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LANOXIN-PG 0.05 MG/ML ELIXIR

Active substance(s): DIGOXIN

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Lanoxin-PG® 0.05 mg/ml Elixir

2856
28.06.16[4]

(digoxin)
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.
This medicine is available using the above name but will be referred to as
Lanoxin-PG throughout the 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’
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 machine 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 lack of vitamin B, known as ‘BeriBeri 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
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 infection (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 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.
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.
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 (5 and 15 ml) may be given each
day for a week.
- maintenance dose
- Your doctor will decide this, depending on your response to LanoxinPG.
- It is usually between 0.125 and 0.25 (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.
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.

5. HOW TO STORE LANOXIN-PG
- Keep 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. Protect from light.
- If the solution become discoloured or show any other signs of
deterioration, consult 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 ml contains digoxin 50 micrograms
(0.05 mg).
- The other ingredients are methyl hydroxybenzoate, sucrose (syrup),
disodium phosphate anhydrous, citric acid monohydrate, quinoline yellow
(E104), ethanol, propylene glycol, lime flavour and purified water.
What Lanoxin-PG looks like and contents of the pack
An amber glass bottle that contains 60 ml of a yellow, lime-flavoured
solution with a plastic pipette dropper cap.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Aspen Bad Oldesloe GmbH, Industriestrasse 32-36,
D-23843 Bad Oldesloe, Germany. Procured from within the EU by Product
Licence holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow,
Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2856

Leaflet revision and issue date (Ref.) 28.06.16[4]
Lanoxin-PG is a trademark of Aspen.

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
- 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.
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
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

Digoxin 0.05 mg/ml Oral
Solution

2856
28.06.16[4]

(digoxin)
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.
This medicine is available using the above name but will be referred to as
Digoxin throughout the 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
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.
The ‘PG’ of Digoxin 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
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’
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.
Take special care with Digoxin
Check with your doctor or pharmacist before using your machine 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 lack of vitamin B, known as ‘BeriBeri 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
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 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
- medicines for cancer
- medicines for epilepsy
- medicines for anxiety or depression
- medicines for bacterial infections (antibiotics)
- medicines for fungal infection (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 apply to you, talk to your doctor or
pharmacist before taking Digoxin.
Taking Lanoxin with food
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.
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
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.
- 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 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 (5 and 15 ml) 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 0.25 (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
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
- 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.
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.
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
Website: 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 DIGOXIN
- Keep out of the sight and reach of children.
- Do not use Digoxin 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. Protect from light.
- If the solution become discoloured or show any other signs of
deterioration, consult 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 Digoxin contains
The active ingredient is digoxin, Each ml contains digoxin 50 micrograms
(0.05 mg).
- The other ingredients are methyl hydroxybenzoate, sucrose (syrup),
disodium phosphate anhydrous, citric acid monohydrate, quinoline yellow
(E104), ethanol, propylene glycol, lime flavour and purified water.
What Digoxin looks like and contents of the pack
An amber glass bottle that contains 60 ml of a yellow, lime-flavoured
solution with a plastic pipette dropper cap.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Aspen Bad Oldesloe GmbH, Industriestrasse 32-36,
D-23843 Bad Oldesloe, Germany. Procured from within the EU by Product
Licence holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow,
Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2856

Leaflet revision and issue date (Ref.) 28.06.16[4]

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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