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LANOXIN -PG TABLETS

Active substance(s): DIGOXIN

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digoxin

Read all of this leaflet carefully before you start
using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you, your
child or the patient. Do not pass it on to others.
It may harm them, even if their symptoms are the
same.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

PHARMA CODE N° 451

In this leaflet:
1. What Lanoxin-PG is and what it is used for
2. Before you take Lanoxin-PG
3. How to take Lanoxin-PG
4. Possible side effects
5. How to store Lanoxin-PG
6. Further information

1. What Lanoxin-PG is
and what it is used for
Lanoxin-PG contains a medicine called digoxin.
This belongs to a group of medicines called ‘cardiac
glycosides’. They work by slowing down the rate
while increasing the force of your heart when it
beats.
It is used to treat certain heart problems, such as:
• heart failure
This is when your heart muscle can’t pump
strongly enough to supply blood around your
whole body. It is not the same as a heart attack
and does not mean that your heart stops.
• certain types of irregular heart beats
These include ‘atrial flutter’ or ‘fibrillation’. They
are caused by problems in the way the upper
chambers of your heart send electrical signals.
They cause your heart to beat too fast or in an
uneven way.
The ‘PG’ of Lanoxin-PG stands for ‘Paediatric and
Geriatric’. This product is made for use in children or
the elderly, but it may be used by others. If you are
a parent, guardian or carer please read ‘you’ or ‘your’
as either ‘your child’ or ‘the patient’ in the rest of this
leaflet.

2. Before you take Lanoxin-PG
Do not take Lanoxin-PG if:
• you are allergic (hypersensitive) to digoxin,
digitoxin or any of the other ingredients of
Lanoxin-PG (listed in Section 6)
• you have been told that you have any of the
following heart problems:
-- ‘Second degree’ or ‘intermittent complete
heart block’
-- Certain types of ‘supraventricular arrhythmias’
-- ‘Ventricular tachycardia’ or ‘Ventricular
fibrillation’
-- ‘Hypertrophic obstructive cardiomyopathy’
Your doctor should have checked your heart problem
and decided that this medicine will help you. If you
are not sure, talk to your doctor or pharmacist before
taking Lanoxin-PG.
Take special care with Lanoxin-PG
Check with your doctor or pharmacist before using
your medicine if:
• you have recently had a heart attack (myocardial
infarction)
• you have been told that you have low potassium
or magnesium levels in your blood (hypokalaemia
or hypomagnesaemia)
• you have been told that you have high calcium
levels in your blood (hypercalcaemia)
• you have a heart problem caused by a lack of
vitamin B, known as ‘Beri-Beri disease’
• you have kidney problems
• you have a lung problem
• you have thyroid problems
• you have digestion problems.

Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines. This
includes medicines obtained without a prescription
and herbal products.
In particular tell your doctor or pharmacist if:
• you have taken either digoxin or digitoxin in the
last 2 weeks. Your doctor may need to change
your dose.
Taking Lanoxin-PG with other medicines can change
how they work or how Lanoxin-PG works. Tell your
doctor or pharmacist if you are taking any of the
following:
• medicines for stomach problems, including
indigestion, diarrhoea and being sick (vomiting)
• medicines for heart problems, including high
blood pressure (hypertension) and irregular heart
beat (arrhythmia)
• medicines for breathing problems, like asthma
• medicines for cancer
• medicines for epilepsy
• medicines for anxiety or depression
• medicines for bacterial infections (antibiotics)
• medicines for fungal infections (antifungals)
• medicines for high cholesterol
• medicines for preventing organ transplant
rejection
• medicines for problems with your immune system
• medicines for preventing blood clots during
kidney dialysis
• water tablets (diuretics)
• laxatives
• steroids
• anaesthetics
• the herbal remedy St John’s wort (Hypericum
perforatum). This should not be taken, when
taking Lanoxin-PG. If you already take
St John’s wort, speak to your doctor, as soon as
possible, before you stop taking St John’s wort.
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before taking
Lanoxin-PG.

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Lanoxin-PG® Tablets

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Package Leaflet: Information for the User

If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before taking this
medicine. Your doctor may change your dose or you
may need a different medicine.

Taking Lanoxin with food
Lanoxin can be taken with most foods. However, you
should avoid taking it with foods that are high in
fibre (e.g. brown bread, cereals, fruit, vegetables and
pulses), also known as ‘roughage’, as the amount of
Lanoxin absorbed into the body may be reduced.

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Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if
you are pregnant, might become pregnant or are
breast-feeding.
Driving and using machines
You may feel dizzy, tired, have a headache or get
blurred vision while taking Lanoxin. If this happens,
do not drive or use any tools or machines.
Important information about some of the
ingredients of Lanoxin-PG
This medicine contains lactose. If you have been told
by your doctor that you have an intolerance to some
sugars, talk to your doctor before taking Lanoxin-PG.

