Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
• Breathing difficulties: Cases of breathing difficulties including dyspnoea,
bronchospasm, exacerbation of asthma, pulmonary eosinophilia and pneumonitis (see section 4.8) have been reported with minocycline use. If patients develop breathing difficulties they should seek urgent medical advice and minocycline should be discontinued.

• Paediatric population: All tetracyclines form a stable calcium complex in any bone forming tissue. An increase in the fibula growth rate has been observed in premature babies administered oral tetracyclines.

Tetracyclines are known to cause a yellow to brown discoloration of the teeth and enamel hypoplasia in the developing child or foetus.

• Hepatic impairment: Minocycline should be used with caution in patients with hepatic dysfunction or in conjunction with potentially hepatotoxic drugs, including alcohol .

• Auto–immune Disorders: Rare cases of auto-immune hepatotoxicity and isolated cases of systemic lupus erythematosus (SLE) and also exacerbation or pre-existing SLE have been reported. If patients develop signs or symptoms of SLE or hepatotoxicity, or suffer exacerbation or pre-existing SLE, minocycline should be discontinued.

• Renal Impairment: Studies indicate there is no significant drug accumulation in patients with mild to moderate renal impairment when treated with the recommended 
dosages of minocycline. In cases of severe renal impairment a reduction of dosage and monitoring of renal function may be required.
• Cross-sensitivities: Micro-organisms can develop cross resistance to tetracyclines and patients can develop cross sensitivity. Minocycline should be discontinued if there are signs/symptoms of overgrowth of resistant organisms, e.g. enteritis, glossitis, stomatitis, vaginitis, pruritus ani or staphylococcal enteritis.

• Myasthenia Gravis: Tetracyclines can cause weak neuromuscular blockade - use with caution in Myasthenia Gravis.

• Intracranial hypertension : As with other tetracyclines, bulging fontanelles in infants and benign intracranial hypertension in juveniles and adults have been reported.
Presenting features were headache and visual disturbances including blurring of vision, scotoma and diplopia. Permanent vision loss has been reported. Treatment should cease if evidence of raised intracranial pressure develops.

• Hyperpigmentation: As with other tetracyclines, minocycline may cause hyperpigmentation at various body sites (see also section 4.8). Hyperpigmentation may present regardless of dose or duration of therapy but develops more commonly during long term treatment. Patients should be advised to report any unusual pigmentation without delay and minocycline should be discontinued. This is generally reversible on cessation of therapy.

• Photosensitivity: Tetracyclines are known to cause photosensitivity reactions. Such patients should be warned to avoid direct exposure to natural or artificial light and to discontinue therapy at the first sign of discomfort.

Effects on Driving

4.7 Effects on ability to drive and use machines
Dizziness, vertigo, headache, light-headedness, visual disturbances, tinnitus and impaired hearing (rarely) have occurred following administration of minocycline.
Patients should be warned of these effects and the possible hazard of driving or operating machinery ,if affected .