Zanidip 10mg Tablets
*Company:
Recordati Ireland LimitedStatus:
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 02 July 2021
File name
zanidip-10mg-spc-ie.pdf
Reasons for updating
- Correction of spelling/typing errors
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated inline with QRD template and excipient guidance
Updated on 29 November 2019
File name
zanidip-10mg-spc.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.6 - 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
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 August 2017
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 4.6 - 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 4.9 - 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2 - updated to bring it in line with the QRD template
Section 4.2-updated to bring it in line with the QRD template
Section 4.3-updated to bring it in line with the QRD template
Section 4.4-updated to bring it in line with the QRD template
Section 4.5-updated to bring it in line with the QRD template
Section-4.6-updated to bring it in line with the QRD template
Section 4.6-updated to bring it in line with the QRD template
Section 4.7-updated to bring it in line with the QRD template
Section 4.8-updated to bring it in line with the QRD template
Section 4.9-updated to bring it in line with the QRD template
Section 5.1-updated to bring it in line with the QRD template
Section 5.2-updated to bring it in line with the QRD template
section 6.4-updated to bring it in line with the QRD template
Section 6.6-updated to bring it in line with the QRD template
Section 10- date of revision has been updated
Section 4.2-updated to bring it in line with the QRD template
Section 4.3-updated to bring it in line with the QRD template
Section 4.4-updated to bring it in line with the QRD template
Section 4.5-updated to bring it in line with the QRD template
Section-4.6-updated to bring it in line with the QRD template
Section 4.6-updated to bring it in line with the QRD template
Section 4.7-updated to bring it in line with the QRD template
Section 4.8-updated to bring it in line with the QRD template
Section 4.9-updated to bring it in line with the QRD template
Section 5.1-updated to bring it in line with the QRD template
Section 5.2-updated to bring it in line with the QRD template
section 6.4-updated to bring it in line with the QRD template
Section 6.6-updated to bring it in line with the QRD template
Section 10- date of revision has been updated
Updated on 18 August 2017
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 4.6 - 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 4.9 - 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
Free text change information supplied by the pharmaceutical company
Section 2 - updated to bring it in line with the QRD template
Section 4.2-updated to bring it in line with the QRD template
Section 4.3-updated to bring it in line with the QRD template
Section 4.4-updated to bring it in line with the QRD template
Section 4.5-updated to bring it in line with the QRD template
Section-4.6-updated to bring it in line with the QRD template
Section 4.6-updated to bring it in line with the QRD template
Section 4.7-updated to bring it in line with the QRD template
Section 4.8-updated to bring it in line with the QRD template
Section 4.9-updated to bring it in line with the QRD template
Section 5.1-updated to bring it in line with the QRD template
Section 5.2-updated to bring it in line with the QRD template
section 6.4-updated to bring it in line with the QRD template
Section 6.6-updated to bring it in line with the QRD template
Section 10- date of revision has been updated
Section 4.2-updated to bring it in line with the QRD template
Section 4.3-updated to bring it in line with the QRD template
Section 4.4-updated to bring it in line with the QRD template
Section 4.5-updated to bring it in line with the QRD template
Section-4.6-updated to bring it in line with the QRD template
Section 4.6-updated to bring it in line with the QRD template
Section 4.7-updated to bring it in line with the QRD template
Section 4.8-updated to bring it in line with the QRD template
Section 4.9-updated to bring it in line with the QRD template
Section 5.1-updated to bring it in line with the QRD template
Section 5.2-updated to bring it in line with the QRD template
section 6.4-updated to bring it in line with the QRD template
Section 6.6-updated to bring it in line with the QRD template
Section 10- date of revision has been updated
Updated on 15 July 2011
Reasons for updating
- 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 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 4.3 - Contraindications
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In Section 2 : The word "Contains" was added to excipients
In Section 3 : " The score line is only to faciliate breaking for ease of swallowing and not to divide into equal doses" was added
In Section 4.2 : "There is no experience in children" was added to Experience in Children
In Section 4.3 : " to the active substance" was deleted and "hydrochloriode" was added in the first sentence
In Section 4.5 : "Interaction studies have only been performed in adults" was added
In Section 4.8 : "WHO ART Body System" was deleted and "MedRA System Organ Class" was added. The Undesirable Effects table was revised to be in line with MedRA Terms
In Section 4.9 : The Overdose Data was updated to include the 3rd case reported of overdose and a table was inserted to summarise experience of overdose thus far
