Lanoxin

Patient Information Leaflet

LANOXIN 0.0625 mg Tablets, 0.125 mg Tablets, 0.250 mg Tablets

digoxin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LANOXIN is and what it is used for

LANOXIN contains the active substance digoxin, which belongs to a group of medicines called digitalis glycosides. These medicines work by reducing the heart rate and increasing the strength of the heart's contraction.
LANOXIN is indicated for:

• Treatment of chronic heart failure with predominant impairment of the heart's contraction (systolic dysfunction). Its effects are more evident if you have an increased volume of the ventricles (the lower chambers of the heart). Digoxin is particularly indicated when heart failure is accompanied by an abnormal heart rhythm (atrial fibrillation).
• Treatment of certain heart rhythm disorders, such as chronic atrial fibrillation and atrial flutter, in order to reduce the ventricular response rate.

Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before taking LANOXIN

Do not take LANOXIN

• if you are allergic to digoxin, to other cardiac glycosides, or to any of the other ingredients of this medicine (listed in section 6).
• if you have intermittent complete heart block (inconsistent complete block of impulse transmission from the heart chambers receiving blood, the atria, to the chambers pumping blood out of the heart, the ventricles) or second-degree atrioventricular block (failure of some impulses to reach the ventricles), especially if you have a history of Stokes-Adams attacks (sudden drop in blood pressure causing temporary loss of consciousness).
• if you have arrhythmias (abnormal heart rhythms) caused by intoxication with cardioactive glycosides (medicines that increase the force of heart contraction).
• if you have supraventricular arrhythmias (heart beating too fast, too slow, or with a completely irregular rhythm), such as in Wolff-Parkinson-White syndrome (a condition that may cause frequent palpitations and tachycardias).
• if you have increased heart rate (ventricular tachycardia) or an abnormal heart rhythm originating in the ventricles (ventricular fibrillation).
• if you suffer from increased thickness of the heart walls (obstructive hypertrophic cardiomyopathy), unless you also have atrial fibrillation or heart failure; even in such cases, digoxin must be used with extreme caution.

Warnings and precautions
Talk to your doctor or pharmacist before taking LANOXIN.
Intoxication with LANOXIN may cause irregular heartbeats. This effect may resemble the conditions for which the medicine is prescribed.
Many of the benefits of LANOXIN in treating irregular heartbeats (arrhythmias) are due to its ability to slow down electrical impulse conduction in the heart. If such slowing already exists, your doctor must consider that your condition could worsen with LANOXIN therapy.
If you have recently had a heart attack (myocardial infarction), your doctor will assess whether using digoxin or similar-acting medicines might, in this case, increase the heart's oxygen demand. Since the heart is damaged after an infarction, it may be unable to meet this increased demand, thereby increasing the risk of ischemia (the mechanism underlying infarction).
Inform your doctor if:

• you have low levels of potassium (hypokalemia), magnesium (hypomagnesemia), or blood oxygen (hypoxia), as these conditions increase the heart's sensitivity to medicines in the same class as digoxin (cardioactive glycosides);
• you have high levels of calcium in the blood (hypercalcemia), as this increases the heart's sensitivity to medicines in the same class as digoxin;
• you suffer from beri-beri heart disease due to vitamin B1 deficiency, because if the deficiency is not simultaneously treated, digoxin may not be effective;
• you have respiratory problems, as these increase the heart's sensitivity to medicines in the same class as digoxin;
• you have thyroid disorders; in this case, your doctor may need to adjust your digoxin dose;
• you have malabsorption syndrome (reduced intestinal absorption) or gastrointestinal reconstructions (previous intestinal surgeries), as your doctor may need to increase your digoxin dose;
• you have heart failure associated with cardiac amyloidosis (accumulation of a protein called amyloid in the heart muscle), in which case digoxin treatment should generally be avoided unless strictly necessary and no other drugs can control heart rate in atrial fibrillation;
• you have myocarditis (inflammation of the heart muscle), as digoxin may rarely trigger partial arterial closure and should therefore be avoided;
• you have constrictive pericarditis (inflammation and hardening of the pericardium, the outer membrane surrounding the heart), as digoxin should not be used unless needed to control ventricular rate during atrial fibrillation or to improve systolic dysfunction;
• you are taking diuretics (medicines that increase urine production and help reduce body fluid) alone or together with an ACE inhibitor (used mainly for treating high blood pressure). Do not stop taking digoxin tablets without consulting your doctor.

Inform your doctor that you are being treated with digoxin if you are scheduled for an exercise electrocardiogram, as digoxin may affect test results.
Your doctor will carefully evaluate the appropriate digoxin dose if you are elderly or have kidney problems.
Your doctor will periodically perform tests to monitor your blood electrolytes and kidney function.
If you have taken cardioactive glycosides (medicines for treating heart failure and certain irregular heartbeats) within the previous two weeks, your doctor should reassess initial dosing recommendations and may advise reducing the dose.

Other medicines and LANOXIN
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines. Some medicines may affect the action of LANOXIN.
In particular, inform your doctor if you are taking the following medicines:

