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LANOXIN PG ELIXIR

Active substance(s): DIGOXIN

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Lanoxin-PG® Elixir
digoxin

Read all of this leaflet carefully before you start using this medicine because
it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Lanoxin is and what it is used for
2. What you need to know before you use Lanoxin-PG Elixir
3. How to use Lanoxin-PG Elixir
4. Possible side effects
5. How to store Lanoxin-PG Elixir
6. Contents of the pack and other information

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1. What Lanoxin is and what it is used for
Lanoxin contains the active substance digoxin, which belongs to a group of
medicines called cardiac glycosides. It is used to treat arrhythmias and heart failure.
An arrhythmia is an irregularity in the heart-beat, which causes the heart to skip a
beat, beat irregularly or beat at the wrong speed. This medicine works by correcting
irregular heartbeats to a normal rhythm and strengthens the force of the heart-beat,
which is why it is useful in heart failure.
2. What you need to know before you use Lanoxin-PG Elixir
Do not use Lanoxin-PG Elixir if you:
- Are allergic to digoxin, other cardiac glycosides or any of the other ingredients of
this medicine (listed in section 6).
- Have serious heart problems, such as those with the conduction of the electrical
impulses in the heart, especially if you have a history of Stokes-Adams attacks
(abrupt, short-lived loss of consciousness caused by a sudden change in heart rate
or rhythm).
- Have an irregular heart-beat caused by cardiac glycoside intoxication or conditions
such as Wolff-Parkinson-White syndrome.
- Have obstructive cardiomyopathy (enlargement of the heart muscle).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using this medicine:
- If you are taking this medicine, your doctor may ask you to have regular blood tests
to determine the amount of Lanoxin in the blood. This may be useful in the case of
patients with kidney disorders.
- If you develop digoxin toxicity, this can lead to various forms of heart rhythm
disturbances, some of which resemble the rhythm disturbances for which the
product was prescribed.
- If you have abnormal heart rhythm (heart block) and you are taking this medicine,
contact your doctor immediately if you feel one or more of the following symptoms:
fainting, short-lasting loss of consciousness, dizziness or light-headedness, fatigue
(tiredness), shortness of breath, chest pain, irregular heart-beat or confusion.
- If you have a sinoatrial disorder (a disorder in the conduction of electrical impulses
in the heart such as Sick Sinus Syndrome), in some patients with a sinoatrial
disorder this medicine can cause a slow and/or irregular heart-beat. Sometimes
this will cause tiredness, weakness and dizziness and when your heartbeat is very
slow you may faint.
- If you have recently suffered a heart attack.
- When heart failure occurs along with the collection of an abnormal protein in the
heart tissue (cardiac amyloidosis), an alternative therapy may be prescribed by the
doctor.
- If you have myocarditis (inflammation of the heart muscle) this may cause
vasoconstriction (narrowing of the blood vessels) on rare occasions. Your doctor
may prescribe you a different medicine.
- If you have Beri-beri disease (caused by a vitamin B1 deficiency).
- If you have constrictive pericarditis (inflammation of the sac which contains the
heart).
- If you are taking diuretics (drugs which promote urine production and help reduce
the amount of water in your body) with or without an ACE inhibitor (mainly used
to treat high blood pressure), your doctor will prescribe a lower dose of Lanoxin.
Do not stop taking Lanoxin without talking to your doctor.
- If you have a heart test called an ECG (electrocardiogram), tell the person doing
the test that you are taking Lanoxin as it can affect the meaning of the results.
- If you have severe respiratory (lung) disease (as you may have an increased
sensitivity to Lanoxin).
- If you have low levels of oxygen reaching certain parts of your body, low levels of
potassium, abnormally low levels of magnesium or increased levels of calcium in
your blood.
- If you have thyroid disease (such as an under-active or over-active thyroid) as you
might require changes in the dose of this medicine.
- If you have malabsorption syndrome (you cannot absorb minerals from your food
properly) or if you have ever had gastrointestinal reconstruction surgery.
- If you will receive electric shock treatment to correct an abnormal heart-beat.
Other medicines and Lanoxin-PG Elixir
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. Taking several medicines can sometimes have harmful consequences
or lead to unwanted interactions.
Sensitivity to Lanoxin can be increased by medicines which lower the level of
potassium in the blood. These include:
- diuretics,
- lithium salts (antidepressants),
- corticosteroid based products,
- carbenoxolone (a product which strengthens the gastric mucosa).

