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DIGOXIN TABLETS BP 250MCG

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.

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

• 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.




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




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.

Taking other medicines

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)



Continued top of next column
AAAG9426 50782549

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

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

colours/plates:
1. Black

item no: AAAG9426

dimensions: 148 x 210 Reel Fed

print proof no: 2

pharmacode:

origination date: 11.06.14

min pt size: 7

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 13.06.14

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1.
2.
3.

Digoxin Tablets 62.5, 125 &
250mcg x 28’s (UK)
JDE No.:

50782549

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 6912
Date Sent:
28/03/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com





Sugar intolerance

• your doctor if you notice any of the following side effects or others
Tell
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 (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.
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.

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, 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 tablets





If you take more Digoxin tablets than your should

4. Possible side effects




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: April 2014

Continued top of next column

AAAG9426 50782549

148x210 Leaflet Reel Fed Profile (BST)

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

colours/plates:
1. Black

item no: AAAG9426

dimensions: 148 x 210 Reel Fed

print proof no: 2

pharmacode:

origination date: 11.06.14

min pt size: 7

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 13.06.14

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1.
2.
3.

Digoxin Tablets 62.5, 125 &
250mcg x 28’s (UK)
JDE No.:

50782549

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 6912
Date Sent:
28/03/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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