Dexamytrex®, Ophthalmic Ointment, 3 g

NAME OF THE MEDICAL PRODUCT
Dexamytrex®

QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of ointment contains:

Active substances:
Gentamicine Sulphate: 5 mg
Dexamethasone Dihydrogenophosphate, disodium salt: 0.3 mg

PHARMACEUTICAL FORM
Ophthalmic ointment, 3 g.

PHARMACOTHERAPEUTIC CLASS
Pharmacotherapeutic group: 15.1.1 - Medicines used in ophthalmic affections; Topical Antiinfectious drugs; antibacterial drugs.
ATC code: S01CA01 Corticosteroids associated to anti-inflammatory drugs.

MARKETING AUTHORIZATION HOLDER
L. Lepori, Lda
Rua João Chagas 53, Piso 3,
1495-072 Algés

THERAPEUTIC INDICATIONS
Infections of the anterior segment of the eye caused by pathogenic germs sensible to gentamicine, i.e., bacterial inflammations of the conjunctiva, cornea – without epithelial lesion – and eyelids that show severe inflammatory reactions.
Highly infected allergic inflamations of the conjunctiva and eyelid.

CONTRAINDICATIONS
Acute purulent diseases of the anterior segment of the eye; herpes “corneae superficialis” lesions and ulcerous processes of the cornea; ocular tuberculosis; fungic infections in the eyes; open or closed angle glaucoma; hypersensitivity to dexamethasone and/or gentamicine.

SIDE EFFECTS
Glaucoma, cataract due to prolonged use, ocular hypertension, visual acuity disorder, pruritus, oedema and conjunctival hyperaemia, ocular pain, cheratitis, conjunctivitis, corneal narrowing and/or eye globe perforation, damage of the optical nerve, loss of crystalline accommodation, mydriasis, eyelid ptosis and secondary ocular infections.

Since systemic absorption may occur after topical application in the eye, there is the possibility to occur systemic adverse effects. Headaches, hypotension, rhinitis, pharyngitis and taste disorders have been related. Other systemic effects associated to the topical instillation of corticoids are rare, but they can increase when the drug is used for a long time.

In rare cases it may occur a pricking sensation of short duration.

DRUG INTERACTIONS AND OTHER FORMS OF INTERACTION
Unknown.

SPECIAL PRECAUTIONS FOR USE
The prolonged use of Dexamytrex Ophtiole may cause an increase of intraocular pressure, thus, it is necessary to monitor intraocular pressure in treatments of more than 10 days.

If there are no improvements after 5 to 7 days of applying the collyrium, or if symptoms are worsened, it is advisable to consult an ophthalmologist.

Corticoids should be administered with caution in children under 2 years.

Eventually opportunist infections may occur, including fungic infections. In this case, treatment should be discontinued and the adequate therapy applied.

The use of topical corticoids may reduce inflammatory manifestations and mask or potentiate the presence of purulent infections.

EFFECTS ON PREGNANT WOMEN, BREAST-FEEDING WOMEN, CHILDREN, ELDERLY PATIENTS AND PATIENTS WITH SPECIAL PATHOLOGIES
Because there are no studies in pregnant women this product should not be used in this situation.

EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
Even when it is correctly used, this medicine influences the visual capacity; drivers should exercise care when using the product.

LIST OF EXCIPIENTS
Chlorobutanol hemihydrate as preservative, myristic alcohol, lanoline, liquid paraffin, white vaseline, alfa--Tocopherol, Oxynex.

POSOLOGY AND ADMINISTRATION MODE
Unless otherwise prescribed, apply a strip of about 5 mm of ointment in the conjunctival sac, 2-3 times a day, before going to bed.

INDICATION OF THE MOST FAVOURABLE MOMENT FOR THE ADMINISTRATION OF THE MEDICINE
Consult your doctor.

DURATION OF THE AVERAGE TREATMENT
The duration of the treatment should not exceed 2 weeks; during treatment results should be checked; it is recommended the surveillance of the intraocular pressure.

INSTRUCTIONS ABOUT WHAT TO DO IF YOU FORGET TO ADMINISTER ONE OR MORE DOSES
If you forget to administer one or more doses, treatment must be continued.

INDICATION OF HOW TO DISCONTINUE THE TREATMENT WHEN ITS DISCONTINUATION CAUSES WITHDRAWAL EFFECTS
No special precaution is necessary to suspend the treatment.

MEASURES TO ADOPT IN CASE OF OVERDOSAGE AND/OR INTOXICATION, EMERGENCY MEASURES AND ANTIDOTES
Overdosage is not to be considered.

ADVICE TO THE PATIENT
If you notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.

Check if the product is within the expiry date mentioned in the package.

Always keep the medicines out of reach and sight of children.

SPECIAL PRECAUTIONS FOR STORAGE
Store at a temperature below 25ºC.

DATE OF THE REVISION OF THE LEAFLET: April 2005.

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