DIGOXIN TABLETS BP 125 MICROGRAMS

Active substance: DIGOXIN

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Digoxin 62.5micrograms,
125micrograms and
250micrograms tablets
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• 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 as yours.

• If you have any further questions, ask your doctor or pharmacist.
• If you have any of the side effects, or if you notice any not listed,
please tell your doctor or pharmacist.

In this leaflet:
1. What Digoxin tablets are and
what they are used for
2. Before you take Digoxin tablets
3. How to take Digoxin tablets
4. Possible side effects
5. How to store Digoxin tablets
6. Further information






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





Digoxin belongs to a group of medicines called cardiac
glycosides, these slow down the rate of the heart but increase
the force with which the heart muscle contracts, making the
heart work more efficiently.
Digoxin tablets are used to treat:
• heart failure.
• irregular heart beats or heart rhythm.





2. Before you take Digoxin tablets




Taking other medicines





Do not take Digoxin tablets if you:

• are allergic (hypersensitive) to Digoxin tablets, other related
medicines such as digitoxin, or any of the ingredients in the
tablet (see section 6). An allergic reaction may include a rash,
itching, difficulty breathing or swelling of the face, lips, throat
or tongue. If this is the first time your doctor has prescribed
this medicine for you, tell them if you have taken any cardiac
glycoside (such as digoxin, digitoxin) within the last two
weeks.
• have any serious heart problems such as inflammation
of the heart, enlargement of the heart muscle, problems in
conduction of the electrical impulses in the heart or irregular
heart beats including Wolff-Parkinson-White syndrome.
Although digoxin is used to treat serious heart problems, it
may make others worse.












Check with your doctor or pharmacist before taking
Digoxin tablets if you:

• have any serious lung or breathing disorders
• have been told you have a low blood potassium or
magnesium level, or a high blood calcium level
• have suffered a recent heart attack
• have any stomach or bowel problems
• suffer from abnormal heart rhythm
• have congestive heart failure.






Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription. Especially:
• 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 Non-Steroidal 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)


AAAE4482 50698363

Digoxin 62.5mcg, 125mcg & 250mcg PIL - UK

colours/plates:
1. Black

item no: AAAE4482 50698363

dimensions:

print proof no: 2

pharmacode: 4315

origination date: 16.10.12

min pt size:

originated by: SA
approved for print/date

148x210 reel fed

2.
3.
4.
5.

M.cort (BST Technical)

6.
Non Printing Colours

revision date: 18.10.12

Technical Approval

revised by: sa

date sent:

12/10/12

supplier: Actavis UK

technically app. date:

12/10/12

1.
2.
3.












Sugar intolerance

• 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.

If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicine as it contains lactose.

Pregnancy and breastfeeding

If you are pregnant, plan to become pregnant or are breast
feeding speak to your doctor before taking this medicine.

Driving and using machines

Digoxin tablets may make you feel drowsy, dizzy, and affect
your vision. Make sure you are not affected before you drive or
operate machinery.

Other treatment or surgery

If you need an operation or other treatment, make sure you tell
the doctor you are taking digoxin.

3. How to take Digoxin tablets















Always take Digoxin tablets exactly as your doctor has told you.
If you are not sure, check with your doctor or pharmacist.
Swallow the tablets whole with water at the same time each
day. Take this medicine for as long as your doctor tells you to as
it may be dangerous to stop without their advice.
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 your should



If you (or someone else) swallow a lot of the tablets all together,
or if you think a child has swallowed any of the tablets, contact
your nearest hospital casualty department, or your doctor,
immediately. Take any remaining tablets and the container with
you to give to the doctor.



If you forget to take Digoxin tablets



If you forget to take a dose, take one as soon as you remember,
unless it is nearly time to take the next one. Never take two
doses together. Take the remaining doses at the correct time. If
you are worried ask your pharmacist or doctor for advice.



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.

5. How to store Digoxin tablets





Keep out of the reach and sight of children.
Store below 25°C in a dry place, and in the original packaging.
Do not use Digoxin tablets after the expiry date stated on the
label/carton/bottle. The expiry date refers to the last day of that
month.
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 tablets contain

• The active substance (the ingredient that makes the tablets
work) is digoxin. Each tablet contains either 62.5microgram
(blue uncoated tablet), 125microgram & 250microgram (white
uncoated tablets) of the active ingredient.
• The other ingredients are lactose, magnesium stearate,
maize starch and pregelatinised maize starch (all 3 strengths),
stearic acid (250microgram only), indigo carmine (E132)
(62.5microgram only).
Contents of the pack
Digoxin tablets are available in pack size of 28
Marketing Authorisation holder and manufacturer
Actavis, Barnstaple, EX32 8NS, UK
Date of last revision: October 2012

4. Possible side effects


Like all medicines, Digoxin tablets 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.

AAAE4482 50698363

Digoxin 62.5mcg, 125mcg & 250mcg PIL - UK

colours/plates:
1. Black

item no: AAAE4482 50698363

dimensions:

print proof no: 2

pharmacode: 4315

origination date: 16.10.12

min pt size:

originated by: SA
approved for print/date

148x210 reel fed

2.
3.
4.
5.

M.cort (BST Technical)

6.
Non Printing Colours

revision date: 18.10.12

Technical Approval

revised by: sa

date sent:

12/10/12

supplier: Actavis UK

technically app. date:

12/10/12

1.
2.
3.

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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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