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The following medicines increase the level of Lanoxin in the blood, which can increase
the risk of toxicity:
- certain products which affect the heart: amiodarone, flecainide, prazosin,
propafenone, quinidine,
- certain antibiotics: erythromycin, clarithromycin, tetracycline, gentamicin,
trimethoprim,
- itraconazole (used to treat fungal infections),
- spironolactone (a drug which increases the amount of urine you produce),
- alprazolam (a sedative which may be used to treat anxiety),
- indomethacin (used to treat inflammation),
- quinine (may be used to prevent malaria infection),
- propantheline (used to prevent muscle spasms),
- nefazodone (an antidepressant),
- atorvastatin (lowers blood cholesterol),
- cyclosporine (an immunosuppressant often used to prevent transplant rejection),
- epoprostenol (used to treat pulmonary arterial hypertension),
- tolvaptan (used to treat low blood sodium levels),
- conivaptan (used to treat low blood sodium levels),
- carvedilol (used to treat mild to severe congestive heart failure and high blood
pressure),
- ritonavir (used to treat HIV infection and AIDS),
- taleprevir (used to treat hepatitis C infection),
- dronedarone (used to treat irregular heart-beat),
- ranolazine (used to treat chest pain),
- telmisartan (used to treat high blood pressure),
- lapatinib (used to treat breast cancer),
- ticagrelor (used to prevent heart attack or stroke),
- verapamil (used to treat high blood pressure),
- felodipine (used to treat high blood pressure),
- tiapamil (used to treat chest pain),
- P-glycoprotein inhibitors.
The following medicines may increase or have no effect on the levels of Lanoxin in
the blood:
- nifedipine, diltiazem, angiotensin receptor blockers (ARBs) and ACE inhibitors
(used to treat high blood pressure and congestive heart failure),
- non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 enzyme
(COX-2) inhibitors (used to treat pain and inflammation).
If you have heart failure and are taking sennosides (increase the amount of stools
you produce to help you have bowel movements) along with Lanoxin you may have a
moderately increased risk of Lanoxin toxicity.
The following medicines reduce the level of Lanoxin in the blood:
- antacids (used to treat gastric acidity),
- some bulk-forming laxatives (increase the amount of stools you produce to help
you have bowel movements),
- kaolin-pectin (used to treat diarrhoea),
- acarbose (used to treat some types of diabetes),
- certain antibiotics: neomycin, penicillamine, rifampicin,
- some cytostatic drugs (used as chemotherapy for cancer treatment),
- metoclopramide (a product for treating nausea and vomiting),
- sulfasalazine (a product to counteract inflammatory diseases of the intestine),
- adrenaline (used to treat severe allergic reactions),
- salbutamol (a product used to treat asthma),
- colestyramine (lowers blood cholesterol),
- phenytoin (used to treat epilepsy),
- St. John’s wort (Hypericum perforatum) (used to treat depression),
- bupropion (used to treat depression),
- P-glycoprotein inducers,
- supplemental enteral nutrition (being fed by a feeding tube).
If you are taking digoxin along with the following medicines you may have an
increased risk of irregular heart rhythm:
- intravenous calcium
- betablockers
- sympathomimetics (used to treat heart attack and low blood pressure)
If you are taking Lanoxin and suxamethonium (used to help muscle relaxation and
treat short-term paralysis), you may have an increased risk of high potassium levels
in the blood.
Lanoxin-PG Elixir with food and drink
This medicine may be taken on an empty stomach or with most meals. However, you
should avoid taking Lanoxin-PG Elixir with foods that are high in fibre, also known
as ‘dietary fibre’, because the level of Lanoxin absorbed by the body can be reduced.
Pregnancy, breastfeeding and fertility
Pregnancy
Your doctor will prescribe this medicine with caution during pregnancy.
You may require a higher dose of this medicine if you are pregnant.
This medicine could be given to the mother to treat abnormally high heart rate and
congestive heart failure in the unborn child.
Side effects of Lanoxin treatment affecting the mother may also affect the unborn
child.
Breastfeeding
This medicine is excreted in breast milk, but in very small amounts. Therefore, this
medicine can be used by women who are breast-feeding.
Fertility
There is no information available on the effect of Lanoxin on fertility.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Since dizziness and blurred or yellow vision have been reported, you should exercise
caution before driving a vehicle, using machinery or participating in dangerous
activities.
Lanoxin-PG Elixir contains methyl parahydroxybenzoate (E218), sucrose,
ethanol and sodium

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Package Leaflet: Information for the User

