Download INFORMATION FOR THE USER Lanoxin PG® 62.5

PACKAGE LEAFLET: INFORMATION FOR THE USER
Lanoxin PG® 62.5 microgram Tablets
(Digoxin)
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
o Keep this leaflet. You may need to read it again.
o If you have any further questions, ask your doctor or pharmacist.
o This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
o If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Lanoxin PG® Tablets are and what they are used for
2. What you need to know before you take Lanoxin PG® Tablets
3. How to take Lanoxin PG® Tablets
4. Possible side effects
5. How to store Lanoxin PG® Tablets
6. Contents of the pack and other information
1. What Lanoxin PG® Tablets are and what they are used for
Lanoxin PG® 62.5 microgram Tablets contain 0.0625mg (62.5 microgram) of the active substance
digoxin. Lanoxin PG® Tablets belong to a group of medicines called cardiac glycosides.
Lanoxin PG® Tablets are used to treat:
o certain types of heart conditions such as chronic heart failure
o certain types of irregular heart beats
2. What you need to know before you take Lanoxin PG® Tablets
Do not take Lanoxin PG® Tablets if you:
o are allergic to digoxin, digitoxin or any of the other ingredients of this medicine (listed in
section 6)
o have a heart condition called hypertrophic obstructive cardiomyopathy
o suffer with heart arrhythmias or heart block such as in the following conditions:
- intermittent complete heart block or second degree atrioventricular block
- history of Stokes-Adams attacks
- supraventricular arrhythmias such as in the Wolff-Parkinson-White syndrome
- ventricular tachycardia or ventricular fibrillation
Warnings and precautions
Talk to your doctor or pharmacist before taking Lanoxin PG® Tablets if you:
o have a kidney problem
o suffer from a deficiency of potassium or magnesium in your blood
o suffer from an excess of calcium in your blood
o have a thyroid problem
o suffer from heart problems due to high blood pressure
o have a lung problem
o suffer from hypoxia (the oxygen supply to certain parts of your body is low)
o have stomach or bowel problems
o have certain heart rhythm problems (e.g. atrial tachycardia)
o have “Sick sinus syndrome” – heart rhythm problems and abnormal electrical activity of the
heart possibly leading to heart block
o
o
o
o
o
have inflammation of the heart muscle
have inflammation of the pericardium (the membrane around the heart)
have had a heart attack or heart failure associated with a condition known as cardiac
amyloidosis in which there is a build-up of a protein in the heart tissue making it harder for
the heart to beat properly
have a heart problem caused by a lack of vitamin B1, known as ‘Beri-Beri’ disease
are elderly
Other medicines and Lanoxin PG® Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular tell your doctor if you are taking any of the following:
o Anti-hypertensives (used to treat high blood pressure) e.g. prazosin, epoprostenol, verapamil,
felodipine
o Anti-arrhythmic agents (used to treat irregular heart rhythms) e.g. amiodarone, flecainide,
propafenone, quinidine
o Cardiac glycosides (used in the treatment of congestive heart failure and cardiac arrhythmia).
Tell your doctor if you are currently taking or have taken a cardiac glycoside in the past two
weeks.
o Diuretics (‘water tablets’ to help you pass more water) e.g. spironolactone
o Anti-depressants (used to treat depression) e.g. nefazodone
o St. John’s Wort (Hypericum perforatum) (a herbal remedy used to treat depression)
o Anti-psychotics (used to treat anxiety) e.g. lithium, alprazolam
o Corticosteroids (used to treat a variety of illnesses)
o Medicines used to treat stomach problems, including indigestion, diarrhoea and vomiting e.g.
