Rythmol Extended Release

RYTHMOL SR (propafenone HCl) capsules are supplied as white, opaque, hard gelatin capsules containing either 225 mg, 325 mg, or 425 mg of propafenone HCl. The 225 mg strength is imprinted in red with GS EUG followed by 225. The 325 mg strength is imprinted in red with GS F1Y followed by 325, and also has a single red band around ¾ of the circumference of the body. The 425 mg strength is imprinted in red with GS UY2 followed by 425, and also has three red bands around ¾ of the circumference of the body.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to RYTHMOL SR 225 mg twice daily in 126 patients, to RYTHMOL SR 325 mg twice daily in 135 patients, to RYTHMOL SR 425 mg twice daily in 136 patients, and to placebo in 126 patients for up to 39 weeks (mean 20 weeks) in a placebo-controlled trial (RAFT) conducted in the US. The most commonly reported adverse events with propafenone (>5% and greater than placebo) excluding those not reasonably associated with the use of the drug or because they were associated with the condition being treated, were dizziness, palpitations, chest pain, dyspnea, taste disturbance, nausea, fatigue, anxiety, constipation, upper respiratory tract infection, edema, and influenza.  The frequency of discontinuation due to adverse events was 17%, and the rate was highest during the first 14 days of treatment.

Cardiac-related adverse events occurring in ≥ 2% of the patients in any of the RAFT propafenone SR treatment groups and more common with propafenone than with placebo, excluding those that are common in the population and those not plausibly related to drug therapy, included the following: angina pectoris, atrial flutter, AV block first degree, bradycardia, congestive cardiac failure, cardiac murmur, edema, dyspnea, rales, wheezing, and cardioactive drug level above therapeutic.

Propafenone prolongs the PR and QRS intervals in patients with atrial and ventricular arrhythmias. Prolongation of the QRS interval makes it difficult to interpret the effect of propafenone on the QT interval [see Clinical Pharmacology (12.2)].

Non-cardiac related adverse events occurring in ≥ 2% of the patients in any of the RAFT propafenone SR treatment groups and more common with propafenone than with placebo, excluding those that are common in the population and those not plausibly related to drug therapy, included the following: blurred vision, constipation, diarrhea, dry mouth, flatulence, nausea, vomiting, fatigue, weakness, upper respiratory tract infection, blood alkaline phosphatase increased, hematuria, muscle weakness, dizziness (excluding vertigo), headache, taste disturbance, tremor, somnolence, anxiety, depression, ecchymosis.

No clinically important differences in incidence of adverse reactions were noted by age or gender. Too few non-Caucasian patients were enrolled to assess adverse events according to race.

Adverse events occurring in 2% or more of the patients in any of the ERAFT [see Clinical Studies (14)] propafenone SR treatment groups and not listed above include the following: bundle branch block left, bundle branch block right, conduction disorders, sinus bradycardia, and hypotension.

Other adverse events reported with propafenone clinical trials not already listed elsewhere in the prescribing information include the following adverse events by body and preferred term.

Blood and Lymphatic System Disorders

Anemia, lymphadenopathy, spleen disorder, thrombocytopenia.

Cardiac Disorders

Unstable angina, atrial hypertrophy, cardiac arrest, coronary artery disease, extrasystoles, myocardial infarction, nodal arrhythmia, palpitations, pericarditis, sinoatrial block, sinus arrest, sinus arrhythmia, supraventricular extrasystoles, ventricular extrasystoles, ventricular hypertrophy.

Ear and Labyrinth Disorders

Hearing impaired, tinnitus, vertigo.

Eye Disorders

Eye hemorrhage, eye inflammation, eyelid ptosis, miosis, retinal disorder, visual acuity reduced.

Gastrointestinal Disorders

Abdominal distension, abdominal pain, duodenitis, dyspepsia, dysphagia, eructation, gastritis, gastroesophageal reflux disease, gingival bleeding, glossitis, glossodynia, gum pain, halitosis, intestinal obstruction, melena, mouth ulceration, pancreatitis, peptic ulcer, rectal bleeding, sore throat.

