DIGOXIN PG 50 MICROGRAMS/ML ELIXIR

Active substance: DIGOXIN

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Ref: 1208/301012/1/F

Lanoxin® PG 50 micrograms/ml elixir
(digoxin)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Lanoxin PG 50 micrograms/ml elixir, and will be
referred to as Lanoxin-PG throughout this Patient Information 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.

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'

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 apply to you, talk to your doctor or
pharmacist before taking Lanoxin-PG.
Taking Lanoxin 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 (glucose). If you have been told by your doctor
that you have an intolerance to some sugars, talk to your doctor before
taking Lanoxin-PG.

3

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)

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.

* you have been told that you have high calcium levels in your blood
(hypercalcaemia)

Taking this medicine

* you have a heart problem caused by a lack of vitamin B, known as

* It is important that you take the right amount. You should measure your

* you have kidney problems
* you have a lung problem
* you have thyroid problems
* you have digestion problems.

* It should be swallowed without mixing with any other liquids.
* You usually take this medicine in two stages:

'Beri-Beri disease'

dose using the pipette, a syringe or a measuring cup.

Ref: 1208/301012/1/B

Lanoxin® PG 50 micrograms/ml elixir
(digoxin)
Patient Information Leaflet (continued)

Common (affects less than 1 in 10 people)

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.

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
* 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.

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.

5

*
*
*
*
*

How to store Lanoxin-PG
Keep out of the sight and reach of children.
Do not use Lanoxin-PG after the expiry date which is stated on the
box/bottle/label. The expiry date refers to the last day of the month.
Do not store above 25°C
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.

If you use more Lanoxin-PG than you should
6

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

Further information

What Lanoxin-PG contains
* The active ingredient is digoxin, each 1 ml contains 0.05 mg.
* The other ingredients are sodium phosphate dibasic, citric acid,
methyl-p-hydroxybenzoate, hydrogenated glucose syrup, quinoline yellow
(E104), lime flavour, ethyl alchol, propylene glycol, and purified water.
What Lanoxin-PG looks like and contents of the pack
An amber glass bottle containing 60 ml of a yellow, lime-flavoured solution
with a graduated plastic pipette dropper and child-resistant cap.
Manufacturer and Licence Holder
Your medicine is manufactured by Glaxo Wellcome GmbH & Co. KG,
Industriestrasse, 32-36, Bad Oldesloe, D-23843, Germany and are procured
from within the EU and repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

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.

Lanoxin is a registered trademark of Glaxo Group Limited

Tell your doctor immediately if:

Revision date: 30/10/12

* 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.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Other side effects that you should tell your doctor about, include:
.

POM

PL 15184/1208 Lanoxin PG 50 micrograms/ml elixir

Ref: 1208/301012/1/F

Digoxin PG 50 micrograms/ml elixir
Patient Information Leaflet
Read all of this leaflet carefully before you start taking 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Digoxin-PG 50 micrograms/ml elixir, and will be
referred to as Digoxin-PG throughout this Patient Information Leaflet.
In this leaflet:
1

What Digoxin-PG and what is it used for

2

Before you take Digoxin-PG

3

How to take Digoxin-PG

4

Possible side effects

5

How to store Digoxin-PG

6

Further information

1

What Digoxin-PG is and what it is used for

Digoxin-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

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 Digoxin-PG with other medicines can change how they work or how
Digoxin-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 Digoxin-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 apply to you, talk to your doctor or
pharmacist before taking Digoxin-PG.

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.

Taking Digoxin-PG with food
Digoxin-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 Digoxin-PG absorbed into the body may be reduced.

The 'PG' of Digoxin-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.

Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might
become pregnant or are breast-feeding.

2

Before you take Digoxin-PG

Do not take Digoxin-PG if:

*
*

you are allergic (hypersensitive) to digoxin, digitoxin or any of the other
ingredients of Digoxin-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 Digoxin-PG.
Take special care with Digoxin-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.

Driving and using machines
You may feel dizzy, tired, have a headache or get blurred vision while taking
Digoxin-PG. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Digoxin-PG
This medicine contains sugar (glucose). If you have been told by your doctor
that you have an intolerance to some sugars, talk to your doctor before
taking Digoxin-PG.

3

How to take Digoxin-PG

Always take Digoxin-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 Digoxin-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 Digoxin-PG levels up to the correct level quickly.
You will either:
- take one large single dose and then begin your maintenance dose
or

Digoxin PG 50 micrograms/ml elixir
Patient Information Leaflet (continued)
- take a smaller dose each day for a week and then begin your
maintenance dose.

Ref: 1208/301012/1/B

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.

*
*

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.

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

* maintenance dose

- Your doctor will decide this, depending on your response to Digoxin-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.

How to store Digoxin-PG

5

Keep out of the sight and reach of children.
Do not use Digoxin-PG after the expiry date which is stated on the
box/bottle/label. The expiry date refers to the last day of the month.
Do not store above 25°C
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.

*
*
*
*
*

* maintenance dose

- The doctor will decide this, depending on your child's response to
Digoxin-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 Digoxin-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 Digoxin-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 Digoxin-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.

6

Further information

What Digoxin-PG contains
* The active ingredient is digoxin, each 1 ml contains 0.05 mg.
* The other ingredients are sodium phosphate dibasic, citric acid,
methyl-p-hydroxybenzoate, hydrogenated glucose syrup, quinoline yellow
(E104), lime flavour, ethyl alchol, propylene glycol, and purified water.
What Digoxin-PG looks like and contents of the pack
An amber glass bottle containing 60 ml of a yellow, lime-flavoured solution
with a graduated plastic pipette dropper and child-resistant cap.
Manufacturer and Licence Holder
Your medicine is manufactured by Glaxo Wellcome GmbH & Co. KG,
Industriestrasse, 32-36, Bad Oldesloe, D-23843, Germany and are procured
from within the EU and repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and will
be able to advise you.

POM
4

Possible side effects

Like all medicines, Digoxin-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.

PL 15184/1208

Digoxin PG 50 micrograms/ml elixir

Revision date: 30/10/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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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