Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about SIGMAXIN.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of you taking SIGMAXIN againstthe benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask yourdoctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.

What is SIGMAXIN

SIGMAXIN belongs to a group of medicines known as cardiac glycosides.They work by slowing down the rate while increasing the force of yourheart when it beats.
It is used to treat certain heart problems, such as:
Chronic Heart failure
Heart failure is when yourheart can’t pump strongly enough to supply blood needed throughout the whole body. It is not the same as a heart attack and doesnot mean that your heart stops.
Certain type of irregular heart beats
Irregular heartrhythms caused by an electrical problem in the upper chamber of yourheart. They cause your heart to beat too fast or in an uneven way.
Your doctor may have prescribed SIGMAXIN for another reason.
Ask your doctor if you have any questions about why SIGMAXINhas been prescribed for you.
There is no evidence that SIGMAXIN is addictive.

Before you take SIGMAXIN

When you must not take it

• digoxin or other cardiac glycosides

• any of the ingredients listed at the end of thisleaflet.

• shortness of breath, wheezing or difficulty breathing

• swelling of the face, lips, tongue or other partsof the body

• skin rash, itching or hives

• intermittent or complete heart block or seconddegree atrioventricular block, (conditions where the heart missesbeats) especially if there is a history of Stokes-Adams attacks.

• ventricular tachycardia and ventricular fibrillation(a type of irregular heart rhythm).

• irregular heart rhythm caused by cardiac glycosideoverdose.

• certain other irregularities of heart rhythm.

Before you start to take it

• any other medicines

• any other substances, such as foods, preservativesor dyes

• Heart disease

• Heart disease caused by lack of vitamin B, knownas ‘Beri-Beri disease’

• Lung problems

• Liver or kidney problems - effect of SIGMAXIN maybe increased because of slower removal from the body

• Thyroid disease - patients with low or high thyroidgland activity may be more or less sensitive to the effects of SIGMAXIN

• High or Low levels of calcium, potassium in yourblood

• Low level of magnesium in your blood

• Digestion problems

Taking other medicines

• amphetamine, appetite suppressants, medicines forcolds, sinus problems, hay fever or other allergies – may increasethe risk of heart rhythm problems

• medicines for heart problems, including high bloodpressure (hypertension) and irregular heart beat (arrhythmia)

• diuretics (water tablets),

• potassium supplements

• medicines for cancer

• medicines for depression

• medicines for bacterial infection (antibiotics)

• medicines for fungal infections (antifungals)

• medicines for stomach problems, including for nausea,vomiting, diarrhoea or indigestion

• some laxatives

• medicines for relieving asthma attacks or otherbreathing problems

• corticosteroids (e.g. hydrocortisone, dexamethasone,prednisolone, prednisone)

• medicines for diabetes (e.g. insulin, glucagon)

• cholestyramine, a medicine used for high cholesterol

• phenytoin, a medicine used to control epilepsy

• indomethacin – medication used for inflammation,gout or arthritis

• St John’s Wort

How to take SIGMAXIN

Follow all directions given to you by your doctor or pharmacistcarefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask yourdoctor or pharmacist for help.

How much to take

How to take it

When to take it

If you forget to take it

How long to take it

If you take too much (Overdose)

While you are using SIGMAXIN

Things you must do

Things you must not do

Things to be careful of

Side effects

All medicines can have side effects. Sometimes they are serious,most of the time they are not. You may need medical treatment if youget some of the side effects.
Ask your doctor or pharmacist to answer any questions you mayhave.
If any of the following happen, tell your doctor or pharmacistimmediately:

• nausea or vomiting, loss of appetite

• diarrhoea

• lower stomach pain

• slow or irregular heart beats (may be fast in children)

• unusual tiredness or extreme weakness

• general feeling of ‘unwellness’

• blurred vision or visual disturbances (e.g. colouredhalos around objects ie. yellow, green, or white)

• depression

• headache

• mental disturbances, such as confusion or feelingindifferent

• skin rash

• painful, swollen breasts, or breast enlargementin men

• bleeding or bruising more easily than normal

• Palpitations

• Chest pain

• Shortness of breath or sweating

After taking SIGMAXIN

Storage

Disposal

Product description

What it looks like

Ingredients

• Digoxin

Supplier

1 Name of Medicine

Digoxin.

