Jamp Digoxin: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• While taking JAMP Digoxin, do not take other prescription, non-prescription or herbal medications without talking to your healthcare professional.

What is JAMP Digoxin used for?

• This medicine is used for patients who have congestive heart failure. Heart failure, results when the heart cannot pump blood well enough to supply the body's needs. As a result, circulation becomes poor, and fluid can build up in the lungs and legs.
• This medicine can also be used in patients with a fast or irregular heartbeat , such as atrial fibrillation (sometimes called "a-fib").

How does JAMP Digoxin work?

JAMP Digoxin contains the medicinal ingredient digoxin. If you have heart failure, digoxin can improve your heart's ability to pump blood. Better pumping of the heart will often improve symptoms such as shortness of breath. As a result, you may find it easier to go about your daily activities.

If you have a fast or irregular heartbeat, digoxin can slow down and control your heart rate.

What are the ingredients in JAMP Digoxin?

Medicinal ingredients: digoxin

Non-medicinal ingredients: D&C Yellow No. 10 (0.125 mg tablets), FD&C Yellow No. 6 (0.0625 mg tablets), Lactose monohydrate, Magnesium stearate, Pregelatinized starch, Hydroxy propyl cellulose, Yellow Ferric Oxide (0.125 mg tablets).

JAMP Digoxin comes in the following dosage forms:

Tablets: 0.0625 mg, 0.125 mg, 0.25 mg

Do not use JAMP Digoxin if you:

• have an irregular heartbeat called “ventricular fibrillation”
• have ever had any unusual or allergic reaction to digoxin medicines, including JAMP Digoxin, or any of the nonmedicinal ingredients in JAMP Digoxin (see What are the ingredients in JAMP Digoxin?)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JAMP Digoxin. Talk about any health conditions or problems you may have, including if you:

• are dehydrated or suffer from excessive vomiting, diarrhea or sweating (electrolyte disorder)
• have heart problems
• have severe lung disease
• have liver or kidney problems
• have thyroid problems

• are pregnant or could become pregnant. JAMP Digoxin should not be used in pregnant women unless absolutely needed

• are breast-feeding. JAMP Digoxin passes into breast milk
• are over 65 years of age. You may be more likely to experience side effects from JAMP Digoxin. Your healthcare professional may have to adjust your dose or monitor you more closely.

• are lactose intolerant or have one of the following rare hereditary diseases:

  • Galactose intolerance
  • Lapp lactase deficiency
  • Glucose-galactose malabsorption

because lactose is a non-medicinal ingredient in JAMP Digoxin.

Other warnings you should know about:

Although digoxin, the medicinal ingredient in JAMP Digoxin, has been used to help some patients lose weight, it should never be used in this way. When used improperly, digoxin can cause serious side effects that can, in some cases, be fatal.

Your healthcare professional may need to do blood tests to make sure you are taking the right dose. They might also need to do bloodwork to check on your overall health since JAMP Digoxin can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

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 JAMP Digoxin:

• other medicines used to treat irregular heartbeat, such as dronedarone, quinidine, amiodarone, propafenone

• antacids or laxatives that contain aluminum, magnesium, or kaolin-pectin, such as Maalox, Rolaids, Mylanta, milk of magnesia . These products should be taken either 2 hours before or 2 hours after JAMP Digoxin.

