Public Assessment Report Decentralised Procedure …

1 PAR Equasym XL 40 mg, 50 mg and 60 mg modified-release capsules, hard UK/H/0819/004-6/DC 1 Public Assessment Report Decentralised Procedure EQUASYM XL 40 MG MODIFIED-RELEASE CAPSULES, HARD EQUASYM XL 50 MG MODIFIED-RELEASE CAPSULES, HARD EQUASYM XL 60 MG MODIFIED-RELEASE CAPSULES, HARD (Methylphenidate hydrochloride) Procedure No: UK/H/0819/004- 6/DC UK Licence No: PL 27303/0007-9 SHIRE PHARMACEUTICALS IRELAND LIMITED PAR Equasym XL 40 mg, 50 mg and 60 mg modified-release capsules, hard UK/H/0819/004-6/DC 2 LAY SUMMARY This is a summary of the Public Assessment Report (PAR) for Equasym XL 40 mg, 50 mg and 60 mg modified-release capsules, hard.

2 These products will be referred to as Equasym XL in the remainder of this summary. This summary explains how Equasym XL w as assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use Equasym XL. For practical information about using Equasym XL patients should read the package leaflet or contact their doctor or pharmacist. What is Equasym XL and what is it used for? Equasym XL is a hybrid generic medicine. This means that the capsules contain the same active substance (methylphenidate hydrochloride) as the reference product, Ritalin 10mg Tablets but contains a different amount of this active substance and the formulation allows for gradual release of the active substance in the body.

3 Equasym XL 40 mg, 50 mg and 60 mg modified-release capsules, hard are additional strengths of previously approved Equasym XL 10 mg, 20 mg and 30 mg modified-release capsules. Equasym XL is used to treat attention deficit hyperactivity disorder (ADHD) in children and young people between the ages of 6 and 18 after treatments such as counselling and behavioural therapy. Children and young people with ADHD find it hard to sit still and concentrate. It is not their fault that they cannot do these things. Many children and young people struggle to do these things. However, with ADHD they can cause problems with everyday life. Children and young people with ADHD may have difficulty learning and doing homework.

4 They find it hard to behave well at home, at school or in other places. ADHD does not affect the intelligence of a child or young person. How is Equasym XL used? Equasym XL should be given in the morning before breakfast. The capsules may be swallowed whole with a drink of water, or alternatively, may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of applesauce and taken immediately and not stored for future use. If the medicine is taken with soft food, some fluids, water, should be taken afterwards. Equasym XL is a modified release form of methylphenidate which releases the medicine gradually over a time period corresponding to the school day (8 hours).

5 It is intended to take the place of the same total daily dose of traditional (immediate release) methylphenidate taken at breakfast and lunchtime. In patients who have not taken methylphenidate before, their doctor will normally start treatment with traditional (immediate release) methylphenidate tablets. If the doctor feels it is necessary, methylphenidate treatment may be started with Equasym XL 10 mg once daily before breakfast. The doctor will usually start treatment with a low dose and increase it gradually as required, however, the maximum daily dose is 60 mg. Patients who do not feel better after 1 month of treatment should tell their doctor as they may PAR Equasym XL 40 mg, 50 mg and 60 mg modified-release capsules, hard UK/H/0819/004-6/DC 3 need a different treatment.

6 Equasym XL can only be obtained with a prescription. How do Equasym XL work? Equasym XL improves the activity of certain parts of the brain which are under-active. The medicine can help improve attention (attention span), concentration and reduce impulsive behaviour. The medicine is given as part of a treatment programme, which usually includes psychological, educational and social therapy. Equasym XL is prescribed only by doctors who have experience in children or young people s behaviour problems. ADHD can be managed using treatment programmes. How has Equasym XL been studied? A study was conducted to determine that Equasym XL is bioequivalent to Equasym XL 10 mg, 20 mg and 30 mg modified release capsules.

7 Equasym XL produces the same levels of active substance in the body as the reference medicines, relative to the capsule doses. What is the risk associated with Equasym XL? For the full list of all side effects reported with Equasym XL, see section 4 of the package leaflet. For the full list of restrictions, see the package leaflet. Why is Equasym XL approved? It was considered that the benefits of using Equasym XL to treat ADHD outweigh the risks and the grant of Marketing Authorisations was recommended. What measures are being taken to ensure the safe and effective use of Equasym XL? A Risk Management Plan has been developed to ensure that Equasym XL is used as safely as possible.

8 Based on this plan, safety information has been included in the Summary of Product Characteristics and the package leaflet for Equasym XL, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously. Other information about Equasym XL The MHRA agreed to grant Marketing Authorisations for Equasym XL on 5 February 2013. For more information about treatment with Equasym XL, read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in August 2015.

9 The full PAR for Equasym XL follows this summary. PAR Equasym XL 40 mg, 50 mg and 60 mg modified-release capsules, hard UK/H/0819/004-6/DC 4 SCIENTIFIC DISCUSSION TABLE OF CONTENTS I Introduction Page 5 II Quality aspects Page 6 III Non-clinical aspects Page 10 IV Clinical aspects Page 11 V User consultation Page 13 VI Overall conclusion, benefit/risk Assessment and recommendation Page 14 Annex 1 - Table of content of the PAR update for MRP and DCP Page 15 PAR Equasym XL 40 mg, 50 mg and 60 mg modified-release capsules, hard UK/H/0819/004-6/DC 5 Scientific discussion I INTRODUCTION Based on the review of the data on quality, safety and efficacy the member states considered that the applications for Equasym XL 40 mg, 50 mg and 60 mg modified-release capsules, hard (PL 27303/0007-9; UK/H/0819/004-6/DC) could be approved.

10 These applications w ere submitted by the Decentralised Procedure , with the UK as Reference Member State (RMS), and Belgium, Germany, Denmark, Spain, Finland, France, Ireland, Italy, Luxembourg, Netherlands, Norway and Portugal as Concerned Member States (CMS). These are prescription-only medicines (POM). Methylphenidate is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10 and should be based on a complete history or evaluation of the patient.