DuoPlavin 75mg/75mg Tablets

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Summary of Product Characteristics last updated on medicines.ie: 24/8/2020

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 24 August 2020 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Correction of typographical error in the SmPC

Updated on 30 July 2020 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 30 July 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 13 December 2019 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 13 December 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 26 November 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 26 November 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 October 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 11 October 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 7 October 2019 SmPC

Reasons for updating

  • New SmPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 1 November 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Cardiac disorders

 

 

 

Kounis syndrome (vasospastic allergic angina / allergic myocardial infarction) in the context of a hypersensitivity reaction due to acetylsalicylic acid* or clopidogrel**

Immune system disorders

 

 

 

Anaphylactic shock*, serum sickness, anaphylactoid reactions, cross‑reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)**, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)**,  aggravation of allergic symptoms of food allergy*

Metabolism and nutrition disorders

 

 

 

Hypoglycaemia*, gout* (see section 4.4)

 

 

 

10.     DATE OF REVISION OF THE TEXT

 

20 September25 October 2018

                  

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/

 

Updated on 9 October 2018 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Clopidogrel plus ASA significantly reduced the relative risk of death from any cause by 7% (p = 0.029), and the relative risk of the combination of re‑infarction, stroke or death by 9% (p = 0.002), representing an absolute reduction of 0.5% and 0.9%, respectively. This benefit was consistent across age, gender and with or without fibrinolytics, and was observed as early as 24 hours.

De-escalation of P2Y12 Inhibitor Agents in ACS

Switching from a more potent P2Y12 receptor inhibitor to clopidogrel in association with aspirin after acute phase in ACS has been evaluated in two randomized investigator-sponsored studies (ISS) – TOPIC and TROPICAL‑ACS – with clinical outcome data.

The clinical benefit provided by the more potent P2Y12 inhibitors, ticagrelor and prasugrel, in their pivotal studies is related to a significant reduction in recurrent ischaemic events (including acute and subacute stent thrombosis (ST), myocardial infarction (MI), and urgent revascularization). Although the ischaemic benefit was consistent throughout the first year, greater reduction in ischaemic recurrence after ACS was observed during the initial days following the treatment initiation.  In contrast, post-hoc analyses demonstrated statistically significant increases in the bleeding risk with the more potent P2Y12 inhibitors, occurring predominantly during the maintenance phase, after the first month post‑ACS. TOPIC and TROPICAL‑ACS were designed to study how to mitigate the bleeding events while maintaining efficacy.

TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome)

This randomized, open-label trial included ACS patients requiring PCI. Patients on aspirin and a more potent P2Y12 blocker and without adverse event at one month were assigned to switch to fixed-dose aspirin plus clopidogrel (de-escalated dual antiplatelet therapy (DAPT)) or continuation of their drug regimen (unchanged DAPT). 

Overall, 645 of 646 patients with STEMI or NSTEMI or unstable angina were analyzed (de-escalated DAPT (n=322); unchanged DAPT (n=323)). Follow-up at one year was performed for 316 patients (98.1%) in the de-escalated DAPT group and 318 patients (98.5%) in the unchanged DAPT group. The median follow-up for both groups was 359 days. The characteristics of the studied cohort were similar in the 2 groups.

The primary outcome, a composite of cardiovascular death, stroke, urgent revascularization, and BARC (Bleeding Academic Research Consortium) bleeding ≥2 at 1 year post ACS, occurred in 43 patients (13.4%) in the de-escalated DAPT group and in 85 patients (26.3%) in the unchanged DAPT group (p<0.01). This statistically significant difference was mainly driven by fewer bleeding events, with no difference reported in ischaemic endpoints (p=0.36), while BARC ≥2 bleeding occurred less frequently in the de-escalated DAPT group (4.0%) versus 14.9%  in the unchanged DAPT group (p<0.01). Bleeding events defined as all BARC occurred in 30 patients (9.3%) in the de‑escalated DAPT group and in 76 patients (23.5%) in the unchanged DAPT group (p<0.TROPICAL-ACS (Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes)

This randomized, open-label trial included 2,610 biomarker-positive ACS patients after successful PCI. Patients were randomized to receive either prasugrel 5 or 10 mg/d (Days 0-14) (n=1309), or prasugrel 5 or 10 mg/d (Days 0-7) then de-escalated to clopidogrel 75 mg/d (Days 8-14) (n=1309), in combination with ASA (<100 mg/day).  At Day 14, platelet function testing (PFT) was performed. The prasugrel‑only patients were continued on prasugrel for 11.5 months. 

 he de-escalated patients underwent high platelet reactivity (HPR) testing.  If HPR≥46 units, the patients were escalated back to prasugrel 5 or 10 mg/d for 11.5 months; if HPR<46 units, the patients continued on clopidogrel 75 mg/d for 11.5 months.  Therefore, the guided de-escalation arm had patients on either prasugrel (40%) or clopidogrel (60%). All patients were continued on aspirin and were followed for one year. 