• Medicines used to treat high blood pressure (antihypertensives), e.g., prazosin, telmisartan, verapamil, felodipine, and tiapamil
• Epoprostenol (used to reduce pulmonary hypertension) (transient effect)
• Medicines used to treat irregular heartbeats (antiarrhythmics), e.g., amiodarone, flecainide, propafenone, quinidine, dronedarone
• Diuretic medicines, e.g., spironolactone, tolvaptan, conivaptan, hydrochlorothiazide
• Medicines used to treat depression, e.g., nefazodone
• Flibanserin (used for low sexual desire in premenopausal women)
• St. John’s wort (Hypericum perforatum), used to treat depression
• Medicines used to treat anxiety (antipsychotics), e.g., lithium, alprazolam
• Corticosteroid medicines (used as anti-inflammatory agents and to suppress the immune system)
• Medicines used to treat stomach problems, including indigestion, diarrhea, and vomiting, e.g., carbenoxolone, propantheline, metoclopramide, bulk-forming laxatives, antacids, kaolin-pectin
• Calcium
• Antibiotics, e.g., erythromycin, clarithromycin, tetracyclines, gentamicin, trimethoprim, neomycin, rifampicin
• Penicillamine (used to treat rheumatoid arthritis)
• Medicines used to treat fungal infections (itraconazole, isavuconazole, posaconazole)
• Mirabegron (a medicine used to treat overactive bladder)
• Ivacaftor (for treating cystic fibrosis)
• Medicines used to treat malaria (antimalarials), e.g., quinine
• Cyclosporine (a medicine used to prevent organ transplant rejection)
• Medicines used to treat infections, e.g., indomethacin, sulfasalazine
• Medicines used to treat heart conditions, e.g., carvedilol, ranolazine, nifedipine, diltiazem
• Medicines used to treat epilepsy, e.g., phenytoin
• Medicines used to treat diabetes, e.g., acarbose or canagliflozin
• Medicines used to treat cancer, e.g., lapatinib, vandetanib, vemurafenib, osimertinib
• Medicines used to lower blood cholesterol, e.g., atorvastatin, cholestyramine
• Medicines used to treat asthma, e.g., salbutamol
• Adrenaline and dopamine
• Medicines used to treat viral infections, e.g., ritonavir/ritonavir-containing regimens, telaprevir, simeprevir, velpatasvir, daclatasvir
• Medicines used to reduce platelet aggregation and prevent blood clots, e.g., ticagrelor
• Suxamethonium (a general anesthetic)
• Medicines for depression and smoking cessation (bupropion)
• Supplemental enteral nutrition (administration of nutrients directly into the stomach or intestine via special tubes when the patient is not adequately fed orally)
• If you have heart failure and are taking sennosides (medicines that increase stool volume to promote bowel movements) together with LANOXIN, you may have a moderately increased risk of digoxin toxicity
• Venetoclax (used to treat patients with chronic lymphocytic leukemia)
• Proton pump inhibitors (PPIs) (used to relieve symptoms of acid reflux or gastroesophageal reflux disease).

Beta-blocking medicines, which slow heart rate and cardiac workload: digoxin may increase conduction time to the ventricles. Medicines affecting renal blood vessel tone may alter kidney blood purification mechanisms.
ACE inhibitors, angiotensin receptor blockers (ARBs), antihypertensives, non-steroidal anti-inflammatory drugs (NSAIDs), and cyclooxygenase-2 inhibitors (painkillers) have not significantly altered the pharmacokinetics (absorption to elimination) of digoxin. However, these medicines may alter kidney function in some patients, resulting in a secondary increase in digoxin levels due to reduced renal elimination.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of LANOXIN during pregnancy is not contraindicated; however, your doctor may consider it necessary to adjust the dose during pregnancy.
Your doctor will evaluate the benefits of LANOXIN therapy for you against potential risks to the fetus.
Breastfeeding
Breastfeeding is not contraindicated.
Newborns and premature infants
Your doctor may need to adjust the dose of LANOXIN in newborns and premature infants.

Driving and using machines
If you experience visual disturbances or nervous system side effects, exercise caution before driving vehicles or operating machinery.

LANOXIN tablets contain lactose; if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take LANOXIN

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
Your doctor will determine the appropriate dose of digoxin for you based on your age, body weight, and renal function.
If you take more LANOXIN than you should
In case of accidental ingestion/overdose of LANOXIN, contact your doctor immediately or go to the nearest hospital.
If you take more LANOXIN than you should, you may experience symptoms similar to those described in the section “Possible side effects”, but these may be more frequent and more severe.
Adults
Effects on the heart
If you take more LANOXIN than you should, the most common symptoms are heart-related problems, such as irregular heartbeat and changes in heart tests.
If you have recently taken more LANOXIN than you should in high doses, this may lead to increased levels of potassium in the blood, which can contribute to the occurrence of irregular heartbeat.
Other effects
If you take more LANOXIN than you should, gastrointestinal disorders and nervous system disturbances may also commonly occur. Symptoms may include: anorexia, nausea and vomiting, dizziness, nervous system disturbances, fatigue, malaise, and visual disturbances. Gastrointestinal disorders may precede heart problems. If you experience long-term toxicity, you may mainly have general symptoms such as malaise and weakness.
Children
Most symptoms in children occur during or immediately after the initial phase of treatment with LANOXIN.
Effects on the heart
Children may experience the same heart-related effects as adults.
Other effects
Other common effects are similar to those observed in adults. However, nausea and vomiting are not common in neonates and younger children. Symptoms may include: weight loss in older children, inadequate growth in neonates, reduced blood flow in the mesenteric artery (intestinal artery) causing abdominal pain, somnolence, and behavioral disturbances including psychotic episodes.
Treatment
If you have recently taken more LANOXIN than you should, your doctor may need to perform gastric lavage.
If you have ingested high doses of LANOXIN, you may need to be treated with high-dose activated charcoal.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In general, digoxin side effects are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect.
The side effects listed below are arranged in order of frequency. Side effects reported after marketing authorisation have been classified as rare or very rare (including isolated cases).

Common (may affect up to 1 in 10 people)

• central nervous system disorders, dizziness
• visual disturbances (blurred or yellow vision)
• arrhythmia (irregular heartbeat), electrocardiogram abnormalities (conduction disturbances, bigeminy, trigeminy, PR segment prolongation, sinus bradycardia)
• heart block (a disorder in the conduction of electrical impulses in the heart)
• nausea, vomiting, diarrhoea
• urticarial or scarlatiniform skin rashes (appearance of raised red patches on the skin), which may be accompanied by marked eosinophilia (increase in eosinophils, a type of white blood cells) in the blood

Uncommon (may affect up to 1 in 100 people)

• depression

Very rare (may affect up to 1 in 10,000 people)

• thrombocytopenia (reduction in platelets)
• anorexia
• psychosis (altered mental state), apathy (state of indifference), confusion
• headache
• changes in heart rate and rhythm (supraventricular tachyarrhythmia, atrial tachycardia (with or without block), junctional tachycardia (of the atrioventricular junction), ventricular arrhythmia, premature ventricular contractions), electrocardiogram abnormalities (ST segment depression)
• intestinal ischaemia (reduced blood supply to the intestine), intestinal necrosis (death of intestinal tissue)
• gynaecomastia (enlargement of the breasts) may occur with long-term administration
• fatigue, malaise, weakness

Not known: frequency cannot be estimated from the available data

• abdominal pain

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LANOXIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp.
The expiry date refers to the product stored in its original, undamaged packaging under the recommended storage conditions.
Store in the original packaging to protect the medicine from moisture.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LANOXIN contains
LANOXIN 0.0625 mg Tablets

• The active substance is digoxin. One tablet contains 0.0625 mg of digoxin.
• The other components are: lactose, corn starch, rice starch, modified corn starch, povidone, indigo carmine (E132), magnesium stearate.

