WARFARIN 1 MG, 3 MG AND 5 MG TABLETS - GOV.UK

1 WARFARIN 1 MG, 3 mg and 5 mg tablets ( WARFARIN sodium clathrate) PL 36390/0136 - 0138 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 10 Steps taken after authorisation summary Summary of Product Characteristics Product Information Leaflet Labelling Page 11 Page 12 Page 12 Page 13 UKPAR WARFARIN 1 mg, 3 mg and 5 mg tablets PL 36390/0136 - 0138 2 LAY SUMMARY WARFARIN 1 mg, 3 mg and 5 mg tablets ( WARFARIN sodium clathrate) This is a summary of the public assessment report (PAR) for WARFARIN 1 mg, 3 mg and 5 mg tablets (PL 36390/0136-0138).

2 It explains how WARFARIN 1 mg, 3 mg and 5 mg tablets w ere assessed and their authorisations recommended, as well as the conditions of use. It is not intended to provide practical advice on how to use WARFARIN 1 mg, 3 mg and 5 mg tablets . For practical information about using WARFARIN 1 mg, 3 mg and 5 mg tablets , patients should read the package leaflet or contact their doctor or pharmacist. What are WARFARIN 1 mg, 3 mg and 5 mg tablets and what are they used for? WARFARIN 1 mg, 3 mg and 5 mg tablets belong to a group of medicines called anticaogulants. They are used to reduce the clotting ability of the blood. WARFARIN 1 mg, 3 mg and 5 mg tablets are used to treat and prevent blood clots from forming in the legs, lungs, brain and heart.

3 These medicines are identical to WARFARIN 1 mg, 3 mg and 5 mg tablets , which were originally authorised in the UK to Neolab Limited on 11 March 2004 (PL 08137/0093-0095). Following subsequent changes of ownership, the current marketing authorisation holder since 17 October 2012 is Aptil Pharma Ltd (PL 40378/0168-0170). Aptil Pharma Ltd has agreed that scientific data presented for WARFARIN 1 mg, 3 mg and 5 mg tablets (PL 40378/0168-0170) can be used for these applications for WARFARIN 1 mg, 3 mg and 5 mg tablets (PL 36390/0136-0138). How are WARFARIN 1 mg, 3 mg and 5 mg tablets used? WARFARIN 1 mg, 3 mg and 5 mg tablets are for oral use only and cannot be obtained without a prescription.

4 Regular blood tests will need to be performed to see how long it takes the blood to clot. These blood tests are very important to ensure that the correct dose has been prescribed. It is recommended that the anticoagulation card is carried at all times. The TABLETS come in three strengths and colours: 1 mg strength comes in the form of a brown tablet, 3 mg strength comes in the form of a blue tablet and the 5 mg strength comes in the form of a pink tablet. It is recommended that the medicines should be taken at the same time each day. The usual maintenance dose for WARFARIN TABLETS is between 3-9 mg. Due to the risk of bleeding, the dose of WARFARIN may need to be lowered before an operation or removal of teeth.

5 If the risk of severe bleeding is likely, WARFARIN intake must be stopped 72 hours before and after surgery. How do WARFARIN 1 mg, 3 mg and 5 mg tablets work? WARFARIN 1 mg, 3 mg and 5 mg tablets contain the active ingredient WARFARIN sodium clathrate. WARFARIN 1 mg, 3 mg and 5 mg tablets are known as anticoagulants. They work by preventing the formation of blood clots in the legs, lungs, brain and heart by reducing the clotting ability of the blood. The clotting ability of WARFARIN 1 mg, 3 mg and 5 mg tablets can be affected by many other medicines, including non-prescription medicines, herbal remedies, vitamins and food supplements, as these UKPAR WARFARIN 1 mg, 3 mg and 5 mg tablets PL 36390/0136 - 0138 3 medicines can increase the effect of WARFARIN sodium clathrate and increase the amount of bleeding.

