Public Assessment Report Decentralised Procedure ...

1 Public Assessment Report Decentralised Procedure Pregabalin Tillomed 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg capsules, hard (pregabalin). Procedure No: UK/H/6627/001-008/DC. UK Licence Number: PL 11311/0561-0568. Tillomed Laboratories Limited UKPAR Pregabalin Tillomed Capsules, hard UK/H/6627/001-008/DC. Lay Summary Pregabalin Tillomed 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg capsules, hard (pregabalin). This is a summary of the Public Assessment Report (PAR) for Pregabalin Tillomed 25mg, 50mg, 75mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg capsules, hard (UK/H/6627/001-008/DC; PL. 11311/0561-0568). These medicinal products will be referred to as Pregabalin Tillomed Capsules through out the remainder of the PAR, for ease of reading. This summary explains how Pregabalin Tillomed Capsules were assessed and their authorisations recommended, as well as their conditions of use. It is not intended to provide practical advice on how to use these products.

2 For practical information about using Pregabalin Tillomed Capsules, patients should read the Patient Information Leaflet (PIL) or contact their doctor or pharmacist. What are Pregabalin Tillomed Capsules and what are they used for? Pregabalin Tillomed Capsules are generic medicines'. This means that Pregabalin Tillomed Capsules are similar to a reference medicine' already authorised in the European Union (EU) called Lyrica 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules authorised to Pfizer Limited (EU/1/04/279/001-006-011-014-017-020-033 -023). Pregabalin Tillomed Capsules are used in adults to treat the following indications: Peripheral and central neuropathic pain Pregabalin Tillomed Capsules are used to treat long lasting pain caused by damage to the nerves. A. variety of diseases can cause peripheral neuropathic pain, such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles.

3 Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life. Epilepsy Pregabalin Tillomed Capsules are used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. The patient's doctor will prescribe Pregabalin Tillomed Capsules to help treat the patient's epilepsy when the patient's current treatment is not controlling their condition. The patients should always take Pregabalin Tillomed Capsules in addition to the patient's current treatment. Pregabalin Tillomed Capsules are not intended to be used alone, but should always be used in combination with other antiepileptic treatment. Generalised Anxiety Disorder Pregabalin Tillomed Capsules are used to treat Generalised Anxiety Disorder (GAD). The symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control.

4 GAD can also cause restlessness or feeling keyed up or on edge, being easily fatigued (tired), having difficulty concentrating or mind going blank, feeling irritable, having muscle tension or sleep disturbance. This is different to the stresses and strains of everyday life. How do Pregabalin Tillomed Capsules work? Pregabalin Tillomed Capsules contain the active ingredient pregabalin, which belongs to a group of medicines called antiepileptics. The way in which pregabalin works is not fully understood, it is thought 2. UKPAR Pregabalin Tillomed Capsules, hard UK/H/6627/001-008/DC. to work by binding to calcium channels found on nerve cells in the brain and spinal cord. This reduces the release of various neurotransmitters from these nerve cells. Neurotransmitters are natural body chemicals that are stored in nerve cells. They are involved in transmitting messages between the nerve cells. How are Pregabalin Tillomed Capsules used? The pharmaceutical form of Pregabalin Tillomed Capsules is capsule, hard, and the route of administration is oral (taken by mouth).

5 The patient must always take Pregabalin Tillomed Capsules exactly as their doctor has told them to. The patient must check with their doctor or pharmacist if they are not sure. The patient's doctor will determine the appropriate doses. The recommend dose of this medicine is: Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder: Take the number of capsules as instructed by the doctor The dose, which has been adjusted for the patient and their condition, will generally be between 150 mg and 600 mg each day. The patient's doctor will tell the patient to take this medicine either twice or three times a day. For twice a day, take Pregabalin Tillomed Capsules once in the morning and once in the evening, at about the same time each day. For three times a day, take Pregabalin Tillomed Capsules once in the morning, once in the afternoon and once in the evening, at about the same time each day. If the patient has the impression that the effect of Pregabalin Tillomed Capsules is too strong or too weak, the patient should talk to their doctor or pharmacist.

