Public Assessment Report UK National Procedure …

1 nefopam Hydrochloride 30mg Film-coated Tablets PL 41830/0014 and PL 41830/0034 1 Public Assessment Report UK National Procedure nefopam Hydrochloride 30mg Film-coated Tablets PL 41830/0014 PL 41830/0034 NRIM Limited nefopam Hydrochloride 30mg Film-coated Tablets PL 41830/0014 and PL 41830/0034 2 LAY SUMMARY This is a summary of the Public Assessment Report (PAR) for nefopam Hydrochloride 30mg Film-coated Tablets. It explains how nefopam Hydrochloride 30mg Film-coated Tablets were assessed and their authorisation recommended, as well as their conditions of use. It is not intended to provide practical advice on how to use nefopam Hydrochloride 30mg Film-coated Tablets.

2 For practical information about using nefopam Hydrochloride 30mg Film-coated Tablets, patients should read the package leaflet or contact their doctor or pharmacist. What are nefopam Hydrochloride 30mg Film-coated Tablets and what are they used for? nefopam Hydrochloride 30mg Film-coated Tablets is a generic medicine. This means that nefopam Hydrochloride 30mg Film-coated Tablets are similar to a reference medicine already authorised in the European Union (EU) called Acupan 30mg Tablets. nefopam is used to relieve acute and chronic pain (for example pain after an operation, dental pain, joint or muscle pain, pain after an injury, or pain caused by cancer).

3 nefopam should not be used to treat the pain from a heart attack. How do nefopam Hydrochloride 30mg Film-coated Tablets work? nefopam belongs to a group of medicines called analgesics, commonly known as pain killers or pain relievers. nefopam interrupts the pain messages being sent to the brain and also acts in the brain to stop pain messages being felt. This means that nefopam does not stop the pain from happening but patients will not be able to feel the pain as much. How are nefopam Hydrochloride 30mg Film-coated Tablets used? nefopam Hydrochloride 30mg Film-coated Tablets should be swallowed with water. The usual initial dose in adults is two tablets taken three times a day.

4 A doctor may increase this dose up to a maximum of three tablets taken three times a day according to their patient s needs. Children over 12 years should take the same dose as adults. nefopam should not be taken by children under 12. In elderly patients the doctor may reduce the number of tablets that are taken. The dosage for patients with kidney and/or liver problems may be adjusted by a doctor, depending upon their patient s condition. nefopam Hydrochloride 30mg Film-coated Tablets can only be obtained with a prescription. What benefits of nefopam Hydrochloride 30mg Film-coated Tablets have been shown in studies? Because nefopam Hydrochloride 30mg Film-coated Tablets is a generic medicine, studies in patients have been limited to tests to determine that this medicine is bioequivalent to the reference medicine, Acupan 30mg Tablets.

5 Two medicines are bioequivalent when they produce the same levels of the active substance in the body. nefopam Hydrochloride 30mg Film-coated Tablets PL 41830/0014 and PL 41830/0034 3 What are the possible side effects of nefopam Hydrochloride 30mg Film-coated Tablets? Because nefopam Hydrochloride 30mg Film-coated Tablets is a generic medicine its possible side effects are taken as being the same as those of the reference medicine, Acupan 30mg Tablets. For the full list of all side effects reported with nefopam Hydrochloride 30mg Film-coated Tablets see section 4 of the package leaflet. For the full list of restrictions, see the package leaflet.

6 Why are nefopam Hydrochloride 30mg Film-coated Tablets approved? It was considered that the benefits of using nefopam Hydrochloride 30mg Film-coated Tablets to relieve acute and chronic pain outweigh the risks and the grant of Marketing Authorisations was recommended. What measures are being taken to ensure the safe and effective use of nefopam Hydrochloride 30mg Film-coated Tablets? A Risk Management Plan has been developed to ensure that nefopam Hydrochloride 30mg Film-coated Tablets are used as safely as possible. Based on this plan, safety information has been included in the Summaries of Product Characteristics and the package leaflet for nefopam Hydrochloride 30mg Film-coated Tablets, including the appropriate precautions to be followed by healthcare professionals and patients.

7 Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored and reviewed continuously. Other information about nefopam Hydrochloride 30mg Film-coated Tablets The MHRA agreed to grant Marketing Authorisations for nefopam Hydrochloride 30mg Film-coated Tablets on 9 February 2015. For more information about treatment with nefopam Hydrochloride 30mg Film-coated Tablets, read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in April 2015. The full PAR for nefopam Hydrochloride 30mg Film-coated Tablets follows this summary. nefopam Hydrochloride 30mg Film-coated Tablets PL 41830/0014 and PL 41830/0034 4 TABLE OF CONTENTS I Introduction Page 5 II Quality aspects Page 6 III Non- clinical aspects Page 9 IV Clinical aspects Page 9 V User consultation Page 12 VI Overall conclusion, benefit/risk Assessment and recommendation Page 12 VII Steps taken for Assessment Page 13 VIII Steps taken after initial authorisation Page 13 nefopam Hydrochloride 30mg Film-coated Tablets PL 41830/0014 and PL 41830/0034 5 I Introduction Based on the review of the data on quality.

8 Safety and efficacy, the Medicines and Healthcare products Regulatory Agency (MHRA) considered that the applications for nefopam Hydrochloride 30mg Film-coated Tablets could be approved. This prescription only medicine (POM) is used for the relief of acute and chronic pain, including post-operative pain, dental pain, musculo-skeletal pain, acute traumatic pain and cancer pain. The applications for nefopam Hydrochloride 30mg Film-coated Tablets were made under Article 10(1) of Directive 2001/83/EC, as amended, as so-called generic applications. The reference medicinal product for these applications is Acupan 30 mg Tablets, which was first authorised to 3M Heath Care Limited (authorisation number: PL 00068/0061) on 2 March 1978.

9 The Marketing Authorisation was transferred to Valeant Pharmaceuticals Ltd (PL 19166/0088) on 30 October 2007 and then to Meda Pharmaceuticals Ltd (PL 15142/0109) on 2 February 2010. As this reference product has been authorised in the EEA for at least 10 years the legal basis of these applications is acceptable. nefopam is a potent and rapidly-acting analgesic. It is totally distinct from other centrally-acting analgesics such as morphine, codeine, pentazocine and propoxyphene. Unlike the narcotic agents, nefopam has been shown not to cause respiratory depression. There is no evidence from pre-clinical research of habituation occurring with nefopam . A bioequivalence study comparing nefopam Hydrochloride 30mg Film-coated Tablets to Acupan 30 mg Tablets ( PL 19166/0088) was submitted with the applications.

10 Assurance has been provided that the study has been conducted according to the principles of Good Clinical Practice (GCP). No new non-clinical data were submitted, which is acceptable given that the applications are for generic versions of an originator product that has been in clinical use for over 10 years. The RMS has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place for these product types at all sites responsible for the manufacture and assembly of these products. For manufacturing sites within the Community, the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those sites.