  Serious Drug Interactions

• Your healthcare professional will need to monitor you closely if you are taking JAMP Digoxin with medicines used to treat HIV infection and AIDS, such as cobicistat, saquinavir/ ritonavir and simeprevir.
• sucralfate, a medicine used to treat and prevent ulcers. JAMP Digoxin should be taken at least 2 hours before sucralfate.
• bupropion, a medicine used to treat depression
• medicines used to lower blood pressure called beta-blockers (such as atenolol, propranolol, acebutolol, metoprolol, labetalol, nadolol) and calcium channel blockers (such as diltiazem, amlodipine, felodipine, nifedipine, verapamil)
• cancer chemotherapy drugs (such as bleomycin, cyclophosphamide, cytarabine, doxorubicin, procarbazine, vandetanib, vincristine) and radiation therapy
• cyclosporine, a medicine used to supress the immune system
• diuretics (water pills), such as hydrochlorothiazide, chlorothiazide, chlorthalidone, furosemide, triamterene, amiloride, spironolactone
• steroid medicine, such as prednisone, methylprednisolone, prednisolone, dexamethasone
• thyroid hormones, used to treat thyroid problems
• cholestyramine and colestipol, medicines used to lower high cholesterol. JAMP Digoxin should be taken either 2 hours before or 4 to 6 hours after these medicines
• antibiotics, medicines used to treat bacterial infections, such as erythromycin, tetracycline, clarithromycin, neomycin
• indomethacin, a medicine used to treat gout
• medicines used to treat fungal infections, such as itraconazole, amphotericin B
• metoclopramide, a medicine used to prevent nausea
• rifampin, an antibiotic used to treat tuberculosis infection
• sulfasalazine, a medicine used to treat arthritis
• atorvastatin, a medicine used to lower high cholesterol
• albuterol, a medicine used to treat breathing problems
• alprazolam, a medicine used to treat mental health problems
• medicines used to treat stomach problems, such as diphenoxylate, propantheline, omeprazole
• barbiturates and phenytoin, medicines used to prevent seizures
• succinylcholine, a medicine used to relax the body during surgery
• St. John’s wort, an herbal medicine used to treat depression

Your healthcare professional may need to adjust your dose or monitor you more closely if are taking any of the medicines listed above.

How to take JAMP Digoxin:

• Take JAMP Digoxin exactly as directed by your healthcare professional. If you do not understand the directions, ask your healthcare professional to explain them to you.
• Take JAMP Digoxin tablets with a full glass of water.
• Try to take JAMP Digoxin at the same time every day.
• Ask your healthcare professional to teach you how to monitor your heart rate and at what heart rate you should notify them before taking any more medication.
• Even if you feel better, do not stop taking JAMP Digoxin without talking to your healthcare professional. Stopping suddenly could make your condition worse.
• Make sure you always have enough JAMP Digoxin on hand for vacations and holidays.
• It may take several weeks to several months for JAMP Digoxin to improve your heart function. Don't be surprised if your symptoms don't get better right away. Keep taking your JAMP Digoxin as prescribed. JAMP Digoxin is used to treat heart conditions that last for a long time, so you may take JAMP Digoxin the rest of your life.

Usual dose:

Your healthcare professional will decide on your dose based on your weight, your age, how well your kidneys work, other medical conditions you might have, other medications you might be taking and how well you respond to JAMP Digoxin.

Overdose:

Symptoms of overdose include nausea, vomiting, decreased appetite, diarrhea, confusion, seizures, hallucinations, light "halos" around objects, green or yellow vision, fatigue, irregular heartbeat, and abnormally fast or slow heartbeat.

Missed Dose:

Take the missed dose up to 12 hours late. If more than 12 hours have passed, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose of this medication. Tell your healthcare professional if you have missed 2 or more days of JAMP Digoxin.

What are possible side effects from using JAMP Digoxin?

These are not all the possible side effects you may have when taking JAMP Digoxin. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• decreased appetite
• nausea, vomiting, diarrhea
• stomach pain
• unusual tiredness or weakness
• headache
• dizziness
• decreased sex drive
• enlarged breasts in males
• rash

Serious side effects and what to do about them

Talk to your healthcare professional

Stop taking drug and

If you think you, or a person you are caring for, have taken too much JAMP Digoxin, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

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.

Storage:

Store at 15°C-30°C in a dry place. Avoid exposure to excessive heat.

Keep out of reach and sight of children.

If you want more information about JAMP Digoxin:

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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.

• 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 (www.jamppharma.com) ,or by calling 1-866-399-9091.

JAMP Pharma Corporation

1310 rue Nobel,

Boucherville, Québec

J4B 5H3, Canada

Last Revised: December 07, 2022