LANOXIN 0.125 mg Tablets

• The active substance is digoxin. One tablet contains 0.125 mg of digoxin.
• The other components are: lactose, corn starch, rice starch, modified corn starch, magnesium stearate.

LANOXIN 0.250 mg Tablets

• The active substance is digoxin. One tablet contains 0.250 mg of digoxin.
• The other components are: lactose, corn starch, rice starch, modified corn starch, magnesium stearate.

Description of the appearance of LANOXIN and pack contents
Blister packs of 30 tablets of 0.0625 mg, 0.125 mg and 0.250 mg.
Marketing Authorization Holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Tel: +39 0687 502 429
Manufacturer
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D23843 Bad Oldesloe, Germany

Patient Information Leaflet: Information for the patient

LANOXIN 0.5 mg/2 ml Injectable Solution

digoxin
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What LANOXIN is and what it is used for
2. What you need to know before taking LANOXIN
3. How to take LANOXIN
4. Possible side effects
5. How to store LANOXIN
6. Package contents and other information

1. What LANOXIN is and what it is used for

LANOXIN contains the active substance digoxin, which belongs to a group of medicines called digitalic glycosides. These medicines work by reducing the heart rate and increasing the force of the heart's contractions.
LANOXIN is indicated for:

• Treatment of chronic heart failure with predominant impairment of heart contraction (systolic dysfunction). Its effects are more evident if you have an increased volume of the ventricles (lower chambers of the heart). Digoxin is particularly indicated when heart failure is accompanied by an abnormal heart rhythm (atrial fibrillation).
• Treatment of certain disturbances of the heart rhythm, such as chronic atrial fibrillation and atrial flutter, in order to reduce the ventricular response rate.

Talk to your doctor if you do not feel better or if you feel worse.

2. What you should know before taking LANOXIN

Do not take LANOXIN

• if you are allergic to digoxin, to other cardiac glycosides, or to any of the other ingredients of this medicine (listed in section 6).
• if you have intermittent complete heart block (incomplete and unstable conduction of electrical impulses from the heart chambers receiving blood, the atria, to the chambers pumping blood out of the heart, the ventricles), or second-degree atrioventricular block (failure of some impulses to reach the ventricles), especially if you have a history of Stokes-Adams attacks (sudden drop in blood pressure causing temporary loss of consciousness).
• if you have arrhythmias (abnormal heart rhythms) caused by intoxication with cardioactive glycosides (medicines that increase the force of heart contractions).
• if you have supraventricular arrhythmias (the heart beats too fast, too slow, or irregularly), such as in Wolff-Parkinson-White syndrome (a condition that may cause frequent palpitations and tachycardias).
• if you have increased heart rate (ventricular tachycardia) or an abnormal heart rhythm originating in the ventricles (ventricular fibrillation).
• if you have thickened heart walls (obstructive hypertrophic cardiomyopathy), unless you also have atrial fibrillation or heart failure; even in such cases, extreme caution is required when using digoxin.

Warnings and precautions
Talk to your doctor or pharmacist before taking LANOXIN.
Toxicity with LANOXIN may cause irregular heartbeats. This effect may resemble the conditions for which the medicine is prescribed.
Many of the benefits of LANOXIN in treating irregular heartbeats (arrhythmias) are due to its ability to slow down electrical conduction in the heart. If such slowing already exists, your doctor must consider that your condition could worsen with LANOXIN therapy.
If you have recently had a heart attack (myocardial infarction), your doctor will assess whether using digoxin or similar-acting medicines might increase the heart's oxygen demand. Since the heart is already damaged by the infarction, it may not meet this increased demand, thereby increasing the risk of ischemia (the mechanism underlying heart attacks).
Inform your doctor if:

• you have low levels of potassium (hypokalemia), magnesium (hypomagnesemia), or blood oxygen (hypoxia), as these conditions increase the heart's sensitivity to medicines in the same group as digoxin (cardiac glycosides);
• you have high levels of calcium in the blood (hypercalcemia), as this increases the heart's sensitivity to medicines in the same group as digoxin;
• you suffer from beriberi heart disease due to vitamin B1 deficiency, because if the deficiency is not simultaneously treated, digoxin may not be effective;
• you have respiratory problems, as these increase the heart's sensitivity to medicines in the same group as digoxin;
• you have thyroid problems, in which case your doctor may need to adjust your digoxin dose;
• you have malabsorption syndrome (reduced intestinal absorption) or gastrointestinal reconstructions (previous intestinal surgeries), as your doctor may need to increase your digoxin dose;
• you have heart failure associated with cardiac amyloidosis (accumulation of a protein called amyloid in the heart muscle), in which case digoxin treatment should generally be avoided unless strictly necessary and no other drugs can control heart rate in atrial fibrillation;
• you have myocarditis (inflammation of the heart muscle), as digoxin may rarely trigger partial closure of arteries and should therefore be avoided;
• you have constrictive pericarditis (inflammation and stiffening of the pericardium, the outer membrane surrounding the heart), as digoxin should not be used unless needed to control ventricular rate during atrial fibrillation or to improve systolic dysfunction;
• you are taking diuretics (medicines that increase urine production and help reduce body fluid) alone or together with an ACE inhibitor (used mainly for treating high blood pressure). Do not stop taking digoxin without consulting your doctor.

Inform your doctor that you are being treated with digoxin if you are scheduled for an exercise electrocardiogram, as digoxin may affect test results.
Your doctor will carefully evaluate the appropriate digoxin dose if you are elderly or have kidney problems.
Your doctor will periodically perform tests to monitor your blood electrolytes and kidney function.
If you have taken cardioactive glycosides (medicines for treating heart failure and certain irregular heartbeats) within the past two weeks, your doctor should reassess the recommended initial dose and may advise reducing it.

For athletes
Medicines containing ethyl alcohol may lead to positive results in anti-doping tests, depending on the blood alcohol concentration limits set by certain sports federations.

