Lanoxin 250 microgram Tablets
(Digoxin)
1. What Lanoxin is and what it is used for
2. What you need to know before you use Lanoxin Tablets
3. How to use Lanoxin Tablets
4. Possible side effects
5. How to store Lanoxin Tablets
6. Contents of the pack and other information
Lanoxin Tablets contains the active substance digoxin, which belongs to a group of medicines called cardiac glycosides. It is used to treat arrhythmias and heart failure. An arrhythmia is an irregularity in the heart-beat, which causes the heart to skip a beat, beat irregularly or beat at the wrong speed. This medicine works by correcting irregular heartbeats to a normal rhythm and strengthens the force of the heart-beat, which is why it is useful in heart failure.
Talk to your doctor, pharmacist or nurse before using this medicine:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Taking several medicines can sometimes have harmful consequences or lead to unwanted interactions.
Sensitivity to Lanoxin can be increased by medicines which lower the level of potassium in the blood.
These include:
The following medicines increase the level of Lanoxin in the blood, which can increase the risk of toxicity:
The following medicines may increase or have no effect on the levels of Lanoxin in the blood:
If you have heart failure and are taking sennosides (increase the amount of stools you produce to help you have bowel movements) along with Lanoxin you may have a moderately increased risk of digoxin toxicity.
The following medicines reduce the level of Lanoxin in the blood:
If you are taking Lanoxin along with the following medicines you may have an increased risk of irregular heart rhythm:
If you are taking Lanoxin and suxamethonium (used to help muscle relaxation and treat short-term paralysis), you may have an increased risk of high potassium levels in the blood.
This medicine may be taken on an empty stomach or with most meals. However, you should avoid taking Lanoxin tablets with foods that are high in fibre, also known as 'dietary fibre,' because the level of Lanoxin absorbed by the body can be reduced.
Pregnancy
Your doctor will prescribe this medicine with caution during pregnancy.
You may require a higher dose of this medicine if you are pregnant.
This medicine could be given to the mother to treat abnormally high heart rate and congestive heart failure in the unborn child.
Side effects of Lanoxin treatment affecting the mother may also affect the unborn child.
Breastfeeding
This medicine is excreted in breast milk, but in very small amounts. Therefore, this medicine can be used by women who are breast-feeding.
Fertility
There is no information available on the effect of Lanoxin on fertility.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Since dizziness and blurred or yellow vision have been reported, you should exercise caution before driving a vehicle, using machinery or participating in dangerous activities.
Lanoxin tablets contain lactose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine is available as a tablet taken orally.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Your doctor will have decided how much of this medicine is right for you:
Taking this medicine
You usually take this medicine in two stages:
The loading dose gets your Lanoxin levels up to the correct level quickly. You will either:
After your loading dose you will take a much smaller dose every day, until your doctor tells you to stop.
Oral Administration
Adults and children over 10 years
Children under 10 years
Elderly
Elderly people may be given a lower dose than the usual adult dose. This is because older people may have reduced kidney function. Your doctor will check the levels of Lanoxin in your blood and may change your dose if necessary.
If you have taken too much of the Lanoxin tablets or a child has taken the medicine by accident, contact your doctor, hospital or poison centre to evaluate the risks and get more information.
The main symptoms of Lanoxin toxicity are heart rhythm disturbances and gastrointestinal symptoms which may happen before heart rhythm disturbances. Gastrointestinal symptoms include loss of appetite, nausea and vomiting. Other symptoms of Lanoxin toxicity include dizziness, fatigue, a general feeling of being unwell and various neurological disturbances including visual disturbances (more yellow-green than usual). The neurological and visual symptoms may persist even after other signs of toxicity have been resolved. In chronic toxicity, non-heart related symptoms, such as weakness and a general feeling of being unwell, may be the main symptoms.
Do not take a double dose to make up for the forgotten dose.
Your doctor will tell you how long you should take Lanoxin. Do not stop your treatment early without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following, talk to your specialist doctor straight away or seek urgent medical advice:
Very rare (may affect up to 1 in 10,000 people)
Other side effects may include:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Very rare (may affect up to 1 in 10,000 people)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on the safety of medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package protected from light.
Do not use this medicine if you notice any visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Each Lanoxin 250 microgram Tablet contains 250 micrograms of the active substance digoxin. The other ingredients are lactose monohydrate, maize starch, modified maize starch, rice starch and magnesium stearate.
Lanoxin 250 microgram Tablets are white, round, biconvex tablets bisected and debossed "DO25" on the same side and plain on the other side.
Lanoxin 250 microgram Tablets are available in bottles containing 500 and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer