Digoxin Kern Pharma 0.25 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Digoxin Kern Pharma 0.25 mg tablets

Read the entire patient information leaflet carefully before you start taking the medicine. Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist. This medicine has been prescribed for you and you should not give it to others, even if they have the same symptoms, as it may harm them. If you think any of the side effects you experience are serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Package leaflet:

1. What Digoxina Kern Pharma is and what it is used for
2. What you need to know before taking Digoxina Kern Pharma
3. How to take Digoxina Kern Pharma
4. Possible side effects
5. How to store Digoxina Kern Pharma
6. Contents of the pack and other information

1. What Digoxina Kern Pharma is and what it is used for

Digoxina Kern Pharma belongs to a group of medicines called cardiac glycosides. Its active substance is digoxin, which increases the force of contraction of the heart muscle by specifically inhibiting an enzyme known as sodium-potassium-dependent adenosine triphosphatase (Na+/K+ ATPase).

This medicine is indicated in the treatment of certain heart conditions, such as:

• Chronic heart failure where the main problem is systolic dysfunction (abnormalities in the heart's contraction),
• when heart failure is accompanied by atrial fibrillation (abnormal heart rhythm or rate originating when the muscle of the upper chambers of the heart (atria) does not contract uniformly),
• in the treatment of certain supraventricular arrhythmias (disorders of heart rate or rhythm originating in the atria), especially atrial flutter (rapid heart rate) and atrial fibrillation (abnormal heart rhythm or rate originating when the muscle of the upper chambers of the heart (atria) does not contract uniformly), the main benefit being the reduction of ventricular rate (slower heartbeat).

2. What you need to know before starting to take

Do not take Digoxina Kern Pharma

• if you are allergic to digoxin, to other digitalis glycosides, or to any of the other ingredients of this medicine,
• if you have been told that you have any of the following heart problems:
  • intermittent heart block or second-degree atrioventricular block (abnormalities in the transmission of electrical impulses between the upper and lower chambers of the heart), especially if you have a history of a heart condition called Stokes-Adams syndrome,
  • certain types of "supraventricular arrhythmias", such as in Wolff-Parkinson-White syndrome (a hereditary heart disorder),
  • "ventricular tachycardia" (a fast heartbeat originating in the ventricles) or "ventricular fibrillation" (a very abnormal heart rhythm (arrhythmia) that can be life-threatening),
  • "obstructive hypertrophic cardiomyopathy" (a condition in which there is excessive growth of heart muscle),
• if you have arrhythmias caused by poisoning with other cardiac glycosides (heart medications),
• if you have a known or suspected accessory pathway (an abnormal electrical connection between the atrium and ventricle) and no history of previous supraventricular arrhythmias, this medicine is also contraindicated.

Warnings and precautions

This medicine must be used only under the supervision and control of a physician. Consult your doctor or pharmacist before starting to take this medicine in any of the following cases:

• if you have recently had a myocardial infarction (heart attack), digoxin should be used with caution,
• if you are being treated with diuretics and an ACE inhibitor (medications for the heart and high blood pressure), or with diuretics alone, since discontinuation of digoxin may lead to worsening of your condition,
• if you have taken cardiac glycosides (heart medications) within the previous two weeks before starting digoxin treatment, your doctor should consider reducing the initial dose,
• if administered to elderly patients or patients with impaired renal function, your doctor should consider reducing both the initial and maintenance doses,
• once you are already on digoxin treatment, your doctor should periodically monitor your serum electrolytes and renal function (levels of an enzyme called serum creatinine). The frequency of monitoring depends on the severity of the case,
• if you have severe respiratory disease, as the myocardium (heart muscle) may be more sensitive to digoxin,
• if you have low blood potassium levels, as this increases the sensitivity of the myocardium (heart muscle) to the effects of digoxin,
• if you have hypoxia (low oxygen levels in the blood), hypomagnesemia (low magnesium levels in the blood), or marked hypercalcemia (high calcium levels in the blood), as these conditions increase the sensitivity of the myocardium (heart muscle) to digoxin,
• if you have thyroid disease, you should use this medicine with caution. The initial and maintenance doses of digoxin should be reduced when thyroid function is low. In cases of hyperthyroidism (high levels of thyroid hormone in the blood), there is relative resistance to digoxin (reduced drug activity), and the dose may need to be increased. During treatment of thyrotoxicosis (excess thyroid hormones), the dose should be reduced as the condition is brought under control,
• patients with malabsorption syndrome (difficulty in properly absorbing vitamins, minerals, and other nutrients from food) or gastrointestinal reconstructions may require higher doses of digoxin.