6 The patient should continue taking Pregabalin Tillomed Capsules until the patient's doctor tells the patient to stop. Please read section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration, and the duration of treatment. This medicine can only be obtained with a prescription from a doctor. For further information on how Pregabalin Tillomed Capsules are used, please see the Summaries of Product Characteristics or the package leaflet available on the MHRA website. What benefits of Pregabalin Tillomed Capsules have been shown in studies? Because Pregabalin Tillomed Capsules are generic medicines, studies have been limited to tests to determine that they are bioequivalent to the reference medicine Lyrica 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. What are the possible side effects from Pregabalin Tillomed Capsules?

7 Because Pregabalin Tillomed Capsules are generic medicines and are bioequivalent to the reference medicine Lyrica 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules, their benefits and possible side effects are taken as being the same as the reference medicine. For the full list of restrictions, see the package leaflet. Why are Pregabalin Tillomed Capsules approved? 3. UKPAR Pregabalin Tillomed Capsules, hard UK/H/6627/001-008/DC. It was concluded that, in accordance with EU requirements, Pregabalin Tillomed Capsules have been shown to have comparable quality and to be bioequivalent to Lyrica 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg capsules. Therefore, the MHRA decided that, as for reference medicine; Lyrica 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300mg hard capsules, the benefits are greater than the risks and recommended that Pregabalin Tillomed Capsules can be approved for use. What measures are being taken to ensure the safe and effective use of Pregabalin Tillomed Capsules?

8 A Risk Management Plan (RMP) has been developed to ensure that Pregabalin Tillomed Capsules 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 Pregabalin Tillomed Capsules, including the appropriate precautions to be followed by healthcare professionals and patients. Other information about Pregabalin Capsules The members states in the procedures below agreed to grant Marketing Authorisations on 14 June 2018: UK/H/6627/001-008/DC: Germany, Spain, Italy and the UK. UK/H/6627/001, 002, 004-006 &008/DC: France Following a national phase in the UK, Marketing Authorisations were granted to Tillomed Laboratories Limited on 10 July 2018. For more information about taking Pregabalin Tillomed Capsules, read the package leaflet, or contact your doctor or pharmacist. The full PAR for Pregabalin Tillomed Capsules follows this summary. This summary was last updated in August 2018.

9 4. UKPAR Pregabalin Tillomed Capsules, hard UK/H/6627/001-008/DC. Table of Contents I Introduction Page 6. II Quality aspects Page 7. III Non-clinical aspects Page 9. IV Clinical aspects Page 9. V User consultation Page 11. VI Overall conclusion, benefit/risk Assessment and Page 11. recommendation Annex 1 Table of content of the PAR update Page 58. 5. UKPAR Pregabalin Tillomed Capsules, hard UK/H/6627/001-008/DC. I INTRODUCTION. The Medicines and Healthcare products Regulatory Agency (MHRA) granted Tillomed Laboratories Limited, Marketing Authorisations for the medicinal products Pregabalin Tillomed 25mg, 50mg, 75mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg Capsules, hard (UK/H/6627/001-008/DC; PL. 11311/0561-0568) on 10 July 2018. These products are prescription only medicines (POM) indicated for the treatment of peripheral and central neuropathic pain in adults; as adjunctive therapy in adults with partial seizures with or without secondary generalisation; and for the treatment of Generalised Anxiety Disorder (GAD) in adults.

10 These applications were submitted using the Decentralised Procedure (DCP), with the UK as Reference Member State (RMS) and Germany, Spain and Italy for UK/H/6627/001-008/DC, and France for UK/H/6627/001, 002, 004-006 & 008/DC as Concerned member states (CMS) for Pregabalin Tillomed Capsules. These applications were submitted under Article 10(1) of Directive 2001/83/EC, as amended, as generic applications. The reference products for these applications are Lyrica 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules authorised via the centralised Procedure to Pfizer Limited (EU/1/04/279/001-006-011-014-017-020-033 -023) on 08 July 2004. The active substance, pregabalin, is a gamma-aminobutyric acid analogue ((S)-3-(aminomethyl)-5-methylhexanoic acid). Pregabalin binds to an auxiliary subunit ( 2- protein) of voltage-gated calcium channels in the central nervous system. With the exception of the bioequivalence study no new non-clinical or clinical studies were submitted, which is acceptable given that these applications were based on being a generic medicinal product of a reference product that has been in clinical use for over 10 years.