Digoxin Teva

Patient Information Leaflet: User Information

DIGOXIN TEVA, 100 g, tablets
DIGOXIN TEVA, 250 g, tablets
Digoxin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Digoxin Teva and what is it used for
• 2. Important information before taking Digoxin Teva
• 3. How to take Digoxin Teva
• 4. Possible side effects
• 5. How to store Digoxin Teva
• 6. Contents of the pack and other information

1. WHAT IS DIGOXIN TEVA AND WHAT IS IT USED FOR

Digoxin Teva contains the active substance digoxin. Digoxin belongs to a group of medicines called cardiac glycosides. The medicine reduces the heart rate and increases the strength of heart contractions. It also affects smooth and skeletal muscles, renal tubules, and the vagus nerve centers.

Indications for Use

• Atrial fibrillation with rapid ventricular response.
• Advanced heart failure.

2. IMPORTANT INFORMATION BEFORE TAKING DIGOXIN TEVA

When Not to Take Digoxin Teva

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if the patient has arrhythmia caused by digitalis glycoside toxicity

• if the patient has ventricular tachycardia and ventricular fibrillation
• if the patient has hypertrophic cardiomyopathy
• if the patient has idiopathic hypertrophic subaortic stenosis
• if the patient has prolonged atrioventricular conduction time (second- or third-degree atrioventricular block)
• if the patient has acute phase of myocardial infarction
• if the patient has acute phase of myocarditis
• if the patient has sick sinus syndrome
• if the patient has Wolff-Parkinson-White syndrome

Warnings and Precautions

Before starting Digoxin Teva, discuss with your doctor if:
the patient has recently had a myocardial infarction,

• the doctor has found low potassium and/or magnesium levels in the patient's blood,
• the doctor has found high calcium levels in the patient's blood,
• the patient has heart disorders due to vitamin B deficiency (beriberi disease),
• the patient has kidney, lung, thyroid, or digestive disorders.

In case of any doubts about the above cases, the patient should contact their doctor or pharmacist. The doctor will decide on possible dose changes or discontinuation of the medicine and replacement with another one.
During treatment with the medicine, the doctor should recommend regular liver and kidney function tests and EKG monitoring.

Digoxin Teva and Other Medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.

• Diuretics - hydrochlorothiazide, spironolactone, amiloride, and furosemide, used together with digoxin, may cause significant hypotension, decreased cardiac output, increased total peripheral vascular resistance, and heart rate acceleration. Spironolactone may cause significant increases in digoxin levels.
• Angiotensin-converting enzyme inhibitors (e.g., captopril) increase left ventricular ejection fraction and decrease the number of ventricular extrasystoles. Captopril increases digoxin levels in serum.
• Vasodilators (losartan, prazosin, dihydralazine) decrease digoxin levels.
• Digoxin levels may be increased during concomitant use of macrolide antibiotics (e.g., clarithromycin), tetracycline, and propafenone.
• Calcium, especially when administered intravenously, may cause severe arrhythmias in patients treated with digitalis glycosides. Increased calcium levels in the blood, regardless of the cause, predispose to digoxin toxicity. Decreased calcium levels in the blood weaken the effect of digitalis glycosides.
• In hypothyroidism, the need for digitalis glycosides is decreased.
• Antiarrhythmic drugs: quinidine and quinine decrease digoxin clearance and volume of distribution; procainamide abolishes ventricular arrhythmias caused by digitalis glycosides; quinidine, calcium channel blockers (verapamil, diltiazem), captopril, gentamicin, carvedilol, amiodarone, and spironolactone increase digoxin levels, and amiodarone, diltiazem, and verapamil also inhibit atrioventricular conduction.
• Sympathomimetics used with digoxin may increase the risk of arrhythmias.
• Concomitant use of digitalis glycosides with calcium channel blockers (e.g., verapamil, diltiazem, nifedipine) may lead to increased digoxin levels.
• Diuretics or potassium-depleting medicines may enhance digoxin toxicity.
• Erythromycin, tetracyclines, indomethacin, and propafenone may increase digoxin absorption.
• Potassium salts used with digoxin may lead to increased potassium levels in the blood.
• Cholestyramine, colestipol, and antacids may decrease digoxin absorption and reduce its half-life in serum by about 50%.
• Digoxin serum levels may be decreased during concomitant use of certain cytostatics, phenytoin, metoclopramide, penicillamine, and herbal medicines containing St. John's Wort (Hypericum perforatum).
• Clarithromycin may increase digoxin toxicity.

Digoxin Teva with Food and Drink

It is best to take the medicine before meals. However, if taking the medicine on an empty stomach causes stomach upset, the medicine can be taken during meals. In this case, the patient should avoid eating foods high in fiber (bran, whole wheat bread), as they may decrease the absorption of the medicine into the bloodstream.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Digoxin Teva may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Digoxin passes into breast milk in small amounts. During treatment with the medicine, breastfeeding women should exercise caution.

Driving and Using Machines

Digoxin Teva does not affect psychophysical abilities, unless side effects such as dizziness or vision disturbances occur.

