PACKAGE LEAFLET: INFORMATION FOR THE USER_

Digoxin tablets BP 125 micrograms Digoxin tablets BP 250 micrograms

Read all of this leaflet carefully before you start taking 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 or pharmacist

♦    This medicine has been prescribed for you. 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 or pharmacist. This includes

any possible side effects not listed in this leaflet._

What is in this leaflet:

1.    What are Digoxin Tablets and what are they used for

2.    What you need to know before you take Digoxin tablets

3.    How to take Digoxin Tablets

4.    Possible side effects

5.    How to Store Digoxin Tablets

6.    Contents of the pack and other information

1. What are Digoxin Tablets and what are they used for

Digoxin Tablets belong to a group of medicines called cardiac glycosides, these slow down the rate of heart but increase the force with which the heart muscle contracts, making the heart work more efficiently.

Digoxin Tablets help the heart to work more efficiently, especially in patients with congestive heart failure or atrial fibrillation (irregular rapid heart beats).

| 2. What you need to know before you take Digoxin Tablets |

Do not take Digoxin Tablets if you:

♦    are allergic (hypersensitive) to digoxin, digitoxin or any of the other ingredients of Digoxin tablets (listed in Section 6)

♦    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.

Warnings and Precautions

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

♦    have recently had a heart attack (myocardial infarction)

♦    suffer from an abnormal heart rhythm

♦    have congestive heart failure

♦    have inflammation of the fibrous sac surrounding the heart (pericardium)

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

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

♦    have a heart problem caused by a lack of vitamin B called ‘Beri-Beri disease’

♦    have kidney problems

♦    have thyroid problems

♦    have digestion problems or have had gastro-intestinal reconstruction surgery

♦    have lung problems or breathing disorders

♦    are having an electrocardiogram (ECG) as this may give false positive changes during exercise testing

Whilst taking this medicine you will need to have regular monitoring of your blood electrolytes (levels of acids, bases and salts in the blood) and kidney function. Patients who are taking this medicine for a long time may need to have other tests during their treatment.

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.

Other medicines and Digoxin Tablets

Tell your doctor or pharmacist if you are taking or might take any other medicines

♦    the herbal remedy St Johns Wort (Hypericum perforatum,) this should not be taken at the same time as digoxin. Consult your doctor before you stop taking St Johns Wort.

♦    telmisartan, prazosin, captopril, nifedipine, nisoldipine, verapamil, diltiazem, nitroprusside, hydralazine, acetazolamide, furosemide, triamterene, spironolactone, or amiloride (used to treat high blood pressure)

♦    sulfasalazine, penicillamine, chloroquine or hydroxychloroquine (used to treat rheumatoid arthritis)

♦    atorvastatin, colestipol or colestyramine (used to lower cholesterol)

♦    kaolin (used to treat stomach upsets) and antacids (used for indigestion)

♦    amiodarone, disopyramide, flecainide, moracizine, propafenone, or quinidine (used to treat irregular heart rhythms), beta blockers (eg propranolol or atenolol used to treat various heart conditions)

♦    tetracycline, azithromycin, clarithromycin, erythromycin, telithromycin, neomycin, rifampicin, trimethoprim (used to treat infections caused by bacteria) or amphotericin, itraconazole (used to treat infections caused by fungi)

♦    nefazodone, trazodone or lithium (used to treat depression) and alprazolam or diazepam (used to treat anxiety)

♦    acarbose (used to treat diabetes)

♦    phenytoin, topiramate (used to treat epilepsy)

♦    quinine (used to treat malaria and night-time leg cramps)

♦    calcium salts (eg calcium gluconate or calcium lactate) and vitamin D

♦    carbimazole (used to treat hyperthyroidism)

♦    ciclosporin (used following organ transplants)

♦    corticosteroids (eg prednisolone, hydrocortisone)

♦    medicines used to treat cancer

♦    edrophonium, suxamethonium, pancuronium, or tizanidine (muscle relaxants)

♦    aspirin, azapropazone, diclofenac, fenbufen, ibuprofen, indometacin, tiaprofenic acid, or phenylbutazone (medicines known as NonSteroidal Anti-inflammatory Drugs (NSAIDs) and used to treat pain)

♦    salbutamol (used to treat asthma)

♦    carbenoxolone, omeprazole, pantoprazole, rabeprazole, or sucralfate (used to treat stomach ulcers

Pregnancy, breast-feeding and Fertility :

♦    Please tell your doctor if you are pregnant, trying to become pregnant or are breast-feeding.

♦    Speak to your doctor or pharmacist before taking any medicine.