Use of Digoxina Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Agents that cause hypokalemia or intracellular potassium deficiency may increase sensitivity to digoxin; these include certain diuretics (medicines to help eliminate fluids), lithium salts, corticosteroids (anti-inflammatory medicines), and carbenoxolone (a medicine used to treat mouth ulcers).

Blood levels of digoxin may increase when taken together with the following medicines:

• Amiodarone, flecainide, prazosin, propafenone, quinidine, spironolactone (medicines for the heart).
• Calcium channel blockers and ACE inhibitors (medicines for high blood pressure).
• Erythromycin, tetracycline, gentamicin, itraconazole, trimethoprim (antibiotic medicines).
• Quinine (a medicine used to treat malaria).
• Alprazolam, lithium salts (a medicine used for depression).
• Diphenoxylate with atropine (a combination medicine used as an antidiarrheal).
• Indomethacin.
• Propantheline (a medicine used to treat ulcers).

Blood levels of digoxin may decrease when taken together with the following medicines:

• Antacids.
• Some laxatives.
• Kaolin-pectin (an antidiarrheal medicine).
• Neomycin, penicillamine, rifampicin (antibiotic medicines).
• Some cytostatic agents (medicines used in cancer treatment).
• Metoclopramide (a medicine used to treat vomiting).
• Sulfasalazine (an anti-inflammatory stomach medicine).
• Adrenaline (a hormone).
• Salbutamol (a medicine used to treat asthma).
• Colestipol (a medicine used to treat high cholesterol).
• Phenytoin (a medicine used to treat epilepsy).
• Inform your doctor if you are taking a medicine containing enzalutamide (used to treat prostate cancer). It may interfere with your digoxin tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

As with all medicines, digoxin should only be used during pregnancy if the expected clinical benefit to the mother outweighs any possible risk to the fetus.

Although digoxin passes into breast milk, the amounts are minimal.

Driving and using machines

There are no data available on how digoxin affects the ability to drive or operate machinery. Therefore, avoid performing tasks that require special attention until you know how you tolerate the medicine.

Digoxina Kern Pharma contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Dogoxina Kern Pharma

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The digoxin dose for each patient must be individually determined based on age, lean body weight, and renal function. The suggested doses are intended only as an initial guide.

Your doctor must take into account the differences in effects between oral and injectable administration of digoxin when switching from one pharmaceutical form to another. For example, if a patient is switched from the oral to the intravenous formulation, the dose should be reduced by at least 33%.

The normal dose is:

Adults and children over 10 years of age:

Loading dose (initial dose):

• Rapid oral administration:

750 to 1500 micrograms (0.75 to 1.5 mg) as a single dose.

• Slow oral administration:

250 to 750 micrograms (0.25 to 0.75 mg) should be administered daily for 1 week.

Maintenance dose:

Your doctor will determine your maintenance dose depending on your response to initial treatment with this medicine.

On average, most patients will be maintained on 125 to 750 micrograms (0.125 to 0.75 mg) of digoxin per day. However, in patients who show increased sensitivity to adverse reactions of digoxin, a daily dose of 62.5 micrograms (0.0625 mg) or lower may be sufficient.

Newborns, infants, and children under 10 years of age (if they have not received cardiac glycosides in the preceding two weeks):

Oral loading dose:

Doses in children depend on their weight.

However, these doses range between 25 and 45 micrograms over 24 hours.