General Disorders and Administration Site Conditions

Chest pain, feeling hot, hemorrhage, malaise, pain, pyrexia.

Hepatobiliary disorders

Hepatomegaly.

Investigations

Abnormal heart sounds, abnormal pulse, carotid bruit, decreased blood chloride, decreased blood pressure, decreased blood sodium, decreased hemoglobin, decreased neutrophil count, decreased platelet count, decreased prothrombin level, decreased red blood cell count, decreased weight, glycosuria present, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, increased blood cholesterol, increased blood creatinine, increased blood glucose, increased blood lactate dehydrogenase, increased blood pressure, increased blood prolactin, increased blood triglycerides, increased blood urea, increased blood uric acid, increased eosinophil count, increased gamma-glutamyltransferase, increased monocyte count, increased prostatic specific antigen, increased prothrombin level, increased weight, increased white blood cell count, ketonuria present, proteinuria present.

Metabolism and Nutrition Disorders

Anorexia, dehydration, diabetes mellitus, gout, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypokalemia.

Musculoskeletal, Connective Tissue and Bone Disorders

Arthritis, bursitis, collagen-vascular disease, costochondritis, joint disorder, muscle cramps, muscle spasms, myalgia, neck pain, pain in jaw, sciatica, tendonitis.

Nervous System Disorders

Amnesia, ataxia, balance impaired, brain damage, cerebrovascular accident, dementia, gait abnormal, hypertonia, hypothesia, insomnia, paralysis, paresthesia, peripheral neuropathy, speech disorder, syncope, tongue hypoesthesia.

Psychiatric Disorders

Decreased libido, emotional disturbance, mental disorder, neurosis, nightmare, sleep disorder.

Renal and Urinary Disorders

Dysuria, nocturia, oliguria, pyuria, renal failure, urinary casts, urinary frequency, urinary incontinence, urinary retention, urine abnormal.

Reproductive System and Breast Disorders

Breast pain, impotence, prostatism.

Respiratory, Thoracic and Mediastinal Disorders

Atelectasis, breath sounds decreased, chronic obstructive airways disease, cough, epistaxis, hemoptysis, lung disorder, pleural effusion, pulmonary congestion, rales, respiratory failure, rhinitis, throat tightness.

Skin and Subcutaneous Tissue Disorders

Alopecia, dermatitis, dry skin, erythema, nail abnormality, petechiae, pruritus, sweating increased, urticaria.

Vascular Disorders

Arterial embolism limb, deep limb venous thrombosis, flushing, hematoma, hypertension, hypertensive crisis, hypotension, labile blood pressure, pallor, peripheral coldness, peripheral vascular disease, thrombosis.

CYP2D6 and CYP3A4 Inhibitors

Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, sertraline) and CYP3A4 (such as ketoconazole, ritonavir, saquinavir, erythromycin, and grapefruit juice) can be expected to cause increased plasma levels of propafenone. The combination of CYP3A4 inhibition and either CYP2D6 deficiency or CYP2D6 inhibition with administration of propafenone may increase the risk of adverse reactions, including proarrhythmia. Therefore, simultaneous use of RYTHMOL SR with both a CYP2D6 inhibitor and a CYP3A4 inhibitor should be avoided [see Warnings and Precautions (5.4) and Dosage and Administration (2)].

Amiodarone

Concomitant administration of propafenone and amiodarone can affect conduction and repolarization and is not recommended.

Cimetidine

Concomitant administration of propafenone immediate-release tablets and cimetidine in 12 healthy subjects resulted in a 20% increase in steady-state plasma concentrations of propafenone.

Fluoxetine

Concomitant administration of propafenone and fluoxetine in extensive metabolizers increased the S propafenone Cmax and AUC by 39 and 50% and the R propafenone Cmax and AUC by 71 and 50%.

Quinidine

Small doses of quinidine completely inhibit the CYP2D6 hydroxylation metabolic pathway, making all patients, in effect, slow metabolizers [see Clinical Pharmacology (12)]. Concomitant administration of quinidine (50 mg three times daily) with 150 mg immediate-release propafenone three times daily decreased the clearance of propafenone by 60% in extensive metabolizers, making them poor metabolizers. Steady-state plasma concentrations increased by more than 2-fold for propafenone, and decreased 50% for 5-OH-propafenone. A 100 mg dose of quinidine increased steady state concentrations of propafenone 3-fold. Avoid concomitant use of propafenone and quinidine.

