Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
General:
• Excedrin should not be taken together with products containing acetylsalicylic acid or paracetamol.
• As with other acute migraine therapies, before treating a suspected migraine 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.
• Patients who experience vomiting with > 20% of their migraine attacks or who require bedrest with >50% of their migraine attacks should not use Excedrin.
• If the patient gets no migraine relief from the first 2-caplet dose of Excedrin, the patient should seek the advice of a physician.
• Prolonged use of any type of painkiller 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 medication overuse headache (MOH) should be suspected in patients who have chronic headaches (15 days or more per month) with concurrent overuse of headache medications for more than 3 months. Therefore, this product should not be used on more than 10 days per month for more than 3 months.
• Caution should be exercised in patients at risk of being dehydrated (e.g. bysickness, diarrhoea, or before or after major surgery).
• Excedrin may mask the signs and symptoms of infection due to its pharmacodynamic properties.

Due to the presence of acetylsalicylic acid:
• Excedrin should be used with caution in patients suffering from gout, impaired renal or hepatic function, dehydration, uncontrolled hypertension, and diabetes mellitus.
• Excedrin should be used with caution in patients suffering from severe glucose-6- phosphate dehydrogenase (G6PD) deficiency, as acetylsalicylic acid may induce hemolysis or hemolytic anemia. Factors that may increase the risk of hemolysis are e.g. high dosage, fever or acute infections.
• Excedrin may lead to an increased bleeding tendency during and after surgical operations (including minor surgeries, e.g. dental extractions) because of the inhibitory effect on platelet aggregation of acetylsalicylic acid which persists for about 4 days after administration.
• Excedrin should not be taken together with anticoagulant or other medicines that inhibit platelet aggregation without a doctor’s supervision (see section 4.5). Patients with defects of haemostasis should be carefully monitored. Caution should be exercised in case of metrorrhagia or menorrhagia.
• Excedrin must be withdrawn immediately if gastrointestinal (GI) bleeding or ulceration occurs in patients receiving this medicinal product. GI bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
They generally have more serious consequences in the elderly. The risk of GI bleeding could be enhanced by alcohol, corticosteroids and NSAIDs (see section 4.5).
• Excedrin may precipitate bronchospasm and induce asthma exacerbations (so-called intolerance to analgesics / analgesics-asthma) or other hypersensitivity reactions. Risk factors are present bronchial asthma, seasonal allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease or chronic infection of the respiratory tract (especially if linked to allergic rhinitis-like symptoms). This applies also for patients showing allergic reactions (e.g. cutaneous reactions, itching, urticaria) to other substances. Special precaution is recommended in such patients (readiness for emergency).
• Excedrin should not be given to children and adolescents aged under 18 years unless specifically indicated because there is a possible association between acetylsalicylic acid and Reye’s syndrome when given to children and adolescents.
Reye’s syndrome is a very rare disease, which affects the brain and liver, and can be fatal.
• Acetylsalicylic acid can interfere with thyroid function tests due to falsely low concentrations of levothyroxine (T4) or tri-iodothyronine (T3) (see section4.5).

Due to the presence of paracetamol:
• Excedrin should be given with care to patients with impaired renal or hepatic function or alcohol dependence.
• The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic medicinal products or medicinal products that induce liver microsomal enzymes (e.g. rifampicin, isoniazide, chloramphenicol, hypnotics and antiepileptics including phenobarbital, phenytoin and carbamazepine). Patients with history of alcohol abuse are at special risk of hepatic damage (see section 4.5).
• Patients should be warned not to take other products containing paracetamol concurrently due to the risk of severe liver damage in case of overdose (see section 4.9)
• Alcoholic beverages should be avoided while taking this medicine because alcohol use in combination with paracetamol may cause liver damage (see section 4.5). Paracetamol should be given with caution to patients with alcohol dependence

Due to the presence of caffeine:
• Excedrin should be given with care to patients with gout, hyperthyroidism and arrhythmia.
• The patient should limit the use of caffeine containing products when taking Excedrin, as excess caffeine may cause nervousness, irritability, sleeplessness and occasionally rapid heart beat.

Effects on Driving

4.7         Effects on ability to drive and use machines
No studies on the effects of the ability to drive and use machines have been performed. If you notice undesirable effects such as dizziness or drowsiness, you should not drive or use machines.
Tell your doctor as soon as possible.