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Rosemont Pharmaceuticals Limited
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
Telephone: +44 (0)113 244 1400
Fax: +44 (0)113 246 0738
WWW: http://www.rosemontpharma.com
Customer Care direct line: +44 (0)800 919 312
Out of Hours Telephone: +44 (0)7836 557 879
Out of Hours contact: pharmacovigilance@rosemontpharma.com

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Summary of Product Characteristics last updated on the eMC: 24/10/2011
SPC Frusol 40mg/5ml Oral Solution

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 24/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.3. Contra-indications 

Contra-indicated conditions

See also

Hypersensitivity to furosemide, amiloride, sulphonamides or sulphonamide derivatives, and/or any of the excipients of the product.

 

Hypovolaemia and dehydration (with or without accompanying

hypotension)

Section 4.4

Severe hypokalaemia: severe hyponatraemia

Section 4.4

Comatose or pre-comatose states associated with hepatic cirrhosis

Section 4.4

Anuria or renal failure with anuria not responding to furosemide, renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents

 

Impaired renal function with a creatinine clearance below 30ml/min per 1.73 m2 body surface area

Section 4.4

Addison’s disease

Section 4.4

Digitalis intoxication

Section 4.5

Concomitant potassium supplements or potassium sparing diuretics

Section 4.5

Breast-feeding women

Section 4.6

4.4 Special Warnings and Precautions for Use

Conditions requiring correction before furosemide is started (see also section 4.3)
• Hypotension
• Hypovolaemia
• Severe electrolyte disturbances – particularly hypokalaemia, hyponatraemia and acid-base disturbances

Furosemide is not recommended
• In patients at high risk for radiocontrast nephropathy - it should not be used for diuresis as part of the preventative measures against radiocontrast-induced nephropathy.
• In elderly patients with dementia taking risperidone - Increased mortality (see below and section 4.5)

Particular caution and/or dose reduction required:
• elderly patients (lower initial dose as particularly susceptible to side-effects - see section 4.2).
• difficulty with micturition including prostatic hypertrophy (increased risk of urinary retention: consider lower dose). Closely monitor patients with partial occlusion of the urinary tract
• diabetes mellitus (latent diabetes may become overt: insulin requirements in established diabetes may increase: stop furosemide before a glucose tolerance test)
• pregnancy (see section 4.6)
• gout (furosemide may raise uric acid levels/precipitate gout)
• impaired hepatic function – hepatic failure and alcoholic cirrhosis particularly predispose to hypokalaemia and hypomagnesaemia (see section 4.3 and below – monitoring required)
• impaired renal function (see section 4.3 and below – monitoring required)
• adrenal disease (see section 4.3 – contraindication in Addison’s disease)
• hypoproteinemia e.g. nephrotic syndrome (effect of furosemide may be impaired and its ototoxicity potentiated - cautious dose titration required).
• acute hypercalcaemia (dehydration results from vomiting and diuresis - correct before giving furosemide). Treatment of hypercalcaemia with a high dose of furosemide results in fluid and electrolyte depletion - meticulous fluid replacement and correction of electrolyte required
• premature infants – possible development of nephrocalcinosis/ nephrolithiasis (see below – monitoring of renal function required)
• some diuretics have been considered unsafe in acute porphyria

Avoidance with other medicines (see also section 4.5 for other interactions)
• concurrent NSAIDs should be avoided – if not possible diuretic effect of furosemide may be attenuated
• ACE-inhibitors & Angiotensin II receptor antagonists – severe hypotension may occur – dose of furosemide should be reduced/stopped (3 days) before starting or increasing the dose of these
• concurrent risperidone in elderly patients with dementia has resulted in increased mortality – no mechanism for and no consistent pattern of deaths identified (see section 4.5)

Laboratory and other monitoring requirements:
• Serum sodium
Particularly in the elderly or in patients liable to electrolyte deficiency

• Serum potassium
The possibility of hypokalaemia should be taken into account, in particular in patients with cirrhosis of the liver, those receiving concomitant treatment with corticosteroids, those with an unbalanced diet and those who abuse laxatives. Regular monitoring of the potassium, and if necessary treatment with a potassium supplement, is recommended in all cases, but is essential at higher doses and in patients with impaired renal function. It is especially important in the event of concomitant treatment with digoxin, as potassium deficiency can trigger or exacerbate the symptoms of digitalis intoxication (see section 4.5). A potassium-rich diet is recommended during long-term use.

