Public Assessment Report Decentralised Procedure - GOV.UK

1 Public Assessment Report Decentralised Procedure mariosea XL 2 mg prolonged - release Capsules mariosea XL 4 mg prolonged - release Capsules Trillblad XL 4 mg prolonged - release Capsules Dengaff XL 4 mg prolonged - release Capsules (tolterodine tartrate). Procedure No: UK/H/4976/001-2/DC. UK/H/4977-8/001/DC. UK Licence No: PL 00289/1772-5. TEVA UK Limited PAR mariosea , Dengaff and Trillblad XL 2 mg and 4 mg prolonged - release Capsules UK/H/4976/001-2/DC. UK/H/4977-8/001/DC. LAY SUMMARY. mariosea XL 2 mg prolonged - release Capsules mariosea XL 4 mg prolonged - release Capsules Trillblad XL 4 mg prolonged - release Capsules Dengaff XL 4 mg prolonged - release Capsules (tolterodine tartrate).

2 This is a summary of the Public Assessment Report (PAR) for mariosea XL 2 mg prolonged - release Capsules (PL 00289/1772; UK/H/4967/001/DC), mariosea XL 4 mg prolonged - release Capsules (PL 00289/1773; UK/H/4967/002/DC), Trillblad XL 4 mg prolonged - release Capsules PL 00289/1774;. UK/H/4978/001/DC) and Dengaff XL 4 mg prolonged - release Capsules (PL 00289/1775;. UK/H/4977/001/DC). It explains how the applications for mariosea , Dengaff and Trillblad XL. prolonged - release Capsules 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 mariosea , Dengaff and Trillblad XL prolonged - release Capsules.

3 For practical information about using mariosea , Dengaff and Trillblad XL prolonged - release Capsules, patients should read the package leaflet or contact their doctor or pharmacist. What are mariosea , Dengaff and Trillblad XL prolonged - release Capsules and what are they used for? mariosea , Dengaff and Trillblad XL prolonged - release Capsules are generic medicines'. This means mariosea , Dengaff and Trillblad XL prolonged - release Capsules are similar to reference medicines'. already authorised in the European Union (EU) called Detrusitol XL prolonged - release Capsules, hard (PL 00032/0286-7). mariosea , Dengaff and Trillblad XL 2 mg and 4 mg prolonged - release Capsules are used for the treatment of the symptoms of overactive bladder syndrome.

4 Patients with overactive bladder syndrome may find that they are unable to control urination and may need to rush to the toilet with no advance warning and/or go to the toilet frequently. How do mariosea , Dengaff and Trillblad XL prolonged - release Capsules work? These medicines contain the active ingredient tolterodine. Tolterodine belongs to a class of medicines called antimuscarinics. How are mariosea , Dengaff and Trillblad XL prolonged - release Capsules used? These medicines can only be obtained with a prescription. The recommended dose in adults is one 4 mg prolonged - release hard capsule daily. In patients with liver or kidney problems the dose may be reduced to one 2 mg prolonged - release hard capsule daily.

5 These medicines are not recommended for children. The capsules are for oral use and should be swallowed whole and not chewed. They can be taken with or without food. A doctor will advise how long your treatment with these medicines will last. Patients should not stop treatment early if they do not see an immediate effect, as the bladder will need some time to adapt. Patients should finish the course of prolonged - release capsules prescribed by the doctor. If they have not noticed any effect by then, they should talk to their doctor. The benefit of the treatment should be re-evaluated after 2 or 3 months. 2. PAR mariosea , Dengaff and Trillblad XL 2 mg and 4 mg prolonged - release Capsules UK/H/4976/001-2/DC.

6 UK/H/4977-8/001/DC. What benefits of mariosea , Dengaff and Trillblad XL prolonged - release Capsules have been shown in studies? Because mariosea , Dengaff and Trillblad XL prolonged - release Capsules are generic medicines, studies in patients have been limited to tests to determine that they are bioequivalent to the reference medicines, Detrusitol XL prolonged - release Capsules, hard. Two medicines are bioequivalent when they produce the same levels of the active substance in the body What are the possible side effects of mariosea , Dengaff and Trillblad XL prolonged - release Capsules? Because mariosea , Dengaff and Trillblad XL prolonged - release Capsules are generic medicines, its possible side effects are taken as being the same as those of the reference medicines.

7 For the full list of all side effects reported with mariosea , Dengaff and Trillblad XL prolonged - release Capsules, see section 4 of the package leaflet. For the full list of restrictions, see the package leaflets. Why were mariosea , Dengaff and Trillblad XL prolonged - release Capsules approved? It was concluded that, in accordance with EU requirements, mariosea , Dengaff and Trillblad XL. prolonged - release Capsules have been shown to have comparable quality and to be bioequivalent to Detrusitol XL prolonged - release Capsules, hard. Therefore, the MHRA decided that, as for Detrusitol XL prolonged - release Capsules, hard, the benefits outweigh the identified risks and recommended that mariosea , Dengaff and Trillblad XL prolonged - release Capsules can be approved for use.

8 What measures are being taken to ensure the safe and effective use of mariosea , Dengaff and Trillblad XL prolonged - release Capsules? Safety information has been included in the Summaries of Product Characteristics (SmPCs) and the package leaflets for mariosea , Dengaff and Trillblad XL prolonged - release Capsules 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 and reviewed continuously. Other information about mariosea , Dengaff and Trillblad XL prolonged - release Capsules Denmark, Norway, Republic of Ireland, Sweden, Slovenia and The Netherlands and the UK agreed to grant Marketing Authorisations for mariosea XL 2 mg prolonged - release Capsules on 20 June 2012.

9 Belgium, Denmark, Finland, Germany, Greece, Luxemburg, Norway, Poland, Republic of Ireland, Spain, The Netherlands, Sweden, Slovenia, Slovakia and the UK agreed to grant Marketing Authorisations for mariosea XL 4 mg prolonged - release Capsules on 20 June 2012. Germany, Spain, Finland and the UK agreed to grant Marketing Authorisations for Dengaff XL 4 mg prolonged - release Capsules on 20 June 2012. Germany and the UK agreed to grant Marketing Authorisations for Trillblad XL 4 mg prolonged - release Capsules on 20 June 2012. Marketing Authorisations were granted in the UK to Pharmathen SA on 07 August 2012 (PL. 17277/0305, 0307 & 0309).

10 These applications underwent a Change of Ownership Procedure on 14 August 2012 and 6 October 2012. to TEVA UK Limited (PL 00289/1772-5). 3. PAR mariosea , Dengaff and Trillblad XL 2 mg and 4 mg prolonged - release Capsules UK/H/4976/001-2/DC. UK/H/4977-8/001/DC. The full PAR for mariosea , Dengaff and Trillblad XL prolonged - release Capsules follows this summary. For more information about treatment with mariosea , Dengaff and Trillblad XL prolonged - release Capsules read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in September 2016. 4. PAR mariosea , Dengaff and Trillblad XL 2 mg and 4 mg prolonged - release Capsules UK/H/4976/001-2/DC.