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DIGOXIN-PG 50 MICROGRAMS/ML ORAL SOLUTION

Active substance(s): DIGOXIN

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S1346 LEAFLET Lanoxin 20160204

PACKAGE LEAFLET: INFORMATION FOR THE USER

LANOXIN® - PG 50 micrograms/ml ELIXIR
(digoxin)

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.

Your medicine is known as Lanoxin - PG 50 micrograms/ml Elixir
but will be referred to as Lanoxin-PG throughout the following
leaflet.

In particular tell your doctor or pharmacist if:

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

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:



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
patients. 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:



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



medicines for stomach problems, including indigestion, diarrhea
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

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



medicines for problems with your immune system

6

Further information



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.

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.

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Lanoxin-PG.



Lanoxin 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 absorbed into the body may be reduced.

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:

Taking Lanoxin with food

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 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.



‘Second degree’ or ‘intermittent complete heart block’

3 HOW TO TAKE LANOXIN-PG



Certain types of ‘supraventricular arrhythmias’



‘Ventricular tachycardia’ or ‘Ventricular fibrillation’

Always take Lanoxin-PG exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.



‘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)



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


you have a heart problem caused by a lack of vitamin B, known
as ‘Beri-Beri disease’

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 have kidney problems



You usually take this medicine in two stages:



you have a lung problem



you have thyroid problems



you have digestion problems.

Stage 1 - loading dose

Very Rare (affects less than 1 in 10,000 people)

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



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



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.



weakness, tiredness or a general feeling of being unwell

Stage 2 - maintenance dose



breast enlargement in men

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



loss of appetite



headache.

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.

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.
Reporting of side effects



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

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.



It is usually between 0.125 and 0.25 mg (2.5 and 5 ml)
daily.

By reporting side effects, you can help provide more information on
the safety of this medicine.

maintenance dose

Children under 10 years




loading dose

5 HOW TO STORE LANOXIN-PG



This is worked out using your child’s weight



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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



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.



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



Do not store above 25°C.



Store in the original package 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.

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

6 FURTHER INFORMATION

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.

What Lanoxin-PG contains


The active substance in Lanoxin-PG is digoxin. Each 1ml
contains 0.05mg.

If you forget to use Lanoxin-PG



The other ingredients are: methyl parahydroxybenzoate (E218),
hydrogenated glucose syrup, sodium phosphate dibasic, citric
acid, quinoline yellow (E104), ethanol, propylene glycol, lime
flavour and purified water.



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

What Lanoxin-PG looks like and contents of the pack


Lanoxin-PG is a yellow, lime-flavoured solution in an amber
glass bottle with a child resistant cap. The box also contains a
plastic pipette dropper for measuring the amount of liquid
required.



Lanoxin-PG is available in 60ml bottles.

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.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Aspen Bad Oldesloe GmbH,
Industriestrasse 32-36, Bad Oldesloe, D-23843, Germany.

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

POM

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

Leaflet revision date: 04 February 2016

PL 19488/1346

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.

Lanoxin-PG is a registered trademark of Aspen Global
Incorporated.
S1346 LEAFLET Lanoxin 20160204

S1346 LEAFLET Digoxin 20160204

PACKAGE LEAFLET: INFORMATION FOR THE USER

DIGOXIN-PG 50 micrograms/ml ORAL SOLUTION
(digoxin)
Your medicine is known as DIGOXIN-PG 50 micrograms/ml ORAL
SOLUTION but will be referred to as Digoxin-PG throughout the
following 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
patients. 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:

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 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, diarrhea
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)

1

What Digoxin-PG is and what it is used for

2

Before you take Digoxin-PG



How to take Digoxin-PG



medicines for high cholesterol

4

Possible side effects



medicines for preventing organ transplant rejection

5

How to store Digoxin-PG



medicines for problems with your immune system

6

Further information



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.

3

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.

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Digoxin-PG.



Lanoxin 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 absorbed into the body may be reduced.

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 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.
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:

Taking Lanoxin with food

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
Digoxin-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 Digoxin-PG.



‘Second degree’ or ‘intermittent complete heart block’

3 HOW TO TAKE DIGOXIN-PG



Certain types of ‘supraventricular arrhythmias’



‘Ventricular tachycardia’ or ‘Ventricular fibrillation’

Always take Digoxin-PG exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.



‘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)



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


you have a heart problem caused by a lack of vitamin B, known
as ‘Beri-Beri disease’

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 have kidney problems



You usually take this medicine in two stages:



you have a lung problem



you have thyroid problems



you have digestion problems.

Stage 1 - loading dose

Very Rare (affects less than 1 in 10,000 people)

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



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



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.



weakness, tiredness or a general feeling of being unwell

Stage 2 - maintenance dose



breast enlargement in men

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



loss of appetite



headache.

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.
Reporting of side effects



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

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.



It is usually between 0.125 and 0.25 mg (2.5 and 5 ml)
daily.

By reporting side effects, you can help provide more information on
the safety of this medicine.

maintenance dose

Children under 10 years




loading dose

5 HOW TO STORE DIGOXIN-PG



This is worked out using your child’s weight



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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



Do not use Digoxin-PG after the expiry date on carton or bottle
label (Exp.). The expiry date refers to the last day of that month.



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



Do not store above 25°C.



Store in the original package 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.

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

6 FURTHER INFORMATION

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.

What Digoxin-PG contains


The active substance in Digoxin-PG is digoxin. Each 1ml
contains 0.05mg.

If you forget to use Digoxin-PG



The other ingredients are: methyl parahydroxybenzoate (E218),
hydrogenated glucose syrup, sodium phosphate dibasic, citric
acid, quinoline yellow (E104), ethanol, propylene glycol, lime
flavour and purified water.



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

What Digoxin-PG looks like and contents of the pack


Digoxin-PG is a yellow, lime-flavoured solution in an amber
glass bottle with a child resistant cap. The box also contains a
plastic pipette dropper for measuring the amount of liquid
required.



Digoxin-PG is available in 60ml bottles.

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-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.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Aspen Bad Oldesloe GmbH,
Industriestrasse 32-36, Bad Oldesloe, D-23843, Germany.

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

POM

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

Leaflet revision date: 04 February 2016

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 19488/1346

S1346 LEAFLET Digoxin 20160204

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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