Digoxin 62.5microgram tablets

Main information

  • Trade name:
  • Digoxin 62.5microgram tablets
  • Dosage:
  • 62.5microgram
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Digoxin 62.5microgram tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02010100; GTIN: 5012617004512

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 0142/0082
  • Last update:
  • 29-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Actavis BST - Packing Technical

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Component:

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JDE No.:

Digoxin Tablets

All Strengths x 28’s (UK)

148x210 (Reel Fed)

50926696

Leaflet for Blisters

7391

R.Wrey

24/02/17

148x210 Leaflet Reel Fed Profile (BST)

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Supplier:

Digoxin 62.5micrograms 125micrograms and 250micrograms tablets PIL UK

Black

Profile

BBBA0584

C.Grant

06/03/17

148x210

Actavis UK

01

Digoxin 62.5micrograms,

125micrograms and

250micrograms tablets

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

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)

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.

Continued over page

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BBBA0584

Actavis BST - Packing Technical

BSTCutterGuideReq@actavis.com

Dimensions:

Component:

Date Sent:

Technologist:

Technically Approved

Pharmacode:

JDE No.:

Digoxin Tablets

All Strengths x 28’s (UK)

148x210 (Reel Fed)

50926696

Leaflet for Blisters

7391

R.Wrey

24/02/17

148x210 Leaflet Reel Fed Profile (BST)

* Please note that only Artwork Studio is permitted to make changes to the above artwork.

No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

approved for print/date

Proof Round

UK-Eire-Artwork-Support@Actavis.com

Technical

Approval

Non Printing Colours

Colours

Date sent:

Date received:

Item no:

Originator:

Origination Date:

Revision Date:

Revised By:

Dimensions:

Min Body Text Size:

Supplier:

Digoxin 62.5micrograms 125micrograms and 250micrograms tablets PIL UK

Black

Profile

BBBA0584

C.Grant

06/03/17

148x210

Actavis UK

01

50926696

BBBA0584

Sugar intolerance

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.

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.

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, 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

Keep out of the sight and reach 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: March 2017

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