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DIGOXIN 0.05MG/ML ORAL SOLUTION

Active substance(s): DIGOXIN

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Package Leaflet: Information for the User
®

Lanoxin-PG 0.05mg/ml Elixir

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:

(digoxin)



medicines for stomach problems, including indigestion, diarrhoea
and being sick (vomiting)

Read all of this leaflet carefully before you start using this
medicine.



medicines for heart problems, including high blood pressure
(hypertension) and irregular heart beat (arrhythmia)



Keep this leaflet. You may need to read it again.

medicines for breathing problems, like asthma



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.

The name of your medicine is Lanoxin-PG 0.05mg/ml Elixir but it will be
referred to as Lanoxin- PG throughout this leaflet.

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.




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:

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.

2 Before you take Lanoxin-PG
Do not take Lanoxin-PG if:

medicines for cancer

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.



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.

It also depends on your age, weight and how well your kidneys
work.

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




you have recently had a heart attack (myocardial infarction)



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

Stage 2 - maintenance dose

you have a lung problem

After your loading dose you will take a much smaller dose every
day, until your doctor tells you to stop.

The loading dose gets your Lanoxin-PG levels up to the correct
level quickly. You will either:

you have been told that you have low potassium or magnesium
levels in your blood (hypokalaemia or hypomagnesaemia)

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.



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.

Adults and children over 10 years



loading dose


Usually between 0.75 and 1.5mg (15 and 30ml) as a single
dose.

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.

For some patients, this may be given in divided doses 6 hours
apart.



Alternatively, between 0.25 and 0.75mg (5 and 15ml) may be
given each day for a week.

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.



maintenance dose




Your doctor will decide this, depending on your response to
Lanoxin-PG.
It is usually between 0.125 and 0.25mg (2.5 and 5ml) daily.

Children under 10 years





loading dose


This is worked out using your child’s weight



Usually between 0.025 and 0.045mg (0.5 and 0.9ml) per kg of
body weight.



This should be given in divided doses between 4 and 8 hours
apart.

maintenance dose

6 Further information
What Lanoxin-PG contains




Each ml contains 50 micrograms (0.05mg) digoxin.
The other ingredients are sodium phosphate dibasic, citric acid,
methyl parahydroxybenzoate, hydrogenated glucose syrup,
quinoline yellow (E104), ethanol, lime flavour, propylene glycol and
purified water.

What Lanoxin-PG looks like and contents of the pack



The doctor will decide this, depending on your child’s response
to Lanoxin-PG.

Clear, yellow, lime-flavoured oral solution.



It is usually a 1/5 (fifth) or a 1/4 (quarter) of the loading dose, to
be taken daily.

Manufactured by: Aspen Bad Oldesloe GmbH, Industriestrasse 32-36,
Bad Oldesloe, Germany.

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.

Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex,
HA4 0NU, UK.
®

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
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.

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.

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



mental disturbances, you may feel confused, indifferent or unable to
judge clearly






weakness, tiredness or a general feeling of being unwell

stomach pain caused by lack of blood supply or damage to your
intestines

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.

5 How to store Lanoxin-PG



Keep out of the sight and reach of children.





Do not store above 25°C.

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 in the original container in order to protect from light.
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.

Lanoxin- PG 0.05mg/ml Elixir; PL 8799/2028

POM

Leaflet date: 24.08.2017

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 0208 515 3763 to obtain
the leaflet in a format suitable
for you.

Package Leaflet: Information for the User

Digoxin 0.05mg/ml Oral Solution
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.

The name of your medicine is Digoxin 0.05mg/ml Oral Solution, but it
will be referred to as Digoxin throughout the remainder of this leaflet.

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

Taking Digoxin with other medicines can change how they work or how
Digoxin 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

1 What Digoxin is and what it is used for
Digoxin 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.

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 Digoxin
Do not take Digoxin if:



you are allergic (hypersensitive) to digoxin, digitoxin or any of the
other ingredients of Digoxin (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’

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 Digoxin. 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 Digoxin.

Taking Digoxin with food
Digoxin 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 Digoxin 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 Digoxin. If this happens, do not drive or use any tools or
machines.

Important information about some of the ingredients of
Digoxin
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 Digoxin.

3 How to take Digoxin
Always take Digoxin 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 Digoxin is right for you:




It depends on what heart problem you have and how serious it is.



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.

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 Digoxin.

It also depends on your age, weight and how well your kidneys
work.

Taking this medicine
Take special care with Digoxin



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.

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 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 been told that you have low potassium or magnesium
levels in your blood (hypokalaemia or hypomagnesaemia)

Stage 1 - loading dose
The loading dose gets your Digoxin levels up to the correct level
quickly. You will either:

you have kidney problems
you have a lung problem



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.

you have thyroid problems

Stage 2 - maintenance dose

you have digestion problems.

After your loading dose you will take a much smaller dose every
day, until your doctor tells you to stop.

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

Adults and children over 10 years



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 usually take this medicine in two stages:

you have taken either digoxin or digitoxin in the last 2 weeks. Your
doctor may need to change your dose.



loading dose


Usually between 0.75 and 1.5mg (15 and 30ml) as a single
dose.



For some patients, this may be given in divided doses 6 hours
apart.



Alternatively, between 0.25 and 0.75mg (5 and 15ml) may be
given each day for a week.

maintenance dose




Your doctor will decide this, depending on your response to
Digoxin.
It is usually between 0.125 and 0.25mg (2.5 and 5ml) daily.

Children under 10 years

What Digoxin looks like and contents of the pack



Clear, yellow, lime-flavoured oral solution.



loading dose


This is worked out using your child’s weight



Usually between 0.025 and 0.045mg (0.5 and 0.9ml) perkg 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 Digoxin.



It is usually a 1/5 (fifth) or a 1/4 (quarter) of the loading dose, to
be taken daily.

If you use more Digoxin 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 Digoxin



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 Digoxin
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
Like all medicines, Digoxin 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.

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.

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



mental disturbances, you may feel confused, indifferent or unable to
judge clearly






weakness, tiredness or a general feeling of being unwell

stomach pain caused by lack of blood supply or damage to your
intestines

breast enlargement in men
loss of appetite
headache.

Digoxin can very rarely cause serious irregular heart rates. Your doctor
may do regular checks to make sure Digoxin 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.

5 How to store Digoxin



Keep out of the sight and reach of children.





Do not store above 25°C.

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 in the original container in order to protect from light.
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 Digoxin contains




Each ml contains 50 micrograms (0.05mg) digoxin.
The other ingredients are sodium phosphate dibasic, citric acid,
methyl parahydroxybenzoate, hydrogenated glucose syrup,
quinoline yellow (E104), ethanol, lime flavour, propylene glycol and
purified water.

Manufactured by: Aspen Bad Oldesloe, Industristrasse 32-36,
Bad Oldesloe, Germany.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Digoxin 0.05mg/ml Oral Solution; PL 18799/2028

POM

Leaflet date: 24.08.2017

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 0208 515 3763 to obtain
the leaflet in a format suitable
for you.

+ Expand Transcript

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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