In Section 5.2 : The following headings were added: Distribution, Biotransformation, Elimination, Linearity/Non-Linearity, Characteristics in Patients
In Section 5.3 : "Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction." was inserted
In Section 6.4 : "In order to protect from light and moisture" was added
In Section 6.5 : Packs of 7, 14 and 28
In Section 6.6 : "Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product" added
In Section 9 : "Date of first authorisation" and "Date of last renewal" inserted
In Section 10 : "July 2011" inserted
In Section 3 : " The score line is only to faciliate breaking for ease of swallowing and not to divide into equal doses" was added
In Section 4.2 : "There is no experience in children" was added to Experience in Children
In Section 4.3 : " to the active substance" was deleted and "hydrochloriode" was added in the first sentence
In Section 4.5 : "Interaction studies have only been performed in adults" was added
In Section 4.8 : "WHO ART Body System" was deleted and "MedRA System Organ Class" was added. The Undesirable Effects table was revised to be in line with MedRA Terms
In Section 4.9 : The Overdose Data was updated to include the 3rd case reported of overdose and a table was inserted to summarise experience of overdose thus far
In Section 5.2 : The following headings were added: Distribution, Biotransformation, Elimination, Linearity/Non-Linearity, Characteristics in Patients
In Section 5.3 : "Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction." was inserted
In Section 6.4 : "In order to protect from light and moisture" was added
In Section 6.5 : Packs of 7, 14 and 28
In Section 6.6 : "Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product" added
In Section 10 : "July 2011" inserted
Updated on 15 July 2011
Reasons for updating
- 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 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 4.3 - Contraindications
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
Free text change information supplied by the pharmaceutical company
In Section 2 : The word "Contains" was added to excipients
In Section 3 : " The score line is only to faciliate breaking for ease of swallowing and not to divide into equal doses" was added
In Section 4.2 : "There is no experience in children" was added to Experience in Children
In Section 4.3 : " to the active substance" was deleted and "hydrochloriode" was added in the first sentence
In Section 4.5 : "Interaction studies have only been performed in adults" was added
In Section 4.8 : "WHO ART Body System" was deleted and "MedRA System Organ Class" was added. The Undesirable Effects table was revised to be in line with MedRA Terms
In Section 4.9 : The Overdose Data was updated to include the 3rd case reported of overdose and a table was inserted to summarise experience of overdose thus far
In Section 5.2 : The following headings were added: Distribution, Biotransformation, Elimination, Linearity/Non-Linearity, Characteristics in Patients
In Section 5.3 : "Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction." was inserted
In Section 6.4 : "In order to protect from light and moisture" was added
In Section 6.5 : Packs of 7, 14 and 28
In Section 6.6 : "Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product" added
In Section 9 : "Date of first authorisation" and "Date of last renewal" inserted
In Section 10 : "July 2011" inserted
In Section 3 : " The score line is only to faciliate breaking for ease of swallowing and not to divide into equal doses" was added
In Section 4.2 : "There is no experience in children" was added to Experience in Children
In Section 4.3 : " to the active substance" was deleted and "hydrochloriode" was added in the first sentence
In Section 4.5 : "Interaction studies have only been performed in adults" was added
In Section 4.8 : "WHO ART Body System" was deleted and "MedRA System Organ Class" was added. The Undesirable Effects table was revised to be in line with MedRA Terms
In Section 4.9 : The Overdose Data was updated to include the 3rd case reported of overdose and a table was inserted to summarise experience of overdose thus far
In Section 5.2 : The following headings were added: Distribution, Biotransformation, Elimination, Linearity/Non-Linearity, Characteristics in Patients
In Section 5.3 : "Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction." was inserted
In Section 6.4 : "In order to protect from light and moisture" was added
In Section 6.5 : Packs of 7, 14 and 28
In Section 6.6 : "Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product" added
In Section 10 : "July 2011" inserted
Updated on 15 August 2006
Reasons for updating
- 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 10: date of revision of text updated.
Updated on 15 August 2006
Reasons for updating
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 10: date of revision of text updated.
Updated on 09 November 2005
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.5 - 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 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 November 2005
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.5 - 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 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Updated on 25 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 June 2003
Reasons for updating
- New SPC for medicines.ie