Rifampin

Concomitant administration of rifampin and propafenone in extensive metabolizers decreased the plasma concentrations of propafenone by 67% with a corresponding decrease of 5-OH-propafenone by 65%. The concentrations of norpropafenone increased by 30%. In poor metabolizers, there was a 50% decrease in propafenone plasma concentrations and increased the AUC and Cmax of norpropafenone by 74 and 20%, respectively. Urinary excretion of propafenone and its metabolites decreased significantly. Similar results were noted in elderly patients: Both the AUC and Cmax propafenone decreased by 84%, with a corresponding decrease in AUC and Cmax of 5-OH-propafenone by 69 and 57%.

Digoxin

Concomitant use of propafenone and digoxin increased steady-state serum digoxin exposure (AUC) in patients by 60 to 270%, and decreased the clearance of digoxin by 31 to 67%. Monitor plasma digoxin levels of patients receiving propafenone and adjust digoxin dosage as needed.

Warfarin

The concomitant administration of propafenone and warfarin increased warfarin plasma concentrations at steady state by 39% in healthy volunteers and prolonged the prothrombin time (PT) in patients taking warfarin. Adjust the warfarin dose as needed by monitoring INR (international normalized ratio).

Orlistat

Orlistat may limit the fraction of propafenone available for absorption. In post marketing reports, abrupt cessation of orlistat in patients stabilized on propafenone has resulted in severe adverse events including convulsions, atrioventricular block and acute circulatory failure.

Beta-Antagonists

Concomitant use of propafenone and propranolol in healthy subjects increased propranolol plasma concentrations at steady state by 113%. In 4 patients, administration of metoprolol with propafenone increased the metoprolol plasma concentrations at steady state by 100 to 400%. The pharmacokinetics of propafenone was not affected by the coadministration of either propranolol or metoprolol. In clinical trials using propafenone immediate-release tablets, patients who were receiving beta-blockers concurrently did not experience an increased incidence of side effects.

Lidocaine

No significant effects on the pharmacokinetics of propafenone or lidocaine have been seen following their concomitant use in patients. However, concomitant use of propafenone and lidocaine has been reported to increase the risks of central nervous system side effects of lidocaine.

RYTHMOL SR (propafenone hydrochloride) is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration.

Chemically, propafenone hydrochloride is 2’-[2-Hydroxy-3-(propylamino)-propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3•HCl.

Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below:

Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform and ethanol. RYTHMOL SR capsules are filled with cylindrical-shaped 2 x 2 mm microtablets containing propafenone and the following inactive ingredients: antifoam, gelatin, hypromellose, red iron oxide, magnesium stearate, shellac, sodium lauryl sulfate, sodium dodecyl sulfate, soy lecithin and titanium dioxide.

See FDA-approved patient labeling (Patient Information).

Information for Patients

• Patients should be instructed to notify their health care providers of any change in over-the-counter, prescription and supplement use. The health care provider should assess the patients’ medication history including all over-the-counter, prescription and herbal/natural preparations for those that may affect the pharmacodynamics or kinetics of RYTHMOL SR [see Warnings and Precautions (5.4)]. • Patients should also check with their health care providers prior to taking a new over-the-counter medicine. • If patients experience symptoms that may be associated with altered electrolyte balance, such as excessive or prolonged diarrhea, sweating, vomiting, or loss of appetite or thirst, these conditions should be immediately reported to their health care provider. • Patients should be instructed NOT to double the next dose if a dose is missed. The next dose should be taken at the usual time.

RYTHMOL SR is a registered trademark of G. Petrik used under license by Abbott Laboratories.

Distributed by:

GlaxoSmithKline

Research Triangle Park, NC 27709

©2013, GlaxoSmithKline. All rights reserved.

