Frumil 40mg/5mg Tablets
*Company:
SANOFIStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 25 March 2024
File name
1.3.1.3 IE-PIL Text - Frumil 40mg5mg clean.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 25 March 2024
File name
1.3.1.3 Package Leaflet (PIL text) Frumil 40mg5mg -clean (2).pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 5 - how to store or dispose
Updated on 07 March 2024
File name
1.3.1.1 - IE SmPC Frumil 40mg5mg clean.pdf
Reasons for updating
- 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)
Updated on 07 March 2024
File name
1.2.2 IE Frumil PIL Mock-up S23.633.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 03 March 2023
File name
IE-PIL Text - Frumil.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 03 March 2023
File name
1.3.1- SmPC Frumil 40mg 5mg.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 March 2022
File name
1.3.2. Mock-up PIL - Frumil Tablets.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 09 April 2019
File name
PIL Frumil IE417.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 09 April 2019
File name
SPC Frumil 40mg.5mg IE417.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.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
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
4.8- 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
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 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
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
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
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
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
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)
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)