Frequent checks of the serum potassium are necessary in patients with impaired renal function and creatinine clearance below 60ml/min per 1.73m2 body surface area as well as in cases where furosemide is taken in combination with certain other drugs which may lead to an increase in potassium levels (see section 4.5 & refer to section 4.8 for details of electrolyte and metabolic abnormalities)

• Renal function
Frequent BUN in first few months of treatment, periodically thereafter. Long-term/high-dose BUN should regularly be measured. Marked diuresis can cause reversible impairment of kidney function in patients with renal dysfunction. Adequate fluid intake is necessary in such patients. Serum creatinine and urea levels tend to rise during treatment. If used in premature infants there is a risk of nephrocalcinosis/nephrolithiasis so renal function must be monitored and renal ultrasonography performed

• Glucose
Adverse effect on carbohydrate metabolism - exacerbation of existing carbohydrate intolerance or diabetes mellitus. Regular monitoring of blood glucose levels is desirable.

• Other electrolytes
Patients with hepatic failure/alcoholic cirrhosis are particularly at risk of hypomagnesemia (as well as hypokalaemia). During long-term therapy (especially at high doses) magnesium, calcium, chloride, bicarbonate and uric acid should be regularly measured.

Clinical monitoring requirements (see also section 4.8):
Regular monitoring for
• blood dyscrasias. If these occur, stop furosemide immediately
• liver damage
• idiosyncratic reactions

4.5. Interactions with other medicinal products and other forms of Interaction

Antihypertensives – enhanced hypotensive effect possible with all types. Concurrent use with ACE inhibitors or Angiotensin II receptor antagonists can result in marked falls in blood pressure, furosemide should be stopped or the dose reduced before starting an ACE-inhibitor or Angiotensin II receptor antagonists (see section 4.4). Increased risk of first dose hypotension with post-synaptic alpha-blockers (eg prazosin)

Antipsychotics – furosemide-induced hypokalaemia increases the risk of cardiac toxicity. Avoid concurrent use with pimozide. Increased risk of ventricular arrhythmias with pimozide (avoid concurrent use), amisulpride or sertindole. Enhanced hypotensive effect with phenothiazines.

In placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone. No consistent pattern for cause of death was observed but caution should be exercised and the risks and benefits of this combination considered prior to the decision to use.

Anti-arrhythmics (including amiodarone, disopyramide, flecainide and sotalol) - risk of cardiac toxicity (because of furosemide-induced hypokalaemia). The effects of lidocaine, tocainide or mexiletine may be antagonised by furosemide.

Cardiac glycosides – hypokalaemia and electrolyte disturbances (including hypomagnesemia) increase the risk of cardiac toxicity.

Drugs that prolong Q-T interval – increased risk of toxicity with furosemide induced electrolyte disturbances

Vasodilators – enhanced hypotensive effect with moxisylyte (thymoxamine) or hydralazine

Other diuretics – profound diuresis possible when furosemide given with metolazone. Increased risk of hypokalaemia with thiazides. Contraindicated with potassium sparing diuretics (eg amiloride spironolactone) - increased risk of hyperkalaemia (see section 4.3). Concurrent use with tetracyclines may increase the risk of rising BUN (see section 4.4 – monitoring)

Renin inhibitors – aliskiren reduces plasma concentrations of furosemide

Nitrates – enhanced hypotensive effect

Lithium - furosemide reduces lithium excretion with increased plasma lithium concentrations (risk of cardio- and/or neuro-toxicity). Avoid concomitant administration unless plasma levels are monitored.

Chelating agents – sucralfate may decrease the gastro-intestinal absorption of furosemide – the 2 drugs should be taken at least 2 hours apart

NSAIDs – increased risk of nephrotoxicity (especially with pre-existing hypovolaemia/dehydration. Indometacin and ketorolac may antagonise the effects of furosemide (avoid if possible see section 4.4)

Salicylates – effects may be potentiated by furosemide. Salicylic toxicity may be increased by furosemide

Antibiotics – increased risk of ototoxicity with aminoglycosides, polymixins or vancomycin - only use concurrently if compelling reasons. Increased risk of nephrotoxicity with aminoglycosides or cefaloridine. Furosemide can decrease vancomycin serum levels after cardiac surgery. Increased risk of hyponatraemia with trimethoprim.

Antiviral – plasma concentrations of diuretics may be increased by nelfinavir, ritonavir or saquinavir

Antidepressants – enhanced hypotensive effect with MAOIs. Increased risk of postural hypotension with TCAs (tricyclic antidepressants). Increased risk of hypokalaemia with reboxetine

Antidiabetics – hypoglycaemic effects antagonised by furosemide

Antiepileptics – increased risk of hyponatraemia with carbamazepine. Diuretic effect reduced by phenytoin.

Antihistamines – hypokalaemia with increased risk of cardiac toxicity

Antifungals – increased risk of hypokalaemia and nephrotoxicity with amphotericin

Anxiolytics and hypnotics – enhanced hypotensive effect. Chloral hydrate or triclofos may displace thyroid hormone from binding site.

