Lercaril 20 mg/10 mg Film-coated Tablets
*Company:
Recordati Ireland LimitedStatus:
UpdatedLegal 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 19 April 2024
File name
IE_Lercaril 20-10_SmPC_July2021.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially “sodium-free”.
Updated on 16 March 2023
File name
IE_Lercaril 20-10_PIL-Apr2021.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change due to harmonisation of PIL
Updated on 22 December 2019
File name
lercaril-20mg-10mg-spc-July 2019.pdf
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 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 December 2019
File name
lercaril-20mg-10mg-pil-July 2019.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 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 04 March 2015
File name
PIL_13972_329.pdf
Reasons for updating
- New PIL for new product
Updated on 04 March 2015
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 02 March 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 March 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Multiple changes made to the SPC as a result of the licence renewal and the RAS-EMEA-H-A-31-1370-PRAC recommendations:
In Section 2.2
Excipients "with known effects" was added
In Section 3
"Circular" replaces "round" and size (8.5mm) added
In Section 4.2
Paediatric population:
Deleted statement about clinical experience and added "There is no relevant use of Lercaril in the paediatric population in the indication of hypertension."
In Section 4.3
Added:
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
· History of angioedema associated with ACE-inhibitor therapy
· Hereditary or idiopathic angioedema
· Association with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1)
Deleted:
A history of angioedema caused by previous therapy with an ACE-inhibitor
Hereditary or idiopathic angioedema
In Section 4.4
Added multiple new warnings and data to most sections
In Section 4.5
Added statement about Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
And updated other interactions
In Section 4.6
For enalapril
Added "Maternal oligohydramnios, presumably representing decreased fetal renal function, has occurred and may result in limb contractures, craniofacial deformations and hypoplastic lung development. "
For enalapril and lercanidipine in association
Added "There are no or limited amount of data from the use of enalapril maleate/lercanidipine HCl in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3)."
Added "Lercaril should not be used in the second and third trimester of pregnancy. It is not recommended in the first trimester of pregnancy and in women of childbearing potential not using contraception."
In Section 4.7
Added "Lercaril has minor influence on the ability to drive and use machines"
In Section 4.8
Added
Summary of the safety profile
Deleted current ADR table and added new table
In Section 4.9
Added post marketing experience
In Section 5.1
Added results from ONTARGET and VA NEPHRON-D clinical trials
Also various typos and grammar corrected throughout SPC
In Section 2.2
Excipients "with known effects" was added
In Section 3
"Circular" replaces "round" and size (8.5mm) added
In Section 4.2
Paediatric population:
Deleted statement about clinical experience and added "There is no relevant use of Lercaril in the paediatric population in the indication of hypertension."
In Section 4.3
Added:
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
· History of angioedema associated with ACE-inhibitor therapy
· Hereditary or idiopathic angioedema
· Association with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1)
Deleted:
A history of angioedema caused by previous therapy with an ACE-inhibitor
Hereditary or idiopathic angioedema
In Section 4.4
Added multiple new warnings and data to most sections
In Section 4.5
Added statement about Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
And updated other interactions
In Section 4.6
For enalapril
Added "Maternal oligohydramnios, presumably representing decreased fetal renal function, has occurred and may result in limb contractures, craniofacial deformations and hypoplastic lung development. "
For enalapril and lercanidipine in association
Added "There are no or limited amount of data from the use of enalapril maleate/lercanidipine HCl in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3)."
Added "Lercaril should not be used in the second and third trimester of pregnancy. It is not recommended in the first trimester of pregnancy and in women of childbearing potential not using contraception."
In Section 4.7
Added "Lercaril has minor influence on the ability to drive and use machines"
In Section 4.8
Added
Summary of the safety profile
Deleted current ADR table and added new table
In Section 4.9
Added post marketing experience
In Section 5.1
Added results from ONTARGET and VA NEPHRON-D clinical trials
Also various typos and grammar corrected throughout SPC
Updated on 21 October 2014
Reasons for updating
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change of revision date to be in line with current approved (HPRA) text
Correction of spelling errors
Correction of spelling errors
Updated on 27 June 2012
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.2 - Pharmacokinetic properties
- 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
In Section 4.6. Added a detailed paragraph on the pharmacokinetics of enalapril in breast milk
In Section 5.2 A Lactation paragraph explaining the plasma levels in milk of enalapril and enalaprilat has been added
In Section 10 Date of Revision of text has been amended
In Section 5.2 A Lactation paragraph explaining the plasma levels in milk of enalapril and enalaprilat has been added
In Section 10 Date of Revision of text has been amended
Updated on 26 June 2012
Reasons for updating
- Change to date of revision
- Addition of manufacturer
Updated on 22 June 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to information about pregnancy or lactation
Updated on 08 January 2009
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 January 2009
Reasons for updating
- New PIL for new product