Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
- As with all antibacterial preparation prolonged use may lead to overgrowth of non- susceptible bacterial strains or fungi. If superinfection occurs, appropriate therapy should be initiated.
1 MAX OIN API SEP20 V4                                                      UK SPC -JUN2020 - Sensitivity to topically applied aminoglycosides may occur in some patients. Cross- sensitivity to other aminoglycosides may also occur. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If signs of serious reactions or hypersensitivity occur, discontinue use of MAXITROL ophthalmic ointment.
- Patients using ophthalmic preparations containing neomycin sulphate should be advised to consult a physician if ocular pain, redness, swelling, or irritation worsens or persists.
- Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic neomycin or when applied topically to open wounds or damaged skin. Nephrotoxic and neurotoxic reactions have also occurred with systemic polymyxin B. Although these effects have not been reported following topical ocular use of this product, caution is advised when used concomitantly with systemic aminoglycoside or polymyxin B therapy.

- Prolonged use of ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity and visual field defects, and posterior subcapsular cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure should be checked routinely and frequently. This is especially important in paediatric patients, as the risk of corticosteroid-induced ocular hypertension may be greater in children and may occur earlier than in adults.

- The risk of corticosteroid-induced raised intraocular pressure and/or cataract formation is increased in predisposed patients (e.g. diabetes).

- Cushing's syndrome and/or adrenal suppression associated with systemic absorption of ocular dexamethasone may occur after intensive or long-term continuous therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat). In these cases, treatment should be progressively discontinued.

- In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.

- Corticosteroids may reduce resistance to and aid in the establishment of non-susceptible bacterial, fungal, parasitic or viral infections and mask the clinical signs of infection or may suppress hypersensitivity reactions to substances in the product. Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these drugs and corticosteroid therapy should be discontinued if fungal infection occurs.

- To avoid the risk of enhancement of herpetic corneal disease, frequent slit lamp examination is essential.

-Topical ophthalmic corticosteroids may slow corneal wound healing. Topical NSAIDs are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. (See section 4.5).

- Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous 2 MAX OIN API SEP20 V4                                                      UK SPC -JUN2020
chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

- Contact lens wear is discouraged during treatment of an ocular infection. Therefore patients should be advised not to wear contact lenses during treatment with MAXITROL ophthalmic ointment.

- This product contains methylparahydroxybenzoate and propylparahydroxybenzoate which may cause allergic reactions (possibly delayed).

- This product also contains lanolin which may cause local skin reactions (e.g. contact dermatitis).

- In patients receiving systemic corticosteroids, new-onset or exacerbation of pre-existing diabetes mellitus may occur. Because of the possibility of reduced glucose tolerance/diabetes mellitus with topical ophthalmic corticosteroids, caution is recommended when administering MAXITROL eye ointment to patients with a personal or family history of diabetes.

Effects on Driving

4.7 Effects on ability to drive and use machines
MAXITROL ophthalmic ointment has no or negligible influence on the ability to drive and use machines. As with any other eye ointment, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If transient blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.