Other medicines and LANOXIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can affect the action of LANOXIN.
In particular, inform your doctor if you are taking any of the following medicines:

• Medicines used to treat high blood pressure (antihypertensives), e.g. prazosin, telmisartan, verapamil, felodipine, and tiapamil
• Epoprostenol (used to reduce pulmonary hypertension) (transient effect)
• Medicines used to treat irregular heartbeats (antiarrhythmics), e.g. amiodarone, flecainide, propafenone, quinidine, dronedarone
• Diuretic medicines, e.g. spironolactone, tolvaptan, conivaptan, hydrochlorothiazide
• Medicines used to treat depression, e.g. nefazodone
• Flibanserin (used for low sexual desire in premenopausal women)
• St. John’s wort (Hypericum perforatum), used to treat depression
• Medicines used to treat anxiety (antipsychotics), e.g. lithium, alprazolam
• Corticosteroids (used as anti-inflammatory agents and to suppress the immune system)
• Medicines used to treat stomach problems, including indigestion, diarrhea, and vomiting, e.g. carbenoxolone, propantheline, metoclopramide, bulk-forming laxatives, antacids, kaolin-pectin
• Calcium
• Antibiotics, e.g. erythromycin, clarithromycin, tetracyclines, gentamicin, trimethoprim, neomycin, rifampicin
• Penicillamine (used to treat rheumatoid arthritis)
• Medicines used to treat fungal infections (itraconazole, isavuconazole, and posaconazole)
• Mirabegron (a medicine used to treat overactive bladder)
• Ivacaftor (for treating cystic fibrosis)
• Medicines used to treat malaria (antimalarials), e.g. quinine
• Cyclosporine (a medicine used to prevent organ transplant rejection)
• Medicines used to treat infections, e.g. indomethacin, sulfasalazine
• Medicines used to treat heart conditions, e.g. carvedilol, ranolazine, nifedipine, diltiazem
• Medicines used to treat epilepsy, e.g. phenytoin
• Medicines used to treat diabetes, e.g. acarbose or canagliflozin
• Medicines used to treat cancers, e.g. lapatinib, vandetanib, vemurafenib, osimertinib
• Medicines used to lower blood cholesterol, e.g. atorvastatin, cholestyramine
• Medicines used to treat asthma, e.g. salbutamol
• Adrenaline and dopamine
• Medicines used to treat viral infections, e.g. ritonavir/ritonavir-containing regimens, telaprevir, simeprevir, velpatasvir, daclatasvir
• Medicines used to reduce platelet aggregation and prevent blood clots, e.g. ticagrelor
• Suxamethonium (a general anesthetic), medicines for depression, and medicines used to quit smoking (bupropion)
• Supplemental enteral nutrition (administration of nutrients directly into the stomach or intestine via special tubes when the patient is not adequately fed orally)
• If you have heart failure and are taking sennosides (medicines that increase stool volume to promote bowel movements) together with LANOXIN, you may have a moderately increased risk of digoxin toxicity
• Venetoclax (used to treat patients with chronic lymphocytic leukemia)
• Proton pump inhibitors (PPIs) (used to relieve symptoms of acid reflux or gastroesophageal reflux disease).

Beta-blocking medicines, which slow heart rate and cardiac workload: digoxin may increase conduction time to the ventricles. Medicines that alter renal vascular tone may affect kidney clearance mechanisms.
Angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor antagonists (ARBs), antihypertensives, non-steroidal anti-inflammatory drugs (NSAIDs), and cyclooxygenase-2 inhibitors (painkillers) have not significantly altered the pharmacokinetics (absorption to elimination) of digoxin.
However, these medicines may alter kidney function in some patients, resulting in a secondary increase in digoxin levels due to reduced renal elimination.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The use of LANOXIN during pregnancy is not contraindicated; however, your doctor may consider it necessary to adjust the dose during pregnancy.
Your doctor will evaluate the benefits of LANOXIN therapy for you against the potential risks to the fetus.

Breastfeeding
Breastfeeding is not contraindicated.

Newborns and premature infants
Your doctor may need to adjust the dose of LANOXIN in newborns and premature infants.

Driving and using machines
If you experience visual disturbances or nervous system effects, you should exercise caution before driving vehicles or operating machinery.

LANOXIN contains ethanol
This medicine contains 10 vol% ethanol (alcohol), i.e., up to 176 mg per dose, equivalent to 5 ml of beer or 2 ml of wine per dose.
It may be harmful for alcoholics.
This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.

3. How to take LANOXIN

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.

Your doctor will determine the appropriate dose of digoxin for you based on your age, body weight, and kidney function.

If you take more LANOXIN than you should

If you accidentally ingest/overdose on LANOXIN, contact your doctor immediately or go to the nearest hospital.

If you take more LANOXIN than prescribed, you may experience symptoms similar to those described in the section “Possible side effects”, but they may occur more frequently and be more severe.

Adults

Effects on the heart
If you take more LANOXIN than you should, the most common symptoms are heart-related problems, such as irregular heartbeat and changes in heart tests.

If you have recently taken higher-than-prescribed doses of LANOXIN, this may lead to increased potassium levels in the blood, which can contribute to the occurrence of irregular heartbeat.

Other effects
If you take more LANOXIN than you should, you may also commonly experience gastrointestinal disorders and nervous system disturbances. Symptoms may include: anorexia, nausea and vomiting, dizziness, nervous system disturbances, fatigue, malaise, and visual disturbances. Gastrointestinal symptoms may precede heart problems. If you experience long-term toxicity, you may mainly have general symptoms such as malaise and weakness.

Children

Most symptoms in children occur during or immediately after the initial phase of treatment with LANOXIN.

Effects on the heart
Children may experience the same heart-related effects as adults.

Other effects
Other frequent effects are similar to those observed in adults. However, nausea and vomiting are not common in neonates and younger children. Symptoms may include: weight loss in older children, inadequate growth in neonates, reduced blood flow in the mesenteric artery (intestinal artery) with abdominal pain, drowsiness, and behavioral disturbances including psychotic episodes.

Treatment

If you have recently taken more LANOXIN than you should, your doctor may need to perform gastric lavage.

If you have ingested high doses of LANOXIN, you may need to be treated with high-dose activated charcoal.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In general, digoxin side effects are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect.
The side effects are listed below by frequency. Side effects reported after marketing authorization have been classified as rare or very rare (including isolated cases).

