Zanidip 20mg Tablets

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 18 August 2017 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

Section 2- updated in line with QRD template
Section 4.2- updated in line with QRD template
Section 4.3- updated in line with QRD template
Section 4.4- updated in line with QRD template
Section 4.5- updated in line with QRD template
Section 4.6- updated in line with QRD template
Section 4.7- updated in line with QRD template
Section 4.8- updated in line with QRD template
Section 4.9- updated in line with QRD template
Section 5.1- updated in line with QRD template
Section 5.2- updated in line with QRD template
Section 6.4- updated in line with QRD template
Section 6.6- updated in line with QRD template
Section 10- date of revision updated

Updated on 18 August 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Section 2- updated in line with QRD template
Section 4.2- updated in line with QRD template
Section 4.3- updated in line with QRD template
Section 4.4- updated in line with QRD template
Section 4.5- updated in line with QRD template
Section 4.6- updated in line with QRD template
Section 4.7- updated in line with QRD template
Section 4.8- updated in line with QRD template
Section 4.9- updated in line with QRD template
Section 5.1- updated in line with QRD template
Section 5.2- updated in line with QRD template
Section 6.4- updated in line with QRD template
Section 6.6- updated in line with QRD template
Section 10- date of revision updated

Updated on 18 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 28 February 2011 PIL

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In Section 2 (Qualitative & Quantitative Composition): Added "Excipients: Contains lactose monohydrate 60mg"
In Section 3 (Pharmaceutical Form): Added "The score line is only to faciliate breaking for ease of swallowing and not to divide into equal doses."
In Section 4.2 (Posology & Method of Administration): Use in Children changed to "There is no experience in children"

In Section 4.3 (Contraindications): First sentence changed from "Hypersensitivity to the active substance "lercanidipine", ot to any dihydropyridine or to any of the excipients of the medicinal product" : "Hypersensitivity to "lercanidipine chloride", to any dihyropyridine or to any of the excipients".

In Section 4.4 (Special Warnings and Precautions for Use): In Use in renal or hepatic dysfunction section - added "(See 4.2)"

In Section 4.5 (Interaction with other medicinal products and other forms of interaction): Inserted sentence at start " Interaction studies have only been performed in adults." In addition the following 2 sentences have been highlighted in BOLD:
"Cyclosporin and lercanidipine should not be administered together (see 4.3)" and "Lercanidipine should not be taken with grapefruit juice (see 4.3)."

In Section 4.8 (Undesirable Effects): The adverse reactions have now been grouped by MedDRA System Organ Class and not by WHO-ART Body System Classification. The adverse drug reactions table has been revised to reflect these changes to the classes.

In Section 4.9 (Overdose) The opening paragraph has been amended to "three cases of overdose reported" and not "two" and a table has replaced the text explanation of the three cases reported.

In Section 5.2 (Pharmacokinetic Properties): The following headings to the paragraphs have been added - Absorption, Distribution, Biotransformation, Elimination and Characteristics in Patients

In Section 5.3 (Preclinical Safety Data): The following sentence has been inserted at the start of the section: "Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, cacinogenic potential, toxicity to reproduction."

In Section 6.4 (Special Precautions for Storage): Changed to "Store in original package in order to protect from light and moisture"

In Section 9 (Date of First Authorisation/Renewal of Authorisation): Added "Date of last renewal: 12 August 2010"

In Section 10 (Date of Revision of Text): Added "December 2010"

Updated on 28 February 2011 SmPC

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • 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

In Section 2 (Qualitative & Quantitative Composition): Added "Excipients: Contains lactose monohydrate 60mg"
In Section 3 (Pharmaceutical Form): Added "The score line is only to faciliate breaking for ease of swallowing and not to divide into equal doses."
In Section 4.2 (Posology & Method of Administration): Use in Children changed to "There is no experience in children"

In Section 4.3 (Contraindications): First sentence changed from "Hypersensitivity to the active substance "lercanidipine", ot to any dihydropyridine or to any of the excipients of the medicinal product" : "Hypersensitivity to "lercanidipine chloride", to any dihyropyridine or to any of the excipients".

In Section 4.4 (Special Warnings and Precautions for Use): In Use in renal or hepatic dysfunction section - added "(See 4.2)"

In Section 4.5 (Interaction with other medicinal products and other forms of interaction): Inserted sentence at start " Interaction studies have only been performed in adults." In addition the following 2 sentences have been highlighted in BOLD:
"Cyclosporin and lercanidipine should not be administered together (see 4.3)" and "Lercanidipine should not be taken with grapefruit juice (see 4.3)."

In Section 4.8 (Undesirable Effects): The adverse reactions have now been grouped by MedDRA System Organ Class and not by WHO-ART Body System Classification. The adverse drug reactions table has been revised to reflect these changes to the classes.

In Section 4.9 (Overdose) The opening paragraph has been amended to "three cases of overdose reported" and not "two" and a table has replaced the text explanation of the three cases reported.

In Section 5.2 (Pharmacokinetic Properties): The following headings to the paragraphs have been added - Absorption, Distribution, Biotransformation, Elimination and Characteristics in Patients

In Section 5.3 (Preclinical Safety Data): The following sentence has been inserted at the start of the section: "Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, cacinogenic potential, toxicity to reproduction."

In Section 6.4 (Special Precautions for Storage): Changed to "Store in original package in order to protect from light and moisture"

In Section 9 (Date of First Authorisation/Renewal of Authorisation): Added "Date of last renewal: 12 August 2010"

In Section 10 (Date of Revision of Text): Added "December 2010"

Updated on 15 August 2006 PIL

Reasons for updating

  • New SPC for medicines.ie

Updated on 15 August 2006 SmPC

Reasons for updating

  • New SPC for medicines.ie

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