RMS:7PI

PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

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PATIENT INFORMATION

RYTHMOL SR® (RITH-Mall)

(propafenone hydrochloride) Extended-Release Capsules

Read this Patient Information Leaflet before you start taking RYTHMOL SR and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is RYTHMOL SR?

RYTHMOL SR is a prescription medicine that is used:

• in certain people who have a heart rhythm disorder called atrial fibrillation (AF) • to increase the amount of time between having symptoms of AF

It is not known if RYTHMOL SR is safe and effective in children.

Who should not take RYTHMOL SR?

Do not take RYTHMOL SR if you have:

• heart failure (weak heart) • had a recent heart attack • have a heart condition called Brugada Syndrome • a heart rate that is too slow, and you do not have a pacemaker • 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 SR if you think you have any of the conditions listed above.

What should I tell my doctor before taking RYTHMOL SR?

Before you take RYTHMOL SR, 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 • are pregnant or plan to become pregnant. It is not known if RYTHMOL SR will harm your unborn baby. • are breastfeeding or plan to breastfeed. RYTHMOL SR can pass into your milk and may harm your baby. You and your doctor should decide if you will breastfeed or take RYTHMOL SR. You should not do both. • have any other medical conditions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. RYTHMOL SR and certain other medicines can affect each other and cause serious side effects. RYTHMOL SR may affect the way other medicines work, and other medicines may affect how RYTHMOL SR works.

Especially tell your doctor if you take:

• amiodarone or other medicines for your abnormal heart beats • an antidepressant medicine • a medicine to treat anxiety • ritonavir (for example, KALETRA®, NORVIR®) or saquinavir (for example, INVIRASE®) • an antibiotic medicine • ketoconazole (for example, NIZORAL®) • digoxin (LANOXIN®) • warfarin sodium (for example, COUMADIN®, JANTOVEN®)

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 SR?

• Take RYTHMOL SR exactly as prescribed. Your doctor will tell you how many capsules 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 SR, and then slowly increase the dose. • Do not open or crush the capsule. • You may take RYTHMOL SR with or without food. • You should not drink grapefruit juice during treatment with RYTHMOL SR. • If you miss a dose of RYTHMOL SR, take your next dose at the usual time. Do not take 2 doses at the same time. • If you take too much RYTHMOL SR, 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 SR?

RYTHMOL SR can 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 SR 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 SR. 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: ∘ fever ∘ sore throat ∘ chills • Worsening of myasthenia gravis in people who already have this condition. Tell your doctor about any change in your symptoms. • RYTHMOL SR 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 SR include:

• dizziness • fast or irregular heart beats • chest pain • trouble breathing • taste changes • nausea • tiredness • feeling anxious • constipation • upper respiratory infection or flu • swelling

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 SR. 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 SR?

• Store RYTHMOL SR at room temperature between 59°F to 86°F (15°C to 30°C). • Keep the bottle tightly closed.

Keep RYTHMOL SR and all medicines out of the reach of children.

General information about RYTHMOL SR

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use RYTHMOL SR for a condition for which it was not prescribed by your doctor. Do not give RYTHMOL SR to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about RYTHMOL SR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about RYTHMOL SR that is written for healthcare professionals. For more information about RYTHMOL SR, call 1-888-825-5249.

What are the ingredients in RYTHMOL SR?

Active Ingredient: Propafenone hydrochloride

Inactive Ingredients: Antifoam, gelatin, hypromellose, red iron oxide, magnesium stearate, shellac, sodium lauryl sulfate, sodium dodecyl sulfate, soy lecithin and titanium dioxide.

RYTHMOL is a registered trademark of G. Petrik used under license by Abbott Laboratories. The other brands listed are trademarks of their respective owners and are not trademarks of GlaxoSmithKline. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.

Manufactured for:

GlaxoSmithKline

Research Triangle Park, NC 27709

Manufactured by:

Abbott Laboratories

North Chicago, IL 60064

©2013, GlaxoSmithKline. All rights reserved.

February 2013

RMS:2PIL

Principal Display Panel

NDC 0173-0823-18

Rythmol® SR

(propafenone HCl)

Extended Release Capsules

225 mg

Rx only

60 Capsules

Do not accept if seal over bottle opening is broken or missing.