3. How to take Lanoxin-PG Elixir
This medicine is available as an oral solution which is taken orally.
Always use this medicine exactly as your doctor has told you. Check with your doctor
if you are not sure.
Your doctor will have decided how much of this medicine 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.
- While you are taking this medicine, your doctor will take regular blood tests. This is
to determine how you are responding to treatment.
- Your doctor will adjust your dose based on your blood test results and on how you
are responding to treatment. This is why you must strictly adhere to the treatment
course prescribed your doctor.
- If you have taken another cardiac glycoside in the past 2 weeks, your doctor may
prescribe a lower dose.
- If you feel that the effect of this medicine is too strong or too weak, talk to your
doctor or pharmacist.
Taking this medicine
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.
Oral administration
Lanoxin-PG Elixir, 0.05 mg in 1 ml, is supplied with a graduated pipette and this
should be used for measurement of all doses.
Lanoxin-PG Elixir should not be diluted.
Adults and children over 10 years
• loading dose
- Usually between 0.75 and 1.5 mg 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 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
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
Elderly
Elderly people may be given a lower dose than the usual adult dose. This is because
older people may have reduced kidney function. Your doctor will check the levels of
Lanoxin in your blood and may change your dose if necessary.
If you use more Lanoxin-PG Elixir than you should
If you have taken too much of the Lanoxin-PG Elixir, or a child has taken the medicine
by accident, contact your doctor, hospital or poison centre to evaluate the risks and
get more information.
main symptoms of Lanoxin toxicity are heart rhythm disturbances and gastrointestinal
symptoms which may happen before heart rhythm disturbances. Gastrointestinal
symptoms include loss of appetite, nausea and vomiting. Other symptoms of Lanoxin
toxicity include dizziness, fatigue, a general feeling of being unwell and various
neurological disturbances including visual disturbances (more yellow-green than
usual). The neurological and visual symptoms may persist even after other signs of
toxicity have been resolved. In chronic toxicity, non-heart related symptoms, such as
weakness and a general feeling of being unwell, may be the main symptoms.
If you forget to use Lanoxin-PG Elixir
Do not take a double dose to make up for the forgotten dose.
If you stop using Lanoxin-PG Elixir
Your doctor will tell you how long you should take Lanoxin. Do not stop your treatment
early without consulting your doctor.

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
If you get any of the following, talk to your specialist doctor straight away or seek
urgent medical advice:
Very rare (may affect up to 1 in 10,000 people)
- palpitations, chest pain, shortness of breath or sweating. These can be symptoms
of a serious heart problem caused by new irregular heartbeats.
Other side effects may include:
Common (may affect up to 1 in 10 people)
- allergic reactions of the skin may occur (rash, urticaria)
- abnormal heart-beat
- nausea, vomiting, diarrhoea
- central nervous system disturbances such as dizziness
- visual disturbances (blurred or yellow vision)
Uncommon (may affect up to 1 in 100 people)
- depression
Very rare (may affect up to 1 in 10,000 people)
- decrease in blood platelets (symptoms include bruises and nose bleeds)
- loss of appetite (anorexia)
- psychosis, apathy, confusion
- headache
- stomach pain caused by lack of blood supply or damage to your intestines
(ischaemia and necrosis)
- enlarged breast tissue in men (gynaecomastia)
- lack of energy (fatigue), a general feeling of being unwell and weakness
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 national reporting system:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of
medicine.
5. How to store Lanoxin-PG
• Keep out of the reach and sight 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.
• Store below 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.
6. Contents of the pack and other information
What Lanoxin-PG Elixir contains
The active ingredient is digoxin, each 1 ml contains 0.05 mg.
The other ingredients are methyl hydroxybenzoate, sucrose (or syrup), sodium
phosphate, citric acid, quinoline yellow (E104), ethanol, propylene glycol, lime flavour
and purified water.
What Lanoxin-PG Elixir 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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Service-Tel: 0800 008 7392 (+ 44 1748 828 391)
Manufactured by: Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D 23843 Bad
Oldesloe, Germany
Product name
Reference number
Leaflet date:

Lanoxin-PG Elixir
PL 39699/0007
November 2013

Lanoxin and Lanoxin-PG are registered trademark of Aspen.
All rights reserved.

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Methyl parahydroxybenzoate (E218):
• May cause allergic reactions (possibly delayed).
Sucrose:
• Lanoxin-PG Elixir contains less 0.3 g of sucrose in each ml of oral solution, i.e. 1.5 g
of sucrose in a 5 ml (0.25 mg digoxin) dose. Depending on the dose the amount of
sucrose will vary. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine. Ask your doctor to
explain this further if your child is taking this medicine. May be harmful to teeth.
Ethanol:
• Lanoxin-PG Elixir contains less than 0.1 ml of ethanol (alcohol) in each ml of oral
solution, i.e. up to 0.44 g of ethanol in a 5 ml (0.25 mg digoxin) dose which is
equivalent to less than 12.5 ml (less than 3 teaspoons) beer, less than 4.5 ml (less
than one teaspoon) wine per 0.25 mg digoxin dose. Depending on the dose the
amount of ethanol will vary. Ask your doctor to explain this further if your child is
taking this medicine. Harmful to those suffering from alcoholism. To be taken into
account in pregnant or breast-feeding woman, children and high-risk groups such
as patients with liver disease, or epilepsy.
Sodium:
• Adults and children over 10 years: Lanoxin-PG Elixir contains 1.653 mmol sodium
or less per dose. Depending on the dose the amount of sodium will vary. To be
taken into consideration by patients on a controlled sodium diet.
• Children under 10 years: Lanoxin-PG Elixir contains 0.0551 mmol of sodium per 1
ml of oral solution. Depending on the dose the amount of sodium will vary. Ask
your doctor to explain this further if your child is taking this medicine.

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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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