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The use of Ciprox should be avoided in patients who have experienced serious adverse reactions in the past when using fluoroquinolones-containing products (see Adverse Reactions). Treatment of these patients with Ciprox should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment.
Ciprox should be used with caution in patients suffering from epilepsy and CNS disorders.
Crystalluria related to the use of ciprofloxacin has been reported.
Patients with a family history of or actual defects in glucose-6-phosphate dehydrogenase activity are prone to haemolytic reactions with quinolones.
Patients should avoid prolonged exposure to strong sunlight or UV radiation during treatment. Ciprox could result in impairment of the patient's ability to drive or operate machinery, particularly in conjunction with alcohol.
Particular caution is advised in patients who need to concurrently take: antacids, any other preparations containing aluminium, calcium, magnesium or iron, anticoagulants (such as warfarin), medicines used to relieve pain and inflammation except aspirin, glibenclamide, probenecid or metoclopramide, cyclosporin, phenytoin.
Exacerbation of myasthenia gravis: Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in person with myasthenia gravis. Post-marketing serious adverse events, including deaths and requirement for ventilator support have been associated with fluoroquinolones use in persons with myasthenia gravis. Avoid fluoroquinolones in patients with known history of myasthenia gravis.
Aortic aneurysm and dissection: Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population. Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, known atherosclerosis).
In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
Prolonged, disabling and potentially irreversible serious adverse drug reactions: Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving fluoroquinolones irrespective of their age and pre-existing risk factors. Ciprox should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice.
Tendinitis and tendon rupture: Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in older patients (above 60 years of age), with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids*. Therefore, concomitant use of corticosteroids should be avoided.
At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with Ciprox should be discontinued and alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.
Peripheral neuropathy: Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypoaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones. Patients under treatment with Ciprox should be advised to inform their doctor and pharmacist prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition (see Adverse Reactions).
Psychiatric reactions: Psychiatric reactions may occur even after the first administration of fluoroquinolones, including Ciprox. In rare cases, depression or psychotic reactions can progress to suicidal ideations/thoughts and self-injurious behaviour, such as attempted or completed suicide (see Adverse Reactions). In the event that the patient develops these reactions, Ciprox should be discontinued and appropriate measures instituted. Caution is recommended if Ciprox is to be used in psychotic patients or in patients with a history of psychiatric disease.
