legs;
• sudden weight gain; or
• fever, chills, sore throat.

Common side effects of Rythmol may include:

• irregular heartbeats;
• nausea, vomiting, constipation;
• headache, dizziness, tiredness; or
• unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the medicine as soon as you can, but if it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Grapefruit may interact with Rythmol and lead to unwanted side effects.
• Avoid the use of grapefruit products.

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medications work.

Rythmol can cause a serious heart problem. Your risk may be higher if you also take certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect Rythmol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all the medicines you are currently taking and any medicine you start or stop using.