CNS stimulants (drugs used for ADHD) – hypokalaemia increases the risk of ventricular arrhythmias

Corticosteroids – diuretic effect anatgonised (sodium retention) and increased risk of hypokalaemia

Cytotoxics – increased risk of nephrotoxicity and ototoxicity with platinum compounds/cisplatin

Anti-metabolites – effects of furosemide may be reduced by methotrexate and furosemide may reduce renal clearance of methotrexate

Potassium salts – contraindicated - increased risk of hyperkalaemia (see section 4.3)

Dopaminergics – enhanced hypotensive effect with levodopa.

Immunomodulators – enhanced hypotensive effect with aldesleukin. Increased
risk of hyperkalaemia with ciclosprin and tacrolimus. Increased risk of gouty arthritis with ciclosporin

Muscle relaxants – enhanced hypotensive effect with baclofen or tizanidine. Increased effect of curare-like muscle relaxants

Oestrogens – diuretic effect antagonised

Progestogens (drospirenone) – increased risk of hyperkalaemia

Prostaglandins – enhanced hypotensive effect with alprostadil

Sympathomimetics – increased risk of hypokalaemia with high doses of beta2 sympathomimetics

Theophylline – enhanced hypotensive effect

Probenecid –effects of furosemide may be reduced by probenecid and furosemide may reduce renal clearance of probenecid.

Anaesthetic agents – general anaesthetic agents may enhance the hypotensive effects of furosemide. The effects of curare may be enhanced by furosemide.

Warfarin and clofibrate – compete with furosemide in binding to serum albumin – possibly significant if this is low (eg nephrotic syndrome).

Aminoglutethimide – concomitant use may increase the risk of hyponatraemia

Alcohol – enhanced hypotensive effect

Laxative abuse - increases the risk of potassium loss

4.8. Undesirable Effects

Hepato-biliary disorders
Pure intra hepatic cholestasis, hepatic function abnormal, increase in liver transaminases. Isolated cases of acute pancreatitis and jaundice have been reported after long term diuretic therapy.

Skin and mucous membrane
Skin and mucous membrane reactions may occasionally occur, e.g. itching, urticaria, other rashes or bullous lesions, erythema multiforme, exfoliative dermatitis, purpura. Steven-Johnson’s syndrome, toxic epidermal necrolysis may occasionally occur

Nervous system disorders
Rarely, paraethesia may occur. Psychiatric disorder NOC.

Renal and urinary disorders
Reduced diuresis, urinary incontinence.
Hepatic encephalopathy in patients with hepatocellular insufficiency may occur.


10. Date of (Partial) Revision of the Text

11th Aug 2011
Updated on 17/08/2009 and displayed until 24/10/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5: Added interactions: salicylate toxicity, cephalosporins, cisplatin, sucralfate, warfain, clobfibrate.
Section 4.8: corrected metabolic acidsosis to alkalosis
Updated on 26/08/2008 and displayed until 17/08/2009
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   13-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1: Name re-arranged as per legislation
Section 6.1: "Solution 1M" removed from sodium hydroxide.
Updated on 29/04/2008 and displayed until 26/08/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1: Name re-arrangement as per legislation
Updated on 02/08/2007 and displayed until 29/04/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3: Added, hypovolaemia, anuria, renal faiure, severe hyperkalaemia, severe hyponatraemia, pre-comatose & comatose states, breast feeding.
Section 4.4: Added comment re: securing urinary output and instances requiring monitoring, porphyria. Close moirtoring of electrolytes.
Section 4.5: Added: salicylate, potentiation of ototoxicity of other drugs (e.g. aminoglycosides), cephlasporins, sucralfate, electrolyte disturbances may increase toxicity of other drugs, phenytoin, carbemazepine, aminoglutethimide, corticosteroids, liquorice, carbenoxolone, beta2 sympathomimetics, laxatives, reboxetine, amphotericin, probenecid, methotrexate.
Section 4.6: Re-written to include, women must not breast feed while taking furosemide, it must be taken during pregnancy unless there are compelling reasons and monitoring of foetal growth.
Section 4.8: Added: Electrolyte disturbances, hypovolaemia and dehydration, obstructed urinary outflow, reduced blood pressure,  transitory increases in blood creatinine and urea, nephrolithiasis, glucose tolerance, hearing disorders and tinnitus, reastions of the skin and mucous membranes, anaphylaxis, thrombocytopenia, leucopenia, eosinophilia, agranulocytosis, aplastic anaemia, haemolytic anaemia, paraesthesiae, patetn ductus arteriosus in new borns.
Updated on 30/05/2007 and displayed until 02/08/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.1: propylene glycol in the cherry flavour is replaced by ethanol
Updated on 07/11/2005 and displayed until 30/05/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 21/09/2005 and displayed until 07/11/2005
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
  furosemide