The primary endpoint (the combined incidence of CV death, MI, stroke and BARC bleeding grade ≥2 at 12 months) was met showing non‑inferiority. Ninety five patients (7%) in the guided de-escalation group and 118 patients (9%) in the control group (p non-inferiority=0.0004) had an event. The guided de-escalation did not result in an increased combined risk of ischemic events (2.5% in the de-escalation group vs 3.2% in the control group; p non-inferiority=0.0115), nor in the key secondary endpoint of BARC bleeding ≥2 ((5%) in the de‑escalation group versus 6% in the control group (p=0.23)). The cumulative incidence of all bleeding events (BARC class 1 to 5) was 9% (114 events) in the guided de‑escalation group versus 11% (137 events) in the control group (p=0.14).

Paediatric population

Updated on 16 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 February 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 30 January 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Added Section 4.2

·         fixed-dose combination

·         and replaces the individual clopidogrel and ASA products.

Added Section 4.8 – Table under Nervous system disorders:-

·         ageusia

Updated on 30 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 12 June 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Clopidogrel CCDS V22 & clopidogrel/ASA CCDS V15 for Indications section - update of SPC section 4.1 “Therapeutic indications” to include “Secondary prevention of atherothrombotic events

Updated on 3 May 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

\

WS1091 - Clopidogrel CCDS V22 & clopidogrel/ASA CCDS V15 for Indications section - update of SPC section 4.1 “Therapeutic indications” to include “Secondary prevention of atherothrombotic events”.

Updated on 15 March 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type II EMEA/H/C/000174/WS/1019

Update based on clopidogrel CCDSv21 and clopidogrel/acetylsalicylic acid CCDSv14 (Kounis syndrome as a new ADR), linked to clopidogrel INN; and, to combine the SmPCs & PIL of both strengths

 

Type II EMEA/H/C/000174/WS/1020

Update based on clopidogrel/acetylsalicylic acid CCDS V14 (new drug-drug interaction between nicorandil and NSAIDs including acetylsalicylic acid (ASA) and lysine-acetylsalicylate (LAS) and its increased risk for severe complications including gastrointestinal ulceration, perforation and haemorrhage), linked to ASA INN

Updated on 27 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 2 June 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of new undesirable effect 'edema'

Updated on 3 February 2016 PIL

Reasons for updating

  • Change to drug interactions

Updated on 28 January 2016 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Interaction with Tenofovir

Updated on 25 January 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, includingIn vitro, this metabolic pathway is mediated by CYP3A4, CYP2C19, CYP1A2, and CYP2B6 and CYP3A4. The active thiol metabolite which has been isolated in vitro, binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation.

 

 

 

4.5       Interaction with other medicinal products and other forms of interaction

 

Medicinal products associated with bleeding risk

There is an increased risk of bleeding due to the potential additive effect. The concomitant administration of medicinal products associated with bleeding risk should be undertaken with caution (see section 4.4).

 

 

4.4       Special warnings and precautions for use

 

Bleeding and haematological disorders

Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8). As a dual antiplatelet agent, DuoPlavin should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with other NSAIDs including Cox-2 inhibitors, heparin, glycoprotein IIb/IIIa inhibitors, selective serotonin reuptake inhibitors (SSRIs), or thrombolytics, or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5). Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive

Updated on 10 December 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to date of revision

Updated on 16 October 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Date of revision and reporting an AE

Updated on 15 June 2015 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.5: the following paragraphs have been updated to amend the information on CYP2C19 inhibitors

Medicinal products that are strong or moderate inhibit CYP2C19 inhibitors include, for example, omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, cibrofloxacin, cimetidine, carbamazepine, oxcarbazepine and chloramphenicolefavirenz.

There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers (except cimetidine which is a weak CYP2C19 inhibitor) or antacids interfere with antiplatelet activity of clopidogrel.

Updated on 10 March 2015 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.5 updated to include information about an interaction with acetazolamide.
Section 4.8 updated to add the following:
- Acute generalised exanthematous pustulosis (AGEP)
- Gynaecomastia
- Kounis syndrome
- Henoch Schonlein purpura
- Acute pancreatitis

Updated on 5 February 2015 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Date of Renewal corrected

Updated on 3 February 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 2 December 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 and section 4.8 'older people' change to 'elderly'. 
Section 5.1: 'Antithrombotic agents' included.
Section 9: Renewal date included.

Updated on 29 October 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 6 August 2014 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type IIC Bulk - WS 538 - adverse events updates (CCDS v6 and v7)
Type IIC Bulk - WS 554 - overdose and increased risk of bleeding (CCDS v7 and v8)
Type IIC Bulk - WS 572 - metamizole interaction (CCDS v8)

Updated on 8 April 2014 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 February 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SSRIs and increased risk of bleedings (WS 476) and to add rash exfoliative as AE (WS 477)

Updated on 3 October 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type IIC Bulk variation to update section 4.4 and 4.8 of the SPC regarding haematological cross-reaction among thienopyridines and acquired haemaphelia.

Updated on 20 June 2013 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided