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.
Section 6.3 Shelf Life:
Current:
6.3 Shelf life
2 years.
Updated to:
Blister packs composed of PVC/PVDC foil backed with aluminium foil: 3 years
Blister packs composed of PP foil backed with aluminium foil: 4 years
In section 1 (name of the medicinal product), the name has been changed to “Beta-Adalat 20mg/50mg Capsules”
In section 2 (qualitative and quantitative composition), the following changes have been made:
BEFORE:
“One capsule contains 20 mg nifedipine and 50 mg atenolol.
For excipients see 6.1.”
AFTER:
“Each hard capsule contains 20 mg nifedipine and 50 mg atenolol.
Excipients: Contains 10mg lactose monohydrate per capsules
For a full list of excipients, see Section 6.1.”
The following changes have been made to section 3 (Pharmaceutical form):
“Capsule, hard.
Brown-reddish, opaque gelatin capsules overprinted with “BETA-ADALAT” and the Bayer cross.”
“Capsule, hard (capsule).
Brown-reddish, opaque gelatin capsules overprinted with “BETA-ADALAT” and the Bayer cross, containing white granules and a pink film-coated, round, biconvex tablet.”
In section 6.1 (List of excipients), the following changes have been made:
“Nifedipine tablets:
Microcrystalline cellulose
Maize starch
Lactose
Polysorbate 80
Magnesium stearate
Hypromellose
Macrogol 4000
Titanium dioxide (E171)
Red iron oxide (E172)
Atenolol granules:
Heavy magnesium carbonate
Sodium laurilsulfate
Gelatin
Capsule shell:
Gelatin”
Microcrystalline cellulose (E460)
Lactose monohydrate
Polysorbate 80 (E433)
Magnesium stearate (E572)
Hypromellose (E464)
Magnesium carbonate, heavy
Printing ink:
Shellac glaze
Soya lecithin
Antifoam DC
In section 6.3 (Shelf life);
“Blister packs composed of PVC/PVDC foil backed with aluminium foil: 3 years.
Blister packs composed of PP foil backed with aluminium foil: 2 years.”
has been changed to: “2 years.”
In section 6.5 (Nature and contents of container), the following changes have been made:
“Blister packs composed of PVC/PVDC foil, backed with aluminium foil, each containing 28 capsules.
Blister packs composed of PP foil, backed with aluminium foil, each containing 28 capsules.”
“Blister packs composed of PP foil, backed with aluminium foil, each containing 28 capsules.”
In section 9 (Date of first authorisation/renewal of the authorisation), the date of last renewal has been changed to “3rd October 2008”
The date of revision of the text (Section 10) has been changed to “July 2010”
The SPC has also been updated to improve readability.
Section 7, Section 8, Section 9 and Section 10 were changed to:7. Marketing Authorisation HolderBayer LimitedThe AtriumBlackthorn RoadDublin 18
8. Marketing Authorisation NumberPA 1410/026/001
9. Date of First Authorisation / Renewal of the AuthorisationDate of first authorisation: 03 October 1988Date of last renewal: 03 October 2003
10. Date of Revision of the TextJanuary 2008
The changes that have been made are purely administrative and include an update of the headings for section 4.3 ('contra-indications' to 'contraindications'), section 6.6 ('instructions for use and handling' to 'special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product'), section 9 ('Date of first authorisation/renewal of authorisation' to 'Date of first authorisation/renewal of the authorisation') and section 10 ('Date of (partial) revision of the text' to 'Date of revision of the text').