Common (may affect up to 1 in 10 people)

• central nervous system disorders, dizziness
• visual disturbances (blurred or yellow vision)
• arrhythmia (irregular heartbeat), electrocardiogram changes (conduction disturbances, bigeminy, trigeminy, PR interval prolongation, sinus bradycardia)
• heart block (a disorder in the conduction of electrical impulses in the heart)
• nausea, vomiting, diarrhoea
• urticarial or scarlatiniform skin rashes (raised red patches on the skin), which may be accompanied by marked eosinophilia (increase in eosinophils, a type of white blood cells) in the blood

Uncommon (may affect up to 1 in 100 people)

• depression

Very rare (may affect up to 1 in 10,000 people)

• thrombocytopenia (reduced platelet count)
• anorexia
• psychosis (altered mental state), apathy (state of indifference), confusion
• headache
• changes in heart rate and rhythm (supraventricular tachyarrhythmia, atrial tachycardia (with or without block), junctional tachycardia (of the atrioventricular junction), ventricular arrhythmia, premature ventricular contractions), electrocardiogram changes (ST segment depression)
• intestinal ischaemia (reduced blood supply to the intestine), intestinal necrosis (death of intestinal tissue)
• gynaecomastia (breast enlargement) may occur with long-term administration
• fatigue, malaise, weakness

Not known: frequency cannot be estimated from the available data

• abdominal pain

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LANOXIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the product in its original, undamaged packaging,
correctly stored.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What LANOXIN contains

• The active substance is digoxin. One 2 ml vial contains 0.5 mg of digoxin.
• The other components are: ethanol, propylene glycol, citric acid, dibasic sodium phosphate, water for injections.

Description of the appearance of LANOXIN and contents of the pack
Box of 6 vials containing 0.5 mg/2 ml injectable solution.
Marketing Authorization Holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24,
Ireland
Tel: +39 0687 502 429
Manufacturer
Cenexi, Fontenay Sous Bois, 52 rue Marcel et Jacques Gaucher, Fontenay-Sous Bois, 94120,
France

The following information is intended exclusively for doctors or healthcare professionals

The difference in the fraction of the drug that reaches the circulation to be used
by the body between LANOXIN Injectable and oral formulations must be taken into
account when switching from one formulation to another. For example, if you switch from
the oral to the intravenous formulation, the dose should be reduced by approximately 33%.
Intramuscular administration is painful and may be associated with muscle necrosis.
This route of administration cannot be recommended.

Monitoring
Serum digoxin concentrations can be expressed in conventional units of nanograms/mL or in SI units of nanomoles/L. To convert nanograms/mL to nanomoles/L, multiply nanograms/mL by 1.28.
Serum digoxin concentrations can be determined by radioimmunoassay.
The blood sample should be taken 6 or more hours after the last dose of digoxin.
There are no strict guidelines regarding the serum concentration range that is most
effective. Various subsequent analyses of patients with heart failure in the Digitalis Investigation Group study have shown that at low serum digoxin concentrations (0.5–0.9 nanograms/mL), digoxin use was associated with reductions in mortality and hospitalizations. Patients with higher serum digoxin levels (>1 nanogram/mL) showed higher rates of illness and mortality, although at these concentrations digoxin reduced hospitalizations for heart failure. Therefore, the optimal minimum serum level of digoxin may range from 0.5 nanograms/mL (0.64 nanomoles/L) to 1.0 nanograms/mL (1.28 nanomoles/L).
Digoxin toxicity is most commonly associated with serum digoxin concentrations greater than 2 nanograms/mL. However, toxicity may occur at lower serum digoxin concentrations.
When determining whether your symptoms are due to digoxin, clinical assessment together with evaluation of serum potassium levels and thyroid function is important (see section “If you take more Lanoxin than you should”).
Other glycosides, including digoxin-derived substances, may interfere with available assay methods, and values that do not appear consistent with the patient's clinical status should always be interpreted with caution.
Regarding the use of the syrup formulation in pediatric age, see also section “Warnings and Precautions”.

Adults and children over 10 years
Rapid oral digitalization:
If clinically appropriate, rapid digitalization can be achieved in several ways, for example: 0.75–1.5 mg as a single dose.
When urgency is less or there is a higher risk of toxicity (e.g., in elderly patients), it is advisable to administer the total dose required for rapid oral digitalization in divided doses (the same dosage split into multiple doses) at six-hour intervals, starting therapy with an initial dose equal to half the total dose. Clinical response should be monitored before each subsequent administration (see section “Warnings and Precautions”).

Slow oral digitalization:
If the patient you are prescribing digoxin for belongs to certain categories, for example, if they have mild heart failure, digitalization may be achieved more slowly with doses of 0.25–0.75 mg daily for one week, followed by an appropriate maintenance dose. Clinical response should be evident within one week.
The dosage of 0.25–0.75 mg daily applies to patients under 70 years of age and/or with good renal function, whereas the dosage for slow oral digitalization in patients over 70 years of age and/or with renal impairment is 0.125 mg daily.
The choice between slow or rapid oral administration depends on the patient's clinical condition and severity of illness.

Parenteral loading dose
To be used if the patient has not received cardiac glycosides within the previous two weeks.
The total intravenous loading dose of digoxin ranges between 0.5 and 1.0 mg, depending on age, lean body mass, and renal function. The total loading dose should be administered in divided doses, with approximately half of the total dose given as the first dose and subsequent fractions administered at four- to eight-hour intervals. The patient's clinical response should be assessed before administering each additional dose. Each dose should be given as an intravenous infusion over 10–20 minutes (see Dilution of Lanoxin Injectable Solution).

Maintenance dose:
The maintenance dose should be calculated based on the percentage of the digitalizing dose eliminated daily. The following formula is widely used in clinical practice:
Maintenance dose = digitalizing dose × 14 + Ccr/5
Where Ccr is creatinine clearance corrected for 70 kg body weight or 1.73 m² body surface area.
If only serum creatinine (Scr) is available, Ccr (corrected for 70 kg body weight) can be calculated in men as follows:
Ccr = (140 – age) / Scr (in mg/100 mL)
Note: When serum creatinine values are obtained in micromoles/L, they must be converted to mg/100 mL (mg%) as follows:
Scr (mg/100 mL) = Scr (micromoles/L) × 113.12 / 10,000 = Scr (micromoles/L) / 88.4
Where 113.12 is the molecular weight of creatinine.
For women, this result should be multiplied by 0.85.
Note: These formulas cannot be used to calculate creatinine clearance in children.

