Medicinal Products

DUOPLAVIN 75 mg / 75 mg

Generic drug of the therapeutic class: Haemostasis and blood
Active Ingredients: Clopidogrel, Acetylsalicylic Acid
laboratory: Sanofi Pharma Bms Snc

Coated tablet
Box of 30
All forms

Indication

DuoPlavin is indicated for the prevention of atherothrombotic events in adults already treated with clopidogrel and acetylsalicylic acid (ASA). DuoPlavin is a fixed combination for the further treatment of a:

• ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing coronary angioplasty with stent placement

ST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy

For more information see section Pharmacodynamic properties .

Dosage DUOPLAVIN 75 mg / 75 mg Film-coated tablet Box of 30

Dosage

• In adults and in the elderly

DuoPlavin should be administered once daily with a 75 mg / 75 mg tablet.

DuoPlavin is used after initial treatment with clopidogrel and ASA administered separately.

- In patients with acute coronary syndrome without ST elevation (unstable angina or non-Q-wave myocardial infarction): the optimal duration of treatment has not been formally established. Data from the clinical trial support its use for up to 12 months and the maximum benefit was found at 3 months (see section 5.1 ). In case of interruption of DuoPlavin, patients can benefit from the continuation of a platelet antiaggregant.

- In patients with acute ST-segment elevation myocardial infarction: treatment should be initiated as soon as possible after the onset of symptoms and continued for at least 4 weeks. The benefit of the combination clopidogrel and AAS beyond 4 weeks has not been studied in this context (see section 5.1 ). In case of interruption of DuoPlavin, patients can benefit from the continuation of a platelet antiaggregant.

In case of forgetting a catch:

- if the patient sees this within 12 hours of the scheduled time of intake: the patient should take this dose immediately and then take the next dose at the usual time.

- if the patient sees this more than 12 hours after the scheduled time: the patient should take the next dose at the usual time, without doubling the dose.

• Pediatric population The safety and efficacy of DuoPlavin in children and adolescents under 18 years of age have not been established. DuoPlavin is not recommended in this population.

• In patients with renal impairment DuoPlavin should not be used in patients with severe renal impairment (see section 4.3 ). The experience of this treatment is limited in patients with mild to moderate renal impairment (see Warnings and Precautions ). Therefore, DuoPlavin should be used with caution in these patients.

• In patients with hepatic impairment DuoPlavin should not be used in patients with severe hepatic impairment (see section 4.3 ). The experience of this treatment is limited in patients with moderate hepatic insufficiency likely to lead to hemorrhagic diathesis (see Warnings and Precautions ). Therefore, DuoPlavin should be used with caution in these patients.

Administration mode

Oral way.

This medication can be given during or after meals.

Against indications

Due to the presence of both components in the drug, DuoPlavin is contraindicated in case of:

• Hypersensitivity to the active substances or to any of the excipients.

• Severe hepatic insufficiency.

• Progressive haemorrhagic lesion such as peptic ulcer or intracranial haemorrhage.

In addition, because of the presence of AAS, its use is also contraindicated in case of:

• Hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) and the syndrome associating asthma, rhinitis and nasal polyps.

• Severe renal insufficiency.

• Third trimester of pregnancy (see section on Pregnancy and lactation ).

Duoplavin side effects

The safety of clopidogrel has been studied in more than 42, 000 patients in clinical trials, including more than 30, 000 who have been treated with clopidogrel and ASA, and more than 9, 000 treated for one year or more. Clinically significant adverse events recorded in 4 large studies, CAPRIE (a study comparing clopidogrel alone with ASA) and CURE, CLARITY and COMMIT studies (studies comparing clopidogrel in combination with AAS alone) are presented below. In CAPRIE, the safety of clopidogrel 75 mg / day was comparable to that of ASA 325 mg / day regardless of age, sex and race. In addition to experience in clinical studies, side effects have been reported spontaneously.

Bleeding is the most commonly reported adverse reaction in both clinical studies and since marketing. They are mainly reported during the first month of treatment.

In CAPRIE, in patients treated with clopidogrel or ASA, the overall incidence of bleeding was 9.3%. The frequency of severe episodes was similar for clopidogrel and ASA.

In CURE, there was no increase in major bleeding with the clopidogrel + ASA combination within 7 days of CABG in patients who discontinued more than 5 days before surgery. In patients who remained on treatment during these 5 days, this frequency was 9.6% for the combination clopidogrel + ASA and 6.3% for ASA.

In CLARITY, an overall increase in bleeding was observed in the clopidogrel + ASA group vs. the ASA group alone. The frequency of major bleeding was similar between the 2 groups. This was homogeneous in the subgroups of patients defined by the initial characteristics of the patients and the type of fibrinolytic treatment or heparin.

In COMMIT, the overall rate of major non-cerebral haemorrhages and cerebral hemorrhages was low and similar in both groups.

Adverse reactions occurring either during clinical studies or spontaneously reported are presented in the table below. Their frequency is defined using the following convention: frequent (≥1 / 100 to <1/10); uncommon (≥1 / 1000 to <1/100); rare (≥1 / 10, 000 to <1/1000); very rare (<1 / 10, 000), not known (can not be estimated based on available data). For each class of organ system, adverse effects are presented in descending order of severity.

Class-organ system

Frequent

Rare

Rare

Very rare, undetermined frequency *

Blood and lymphatic system disorders

Thrombocytopenia, leukopenia, eosinophilia

Neutropenia, including severe neutropenia

Thrombocytopenic thrombocytopenic purpura (TTP) (see Warnings and precautions for use ), bone marrow suppression, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anemia

Immune system disorders

Anaphylactic shock *, serum sickness, anaphylactoid reactions, worsening of food allergy symptoms *

Metabolism and nutrition disorders

Hypoglycaemia *, gout * (see Warnings and Precautions section )

Psychiatric disorders

Hallucinations, confusion

Nervous system disorders

Intracranial hemorrhage (some fatal cases have been reported), headache, paresthesia, dizziness

Taste disorders

Eye disorders

Eye bleeding (conjunctival, intraocular, retinal)

Affections of the ear and labyrinth

Fear of heights

Loss of hearing * or tinnitus *

Vascular disorders

Hematoma

Serious hemorrhage, bleeding from an operative wound, vasculitis, hypotension

Respiratory, thoracic and mediastinal disorders

Epistaxis

Bleeding of the airways (haemoptysis, pulmonary hemorrhage), bronchospasm, interstitial lung disease

Gastrointestinal disorders

Gastrointestinal bleeding, diarrhea, abdominal pain, dyspepsia

Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence

Retroperitoneal hemorrhage

Gastrointestinal and retro-peritoneal haemorrhage with fatal outcome, pancreatitis, peptic ulcer / perforation *, colitis (including ulcerative colitis and lymphocytic colitis), high gastrointestinal symptoms such as gastralgia * (see Warnings and precautions for use ), stomatitis

Hepatobiliary disorders

Acute hepatic insufficiency, hepatitis, abnormal liver function tests

Skin and subcutaneous tissue disorders

Contusion

Rash, pruritus, skin bleeding (purpura)

Bullous eruption (Lyell's syndrome, Stevens-Johnson syndrome, erythema multiforme), angioedema, rash erythematosus, urticaria, eczema, lichen planus

Musculoskeletal and systemic disorders

Musculo-articular bleeding (hemarthrosis), arthritis, arthralgia, myalgia

Renal and urinary disorders

hematuria

Acute renal failure (especially in patients already suffering from renal insufficiency, cardiac decompensation, renal syndrome, or treated with diuretics) *, glomerulonephritis, increased blood creatinine

General disorders and administration site conditions

Bleeding at the injection site

Fever

investigations

Longer bleeding time, fewer neutrophils, fewer platelets

* For ASA, the indeterminate frequency means that adverse events are from published data.

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