6 How have WARFARIN 1 mg, 3 mg and 5 mg tablets been studied? These applications are identical to the previously granted applications for WARFARIN 1 mg, 3 mg and 5 mg tablets ( PL 40378/0168-0170; Aptil Pharma Ltd). The applicant (Cipla (EU) Limited) referred to data provided by Aptil Pharma Ltd for the grant of WARFARIN 1 mg, 3 mg and 5 mg tablets (PL 40378/0168-0170) as a basis for the grant of identical licences for WARFARIN 1 mg, 3 mg and 5 mg tablets (PL 36390/0136-0138). What are the benefits and risks of WARFARIN 1 mg, 3 mg and 5 mg tablets ? WARFARIN 1 mg, 3 mg and 5 mg tablets are considered identical to previously authorised WARFARIN 1 mg, 3 mg and 5 mg tablets (Aptil Pharma Ltd), with the same benefits and risks.

7 Why are WARFARIN 1 mg, 3 mg and 5 mg tablets approved? No new or unexpected safety concerns arose from these applications. It was, therefore, considered that the benefits of WARFARIN 1 mg, 3 mg and 5 mg tablets outweigh their risks; and the grant of Marketing Authorisations was recommended. What measures are being taken to ensure the safe and effective use of WARFARIN 1 mg, 3 mg and 5 mg tablets ? A risk management plan has been developed to ensure that WARFARIN 1 mg, 3 mg and 5 mg tablets are used as safely as possible. Based upon this plan, safety information has been included in the Summary of Product Characteristics and the package leaflet for WARFARIN 1 mg, 3 mg and 5 mg tablets , including the appropriate precautions to be followed by healthcare professionals and patients.

8 Other information about WARFARIN 1 mg, 3 mg and 5 mg tablets Marketing Authorisations were granted in the UK on 22 January 2014. For more information about treatment with WARFARIN 1 mg, 3 mg and 5 mg tablets , read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in March 2014. The full PAR for WARFARIN 1 mg, 3 mg and 5 mg tablets follows this summary. UKPAR WARFARIN 1 mg, 3 mg and 5 mg tablets PL 36390/0136 - 0138 4 WARFARIN 1 MG, 3 mg and 5 mg tablets (PL 36390/0136-0138) SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 5 Pharmaceutical assessment Page 6 Non-clinical assessment Page 8 Clinical assessment Page 9 Overall conclusions and benefit/risk assessment Page 9 UKPAR WARFARIN 1 mg, 3 mg and 5 mg tablets PL 36390/0136 - 0138 5 INTRODUCTION Based on the review of the data on quality, safety and efficacy, the UK granted Marketing Authorisations for the medicinal products WARFARIN 1 mg, 3 mg and 5 mg tablets (PL 36390/0136-0138)

9 On 22 January 2014 to Cipla (EU) Limited. These applications for WARFARIN 1 mg, 3 mg and 5 mg tablets w ere submitted as abridged simple applications, according to Article 10c of Directive 2001/83/EC, as amended, cross-referring to WARFARIN 1 mg, 3 mg and 5 mg tablets , which were authorised in the UK to Neolab Limited on 11 March 2004 (PL 08137/0093-0095). Following subsequent changes of ownership, the current marketing authorisation holder since 17 October 2012 is Aptil Pharma Ltd (PL 40378/0168-0170). These medicines are prescription only medicines (legal status POM). WARFARIN 1 mg, 3 mg and 5 mg tablets contain the active ingredient WARFARIN sodium clathrate and are indicated for: prophylaxis of systemic embolism in patients with rheumatic heart disease and atrial fibrillation prophylaxis after insertion of prosthetic heart valves prophylaxis and treatment of venous thrombosis and pulmonary embolism and transient attacks of cerebral ischaemia.

10 WARFARIN is a synthetic anticoagulant of the coumarin series. It acts by inhibiting the formation of active clotting factors II, VII, IX and X. UKPAR WARFARIN 1 mg, 3 mg and 5 mg tablets PL 36390/0136 - 0138 6 PHARMACEUTICAL ASSESSMENT LICENCE NO: PL 36390/0136-0138 PROPRIETARY NAME: WARFARIN 1 mg, 3 mg and 5 mg tablets ACTIVE(S): WARFARIN sodium clathrate COMPANY NAME: Cipla (EU) Limited ARTICLE: Article 10c of Directive 2001/83/EC, as amended LEGAL STATUS: POM 1. INTRODUCTION These are simple, piggyback applications for WARFARIN 1 mg, 3 mg and 5 mg tablets submitted under Article 10c of Directive 2001/83/EC, as amended.