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LANOXIN 0.05MG/ML ORAL SOLUTION

Active substance(s): DIGOXIN

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Lanoxin-PG® Elixir
Lanoxin® 0.05mg/ml Oral Solution
(digoxin)
Your medicine is known by one of the above names but will be referred to
as Lanoxin-PG throughout the following:

Patient Information Leaflet
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.
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.

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 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.
Taking Lanoxin-PG with food
Lanoxin-PG can be taken with most foods. However, you should avoid
taking it with foods that are high in fibre also known as ‘roughage’ as the
amount of Lanoxin-PG absorbed into the body may be reduced.
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-PG. 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 sugar. If you have been told by your doctor that
you have an intolerance to some sugars, talk to your doctor before taking
Lanoxin-PG. Lanoxin-PG also contains methyl-parahydroxybenzoate
(E218) which may cause allergic reactions (possibly delayed).

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
• It is important that you take the right amount. You should measure
your dose using the pipette, a syringe or a measuring cup.
• It should be swallowed without mixing with any other liquids.
• You usually take this medicine in two stages:
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.
Adults and children over 10 years
• loading dose
Usually between 0.75 and 1.5 mg (15 and 30 ml) 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 (5 and 15 ml) may be
given each day for a week.
• maintenance dose
Your doctor will decide this, depending on your response to
Lanoxin-PG.
It is usually between 0.125 and 0.25 mg (2.5 and 5 ml) daily.
Children under 10 years
• loading dose
This is worked out using your child’s weight
Usually between 0.025 and 0.045 mg (0.5 and 0.9 ml) 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.



visual disturbances, with blurred or yellow-green sight.

Uncommon (affects less than 1 in 100 people)
• depression.
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.
Reporting of side effects
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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5) How to store Lanoxin-PG






Keep all medicines out of the sight and reach 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.
Do not store above 25°C. Store in external package to protect from
light.
If your medicine becomes discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.
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 1ml of the oral solution contains
0.05mg of digoxin.
- The other ingredients are sodium phosphate dibasic, citric acid,
methyl-parahydroxybenzoate (E218), hydrogenated glucose syrup,
quinoline yellow (E104), ethanol, propylene glycol, lime flavour and
purified water.
What Lanoxin-PG looks like and contents of the pack
Lanoxin-PG is a yellow, lime-flavoured solution. It comes as a pack size of
60ml contained in an amber glass bottle fitted with a white, plastic, childresistant and tamper-evident cap. Also included in the pack is a plastic
graduated dropper pipette.
PL 10383/1848

POM

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.

Who makes and repackages your medicine?
Your medicine is manufactured by Aspen Bad Oldesloe GmbH,
Industriestrasse, 32-36, Bad D23843 Oldesloe, Germany. Procured from
within the EU and repackaged by Product Licence Holder: Primecrown Ltd,
4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Tell your doctor immediately if:
• you have palpitations, chest pain, shortness of breath or sweating.

Leaflet date: 07.04.2016

These can be symptoms of a serious heart problem caused by new
irregular heartbeats. If these happen, tell your doctor immediately.

Lanoxin-PG® and Lanoxin® are registered trademarks of Aspen Global
Incorporated, Mauritius.

4) Possible side effects

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

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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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