When a pharmaceutical company changes an SPC or PIL, 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.
Product ownership changed from GSK to Aspen
Section 1. NAME OF THE MEDICINAL PRODUCT
· Inserted space between ‘5’ and ‘mg’ Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION · Changed wording from ‘Tablet containing’ to ‘Each tablet contains’ · Where quantities are detailed, inserted space between quantity and unit, e.g. between ‘5’ and ‘mg’ Section 4.2 Posology and Method of Administration · Where quantities are detailed, inserted space between quantity and unit, e.g. between ‘2.5’ and ‘mg’ Section 9 DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION · Included the texts ‘Date of first authorisation’ and ‘Date of last renewal’ · Corrected the date of last renewal to ‘2009’
Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
· Changed wording from ‘Tablet containing’ to ‘Each tablet contains’ · Where quantities are detailed, inserted space between quantity and unit, e.g. between ‘5’ and ‘mg’ Section 4.2 Posology and Method of Administration · Where quantities are detailed, inserted space between quantity and unit, e.g. between ‘2.5’ and ‘mg’ Section 9 DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION · Included the texts ‘Date of first authorisation’ and ‘Date of last renewal’ · Corrected the date of last renewal to ‘2009’
· Where quantities are detailed, inserted space between quantity and unit, e.g. between ‘5’ and ‘mg’ Section 4.2 Posology and Method of Administration · Where quantities are detailed, inserted space between quantity and unit, e.g. between ‘2.5’ and ‘mg’ Section 9 DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION · Included the texts ‘Date of first authorisation’ and ‘Date of last renewal’ · Corrected the date of last renewal to ‘2009’
Section 4.2 Posology and Method of Administration
· Where quantities are detailed, inserted space between quantity and unit, e.g. between ‘2.5’ and ‘mg’ Section 9 DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION · Included the texts ‘Date of first authorisation’ and ‘Date of last renewal’ · Corrected the date of last renewal to ‘2009’
Section 9 DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
· Included the texts ‘Date of first authorisation’ and ‘Date of last renewal’ · Corrected the date of last renewal to ‘2009’
· Corrected the date of last renewal to ‘2009’
Kemadrin 5mg Renewal: Amended Text Highlighted in Red:
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing Procyclidine Hydrochloride. 5mg
Excipients-Contains Lactose Monohydrate 174.0mg and Sodium0.5mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets.
White, biconvex tablets, scored, coded ‘S3A’ and branded ‘Wellcome’.
The score line is to allow breaking for ease of swallowing
6.5 Nature and Contents of Containers
Not all pack sizes may be marketed
5.3 Preclinical Safety Data
Mutagenicity, Carcinogenicity:
Procyclidine was not genotoxic in in-vitro bacterial mutation or mouse lymphoma assays