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LANOXIN -PG TABLETS

Active substance(s): DIGOXIN

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Package Leaflet: Information for the User
®

Lanoxin-PG Tablets
digoxin

PHARMA CODE N° xxxx

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 Tablets
3. How to use Lanoxin-PG Tablets
4. Possible side effects
5. How to store Lanoxin-PG Tablets
6. Contents of the pack and other information
1. What Lanoxin-PG is and what it is used for
Lanoxin-PG Tablets 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 heartbeat, which is why it is useful in heart failure.
2. What you need to know before you use Lanoxin-PG Tablets
Do not use Lanoxin-PG Tablets 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 Tablets
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).
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 cyclooxygenase2 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 digoxin 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 Lanoxin along with the following medicines you may
have an increased risk of irregular heart rhythm:
- intravenous calcium,
- beta-blockers,
- 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 Tablets with food and drink
This medicine may be taken on an empty stomach or with most meals.
However, you should avoid taking Lanoxin tablets with foods that are
high in fibre, also known as ‘dietary fibre’, because the level of Lanoxin
absorbed by the body can be reduced.

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3. How to take Lanoxin-PG Tablets
This medicine is available as a tablet 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
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 Tablets than you should
If you have taken too much of the Lanoxin tablets or a child has taken
the medicine by accident, contact your doctor, hospital or poison centre
to evaluate the risks and get more information.
The 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 Tablets
Do not take a double dose to make up for the forgotten dose.
If you stop using Lanoxin-PG Tablets
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 theYellow 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 Tablets
• 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 Tablets contains
• The active ingredient is digoxin, each tablet contains 0.0625 mg
(62.5 micrograms).
• The other ingredients are lactose, starches, indigo carmine, oxidised
starch, povidone and magnesium stearate.
What Lanoxin-PG Tablets looks like and contents of the pack
Within the carton is an amber glass bottle that contains 500 blue tablets.
A blue, round, biconvex tablet debossed “DO6” on the one side and plain
on the other side
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
PL 39699/0008
Leaflet date: August 2014
Lanoxin and Lanoxin-PG are registered trademark of Aspen.
All rights reserved

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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 tablets contain lactose
Lanoxin tablets contain lactose (a sugar). If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

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