PHARMA CODE N° 451

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3. How to take Lanoxin-PG
Always take Lanoxin-PG exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Your doctor will have decided how much Lanoxin-PG
is right for you:
• It depends on what heart problem you have and
how serious it is.
• It also depends on your age, weight and how well
your kidneys work.
• Your dose may go up or down depending on how
you respond to the medicine. Your doctor will do
checks to see how well the medicine is working.
These may involve blood and urine tests.
Taking this medicine
• Tablets should be swallowed whole.
• You usually take this medicine in two stages:

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Children under 10 years
• loading dose
-- This is worked out using your child’s weight
-- Usually between 0.025 and 0.045 mg per kg
of body weight.
-- This should be given in divided doses between
4 and 8 hours apart.
• maintenance dose
-- The doctor will decide this, depending on your
child’s response to Lanoxin-PG.
-- It is usually a 1/5 (fifth) or a 1/4 (quarter) of
the loading dose, to be taken daily.
If you use more Lanoxin-PG than you should
If you take too much or if somebody else takes
your medicine by mistake, go to the hospital
immediately. You may get any of the side effects
and symptoms listed in Section 4, but these can be
serious.
If you forget to use Lanoxin-PG
• If you forget to take a dose, take it as soon as you
remember. However, if it is almost time for the
next dose, skip the missed dose.
• Do not take a double dose to make up for the one
that you missed.
If you stop using Lanoxin-PG
Do not stop taking this medicine, as your heart
problem may get worse. Talk to your doctor if you
want to stop.
If you have any further questions on taking this
medicine, ask your doctor or pharmacist.

4. Possible side effects

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• maintenance dose
-- Your doctor will decide this, depending on
your response to Lanoxin-PG.
-- It is usually between 0.125 and 0.25 mg
(2 and 4 tablets) daily.

5. How to store Lanoxin-PG
• Keep out of the reach and sight of children.
• Do not use Lanoxin-PG after the expiry date on
carton or bottle label (Exp.). The expiry date refers
to the last day of that month.
• Store below 25°C
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Further information
What Lanoxin-PG contains
• The active ingredient is digoxin, each tablet
contains 0.0625 mg (62.5 micrograms).
• The other ingredients are lactose, starches,
indigo carmine, oxidised starch, povidone and
magnesium stearate.

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PHARMA CODE N° 451

Adults and children over 10 years
• loading dose
-- Usually between 0.75 and 1.5 mg
(12 and 24 tablets) as a single dose.
-- For some patients, this may be given in
divided doses 6 hours apart.
-- Alternatively, between 0.25 and 0.75 mg
(4 and 12 tablets) may be given each day for
a week.
-- You may take a higher strength tablet for the
loading dose.

Very Rare (affects less than 1 in 10,000 people)
• bruising or bleeding more easily than normal
• stomach pain caused by lack of blood supply or
damage to your intestines
• mental disturbances, you may feel confused,
indifferent or unable to judge clearly
• weakness, tiredness or a general feeling of being
unwell
• breast enlargement in men
• loss of appetite
• headache.
Lanoxin-PG can very rarely cause serious irregular
heart rates. Your doctor may do regular checks to
make sure Lanoxin-PG is working safely for you.
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

What Lanoxin-PG looks like and contents of the
pack
Within the carton is an amber glass bottle that
contains 500 blue tablets. A blue, round, biconvex
tablet debossed “DO6” on the one side and plain on
the other side
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Service-Tel: 0800 008 7392 (+ 44 1748 828 391)
Manufactured by:
Aspen Bad Oldesloe GmbH,
Industriestrasse 32-36,
D 23843 Bad Oldesloe, Germany
PL 39699/0008
Leaflet date: August 2014
Lanoxin and Lanoxin-PG are registered trademark of
Aspen.
All rights reserved

Like all medicines, Lanoxin-PG 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.
Tell your doctor immediately if:
• you have palpitations, chest pain, shortness of
breath or sweating.
These can be symptoms of a serious heart problem
caused by new irregular heart beats. If these happen,
tell your doctor immediately.

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PHARMA CODE N° 451

Stage 1 - loading dose
The loading dose gets your Lanoxin-PG levels up
to the correct level quickly. You will either:
-- take one large single dose and then begin
your maintenance dose or
-- take a smaller dose each day for a week and
then begin your maintenance dose.
Stage 2 - maintenance dose
After your loading dose you will take a much
smaller dose every day, until your doctor tells you
to stop.

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Other side effects that you should tell your
doctor about, include:
Common (affects less than 1 in 10 people)
• slow or irregular heart rate
• feeling sick, being sick or diarrhoea
• skin rash that may be itchy
• drowsiness or dizziness
• visual disturbances, with blurred or yellow-green
sight.

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Uncommon (affects less than 1 in 100 people)
• depression.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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