Lercaril 10 mg/10 mg Film-coated Tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/03/15

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Summary of Product Characteristics last updated on medicines.ie: 2/3/2015
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Recordati Ireland Limited

Recordati Ireland Limited

Company Products

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Medicine Name Citrafleet Active Ingredients Citric Acid (Anhydrous), Magnesium Oxide Light, Sodium picosulfate
Medicine Name Cleenema Ready-to-Use 21.4g / 9.4g Enema Active Ingredients Disodium Phosphate Dodecahydrate, Sodium Dihydrogen Phosphate Dihydrate
Medicine Name Kentera oxybutynin transdermal patch Active Ingredients Oxybutynin
Medicine Name Lercaril 10 mg/10 mg Film-coated Tablets Active Ingredients Enalapril Maleate, Lercanidipine Hydrochloride
Medicine Name Lercaril 20 mg/10 mg Film-coated Tablets Active Ingredients Enalapril Maleate, Lercanidipine Hydrochloride
Medicine Name Lercaril 20 mg/20 mg Film-coated Tablets Active Ingredients Enalapril Maleate, Lercanidipine Hydrochloride
Medicine Name Phospho-soda 24.4g / 10.8g oral solution Active Ingredients Disodium Phosphate Dodecahydrate, Sodium Dihydrogen Phosphate Dihydrate
Medicine Name Reagila 1.5 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Reagila 3 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Reagila 4.5 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Reagila 6 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Urispas 200mg film-coated tablets Active Ingredients Flavoxate Hydrochloride, Lactose
Medicine Name Urorec 4 mg capsules Active Ingredients Silodosin
Medicine Name Urorec 8 mg capsules Active Ingredients Silodosin
Medicine Name Urorec capsules Active Ingredients Silodosin
Medicine Name Vitaros 3mg/g Cream Active Ingredients Alprostadil
Medicine Name Zanidip 10mg and 20mg Tablets Active Ingredients Lercanidipine Hydrochloride
Medicine Name Zanidip 10mg Tablets Active Ingredients Lercanidipine Hydrochloride
Medicine Name Zanidip 20mg Tablets Active Ingredients Lercanidipine Hydrochloride
1 - 0 of 20 items.Total: Infinity pages

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 4 March 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 4 March 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 March 2015 SmPC

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 - 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 4.6
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

Deleted:

Deleted:

Updated on 2 March 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 21 October 2014 SmPC

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

Revision date corrected to be in line with current approved (HPRA) SPC
Spelling errors corrected

Updated on 27 June 2012 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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 4.8  The table of undesirable effects has been amended to reflect the effects reported in controlled clinical trials in the (higher)Lercaril 20mg / 10mg dose. This has resulted in the following changes to the table: Headache frequency has moved from "uncommon" to "common", tachycardia has been removed, circulatory collapse has been removed, throat has been deleted and "pharyngeal pain" added, hypersensitivity has been removed and angioedema added, "(including dizziness postural)" has been added to dizziness.
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 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 22 June 2012 PIL

Reasons for updating

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

Updated on 8 January 2009 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 January 2009 SmPC

Reasons for updating

  • New SPC for new product

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