Company: Novartis Consumer Health.
Legal category: Pharmacy only. Sport permitted.
Active ingredients: Acetylsalicylic acid (aspirin)/paracetamol/caffeine 250/250/65mg.
Description: White, oblong-shaped, film-coated tablet marked E.
Presentation: 10, €2.66; 20, €4.66.
Indications: Acute treatment of headache and migraine attacks with or without aura.
Pharmacology: Acetylsalicylic acid (ASA) has analgesic, antipyretic and antiinflammatory properties, primarily due to the inhibition of the biosynthesis of prostaglandins and thromboxanes from arachidonic acid by irreversible acetylation of cyclooxygenase enzymes. Paracetamol has analgesic and antipyretic properties. Caffeine augments the antinociceptive effects of ASA and paracetamol.
Dosage: Adult: Take with a full glass of water. Do not exceed 6 tablets in 24 hours. Headache: 1 tablet (can take a second tablet 4-6 hours later if necessary). For intense pain dose can be doubled. Duration, up to 4 days. Migraine: 2 tablets. If needed an additional 2 tablets can be taken, with 4 to 6 hours between doses. Duration, up to 3 days. Elderly: Over 65 years, caution (especially with low body weight). Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active ingredients or to any of the excipients. Patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by ASA or other non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac or ibuprofen. Active gastric or intestinal ulcer, gastrointestinal (GI) bleeding or perforation, history of peptic ulceration. Haemophilia or other haemorrhagic disorders. Severe hepatic/renal/ cardiac failure. Pregnancy, lactation.
Special precautions: Do not use if patients vomit with >20% or require bedrest with >50% of migraine attacks. Caution: Mild to moderate hepatic/ renal impairment, dehydration, gout, uncontrolled hypertension, diabetes, severe glucose-6-phosphate dehydrogenase deficiency, metrorrhagia or menorrhagia, (history of) alcohol abuse. Exclude other potentially serious neurological conditions in migraine-naïve patients and in migraineurs with atypical symptoms. Seek medical advice if no migraine relief from the first dose. Carefully monitor patients with haemostasis defects. GI bleeding, ulceration or perforation (can be fatal) reported with all NSAIDs; withdraw immediately if GI bleeding or ulceration occurs (especially elderly). Surgery and post-surgery (including tooth extraction); may increase bleeding tendency. May mask infections. May precipitate bronchospasm, induce asthma exacerbations or other hypersensitivity reactions. Prolonged use, hyperthyroidism, arrhythmia.
Drug interactions: Contraindicated: Methotrexate (>15mg per week). Do not use other products containing ASA or paracetamol. Avoid: Alcohol, selective serotonin reuptake inhibitors, disulfiram, quinolones, terbinafine, cimetidine, fluvoxamine, oral contraceptives. Not recommended: Other NSAIDs, corticosteroids, oral anticoagulants, thrombolytics, heparin and platelet aggregation inhibitors, liver enzyme inducers or potentially hepatotoxic substances, zidovudine (unless monitored by doctor), probenecid, lithium, ephedrines, sympathomimetics, levothyroxine, clozapine, other potentially hepatotoxic drugs or drugs inducing liver microsomal enzymes (e.g. rifampicin, isoniazide, chloramphenicol, hypnotics, antiepileptics including phenobarbital, phenytoin, carbamazepine). Methotrexate (≤15mg/week), valproate, aldosterone antagonists, loop diuretics, antihypertensives, uricosurics, sulphonylureas, insulin, propantheline/ metoclopramide or other agents slowing/ accelerating gastric emptying, cholestyramin (within 1 hour), theophylline, nicotine, phenytoin, phenylpropanolamine. Caffeine-containing products. Interferes with several lab tests (see SPC).
Adverse drug reactions: Nervousness, dizziness, GI upset.
Full prescribing information and references available from Novartis Consumer Health. Telephone: (0044) 1276 687 202. E-mail: medicalaffairs.uk@norvartis.com