Digoxin 125microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Digoxin

Available from:

Accord-UK Ltd

ATC code:

C01AA05

INN (International Name):

Digoxin

Dosage:

125microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02010100; GTIN: 5012617004529

Patient Information leaflet

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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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DIGOXIN 62.5MICROGRAMS 125MICROGRAMS AND 250MICROGRAMS TABLETS PIL UK
Black
Profile
BBBA0584
C.Grant
06/03/17
148x210
7pt
Actavis UK
N/A
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, di

Summary of Product characteristics

OBJECT 1
DIGOXIN TABLETS BP 125 MICROGRAMS
Summary of Product Characteristics Updated 20-Mar-2014 | Accord-UK Ltd
1. Name of the medicinal product
DIGOXIN TABLETS BP 125 micrograms
2. Qualitative and quantitative composition
Each tablet contains 125 micrograms Digoxin PhEur.
3. Pharmaceutical form
White uncoated tablets.
White, circular, flat bevelled-edge, uncoated tablets impressed “C“
on one face and the identifying
letters “DF“ on the reverse.
4. Clinical particulars
4.1 Therapeutic indications
• Digoxin is indicated for the treatment of congestive cardiac
failure.
• Digoxin may be used for certain supraventricular dysrhythmias,
particularly atrial fibrillation.
4.2 Posology and method of administration
The following schedules are intended as an initial guide but each
patient has to be tailored individually
according to age, lean body weight and renal function for his/her
needs:
_Adults and children over 10 years:_
Rapid oral loading:
750-1500micrograms (0.75mg-1.5mg) as a single dose. If a greater risk
or less urgency eg the elderly, the
oral loading dose should be given in divided doses 6 hours apart,
assessing clinical response, before
giving each additional dose.
Slow oral loading:
250-750micrograms (0.25mg-0.75mg) should be given daily for 1 week,
followed by appropriate
maintenance dose. A clinical response should be seen within one week.
NB
The clinical state of the patient and the urgency of the condition
will depend on the choice between slow
or rapid oral loading
The maintenance dosage should be based upon the percentage of the peak
body stores lost each day
through elimination. The following formula has had wide clinical use:
Maintenance dose:
is peak body stores x (% daily loss ÷ 100)
Where: peak body stores = loading dose; % daily loss = 14 + creatinine
clearance (C
cr
)/5.
C
cr
is creatinine clearance corrected to 70kg body weight or 1.73m
2
body surface area. If only serum
creatinine (S
cr
) concentrations are available, a C
cr
(corrected to 70kg body weight) may be estimated in
men as