2 Qualitative and Quantitative Composition

Sigmaxin tablets contain digoxin 250 microgram. Excipients include lactose monohydrate, maize starch, oxidised maize starch, rice starch and magnesium stearate.
Sigmaxin PG tablets contain digoxin 62.5 microgram. Excipients include lactose monohydrate, oxidised maize starch, hydrolyzed maize starch, rice starch, magnesium stearate, povidone and indigo carmine.
Excipients with known effect. Sugars (as lactose monohydrate).

3 Pharmaceutical Form

Tablets, 250 microgram (white, biconvex, round tablet, scored and coded "X3A" on upper face, bottom face plain): 100s.
PG (paediatric/geriatric) tablets, 62.5 microgram (blue, biconvex, round tablet, coded "U3A" on upper face, bottom face plain): 200s.

4 Clinical Particulars

4.9 Overdose

Symptoms and signs. See Section 4.8 Adverse Effects (Undesirable Effects).
The symptoms and signs of toxicity are generally similar to those described in Section 4.8 Adverse Effects (Undesirable Effects) but may be more frequent and can be more severe.
Signs and symptoms of digoxin toxicity become more frequent with levels above 2.0 nanogram/mL although there is considerable interindividual variation. However, in deciding whether a patient's symptoms are due to digoxin, the clinical state, together with serum electrolyte levels and thyroid function are important factors (see Section 4.2 Dose and Method of Administration).
Adults. In adults without heart disease, clinical observation suggests that an overdose of digoxin of 10 to 15 mg was the dose resulting in death of half of the patients. If more than 25 mg of digoxin was ingested by an adult without heart disease, death or progressive toxicity responsive only to digoxin immune Fab (Digibind) resulted.
Cardiac manifestations. Cardiac manifestations are the most frequent and serious sign of both acute and chronic toxicity. Peak cardiac effects generally occur 3 to 6 hours following overdosage and may persist for the ensuing 24 hours or longer. Digoxin toxicity may result in almost any type of arrhythmia. Multiple rhythm disturbances in the same patient are common. These include paroxysmal atrial tachycardia with variable atrioventricular (A-V) block, accelerated junctional rhythm, slow atrial fibrillation (with very little variation in the ventricular rate) and bidirectional ventricular tachycardia.
Premature ventricular contractions (PVCs) are often the earliest and most common arrhythmia. Bigeminy or trigeminy also occur frequently.
Sinus bradycardia and other bradyarrhythmias are very common.
First, second, third degree heart blocks and A-V dissociation are also common.
Early toxicity may only be manifested by prolongation of the PR interval.
Ventricular tachycardia may also be a manifestation of toxicity.
Cardiac arrest from asystole or ventricular fibrillation due to digoxin toxicity is usually fatal.
Acute massive digoxin overdosage can result in mild to pronounced hyperkalaemia due to inhibition of the sodium-potassium (Na⁺-K⁺) pump. Hypokalaemia may contribute to toxicity (see Section 4.4 Special Warnings and Precautions for Use).
Non-cardiac manifestations. Gastrointestinal symptoms are very common in both acute and chronic toxicity. The symptoms precede cardiac manifestations in approximately half of the patients in most literature reports. Anorexia, nausea and vomiting have been reported with an incidence up to 80%. These symptoms usually present early in the course of an overdose.
Neurologic and visual manifestations occur in both acute and chronic toxicity. Dizziness, various CNS disturbances, including headache, disorientation, confusion, fatigue and malaise are very common, more rarely are hallucinations and psychosis. The most frequent visual disturbance is an aberration of colour vision (predominance of yellow green). These neurological and visual symptoms may persist even after other signs of toxicity have resolved.
In chronic toxicity, non-specific extracardiac symptoms, such as malaise and weakness, may predominate.