In practice, most patients with heart failure will be maintained on 0.125–0.25 mg of digoxin daily; however, for those who show increased sensitivity to digoxin's adverse effects, a dosage of 0.0625 mg daily (or less) may be sufficient.
Conversely, some patients may require a higher dose.

• Neonates, infants, and children up to 10 years (if cardiac glycosides have not been administered in the previous two weeks)
  If cardiac glycosides have been administered within the previous two weeks before starting digoxin therapy, the optimal loading dose of digoxin is expected to be lower than that recommended below.

In neonates, particularly if premature, digoxin renal clearance is reduced, and appropriate dose reductions beyond those recommended in general dosing instructions should be implemented.
After the initial neonatal period, children generally require proportionally higher doses than adults based on body weight and body surface area, as indicated in the following table. Children over 10 years of age require adult dosages based on their body weight.

Parenteral loading dose:
The intravenous loading dose in the groups listed below should be administered according to the following dosages:

The loading dose should be administered in multiple doses, with approximately half of the total dose given as the first dose, and the remaining fractions of the total dose administered at intervals of 4–8 hours, monitoring the clinical response before administering each subsequent dose. Each dose must be given by intravenous infusion (see section “Dilution”) over a period of 10–20 minutes.

Oral loading dose:
Oral digitalization should be performed according to the following dosage regimens:

The loading dose should be administered in divided doses, with approximately half of the total dose given as the first dose and the remaining fractions of the total dose administered at intervals of 4–8 hours, monitoring the clinical response before administering each subsequent dose.

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

Preterm neonates: Daily dose = 20% of the loading dose over 24 hours (intravenous or oral)

Term neonates and children up to 10 years: Daily dose = 25% of the loading dose over 24 hours (intravenous or oral)

These dosage regimens should be considered as guidelines. Careful clinical observation and close monitoring of serum digoxin levels (see section “Monitoring”) must be used as the basis for adjusting dosage in these pediatric patient groups.

• Elderly patients:
  The tendency towards reduced renal function and reduced lean body mass in the elderly influences the absorption, distribution, metabolism, and elimination of digoxin, so that high serum digoxin levels with associated toxicity may develop quite rapidly unless lower digoxin doses than those used in non-elderly patients are employed. Serum digoxin levels should be monitored regularly, and hypokalemia must be avoided.

• Dosage recommendations in specific patient groups:
  See section “Warnings and precautions”.

Dilution of LANOXIN Injectable Solution:
LANOXIN Injectable Solution may be administered undiluted or diluted with a volume of diluent equal to or greater than 4 times the volume of LANOXIN. Using a diluent volume less than 4 times the volume of LANOXIN may result in precipitation of digoxin.

LANOXIN Injectable Solution, 250 micrograms per ml, when diluted at a ratio of 1:250 (e.g., a 2 ml vial containing 500 micrograms added to 500 ml of infusion solution), is compatible with and stable for up to 48 hours at room temperature (20–25°C) in the following infusion solutions:

• Sodium Chloride 0.9% w/v Intravenous Infusion Solution, B.P.;
• Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion Solution, B.P.;
• Glucose 5% w/v Intravenous Infusion Solution, B.P.

Dilution must be performed under aseptic conditions or immediately before use. Unused solution must be discarded. Rapid intravenous injection may cause arterial contraction, reduction in arterial diameter, leading to hypertension and/or reduced blood supply to the coronary arteries. Therefore, slow intravenous administration is particularly important in heart failure of hypertensive origin and in acute myocardial infarction.

Patient information leaflet

LANOXIN 0.05 mg/ml Syrup

digoxin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LANOXIN is and what it is used for

LANOXIN contains the active substance digoxin, which belongs to a group of medicines called digitalic glycosides. These medicines work by decreasing the heart rate and increasing the strength of the heart's contraction.
LANOXIN is indicated for:

• Treatment of chronic heart failure with predominant impairment of heart contraction (systolic dysfunction). Its effects are more evident if you have ventricular dilatation (enlargement of the lower chambers of the heart). Digoxin is particularly indicated when heart failure is associated with an abnormal heart rhythm (atrial fibrillation).
• Treatment of certain cardiac rhythm disorders, such as chronic atrial fibrillation and atrial flutter, in order to reduce the ventricular response rate.

Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking LANOXIN

Do not take LANOXIN

• if you are allergic to digoxin, to other cardiac glycosides, or to any of the other ingredients of this medicine (listed in section 6).

• if you have complete intermittent heart block (inconsistent and complete blockage of electrical impulse transmission from the heart chambers receiving blood, the atria, to the chambers pumping blood out of the heart, the ventricles), or second-degree atrioventricular block (failure of some impulses to reach the ventricles), especially if
  you have a history of Stokes-Adams attacks (a sudden drop in blood pressure causing temporary loss of consciousness).

• if you have arrhythmias (abnormal heart rhythms) caused by intoxication with cardioactive glycosides (medicines that increase the force of heart contractions).

• if you have supraventricular arrhythmias (the heart beats too fast, too slow, or with a completely irregular rhythm), such as in Wolff-Parkinson-White syndrome (a condition that may cause frequent palpitations and tachycardias).

• if you have an increased heart rate (ventricular tachycardia) or an abnormal heart rhythm originating in the ventricles (ventricular fibrillation).

• if you have thickening of the heart walls (obstructive hypertrophic cardiomyopathy), unless you also have atrial fibrillation or heart failure; even in such cases, digoxin must be used with extreme caution.

• if you are pregnant (see section “Pregnancy, breastfeeding and fertility”),

• if you have liver problems, if you suffer from alcoholism, or if you have brain injuries or neurological diseases, due to the presence of ethanol (see section “Other medicines and LANOXIN”).

Warnings and precautions
Talk to your doctor or pharmacist before taking LANOXIN.
Toxicity from LANOXIN may cause irregular heartbeats. This effect may resemble the conditions for which the medicine is prescribed.
Many of the benefits of LANOXIN in treating irregular heartbeats (arrhythmias) are due to its ability to slow down electrical conduction in the heart.
If such slowing already exists, your doctor must consider that your condition could worsen with LANOXIN therapy.
If you have recently had a heart attack (myocardial infarction), your doctor will assess whether using digoxin or similar-acting medicines might increase the heart's oxygen demand. Since the heart is damaged after an infarction, it may not meet this increased demand, thereby increasing the risk of ischemia (the mechanism underlying heart attacks).