The loading dose should be administered in divided doses, with approximately half of the total dose given as the first dose, and additional fractions of the total dose administered at intervals of 4 to 8 hours, with clinical response evaluated before each additional dose.

Maintenance dose:

Your doctor will determine the maintenance dose based on the child's response to initial treatment with this medicine.

On average, most patients will be maintained at 20% to 25% of the loading dose, administered every 24 hours.

If you take more Digoxina Kern Pharma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Digoxina Kern Pharma

Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, digoxin may cause adverse effects, although not everyone experiences them.

In general, adverse reactions to digoxin are dose-dependent and occur at doses higher than those required to achieve a therapeutic effect. Consequently, adverse reactions are less common when digoxin is used within the recommended dose range or within the therapeutic serum concentration range, and when careful attention is paid to concomitant conditions and medications.

Cardiac disorders:

Cardiac arrhythmias and disturbances in the heart's electrical conduction, including:

• Premature ventricular contractions, which may progress to bigeminy (a cardiac rhythm disorder in which normal heartbeats alternate with premature beats) or even trigeminy (a cardiac rhythm disorder in which two normal heartbeats alternate with one premature beat).
• Atrial tachycardias (a heart rhythm disorder (pulse), such as excessively rapid beats originating in the upper chambers of the heart). These are often accompanied by atrioventricular block (a disorder in the electrical conduction between the atria (upper chambers) and ventricles (lower chambers) of the heart), and the pulse is not always rapid (see section 2.).
• Changes in electrocardiogram results.
• Sinus bradycardia (a disorder causing a reduced heart rate). In children, this may be a sign of digoxin toxicity.
• In children, digoxin use may cause any type of arrhythmia. The most common are disturbances in electrical impulse conduction or supraventricular tachyarrhythmias (heart rhythm disturbances not originating in the ventricles).

Gastrointestinal disorders:

Anorexia, nausea, and vomiting, which resolve within a few hours after taking the medicine.

Diarrhea may also occur.

Oral digoxin has also been associated with intestinal ischaemia (interruption of blood supply to the intestine) and, rarely, intestinal necrosis (death of part of the intestine due to interruption of blood supply).

Reproductive system and breast disorders:

Gynaecomastia (breast development in males) may occur with long-term administration.

Nervous system disorders:

Reported effects include weakness, apathy, fatigue, malaise, headache, visual disturbances, depression, and even psychosis.

Skin and subcutaneous tissue disorders:

Skin rashes of urticarial type (red, itchy raised patches on the skin) or scarlatiniform type (generalized skin redness with small raised lesions).

Blood and lymphatic system disorders:

Marked eosinophilia (increased number of white blood cells in the blood).

Thrombocytopenia (decreased number of platelets in the blood).

If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet.

5. Storage of Digoxin Kern Pharma

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Digoxin Kern Pharma

• The active substance is digoxin.
• The other components are: lactose, maize starch, hydrolysed maize starch, and magnesium stearate.

Appearance of the product and contents of the pack

Round, biconvex tablets, white in colour, with a score line on both sides. The score line is intended to facilitate splitting and swallowing, but not for dividing the tablet into equal doses.

Packs containing 50 tablets or 500 tablets.

Other presentations

• Digoxin Kern Pharma 0.25 mg/ml injectable solution. Each pack contains 5 ampoules of 2 ml.
• Digoxin 0.05 mg/ml paediatric oral solution marketed under the name Lanacordin Paediatric. 60 ml bottle supplied with a dosing syringe.

Marketing Authorisation Holder and Manufacturer

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus, 72

08228 Terrassa (Barcelona)

Spain

Date of the most recent review of this leaflet: August 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

___________________________________________________________________________

This information is intended solely for physicians or healthcare professionals:

The greatest therapeutic benefit of digoxin is obtained in patients with ventricular dilatation.

DIRECTIONS FOR USE:

Intramuscular administration is painful and associated with muscle necrosis (death of cardiac muscle cells). This route is not recommended.