Driving and using machines:

♦    This medicine may make you feel drowsy, dizzy and affect your vision. DO NOT drive or operate machinery if affected.

♦    If in any doubt, talk to your pharmacist or doctor.

Digoxin Tablets contain Lactose.

♦    If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

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3. How to take Digoxin Tablets

♦    Always take Digoxin Tablets exactly as prescribed by your doctor. You should check with your doctor or pharmacist if you are unsure.

♦    Check the label to see how often you should take your tablets.

♦    Swallow the tablets whole with a drink of water or milk. Do not crush or chew the tablets.

Dosage:

The first time you take Digoxin tablets, your doctor will ask you to take a certain number of tablets as a single dose, this is called the initial dose. They will monitor your response which may involve a blood test.

This initial dose is followed by a maintenance daily dose. This might be a different number of tablets depending on how you respond. Your doctor might recommend that you take this maintenance dose in divided doses.

The usual doses are:

Adults and children over 10 years: initial dose is either between 750micrograms and 1500micrograms as a single dose or 250micrograms and 750micrograms once a day for 7 days depending on how quickly your doctor wants you to start the tablets. This is then followed by a maintenance dose, which is usually 125micrograms to 250micrograms daily.

Children under 10 years: initial dose is between 25 and 45micrograms per kg of bodyweight over a 24 hour period (this will depend on the child’s age). Depending on the child’s response the doctor will decide upon the best maintenance dose.

Elderly or patients with kidney, thyroid or bowel disorders: different doses will be given depending on the condition.

If you take more Digoxin Tablets than you should

♦    Tell your doctor or go to a hospital casualty department (A&E) straight away. Take your tablets with you.

♦    Signs of overdose are nausea, vomiting, diarrhoea, drowsiness, confusion, slowing of heartbeat.

If you forget to take Digoxin Tablets

♦    Do not worry and wait until the next scheduled time. DO NOT take a double dose to make up for the forgotten individual dose.

If you stop taking Digoxin Tablets

♦    Make sure you do not run out of your tablets.

♦    Do not stop taking them without talking to your doctor first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

|    4. Possible side effects    |

Like all medicines Digoxin can cause side effects, although not everybody gets them.

♦ Stop taking the tablets and tell your doctor immediately or contact the casualty department at your nearest hospital if the following allergic reaction occurs: skin rash, which might be itchy and/or red and swelling of the mouth, tongue and throat causing difficulty swallowing or breathing. This is a very rare but serious side effect, you may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following side effects or others not listed:

Effects on blood: changes in the number and type of certain blood cells. If you notice unusual bruising, nose bleeds or infections you should tell your doctor.

Effects on hormones: swelling of the breasts in men.

Effects on mental health: disorientation, confusion, forgetfulness, delirium, psychosis, depression, hearing or seeing things that are not there and fits. Effects on the nervous system headache, fatigue, weakness, dizziness, sleepiness, bad dreams, restlessness, nervousness, agitation and lack of interest in everyday life.

Effects on the eyes: blurred vision, intolerance to light, colour vision may be affected with objects appearing yellow, or less frequently, green, red, blue, brown or white.

Effects on the heart: irregular or fast heartbeats or heart failure (new or worsening of an old condition).

Effects on the stomach and intestines: loss of appetite, feeling or being sick. Diarrhoea and abdominal pain particularly in the elderly.

Side-effects in children:

Children are especially sensitive to the effects of digoxin. Side-effects may include loss of appetite, feeling or being sick and diarrhoea. Irregular or fast heartbeats have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Tablets    1

♦    Keep this medicine out of the sight and reach of children

♦    Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

♦    Do not store above 25⁰C. Store in the original package.

♦    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

|    6. Contents of the pack and other information 1

What Digoxin Tablets Contain:

♦    The active substance in Digoxin tablets is Digoxin

♦    The other ingredients are Lactose, Industrial Methylated Spirit, Maize Starch, Stearic Acid and Magnesium Stearate.

What Digoxin tablet looks like and contents of the pack

♦    Digoxin 125mcg tablets are white, round, biconvex, uncoated tablets embossed with ‘125’ on one face and ‘BL’ on the other.

♦    Digoxin 250mcg tablets are white, round, biconvex, uncoated tablets embossed with ‘250’ on one face and ‘BL’ on the other

♦    The tablets are supplied in blister packs of 28 tablets and containers of 500 and 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Name and    address:    Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,

United Kingdom, HP4 1EG Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

Email:    info@bristol-labs.co.uk

Digoxin tablets BP 125 micrograms; PL 17907/0115 Digoxin tablets BP 250 micrograms; PL 17907/0114 This leaflet was last revised in January 2014 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address above (or telephone, fax, email).

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