Document: leaflet MAH BRAND_PLPI 20636-2825 change

• leaflet MAH BRAND_PLPI 15814-1189
• leaflet MAH BRAND_PLPI 20636-2825
• leaflet MAH BRAND_PLPI 39352-0349

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Lanoxin® 0.25 mg tablets

(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. 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 throughout this leaflet.

In this leaflet:

1.    What Lanoxin is and what it is used for

2.    Before you take Lanoxin

3.    How to take Lanoxin

4.    Possible side effects

5.    How to store Lanoxin

6.    Further information

1.    WHAT LANOXIN IS AND WHAT IT IS USED FOR

Lanoxin 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.

2.    BEFORE YOU TAKE LANOXIN Do not take Lanoxin if:

-    you are allergic (hypersensitive) to digoxin, digitoxin or any of the other ingredients of Lanoxin (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.

Take special care with Lanoxin

Check with your doctor or pharmacist before using your medicine if:

-    you have recently had a heart attack (myocardial infarction)

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

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

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

-    you have kidney problems

-    you have a lung problem

-    you have thyroid problems

-    you have digestion problems.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine. Your doctor may change your dose or you may need a different medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal products. In particular tell your doctor or pharmacist if:

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

Taking Lanoxin with other medicines can change how they work or how Lanoxin 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. 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.

Taking Lanoxin with food

Lanoxin can be taken with most foods. However, you should avoid taking it with foods that are high in fibre (e.g. brown bread, cereals, fruit, vegetables and pulses), 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

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking Lanoxin.

3. HOW TO TAKE LANOXIN

Always take Lanoxin 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 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

-    Tablets should be swallowed whole.

-    You usually take this medicine in two stages:

Stage 1 - loading dose

The loading dose gets your Lanoxin 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 (3 and 6 tablets) 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 (1 and 3 tablets) may be given each day for a week.

-    maintenance dose

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

-    It is usually between 0.125 and 0.25 mg daily.

-    You may take a lower strength tablet for the maintenance dose.

Children under 10 years

-    loading dose

-    This is worked out using your child's weight

-    Usually between 0.025 and 0.045 mg 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.

-    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 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

-    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

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 Lanoxin contains

-    The active ingredient is digoxin.

Each tablet contains 0.25 mg digoxin.

-    The other ingredients are lactose monohydrate, maize starch, hydrolysed starch, rice starch and magnesium stearate.

What Lanoxin looks like and contents of the pack

White, round, biconvex tablet bisected and debossed “DO25” on the same side and plain on the other side.

Lanoxin is available in pack size of 30, 60 and 120 tablets.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Lanoxin is manufactured by Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D-23843, Germany and procured from within the EU by Product Licence holder: Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

POM

Leaflet revision and issue date (Ref) 16.05.16[2] Lanoxin is a trademark of Aspen Global Incorporation.

Digoxin 0.25 mg tablets

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. 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 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

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.

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 medicine if:

-    you have recently had a heart attack (myocardial infarction)

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

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

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

-    you have kidney problems

-    you have a lung problem

-    you have thyroid problems

-    you have digestion problems.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine. Your doctor may change your dose or you may need a different medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal products. In particular tell your doctor or pharmacist if:

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

Taking 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 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 (e.g. brown bread, cereals, fruit, vegetables and pulses), 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 lactose. 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

-    Tablets should be swallowed whole.

-    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 (3 and 6 tablets) 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 (1 and 3 tablets) 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 mg daily.

-    You may take a lower strength tablet for the maintenance dose.

Children under 10 years

-    loading dose

-    This is worked out using your child's weight

-    Usually between 0.025 and 0.045 mg 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.

6. FURTHER INFORMATION What Digoxin contains

-    The active ingredient is digoxin.

Each tablet contains 0.25 mg digoxin.

-    The other ingredients are lactose monohydrate, maize starch, hydrolysed starch, rice starch and magnesium stearate.

What Digoxin looks like and contents of the pack

White, round, biconvex tablet bisected and debossed “DO25” on the same side and plain on the other side.

Digoxin is available in pack size of 30, 60 and 120 tablets.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Digoxin is manufactured by Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D-23843, Germany and procured from within the EU by Product Licence holder: Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

POM

Leaflet revision and issue date (Ref) 16.05.16[2]

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 at: www.mhra.gov.uk/yellowcard.

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

5. HOW TO STORE DIGOXIN

-    Keep out of the sight and 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.

-    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 the tablets become discoloured or show any other signs of deterioration,

consult your pharmacist who will tell you what to do.