Rapid intravenous injection may cause vasoconstriction leading to hypertension and/or reduced coronary blood flow. Therefore, a slow injection rate is important in hypertensive heart failure and acute myocardial infarction.

Adults and children over 10 years of age:

Loading dose (initial dose):

• Rapid oral administration:

750 to 1500 micrograms (0.75 to 1.5 mg) as a single dose.

In less urgent cases, or when there is a higher risk of toxicity (e.g. in elderly patients), the oral loading dose should be administered in divided doses every six hours, with approximately half of the total dose given in the first dose. Clinical response should be evaluated before administering each additional dose (see section 2).

• Slow oral administration:

250 to 750 micrograms (0.25 to 0.75 mg) should be administered daily for 1 week, followed by an appropriate maintenance dose. A clinical response should be observed within one week.

NOTE: The choice between a slow or rapid oral digitalization regimen depends on the patient's clinical condition and the urgency of the clinical indication.

Maintenance dose:

Your doctor will determine your maintenance dose based on your response to initial treatment with this medicine.

On average, most patients are maintained on 125 to 750 micrograms (0.125 to 0.75 mg) of digoxin daily. However, in patients showing increased sensitivity to adverse effects of digoxin, a daily dose of 62.5 micrograms (0.0625 mg) or lower may be sufficient.

The maintenance dose should be based on the percentage of body stores lost each day through elimination. The following formula has been widely used clinically:

Maintenance dose = Maximum body stores × Daily loss (%)

100

Where:

• Maximum body stores = loading dose

Daily loss (%) = 14 + Creatinine clearance (Ccr) / 5

• Ccr is the creatinine clearance corrected for a body weight of 70 kg or 1.73 m² body surface area. If only serum creatinine concentrations (Scr) are available, Ccr (corrected for a body weight of 70 kg) in men is estimated as:

Ccr = (140 - age)

Scr (in mg/100 ml)

NOTE: When serum creatinine values are obtained in µmol/L, they can be converted to mg/100 ml (mg%) as follows:

Scr (mg/100 ml) = Scr (µmol/L) × 113.12

10,000

= Scr (µmol/L)

88.4

• Where 113.12 is the molecular weight of creatinine.
• In women, this result should be multiplied by 0.85.
• These formulas cannot be used for creatinine clearance in children.

In practice, this means that most patients are maintained on 125 to 750 micrograms (0.125 to 0.75 mg) of digoxin daily. However, in patients showing increased sensitivity to adverse effects of digoxin, a daily dose of 62.5 micrograms (0.0625 mg) or lower may be sufficient.

Newborns, infants, and children under 10 years of age (if they have not received cardiac glycosides in the preceding two weeks):

Oral loading dose:

Doses in children depend on body weight.

Nevertheless, these doses range between 25 and 45 micrograms per 24 hours.

The loading dose should be administered in divided doses, with approximately half of the total dose given as the first dose and additional fractions of the total dose administered at 4 to 8 hour intervals, with clinical response evaluated before each additional dose.

Maintenance:

Your doctor will determine the maintenance dose based on the child's response to initial treatment with this medicine.

On average, most patients will be maintained on 20% to 25% of the loading dose, administered every 24 hours.

In newborns, especially premature infants, renal clearance of digoxin is reduced and appropriate dose reductions should be considered beyond general dosing instructions.

After the newborn phase, children generally require proportionally higher doses than adults based on body weight or body surface area, as indicated in the table below. Children over 10 years of age require adult doses adjusted according to body weight.

• Oral loading dose:

This should be administered according to the following regimen:

Preterm newborns < 1.5 kg: 25 micrograms/kg over 24 hours.

Preterm newborns 1.5 kg - 2.5 kg: 30 micrograms/kg over 24 hours.

Term newborns up to 2 years: 45 micrograms/kg over 24 hours.

2 to 5 years: 35 micrograms/kg over 24 hours.

5 to 10 years: 25 micrograms/kg over 24 hours.

The loading dose should be administered in divided doses, with approximately half of the total dose given as the first dose and additional fractions of the total dose administered at 4 to 8 hour intervals, with clinical response evaluated before each additional dose.

