For corticosteroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and
anterior segment of the globe.

Instill 1-2 drops in to the conjunctival sac of the eyes three to four times daily or as directed
by the physician.

Sodium Cromoglicate Patients with known hypersensitivity to any of the ingredients. Fluorometholone Fluorometholone is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, as well as mycobacterial and untreated bacterial infection of the eye and fungal diseases of ocular structures, and any undiagnosed 'red eye' as this may indicate a viral infection.

Fluorometholone
Eye drops containing corticosteroids should not be used for longer than a week except under
an eye specialist's careful surveillance combined with regular measurement of intraocular
pressure.
Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP) with possible
development of glaucoma and infrequent damage to the optic nerve, defects in visual acuity
and fields of vision, posterior subcapsular cataract formation, and delayed wound healing.
Prolonged use may also suppress the host immune response and thus increase the hazard of
secondary ocular infections. Steroids should be used with caution in the presence of glaucoma.
Intraocular pressure should be checked frequently.
Acute untreated infection of the eye may be masked or activity enhanced by the presence of
steroid medication.
Use of intraocular steroids may prolong the course and may exacerbate the severity of many
viral infections on the eye (including herpes simplex). Use of a corticosteroid medication in
the treatment of the patients with a history of herpes simplex keratitis requires great caution.
Frequent follow-ups including slit lamp microscopy is recommended.
To prevent eye injury or contamination, care should be taken to avoid touching the applicator
tip to the eye or to any other surface. The use of the bottle by more than one person may spread
infection.
It contains benzalkonium chloride which is irritant to the eye and could cause discoloration of
soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses before use
and wait for at least 15 minutes before reinsertion.
Concomitant ocular medication should be administered 5 minutes prior to the installation.

Visual disturbance
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 chorioretinopathy (CSCR)
which have been reported after use of systemic and topical corticosteroids.

Sodium Cromoglicate
Discard any remaining contents four weeks after opening the bottle.
It contains benzalkonium chloride. As with other ophthalmic solutions containing
benzalkonium chloride, soft contact lenses should not be worn during the treatment period.
Sodium cromoglicate can be used prophylactically. Patients should seek advice before they
discontinue use of the product.
 

Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
 

Fluorometholone
Pregnancy
There are no or limited amount of data from the use of fluorometholone in pregnant women.
Studies in animals have shown reproductive toxicity.
Fluorometholone is not recommended during pregnancy.
Lactation
It is unknown whether fluorometholone is excreted in human milk. Should not be used
during breast-feeding.
Sodium Cromoglicate
Pregnancy:
As with all medication, caution should be exercised especially during the first trimester of
pregnancy. Cumulative experience with sodium cromoglicate suggests that it has no adverse
effects on fetal development. It should be used in pregnancy only where there is a clear need.

Lactation:
It is not known whether sodium cromoglicate is excreted in human breast milk but, on the
basis of its physicochemical properties, this is considered unlikely. There is no information
to suggest the use of sodium cromoglicate has any undesirable effects on the baby.

Instillation of any eye drop could result in transient blurring of vision. If this occurs, the
patient should wait for the blurring to subside before driving or operating machinery or taking
part in any activity where this could put themselves or others at risk.

Fluorometholone
Class effects:
Although systemic effects are extremely uncommon, there have been rare occurrences of
systemic hypercorticoidism after use of topical steroids.
The following undesirable effects have been reported.
Frequency:
Common: affecting >1/100 and <1/10 patients
Not known: the incidence cannot be determined from available information.
Immune system disorders
Not known: Hypersensitivity

Eye disorders
Common: Intraocular pressure increased
Not known: Eye irritation, conjunctival/ocular hyperaemia, eye pain, visual disturbance,
foreign body sensation in eyes, eyelid oedema, blurred vision*, eye discharge, eye pruritis,
lacrimation increased, eye oedema/eye swelling, mydriasis, cataract (including subcapsular)*,
ulcerative keratitis, ocular infection (including bacterial, fungal*, and viral* infections),
visual field defect, punctate keratitis.
Gastrointestinal disorders
Not known: Dysgeusia
Skin and subcutaneous tissue disorders

