ELYXYB

Posology The recommended dose is 120 mg celecoxib. The maximum dose in a 24-hour period is 120 mg. The safety and efficacy of a second dose in a 24-hour period have not been established. The oral solution can be taken with or without food.

2). No dose recommendation can be provided. Hepatic impairment Use of Elyxyb in patients with severe hepatic impairment (Child-Pugh Class C) is contra-indicated. Elyxyb has not been studied in patients with hepatic impairment and caution is advised when treating this patient population.

No dose recommendation can be provided. Renal impairment Elyxyb is contra-indicated in patients with severe renal impairment. Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution.

No dose recommendation can be provided. , warfarin, phenytoin), celecoxib should be administered with caution. No dose recommendation can be provided. Paediatric population Elyxyb is not indicated for use in children and adolescents. Method of administration Oral use.

Each single-dose container is intended for single use only. After taking Elyxyb, a glass of water may be drunk.

The safety of Elyxyb is based on data from two randomized, double-blind, placebo- controlled phase 3 clinical studies (Study 1 and Study 2) in adult patients with migraine with or without aura. A total of 815 subjects in the Any Active group were exposed to at least one dose of Elyxyb at any time during the studies.

01 % and greater than those reported for placebo during 12 placebo- and/or active-controlled clinical trials of duration up to 12 weeks at celecoxib daily doses from 100 mg up to 800 mg. In additional studies using non-selective NSAID comparators, approximately 7400 arthritis patients have been treated with celecoxib at daily doses up to 800 mg, including approximately 2300 patients treated for 1 year or longer.

The adverse reactions observed with celecoxib in these additional studies were consistent with those for osteoarthritis and rheumatoid arthritis patients listed in Table 2. - Adverse reactions reported at incidence rates greater than placebo for subjects treated with celecoxib 400 mg daily in long-term polyp prevention trials of duration up to 3 years (the Adenoma Prevention with Celecoxib (APC) and Prevention of Colorectal Sporadic Adenomatous Polyps (PreSAP) trials.

- Adverse drug reactions from post-marketing surveillance as spontaneously reported during a period in which an estimated >70 million patients were treated with celecoxib (various doses, durations, and indications). Even though these were identified as reactions from post-marketing reports, trial data was consulted to estimate frequency.

Frequencies are based on a cumulative meta-analysis with pooling of trials representing exposure in 38102 patients.

Table 2:

Adverse drug reactions in celecoxib capsules clinical trials and surveillance experience (MedDRA preferred terms)1,2 Adverse Drug Reaction Frequency System organ class Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from available data) Infections and infestations Sinusitis, upper respiratory tract infection, pharyngitis, urinary tract infection Blood and lymphatic system disorders Anaemia Leukopenia, thrombo-cytopenia Pancytopenia4 Immune system disorders Hyper-sensitivity Anaphylactic shock4, anaphylactic reaction4 Metabolism and nutrition disorders Hyperkalaemia Psychiatric disorders Insomnia Anxiety, depression, fatigue Confusional state, hallucinations4 Adverse Drug Reaction Frequency System organ class Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from available data) Nervous system disorders Dizziness, hypertonia, headache4 Cerebral infarction1, paraesthesia, somnolence Ataxia, dysgeusia Haemorrhage intracranial (including fatal intracranial haemorrhage)4, meningitis aseptic4, epilepsy (including aggravated epilepsy)4, ageusia4, anosmia4 Eye disorders Vision blurred, conjunctivitis4 Eye haemorrhage4 Retinal artery occlusion4, retinal vein occlusion4 Ear and labyrinth disorders Tinnitus, hypoacusis1 Cardiac disorders Myocardial infarction1 Cardiac failure, palpitations, tachycardia Arrhythmia4 Vascular disorders Hyper-tension1 (including aggravated hyper- tension) Pulmonary embolism4, flushing4 Vasculitis4 Respiratory, thoracic, and mediastinal disorders Rhinitis, cough, dyspnoea1 Bronchospasm4 Pneumonitis4 Gastrointestinal disorders Nausea4, abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting1, dysphagia1 Constipation, gastritis, stomatitis, gastrointestinal inflammation (including aggravation of gastrointestinal inflammation), eructation Gastrointestinal haemorrhage4, duodenal ulcer, gastric ulcer, oesophageal ulcer, intestinal ulcer, large intestinal ulcer, intestinal perforation, oesophagitis, melaena, pancreatitis, colitis4 Hepatobiliary disorders Hepatic function abnormal, hepatic enzyme increased (including increased SGOT and SGPT) Hepatitis4 Hepatic failure4 (sometimes fatal or requiring liver transplant), hepatitis fulminant4 (some with fatal outcome), hepatic necrosis4, cholestasis4, hepatitis cholestatic4, jaundice4 Adverse Drug Reaction Frequency System organ class Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from available data) Skin and subcutaneous tissue disorders Rash, pruritus (includes pruritus generalised) Urticaria, ecchymosis4 Angioedema4, alopecia, photo- sensitivity Dermatitis exfoliative4, erythema multiforme4, Stevens-Johnson syndrome4, toxic epidermal necrolysis4, drug reaction with eosinophilia and systemic symptoms (DRESS)4, acute generalised exanthematous pustulosis (AGEP)4, dermatitis bullous4 Musculoskeletal and connective tissue disorders Arthralgia4 Muscle spasms (leg cramps) Myositis4 Renal and urinary disorders Blood creatinine increased, blood urea increased Renal failure acute4, […]

Elyxyb should only be used where there is a clear diagnosis of migraine. Elyxyb is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine. Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions.

, CVA or TIA). Elyxyb is not indicated for the preventive treatment of migraine. Medication overuse headache (MOH) Overuse of any type of medicinal products for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained, and treatment should be discontinued.

The diagnosis of MOH should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications. Gastrointestinal (GI) effects Upper and lower gastrointestinal complications (perforations, ulcers, or bleedings [PUBs]), some of them resulting in fatal outcome, have occurred in patients treated with celecoxib.

Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or antiplatelet medicinal products (such as acetylsalicylic acid) or glucocorticoids concomitantly, patients using alcohol, or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.

There is further increase in the risk of gastrointestinal adverse effects for celecoxib (gastrointestinal ulceration or other gastrointestinal complications) when celecoxib is taken concomitantly with acetylsalicylic acid (even at low doses).

A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials. Concomitant NSAID use The concomitant use of celecoxib and a non-acetylsalicylic acid NSAID should be avoided.

1. - Hypersensitivity to sulfonamides. - Active peptic ulceration or gastrointestinal (GI) bleeding. - Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors.

6). 3). - Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10). - Patients with estimated creatinine clearance <30 ml/min. - Inflammatory bowel disease. - Congestive heart failure (NYHA II-IV). - Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.