• Maintenance:

The maintenance dose should be administered according to the following regimen:

Preterm newborns:

• Daily dose = 20% of the 24-hour loading dose (intravenous or oral).

Term newborns and children up to 10 years:

• Daily dose = 25% of the 24-hour loading dose (intravenous or oral).

These dosing regimens are intended as guidelines; careful clinical observation and monitoring of serum digoxin levels (see Monitoring) are required to adjust the dose in these paediatric patient groups.

If cardiac glycosides have been administered within the two weeks preceding the start of treatment with this medicine, optimal digoxin loading doses will be lower than those recommended above.

Cardiac glycosides are a significant cause of accidental poisoning in children. Newborn tolerance to cardiac glycosides is variable due to reduced renal clearance of the drug. Premature and immature newborns are especially sensitive.

Elderly:

The tendency towards impaired renal function and low lean body mass in the elderly affects the pharmacokinetics of this medicine such that high serum digoxin levels and associated toxicity may easily occur unless lower digoxin doses than those used in non-elderly patients are administered. Serum digoxin levels should be monitored regularly and hypokalaemia should be avoided.

Dose recommendations in specific patient groups:

See section "Warnings and precautions".

Monitoring:

Serum digoxin concentrations can be expressed in conventional units of ng/ml or in SI units of nmol/l. To convert ng/ml to nmol/l, multiply ng/ml by 1.28.

Serum digoxin concentration can be determined by radioimmunoassay. Blood should be drawn at least 6 hours or more after the last dose of this medicine. There are no strict guidelines on the optimal serum concentration range, but most patients benefit with minimal risk of developing signs and symptoms of toxicity at digoxin concentrations between 0.8 ng/ml (1.02 nmol/l) and 2.0 ng/ml (2.56 nmol/l). Above this range, signs and symptoms of toxicity may become more frequent, and levels above 3.0 ng/ml (3.84 nmol/l) are very likely to be toxic. However, when determining whether a patient's symptoms are due to digoxin, clinical status, serum potassium levels, and thyroid function are important factors to consider.

Other glycosides, including digoxin metabolites, may interfere with available assays; therefore, caution should be exercised when values do not appear consistent with the patient's clinical status.

SYMPTOMS OF OVERDOSE AND TREATMENT:

Adults:

In adults without heart disease, clinical observation indicates that a digoxin overdose of 10–15 mg was the dose that led to death in half of patients. If an adult without heart disease ingested more than 25 mg of digoxin, death or progressive toxicity would occur, which would respond only to administration of antibody fragments that bind digoxin.

Children:

In children aged 1 to 3 years without heart disease, clinical observation suggests that a digoxin overdose of 6 to 10 mg was the dose that led to death in half of patients. If more than 10 mg of digoxin were ingested by a child aged 1 to 3 years without heart disease, the outcome would be invariably fatal unless antibody fragments were administered.

After recent ingestion, whether accidental or intentional self-poisoning, the amount available for absorption may be reduced by gastric lavage.

In cases of massive digitalis ingestion, patients should receive large doses of activated charcoal to prevent absorption and to bind digoxin in the intestine during enteroenteric recirculation.

If hypokalaemia is present, it should be corrected with potassium supplements either orally or intravenously, depending on the urgency of the situation. In cases where a large amount of digoxin has been ingested, hyperkalaemia may occur due to potassium release from skeletal muscle. Serum potassium levels must be known before administering potassium in cases of digoxin overdose.

Bradycardic arrhythmias may respond to atropine, but temporary cardiac pacing may be required. Ventricular arrhythmias may respond to lignocaine (an anaesthetic medicine) or phenytoin (an antiepileptic medicine).

Dialysis is not particularly effective in removing digoxin from the body in life-threatening toxicity cases.

After intravenous administration of digoxin-specific antibody fragments (of ovine origin), a rapid reversal of complications associated with severe poisoning by digoxin, digitoxin, and related glycosides occurs.