CO-CODAMOL 30MG/500MG TABLETS PL …

1 MHRA-UKPAR CO-CODAMOL 30MG/500MG TABLETS PL 17907/0235 - 1 - CO-CODAMOL 30MG/500MG TABLETS PL 17907/0235 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Steps taken after authorisation summary Page 12 Summary of Product Characteristics Page 13 Patient Information Leaflet Page 18 Labelling Page 20 MHRA-UKPAR CO-CODAMOL 30MG/500MG TABLETS PL 17907/0235 - 2 - CO-CODAMOL 30MG/500MG TABLETS PL 17907/0235 LAY SUMMARY The Medicines and Healthcare products Regulatory Agency granted Bristol Laboratories Limited a Marketing Authorisation (licence)

2 For the medicinal product CO-CODAMOL 30MG/500MG TABLETS (PL 17097/0235 on 23rd May 2011. This is a prescription-only medicine (POM). CO-CODAMOL 30MG/500MG TABLETS contain two active ingredients-codeine and paracetamol both of which belong to a group of medicines called painkillers (analgesics). CO-CODAMOL TABLETS are a compound analgesic and are used to provide relief from severe pain. No new or unexpected safety concerns arose from this application and it was, therefore, judged that the benefits of taking CO-CODAMOL 30MG/500MG TABLETS outweigh the risks; hence a Marketing Authorisation has been granted.)

3 MHRA-UKPAR CO-CODAMOL 30MG/500MG TABLETS PL 17907/0235 - 3 - CO-CODAMOL 30MG/500MG TABLETS PL 17907/0235 SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 4 Pharmaceutical assessment Page 5 Preclinical assessment Page 8 Clinical assessment Page 9 Overall conclusions and risk benefit assessment Page 10 MHRA-UKPAR CO-CODAMOL 30MG/500MG TABLETS PL 17907/0235 - 4 - INTRODUCTION The UK granted a Marketing Authorisation for the medicinal product CO-CODAMOL 30MG/500MG (PL 17907/0235) to Bristol Laboratories Limited on 23rd May 2011.

4 This product is a prescription-only medicine. This application was submitted as an abridged application according to Article 10(1) of Directive 2001/83/EC. The applications refer to the originator product, Solpadol 30MG/500MG Caplets (PL 11723/0071), authorised to Sanofi Aventis on 12 September 1989. The reference product has been authorised in the EEA for over 10 years. Paracetamol is an analgesic which acts peripherally, probably by blocking impulse generation at the bradykinin sensitive chemo-receptors which evoke pain.

5 Paracetamol also exhibits antipyretic activity. Codeine is a centrally acting analgesic which produces its effect by its action at opioid-binding sites ( -receptors) within the CNS. It is a full agonist. CO-CODAMOL TABLETS are indicated in the relief of severe pain. The pharmacovigilance system, as described by the MAH, fulfils the requirements and provides adequate evidence that the MAH has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country.

6 The MAH has provided adequate justification for not submitting a Risk Management Plan (RMP). As the application is for a generic version of an already authorised reference product, for which safety concerns requiring additional risk minimisation have not been identified, a risk minimisation system is not considered necessary. The reference product has been in use for many years and the safety profile of the active is well established. No new pre-clinical or clinical studies were performed, which is acceptable given that the proposed product is a generic medicinal product of the reference product that have been licensed for over 10 years.

7 No new or unexpected safety concerns arose during the review of information provided by the Marketing Authorisation Holder (MAH) and it was, therefore, judged that the benefits of taking product CO-CODAMOL 30MG/500MG TABLETS outweigh the risks; hence a Marketing Authorisation has been granted. MHRA-UKPAR CO-CODAMOL 30MG/500MG TABLETS PL 17907/0235 - 5 - PHARMACEUTICAL ASSESSMENT DRUG SUBSTANCE (1) Paracetamol INN: Paracetamol Ph Eur 500mg Chemical name: Paracetamol Acetaminophen N-Acetyl-p-aminophenol Paracetamolum 4 -hydroxyacetanilide N-(4-hydroxyphenyl)acetanilide Structure: Molecular mass: Molecular formula: C8H9N02 General Properties Description: White odourless crystalline powder.

8 Paracetamol is the subject of a European Pharmacopoeia monograph (Ph Eur). Manufacture All aspects of the manufacture and control of the active substance paracetamol are covered by a European Directorate for the Quality of Medicines (EDQM) Certificate of Suitability. DRUG SUBSTANCE (2) Codeine INN: Codeine phosphate hemihydrate Molecular mass: Molecular formula: C18H21NO3 H2O MHRA-UKPAR CO-CODAMOL 30MG/500MG TABLETS PL 17907/0235 - 6 - General Properties Description: White odourless crystalline powder.

9 Codeine is the subject of a European Pharmacopoeia monograph (Ph Eur). Manufacture All aspects of the manufacture and control of the active substance codeine phosphate hemihydrate are covered by a European Directorate for the Quality of Medicines (EDQM) Certificate of Suitability. DRUG PRODUCT Description and Composition CO-CODAMOL 30MG/500MG TABLETS are presented as a white to off white capsule shaped biconvex uncoated plain TABLETS . Each tablet contains 30mg of codeine phosphate hemihydrate and 500mg of paracetamol.

10 Other ingredients consist of pharmaceutical excipients, namely pregelatinised maize starch, microcrystalline cellulose, sodium starch glycollate Type A, sodium metabisulfite, and magnesium stearate. Appropriate justification for the inclusion of each excipient has been provided. All excipients used comply with their relevant European Pharmacopoeia (Ph. Eur) monographs. Satisfactory Certificates of Analysis have been provided for all excipients. The applicant has provided a declaration confirming that there are no materials of human or animal origin contained in or used in the manufacturing process of the proposed product.