FUROSEMIDE TABLETS BP Uncoated tablet (2018)
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Περιεχόμενα
Name of the medicinal product
FUROSEMIDE TABLETS BP 40mg.
Qualitative and quantitative composition
Each tablet contains 40mg Furosemide PhEur.
Pharmaceutical form
White uncoated tablets.
Therapeutic indications
Furosemide is a diuretic recommended for use in all indications where a prompt and effective diuresis is required. The treatment of oedema associated with congestive heart failure, cirrhosis of the liver, ...
Posology and method of administration
Posology Adults and children over 12 years Oedema Initially 40mg daily in the morning; ordinarily a prompt diuresis ensues and the starting dose can then be maintained or even reduced. Diuresis lasts for ...
Contraindications
Furosemide is contraindicated in the following circumstances Hypersensitivity to furosemide, any of its excipients, sulphonamides, sulphonamide derivatives/amiloride. Anuria and impaired renal function ...
Special warnings and precautions for use
Hypotension and/or hypovolaemia (see also section 4.3) These and any acid-base disturbances should be corrected before furosemide is started. Symptomatic hypotension leading to dizziness, fainting or loss ...
Interaction with other medicinal products and other forms of interaction
Antihypertensives: enhanced hypotensive effect possible with all types. Concurrent use with ACEinhibitors can result in marked falls in blood pressure. Furosemide should be stopped or the dose reduced ...
Pregnancy and lactation
The teratogenic and embryotoxic potential of furosemide in humans is unknown. There is little evidence of safety of high-dose furosemide in human pregnancy, although the results of animal work, in general, ...
Effects on ability to drive and use machines
Patients should be warned that reduced mental alertness may impair ability to drive or operate dangerous machinery.
Undesirable effects
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); Frequency not known (cannot be estimated from the available data). Blood ...
Overdose
Symptoms include dehydration and electrolyte depletion due to excessive diuresis. In cirrhotic patients, overdosage may precipitate hepatic coma. Treatment should be aimed at fluid replacement and correction ...
Pharmacodynamic properties
ATC code: CO3CA01 The evidence from many experimental studies suggests that furosemide acts along the entire nephron with the exception of the distal exchange site. The main effect is on the ascending ...
Pharmacokinetic properties
Furosemide is a weak carboxylic acid which exists mainly in the dissociated form in the gastrointestinal tract. Furosemide is rapidly but incompletely absorbed (60-70%) on oral administration and its effect ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Also contains: Lactose Magnesium stearate Maize starch Stearic acid
Incompatibilities
None known.
Shelf life
Three years from the date of manufacture. Shelf-life after dilution/reconstitution: Not applicable. Shelf-life after first opening: Not applicable.
Special precautions for storage
Store below 25°C in a dry place. Protect from light.
Nature and contents of container
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation: Actavis UK Limited (Trading style: Actavis), Whiddon Valley, BARNSTAPLE, N Devon EX32 8NS ...
Marketing authorization number(s)
PL 0142/0371
Date of first authorization / renewal of the authorization
21.2.94 (Renewed: 11.3.99)
Date of revision of the text
18<sup>th</sup> January 2018
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