Tell your doctor if:

• you have low levels of potassium (hypokalemia), magnesium (hypomagnesemia), or blood oxygen (hypoxia), as these conditions increase the heart's sensitivity to medicines in the same group as digoxin (cardioactive glycosides);
• you have high levels of calcium in the blood (hypercalcemia), as this increases the heart's sensitivity to medicines in the same group as digoxin;
• you suffer from beri-beri heart disease due to vitamin B1 deficiency, because unless the deficiency is simultaneously treated, digoxin may not be effective;
• you have respiratory problems, as these increase the heart's sensitivity to medicines in the same group as digoxin;
• you have thyroid problems, in which case your doctor may need to adjust your digoxin dose;
• you have malabsorption syndrome (reduced intestinal absorption) or gastrointestinal reconstructions (previous intestinal surgeries), as your doctor may need to increase your digoxin dose;
• you have heart failure associated with cardiac amyloidosis (accumulation of a protein called amyloid in the heart muscle), as digoxin treatment should generally be avoided unless strictly necessary and no other drugs can be used to control heart rate in atrial fibrillation;
• you have myocarditis (inflammation of the heart muscle), as digoxin may rarely trigger partial closure of arteries and should therefore be avoided;
• you have constrictive pericarditis (inflammation and hardening of the pericardium, the outer membrane surrounding the heart), as digoxin should not be used unless needed to control ventricular rate during atrial fibrillation or to improve systolic dysfunction;
• you are taking diuretics (medicines that increase urine production and help reduce body fluid) alone or in combination with an ACE inhibitor (used mainly for treating high blood pressure). Do not stop taking digoxin without consulting your doctor.

Inform your doctor that you are being treated with digoxin if you are scheduled for an exercise electrocardiogram, as digoxin may affect the test results.
Your doctor will carefully evaluate the appropriate digoxin dose if you are elderly or have kidney problems.
Your doctor will periodically perform tests to monitor your blood electrolytes and kidney function.
If you have taken cardioactive glycosides (medicines for treating heart failure and certain irregular heartbeats) within the past two weeks, your doctor should reassess the initial dosing recommendations and may advise reducing the dose.

The alcohol content in LANOXIN may alter or enhance the effects of other medicines.
100 ml of LANOXIN contains 10.5 ml of 96% ethyl alcohol.
1 ml of LANOXIN contains 0.105 ml of 96% ethyl alcohol: the maximum single dose used in adults and children over 10 years of age during rapid oral digitalization corresponds to 2.52 g of alcohol.
In cases of rapid oral digitalization in children over 10 years of age, LANOXIN administration results in daily alcohol intake exceeding 3 g in total. In cases of rapid oral digitalization in children under 10 years of age, LANOXIN administration results in daily alcohol intake below 3 g.

For athletes
The use of medicines containing ethyl alcohol may lead to positive anti-doping test results, depending on the blood alcohol concentration limits set by certain sports federations.

Other medicines and LANOXIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may affect the action of LANOXIN.
In particular, inform your doctor if you are taking any of the following medicines:

• Medicines used to treat high blood pressure (antihypertensives), e.g., prazosin, telmisartan, verapamil, felodipine, and tiapamil
• Epoprostenol (used to reduce pulmonary hypertension) (transient effect)
• Medicines used to treat irregular heartbeats (antiarrhythmics), e.g., amiodarone, flecainide, propafenone, quinidine, dronedarone
• Diuretic medicines, e.g., spironolactone, tolvaptan, conivaptan, hydrochlorothiazide
• Medicines used to treat depression, e.g., nefazodone
• Flibanserin (used for low sexual desire in premenopausal women)
• St. John’s wort (Hypericum perforatum), used to treat depression
• Medicines used to treat anxiety (antipsychotics), e.g., lithium, alprazolam
• Corticosteroid medicines (used as anti-inflammatory agents and to suppress the immune system)
• Medicines used to treat stomach problems, including indigestion, diarrhea, and vomiting, e.g., carbenoxolone, propantheline, metoclopramide, bulk-forming laxatives, antacids, kaolin-pectin
• Calcium
• Antibiotics, e.g., erythromycin, clarithromycin, tetracyclines, gentamicin, trimethoprim, neomycin, rifampicin
• Penicillamine (used to treat rheumatoid arthritis)
• Medicines used to treat fungal infections (itraconazole, isavuconazole, and posaconazole)
• Mirabegron (a medicine used to treat overactive bladder)
• Ivacaftor (for the treatment of cystic fibrosis)
• Medicines used to treat malaria (antimalarials), e.g., quinine
• Cyclosporine (a medicine used to prevent organ transplant rejection)
• Medicines used to treat infections, e.g., indomethacin, sulfasalazine
• Medicines used to treat heart conditions, e.g., carvedilol, ranolazine, nifedipine, diltiazem
• Medicines used to treat epilepsy, e.g., phenytoin
• Medicines used to treat diabetes, e.g., acarbose or canagliflozin
• Medicines used to treat cancer (e.g., lapatinib, vandetanib, vemurafenib, osimertinib)
• Medicines used to lower blood cholesterol, e.g., atorvastatin, cholestyramine
• Medicines used to treat asthma, e.g., salbutamol
• Adrenaline and dopamine
• Medicines used to treat viral infections (e.g., ritonavir/ritonavir-containing regimens, telaprevir, simeprevir, velpatasvir, daclatasvir)
• Medicines used to reduce platelet aggregation and prevent blood clots, e.g., ticagrelor
• Succinylcholine (a general anesthetic)
• Medicines for depression and smoking cessation (bupropion)
• Enteral supplemental nutrition (administration of certain nutrients directly into the stomach or intestine via specialized tubes when the patient is not adequately fed)
• If you have heart failure and are taking sennosides (medicines that increase stool volume to promote bowel movements) together with LANOXIN, you may have a moderately increased risk of digoxin toxicity.
• Venetoclax (used to treat patients with chronic lymphocytic leukemia)
• Proton pump inhibitors (PPIs) (used to relieve symptoms of acid reflux or gastroesophageal reflux disease).