carbenoxolone, propantheline, metoclopramide, bulk-laxatives, antacids, kaolin-pectin
o Calcium
o Antibiotics (used to treat various infections) e.g. erythromycin, clarithromycin, tetracycline,
gentamicin, trimethoprim, neomycin, rifampicin
o Penicillamine (used to treat rheumatoid arthritis)
o Itraconazole (used to treat fungal infections)
o Anti-malarial (used to treat malaria) e.g. quinine
o Ciclosporin (medicine used after organ transplant to prevent organ rejection)
o Anti-inflammatory drugs (used to treat inflammation) e.g. indometacin, sulfasalazine
o Medicines used to treat heart conditions e.g. carvedilol, milrinone, tiapamil, nifedipine,
diltiazem
o Anti-epileptics (used to treat epilepsy) e.g. phenytoin
o Anti-diabetics (used to treat diabetes) e.g. acarbose
o Medicines used to treat cancer
o Medicines used to treat high cholesterol e.g. atorvastatin, cholestyramine
o Medicines used to treat asthma e.g. salbutamol
o Adrenaline
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
Driving and using machines
Lanoxin PG® Tablets can cause some visual disturbances. If you are affected, do not drive or operate
machinery. Ask your doctor for advice.
Lanoxin PG® Tablets contain lactose monohydrate
Lanoxin PG® Tablets contain lactose monohydrate. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Lanoxin PG® Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Your dose will be determined by your doctor and will vary according to your weight, age and kidney
function.
Adults and children over 10 years
A suitable starting dose and daily dose (maintenance dose) will be decided upon by your doctor.
The usual daily dose is between 0.125mg and 0.25mg daily.
The elderly
Elderly patients may receive a lower dose than for adults. Your doctor may give the whole dose
divided in two doses 6 hours apart.
Use in children under 10 years
The usual starting dose is between 0.025mg and 0.045mg per kg of bodyweight over a 24 hour period.
Depending on your child’s response to this medicine your doctor will decide upon the most
appropriate daily dose.
If you take more Lanoxin PG® Tablets than you should
If you take too many Lanoxin PG® Tablets or if someone else takes your medicine by mistake, tell
your doctor immediately. Take the tablet pack with you.
If you forget to take Lanoxin PG® Tablets
If you forget to take a dose tell your doctor. Do not take a double dose to make up for a forgotten
dose.
If you stop taking Lanoxin PG® Tablets
Do not stop taking Lanoxin PG® Tablets without consulting your doctor as your condition may get
worse.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. In general,
the side effects tend to happen if the dose you are taking is too high. Your doctor may adjust your
dose if this occurs.
Tell your doctor immediately if you experience:
o palpitations, chest pain, shortness of breath or sweating
These can be symptoms of a serious heart problem caused by new irregular heartbeats.
Other side effects may include:
Common (may affect up to 1 in 10 people)
o feeling sick, being sick or diarrhoea
o visual disturbances, blurred or yellow vision
o dizziness or drowsiness
o slow or irregular heart rate
o skin rash that may be itchy
Uncommon (may affect up to 1 in 100 people)
o depression
Very Rare (may affect up to 1 in 10,000 people)
o loss of appetite
o headache
o breast enlargement in men
o weakness, tiredness or a general feeling of being unwell
o mental disturbances, feeling confused, indifferent or unable to judge clearly
o bruising or bleeding more easily than normal
o stomach pain caused by lack of blood supply or damage to your intestines
Many of the above mentioned side effects should disappear when treatment is stopped. Tell your
doctor if you have any other unwanted side effects not mentioned above.
5. How to store Lanoxin PG® Tablets
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.
6. Contents of the pack and other information
What Lanoxin PG® Tablets contain
Each Lanoxin PG® 62.5 microgram Tablet contains 62.5 micrograms of the active substance digoxin.
The other ingredients are lactose monohydrate, maize starch, oxidised starch, rice starch, indigo
carmine (E132), povidone and magnesium stearate.
What Lanoxin PG® Tablets look like and contents of the pack
Lanoxin PG® 62.5 microgram Tablets are blue, round, biconvex tablets debossed "DO6" on one side
and plain on the other side.
Lanoxin PG® 62.5 microgram Tablets are available in bottles containing 60, 100 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland.
Manufacturer
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D-23843 Bad Oldesloe, Germany.
This leaflet was last revised in April 2014.