Important Information about Some Ingredients of Digoxin Teva

Digoxin Teva contains lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. HOW TO TAKE DIGOXIN TEVA

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.
Digoxin Teva should be taken strictly according to the doctor's instructions. It is usually taken once a day. The patient should aim to take the medicine at regular intervals (e.g., at the same time every day).
The dosage of digoxin is determined individually for each patient by the doctor, depending on the indication, age, body weight, kidney function, and serum electrolyte levels.
During treatment, the doctor will modify the dosage based on the patient's response to the medicine.
In case of discrepancies between the expected and actual effect, it is recommended to modify the dosage by the doctor, based on clinical symptoms and serum digoxin levels. Monitoring digoxin levels may be helpful in managing therapy and diagnosing overdose. Digoxin serum levels below 0.8 ng/ml rarely cause toxicity symptoms. In about 2/3 of patients with digoxin toxicity symptoms, levels above 2 ng/ml are found. Levels above 3 ng/ml almost always cause toxicity symptoms.
Adults
Treatment with digoxin starts with a loading dose.

For rapid loading, the initial dose is 500 μg to 750 μg.
Then, 125 μg to 375 μg is administered every 6-8 hours, up to a total loading dose of 750 μg to 1500 μg given in the first 24 hours. The loading dose depends on body weight and is 10 μg to 15 μg/kg/day, given in 2-3 doses every 6-8 hours.

For slow loading, 250 μg to 750 μg is administered daily, which in patients with normal kidney function leads to a steady-state level in 6-7 days.
The usual maintenance dose is 250 μg once or twice daily. In patients under 60 years of age with normal kidney function, the maintenance dose ensuring therapeutic serum levels is usually 375 μg; between 60 and 80 years of age, it is 250 μg of digoxin per day.

Use in Children and Adolescents

In children, the daily dose is determined based on age and body weight and is given in 3-4 divided doses.

• Infants and children up to 2 years of age:
• loading dose: 20 to 35 μg/kg
• maintenance dose: 5 to 9 μg/kg (25%-35% of the loading dose)

Children from 2 to 12 years of age:

• loading dose: 10 to 15 μg/kg
• maintenance dose: 3 to 5 μg/kg

Patients with Renal Impairment

In patients with renal impairment, the dosage should be adjusted based on creatinine clearance.

Creatinine Clearance (ml/min) Maintenance Dose

• 50 – 59
• 188 – 375 μg per day
• 20 – 49
• 125 – 250 μg per day; below 20: 125 μg per day or every 48 hours

Taking a Higher Than Recommended Dose of Digoxin Teva

Symptoms
The following digoxin toxicity symptoms may occur: weakness, loss of appetite, nausea, vomiting, diarrhea, yellow vision, double vision, dizziness, and headaches, mental and motor agitation, confusion, disorientation, anxiety, visual hallucinations, hypotension, bradycardia or tachycardia, and arrhythmias. In acute toxicity, high calcium levels occur, while in chronic toxicity, low potassium levels are found in the serum. Acute poisonings occur more frequently in children than in adults.

Procedure
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor.
In the treatment of digoxin toxicity, the doctor may recommend gastric lavage with activated charcoal in severe cases. Cholestyramine, atropine, or ipratropium bromide, lidocaine, or phenytoin, beta-adrenolytics, potassium preparations, and sometimes temporary electrical cardiac pacing may be administered.

Missing a Dose of Digoxin Teva

Do not take a double dose to make up for a missed dose of Digoxin Teva.

Stopping Digoxin Teva Treatment

Do not stop taking the medicine, as the heart condition may worsen. Consult your doctor if you plan to stop taking Digoxin Teva.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
In case of any further doubts about the use of the medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Digoxin Teva can cause side effects, although not everybody gets them.
Side effects usually occur if the dose of the medicine taken by the patient is too high.
The doctor should adjust the dose of the medicine in such cases.

Inform Your Doctor Immediately If:

• You experience palpitations, chest pain, shortness of breath, or increased sweating. These may be symptoms of a serious heart rhythm disorder caused by arrhythmia.

Other side effects that should be reported to the doctor include:
Common (more than 1 in 100 patients, but less than 1 in 10 patients)

• Slow or irregular heart rhythm
• Nausea, vomiting
• Rash with urticaria
• Drowsiness, dizziness
• Vision disturbances (blurred or yellow vision)

Uncommon (more than 1 in 1000 patients, but less than 1 in 100 patients)

• Depression

Rare (less than 1 in 1000 patients)

• Thrombocytopenia (decreased platelet count)
• Anorexia
• Abdominal pain due to ischemia or intestinal injury
• Headaches
• Psychiatric disorders (psychosis, apathy, disorientation)
• Feeling of fatigue, weakness, general malaise
• Gynecomastia (breast enlargement in men)
• Arrhythmias

Digoxin Teva may rarely cause severe irregular heart rhythm. The doctor should recommend regular tests to ensure that Digoxin Teva is working properly.
Reporting Side Effects
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. HOW TO STORE DIGOXIN TEVA

Store in a temperature below 25°C.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Digoxin Teva Contains

• The active substance is digoxin.
• The other ingredients are lactose monohydrate, powdered cellulose, colloidal anhydrous silica, talc, magnesium stearate.

What Digoxin Teva Looks Like and Contents of the Pack

• Digoxin Teva, 100 μg, tablets
• White, round tablets with a smooth surface.
• Digoxin Teva, 250 μg, tablets
• White, convex tablets with a smooth surface and a score line on one side.

1 blister pack of 30 tablets (30 units) in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Date of Last Revision of the Leaflet:April 2022