Not known: Rash
*See section 4.4 for further information
Adverse reactions reported in phosphate containing eye drops
Cases of corneal calcification have been reported very rarely in association with the use of
phosphate containing eye drops in some patients with significantly damaged corneas.
Sodium Cromoglicate
Eye disorders
Transient stinging and burning may occur after instillation. Other symptoms of local
irritation have been reported rarely.
To report any side effect(s):
• Saudi Arabia:
- The National Pharmacovigilance and
Drug Safety Centre (NPC)
• Fax: +966-11-205-7662
• Call NPC at +966-11-2038222, Exts: 2317-2356-2340.
• Toll free phone: 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: www.sfda.gov.sa/npc
• Other GCC States:
− Please contact the relevant competent authority.

Overdosage by the topical ophthalmic route will not ordinarily cause acute problems.
If accidental overdosage occurs in the eye, the eye should be flushed with water or normal saline.
If accidentally ingested, the patient should drink fluids to dilute.

Fluorometholone
Pharmacotherapeutic group: Corticosteroids, plain
ATC code: S01CB05
Fluorometholone is a synthetic corticosteroid (glucocorticoid), a derivative of
desoxyprednisolone. It is a member of the group of universally known steroids used for the
treatment of eye inflammation.
Glucocorticosteroids bind to cytoplasmic receptors and control the synthesis of infection
mediators thus damping inflammatory reactions (swelling, fibrin deposition, capillary
dilatation, phagocyte migration) and also capillary proliferation, collagen deposition and
scarring.
Although topical corticosteroid treatment often increases intraocular pressure both in normal
eyes and in the eyes of a patient with increased intraocular pressure, fluorometholone increases
intraocular pressure less than, for example, dexamethasone. A study showed that
fluorometholone after six weeks' treatment increased intraocular pressure statistically
significantly less than dexamethasone (mean change dexamethasone: 9 mmHg, mean change
fluorometholone: 3 mmHg).
Sodium Cromoglicate
The solution exerts its effect locally in the eye.
In vitro and in vivo animal studies have shown that sodium cromoglicate inhibits the
degranulation of sensitised mast cells which occurs after exposure to specific antigens. Sodium
cromoglicate acts by inhibiting the release of histamine and various membrane derived
mediators from the mast cell.
Sodium cromoglicate has demonstrated the activity in vitro to inhibit the degranulation of nonsensitised
rat mast cells by phospholipase A and subsequent release of chemical mediators.
Sodium cromoglicate did not inhibit the enzymatic activity of released phospholipase A on its
specific substrate.
Sodium cromoglicate has no intrinsic vasoconstrictor or antihistamine activity.

Fluorometholone
When tritium-labelled 0.1 % fluorometholone suspension was administered locally, the peak
concentration of the radioactive substance in aqueous humour was achieved 30 minutes after
administration. A rapidly forming metabolite occurred at high concentrations both in aqueous
humour and corneal extracts, which shows that fluorometholone is metabolised to a certain
extent while penetrating the cornea and aqueous humour.
Sodium Cromoglicate
Sodium cromoglicate is poorly absorbed. When multiple doses of sodium cromoglicate
ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered
dose of sodium cromoglicate is absorbed into the systemic circulation (presumably by way of
the eye, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than
0.01%) of the sodium cromoglicate does penetrate into the aqueous humour and clearance from
this chamber is virtually complete within 24 hours after treatment is stopped.

In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of sodium
cromoglicate is absorbed following administration to the eye.
Sodium cromoglicate is not metabolised.

Fluorometholone
Non-clinical data reveal no special hazard for humans based on conventional studies of
repeated dose ocular toxicity and repeated dose systemic toxicity.
Sodium Cromoglicate
None

Benzalkonium Chloride
Polysorbate 80
Disodium Edetate
Sorbitol
Polyvinyl Alcohol
Sodium Hydroxide to adjust pH
Water for Injection

Not applicable.

24 months

Do not store above 30°C.

LDPE Opaque bottle.

Discard after 30 days of opening.