Beta-blockers (medicines that slow heart rate and reduce heart workload): digoxin may increase the conduction time to the ventricles. Medicines affecting renal vascular tone may alter the kidney's blood purification mechanism.
Angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin receptor blockers (ARBs), antihypertensives, non-steroidal anti-inflammatory drugs (NSAIDs), and cyclooxygenase-2 inhibitors (analgesics) have not significantly altered the pharmacokinetics (absorption to elimination) of digoxin.
However, these medicines may alter kidney function in some patients, resulting in a secondary increase in digoxin levels due to reduced renal elimination.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The use of LANOXIN is contraindicated during pregnancy (see section “Do not take LANOXIN”).

Breastfeeding
Breastfeeding is not contraindicated.

Newborns and premature infants
Your doctor may need to adjust the dose of LANOXIN in newborns and premature infants.

Driving and using machines
If you experience visual disturbances or nervous system side effects, exercise caution before driving or operating machinery.
Due to the presence of ethyl alcohol, LANOXIN may reduce your ability to drive or operate machinery.

LANOXIN contains methyl 4-hydroxybenzoate; it may cause allergic reactions (including delayed reactions).

LANOXIN contains ethyl alcohol
The alcohol content in LANOXIN may alter or enhance the effects of other medicines.
100 ml of LANOXIN contains 10.5 ml of 96% ethyl alcohol.
1 ml of LANOXIN contains 0.105 ml of 96% ethyl alcohol: the maximum single dose used in adults and children over 10 years of age during rapid oral digitalization corresponds to 2.52 g of alcohol.
In cases of rapid oral digitalization in children over 10 years of age, LANOXIN administration results in daily alcohol intake exceeding 3 g in total.
In cases of rapid oral digitalization in children under 10 years of age, LANOXIN administration results in daily alcohol intake below 3 g.
Therefore, prescribers are reminded to carefully evaluate, based on the individual clinical situation, the risk-benefit balance of rapid oral digitalization versus the potential adverse effects related to alcohol content in the formulation.

LANOXIN contains hydrogenated glucose syrup
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take LANOXIN

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
Your doctor will determine the appropriate dose of digoxin for you based on your age, body weight, and kidney function.
To measure doses of LANOXIN (0.05 mg/1 ml), use the graduated dosing device provided.
Do not dilute LANOXIN.

Instructions for use:

TO OPEN
Press and simultaneously turn.
TO CLOSE
Screw tightly.

If you take more LANOXIN than you should
If you accidentally ingest/overdose on LANOXIN, contact your doctor immediately or go to the nearest hospital.
If you take more LANOXIN than prescribed, you may experience symptoms similar to those described in the section “Possible side effects,” but they may occur more frequently and be more severe.

Adults
Effects on the heart
The most common effects of taking too much LANOXIN are heart-related problems, such as irregular heartbeat and changes in heart tests.
If you have recently taken excessive doses of LANOXIN, this may lead to increased levels of potassium in the blood, which can contribute to the development of irregular heartbeats.

Other effects
You may also commonly experience gastrointestinal disturbances and nervous system disorders. Symptoms may include: loss of appetite, nausea and vomiting, dizziness, nervous system disturbances, fatigue, malaise, and visual disturbances. Gastrointestinal symptoms may appear before heart-related problems. If you experience long-term toxicity, you may mainly have general symptoms such as malaise and weakness.

Children
Most symptoms in children occur during or immediately after the initial phase of treatment with LANOXIN.

Effects on the heart
Children may experience the same heart-related effects as adults.

Other effects
Other frequent effects are similar to those observed in adults. However, nausea and vomiting are not common in newborns and younger children. Symptoms may include: weight loss in older children, inadequate growth in newborns, reduced blood flow in the mesenteric artery (intestinal artery) causing abdominal pain, drowsiness, and behavioral disturbances including psychotic episodes.

Treatment
If you have recently taken more LANOXIN than prescribed, your doctor may perform gastric lavage.
If you have ingested high doses of LANOXIN, you may need to be treated with high-dose activated charcoal.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
In general, digoxin side effects are dose-dependent and occur at doses higher than those
required to achieve a therapeutic effect.
The side effects are listed below in order of frequency. Side effects reported after marketing
authorisation have been classified as rare or very rare (including isolated cases).

Common (may affect up to 1 in 10 people)

• Central nervous system disorders, dizziness
• Visual disturbances (blurred or yellow vision)
• Arrhythmia (irregular heartbeat), electrocardiogram changes (conduction disorders, bigeminy, trigeminy, PR interval prolongation, sinus bradycardia)
• Heart block (a disturbance in the conduction of electrical impulses in the heart)
• Nausea, vomiting, diarrhoea
• Urticarial or scarlatiniform skin rashes (raised red patches on the skin), which may be accompanied by marked eosinophilia (increase in eosinophils, a type of white blood cells) in the blood

Uncommon (may affect up to 1 in 100 people)

• Depression

Very rare (may affect up to 1 in 10,000 people)

• Thrombocytopenia (reduction in platelets)
• Anorexia
• Psychosis (altered mental state), apathy (state of indifference), confusion
• Headache
• Changes in heart rate and rhythm (supraventricular tachyarrhythmia, atrial tachycardia (with or without block), junctional tachycardia (of the atrioventricular junction), ventricular arrhythmia, premature ventricular contractions), electrocardiogram changes (ST segment depression)
• Intestinal ischaemia (reduced blood supply to the intestine), intestinal necrosis (death of intestinal tissue)
• Gynaecomastia (breast enlargement) may occur with long-term administration
• Fatigue, malaise, weakness

Not known: frequency cannot be estimated from the available data

• Abdominal pain

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LANOXIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the product in its original packaging, correctly stored.
Store in the original packaging to protect the medicine from light.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LANOXIN contains

• The active substance is digoxin. 100 ml contain 5 mg of digoxin.
• The other components are: disodium hydrogen phosphate, citric acid, methyl parahydroxybenzoate, hydrogenated glucose syrup, quinoline yellow (E104), lime flavour, ethanol, propylene glycol, purified water.

Description of the appearance of LANOXIN and contents of the pack
60 ml bottle of syrup at 0.05 mg/ml.
Marketing Authorization Holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Tel: +39 0687 502 429
Manufacturer
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D-23843 Bad Oldesloe, Germany