Frumil 40mg/5mg Tablets

Product Information *

  • Company:

    SANOFI
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 09 April 2019

File name

PIL Frumil IE417_1554797642.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 09 April 2019

File name

SPC Frumil 40mg.5mg IE417_1554798928.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.8  Undesirable effects

 

The following CIOMS V convention is used: (very common (>1/10), common (1/10 – 1/100), uncommon (1/100 – 1/1000), rare (1/1000 – 1/10000), very rare (<1/10000), Not known.

 

 

Blood and the lymphatic system disorders:

Rare:  thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia or, haemolytic anaemia, eosinophilia, haemoconcentration.

 

Immune system disorders:

Rare:  severe anaphylactic or anaphylactoid reaction, anaphylactic shock.(e.g with shock)

Not known : exacerbation or activation of systemic lupus erythematosus

 

 

Metabolism and nutrition disorders (see section 4.4):

The two active ingredients exert opposing influences on potassium excretion.  The serum potassium concentration may decrease, especially at the commencement of treatment (owing to the earlier onset of action of furosemide), although, particularly as treatment is continued, the potassium concentration may increase (owing to the later onset of action of amiloride), especially in patients with impairment of renal function.

 

Common:  hypokalaemia, gout attack.

Rare:  hyponatremia, urine volume increased, hyperkalemia (especially in patients with impairment of renal function), blood creatinine increased, blood cholesterol increased, blood triglycerides increased, blood uric acid increased, electrolyte disturbances imbalance (including symptomatic), metabolic alkalosis due to furosemide, dehydration/hypovolemia (especially in elderly patients),  hypochloremia, hypocalcemia, hypomagnesemia, blood urea increased,  glucose tolerance impaired (latent diabetes mellitus may become manifest-see section 4.5), Pseudo-Bartter syndrome.

Not known: metabolic acidosis due to amiloride,

 

Nervous system disorders:

Rare: paraesthesia, hepatic encephalopathy in patients with hepatocellular insufficiency (see section 4,3).

Not Known: Dizziness, fainting or loss of consciousness, headache.

 

 

Ear and labyrinth disorders:

Rare: hearing impaireddisorders (usually transitory, particularly in patients with renal failure, hypoproteinaemia (e.g. in nephrotic syndrome) and/or when intravenous furosemide has been given too rapidly, tinnitus, deafness.

Uncommon: deafness (sometimes irreversible)

 

 

Vascular disorders:

Common: thrombosis.

Rare:  hypotension including orthostatic hypotension (see section 4.4), vasculitis.

 

Gastrointestinal disorders:

Very common:  nausea.

Uncommon:  vomiting, diarrhoea.

Rare: pancreatitis acute.

 

Hepato-biliary disorders:

Rare: cholestasis, transaminases increased.

 

Skin and subcutaneous tissue disorders:

Common: rash.

Rare:  pruritus, urticaria,  dermatitis bullous, erythema multiforme, bullous pemphigoid,  dermatitis exfloliative, purpura, photosensitivity reaction. Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, purpura, photosensitivity, acute generalised exanthematous pustulosis, DRESS (drug rash with eosinophilia and systemic symptoms).

Not Known: acute generalised exanthematous pustulosis (AGEP), rashes, lichenoid reactions

 

 

 

 

Renal and urinary disorders:

Common:  urinary retention urine retention (acute retention of urine in patients with a partial obstruction of urinary outflow see section 4.4).

Rare:  tubulointerstitial nephritis, nephrocalcinosis, nephrolithiasis (in premature infants).

Not Known: Urine volume increased, urine sodium increased, urine chloride increase, renal failure (see section 4.5)

 

General disorders and administration site conditions:

Rare: fever.

 

Musculoskeletal and connective tissue disorders

Not known: cases of rhabdomyolysis have been reported, often in the context of severe hypokalaemia (see section 4.3)

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

 

 

 

 

4.9       Overdose

Updated on 12 September 2018

File name

Frumil CCDS V12 WSP PIL 89032323_1536705284.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 10 July 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 July 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

TII CCDS V11- Update of section 4.8 Undesirable Effects as per below tracked changes:

PA 540/101/2

4.8 of the SmPC: Not Known: Dizziness, fainting or loss of consciousness, headache.

 

The PIL has been updated accordingly to reflect the SPC update. 

Updated on 05 July 2017

File name

PIL_13722_435.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 July 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 15 September 2016

Reasons for updating

  • Addition of manufacturer

Updated on 07 September 2016

Reasons for updating

  • Change of manufacturer

Updated on 22 August 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.8


Skin and subcutaneous tissue disorders:

Common: rash.

Rare:  pruritus, urticaria, dermatitis bullous, erythema multiforme, bullous pemphigoid, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, purpura, photosensitivity, acute generalised exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms.

Not Known: acute generalised exanthematous pustulosis (AGEP)

 

 

Renal and urinary disorders:

Common:  urinary retention (acute retention of urine in patients with a partial obstruction of urinary outflow).

Rare:  tubulointerstitial nephritis, nephrocalcinosis, nephrolithiasis (in premature infants).

 

General disorders and administration site conditions:

Rare: fever.

 

Musculoskeletal and connective tissue disorders

Not known: cases of rhabdomyolysis have been reported, often in the context of severe hypokalaemia (see section 4.3)

Updated on 18 April 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

.

Updated on 26 February 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 08 January 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.4- Addition of Lupus as a potential side effect

4.8- Unknown incidence of Lupus and reporting a side effect via the HPRA

Updated on 06 January 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 13 December 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type II.C.I.4 variation to update section 4.8 of the Summary of Product Characteristics in line with the Company Core Safety Data, version 7, for Furosemide, following a Global Labelling Review.

Updated on 10 December 2013

Reasons for updating

  • Change to side-effects

Updated on 11 June 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type IB variation to update the SPC and leaflet.

Updated on 06 June 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to dosage and administration

Updated on 11 April 2013

Reasons for updating

  • Change to marketing authorisation holder

Updated on 20 September 2012

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.5 has been updated to change the colour of the PVC films from green to white.
Section 7 has been updated to include 'T/A SANOFI'

Updated on 21 December 2010

Reasons for updating

  • Correction of spelling/typing errors

Updated on 14 May 2010

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of SJS & TEN to Section 4.8

Updated on 10 February 2010

Reasons for updating

  • 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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update sections 4.4 and 4.5 in relation to use with risperidone.

Updated on 07 January 2009

Reasons for 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 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

update sections 4.3, 4.4, 4.5, 4.6, 4.8, 4.9

Updated on 07 January 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to information about pregnancy or lactation
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions

Updated on 02 October 2008

Reasons for updating

  • New PIL for medicines.ie

Updated on 04 September 2008

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 29 April 2008

Reasons for updating

  • Change to section 4.3 - Contraindications

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update Section 4.3 Contraindications

Updated on 27 August 2007

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.3    Additional Contraindications
Section 4.4    Additional warnings
Section 4.6    Reworded to advise use in pregnancy only if considered essential by physician
Section 4.7    Changed to include warning
Section 6.1    The term 'Aerosil' removed from Colloidal anhydrous silica
Section 6.3    Summarised to '3 years'
Section 7       Changed name of MA holder to sanofi-aventis
Section 9       Inserted subheadings
Section 10     Updated to March 2007

Updated on 04 September 2006

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Submission of individual SPC.
Previously combined SPC.
Update to Section 4.4 - Interactions divided into three categories.
Update to Section 4.8 - Undesirable Effects grouped per organ class

Updated on 04 September 2006

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)