Usual Dosage: See accompanying prescribing information.

Store at 25oC (77oF); excursions permitted to 15o-30oC (59o-86oF) [see USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP.

Manufactured for

GlaxoSmithKline

Research Triangle Park, NC 27709

by Abbott Laboratories

North Chicago, IL 60064

Made in Switzerland

10000000088657 Rev. 12/10

Principal Display Panel

NDC 0173-0824-18

Rythmol® SR

(propafenone HCl)

Extended Release Capsules

325 mg

Rx only

60 Capsules

Do not accept if seal over bottle opening is broken or missing.

Usual Dosage: See accompanying prescribing information.

Store at 25oC (77oF); excursions permitted to 15o-30oC (59o-86oF) [see USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP.

Manufactured for

GlaxoSmithKline

Research Triangle Park, NC 27709

by Abbott Laboratories

North Chicago, IL 60064

Made in Switzerland

10000000088658 Rev. 12/10

Principal Display Panel

NDC 0173-0826-18

Rythmol® SR

(propafenone HCl)

Extended Release Capsules

425 mg

Rx only

60 Capsules

Do not accept if seal over bottle opening is broken or missing.

Usual Dosage: See accompanying prescribing information.

Store at 25oC (77oF); excursions permitted to 15o-30oC (59o-86oF) [see USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP.

Manufactured for

GlaxoSmithKline

Research Triangle Park, NC 27709

by Abbott Laboratories

North Chicago, IL 60064

Made in Switzerland

10000000088659 Rev. 12/10

RYTHMOL  SR propafenone hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0823 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROPAFENONE HYDROCHLORIDE (PROPAFENONE) PROPAFENONE HYDROCHLORIDE 225 mg

Inactive Ingredients Ingredient Name Strength GELATIN   HYPROMELLOSES   FERRIC OXIDE RED   MAGNESIUM STEARATE   SHELLAC   SODIUM LAURYL SULFATE   LECITHIN, SOYBEAN   TITANIUM DIOXIDE

Product Characteristics Color WHITE (Opaque) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code GS;EUG;225 Contains

Packaging # Item Code Package Description 1 NDC:0173-0823-18 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021416 03/17/2011

RYTHMOL  SR propafenone hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0824 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROPAFENONE HYDROCHLORIDE (PROPAFENONE) PROPAFENONE HYDROCHLORIDE 325 mg

Inactive Ingredients Ingredient Name Strength GELATIN   HYPROMELLOSES   FERRIC OXIDE RED   MAGNESIUM STEARATE   SHELLAC   SODIUM LAURYL SULFATE   LECITHIN, SOYBEAN   TITANIUM DIOXIDE

Product Characteristics Color WHITE (Opaque) , RED (single band) Score no score Shape CAPSULE Size 21mm Flavor Imprint Code GS;F1Y;325 Contains

Packaging # Item Code Package Description 1 NDC:0173-0824-18 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021416 03/17/2011

RYTHMOL  SR propafenone hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0826 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROPAFENONE HYDROCHLORIDE (PROPAFENONE) PROPAFENONE HYDROCHLORIDE 425 mg

Inactive Ingredients Ingredient Name Strength GELATIN   HYPROMELLOSES   FERRIC OXIDE RED   MAGNESIUM STEARATE   SHELLAC   SODIUM LAURYL SULFATE   LECITHIN, SOYBEAN   TITANIUM DIOXIDE

Product Characteristics Color WHITE (Opaque) , RED (3 bands) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code GS;UY2;425 Contains

Packaging # Item Code Package Description 1 NDC:0173-0826-18 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021416 03/17/2011

Labeler - GlaxoSmithKline LLC (167380711)

Revised: 02/2013   GlaxoSmithKline LLC

Common side effects of Rythmol SR include: constipation, dyspnea, nausea, and dysgeusia. Other side effects include: cardiac rate disturbance, death, atrial flutter, blurred vision, heart murmur, myasthenia, asthenia, diarrhea, first degree atrioventricular block, vomiting, and ecchymoses. See below for a comprehensive list of adverse effects.