Children. In children aged 1 to 3 years without heart disease, clinical observation suggests that an overdose of digoxin of 6 to 10 mg was the dose resulting in death in half of the patients. If more than 10 mg of digoxin was ingested by a child aged 1 to 3 years without heart disease, the outcome was uniformly fatal when Digibind Fab fragment treatment was not given.
Most manifestations of toxicity in children occur during or shortly after the loading phase with digoxin.
Cardiac manifestations. The same arrhythmias or combination of arrhythmias that occur in adults can occur in paediatrics. Sinus tachycardia, supraventricular tachycardia and rapid atrial fibrillation are seen less frequently in the paediatric population.
Paediatric patients are more likely to present with an A-V conduction disturbance or a sinus bradycardia.
Ventricular ectopy is less common, however in massive overdose, ventricular ectopy, ventricular tachycardia and ventricular fibrillation have been reported.
In neonates, sinus bradycardia or sinus arrest and/or prolonged PR intervals are frequent signs of toxicity. Sinus bradycardia is common in young infants and children. In older children, A-V blocks are the most common conduction disorders.
Any arrhythmia or alteration in cardiac conduction that develops in a child taking digoxin should be assumed to be caused by digoxin, until further evaluation probes otherwise.
Extracardiac manifestations. The frequent extracardiac manifestations similar to those seen in adults are gastrointestinal, CNS and visual. However, nausea and vomiting are not frequent in infants and small children.
In addition to the undesirable effects seen with recommended doses, weight loss in older age groups and failure to thrive in infants, abdominal pain due to mesenteric artery ischaemia, drowsiness and behavioural disturbances including psychotic manifestations have been reported in overdose.
Treatment. After recent ingestion, such as accidental or deliberate self-poisoning, the load available for absorption may be reduced in conscious patients, who are not exhibiting signs of heart block or sinus bradycardia, by gastric lavage. In patients with signs of heart block or sinus bradycardia, gastric lavage can cause an increase in vagal tone and result in worsening of cardiac toxicity.
Patients with massive digitalis ingestion should receive large doses of activated charcoal to prevent absorption and bind digoxin in the gut during enteroenteric recirculation.
Supportive and symptomatic treatment should be initiated depending on the type of cardiotoxicity, and continuous ECG monitoring is advisable, along with monitoring of serum electrolytes (especially potassium, calcium and perhaps magnesium).
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 be present due to release of potassium from skeletal muscle. Before administering potassium in digoxin overdose, the serum potassium level must be known.
Bradyarrhythmias may respond to atropine but temporary cardiac pacing may be required. Ventricular arrhythmias may respond to lignocaine or phenytoin.
Dialysis is not particularly effective in removing digoxin from the body in potentially life-threatening toxicity.
Rapid reversal of the complications that are associated with serious poisoning by digoxin, digitoxin and related glycosides has followed intravenous administration of digoxin immune Fab (Digibind) when other therapies have failed. Digibind is the only specific treatment for digoxin toxicity and is very effective. For details consult the literature supplied with Digibind.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data are available on whether or not digoxin has mutagenic, carcinogenic or teratogenic effects; however, maternally administered digoxin has been used to treat foetal tachycardia and congestive heart failure.
Carcinogenicity. See above.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDIGOXI.gif Digoxin has the molecular formula C₄₁H₆₄O₁₄ with a molecular weight of 781.0. It is practically insoluble in water and in ether and slightly soluble in alcohol. Digoxin is obtained from the leaves of Digitalis lanata and occurs as odourless, colourless or white crystals or a white or almost white powder.
CAS number. The CAS number is 20830-75-5.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SIGMAXST.gif