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Logo PRED FORTE Sterile Eye Suspension

SCHEDULING STATUS
Schedule 4

PROPRIETARY NAME
(and dosage form)

PRED FORTE Sterile Eye Suspension

COMPOSITION
PRED FORTE Sterile Eye Suspension contains:
Prednisolone acetate 10 mg/mL
Preservative: Benzalkonium chloride 0,004% m/v
Excipients included in the formulation: Boric acid, disodium edetate, hypromellose, sodium chloride, sodium citrate dihydrate, sodium metabisulphite, polysorbate 80, purified water.

PHARMACOLOGICAL CLASSIFICATION
A 15.2 Ophthalmic preparations with corticosteroids.

PHARMACOLOGICAL ACTION
Pharmacodynamic properties
Prednisolone acetate is a synthetic corticosteroid with anti-inflammatory properties. Prednisolone acetate has, on a weight to weight basis, an anti-inflammatory potency three to five times that of hydrocortisone.
Pharmacokinetic properties
The pharmacokinetic profile following topical ocular administration of 1% prednisolone acetate has been evaluated in human volunteers undergoing cataract surgery; peak concentration of prednisolone in aqueous humour was found to occur within two hours after instillation, and the half life in aqueous humour was estimated to be approximately 30 minutes.
Prednisolone is mainly metabolised in the liver. After intravenous administration of 14C-prednisolone, greater than 90% of the administered radioactivity was excreted in the urine, and approximately 10 - 30% of the dose was excreted unchanged in urine.

INDICATIONS
For steroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye globe.

CONTRA INDICATIONS
Acute, untreated purulent ocular infections, superficial herpes simplex (dendritic keratitis), vaccinia, varicella and other viral diseases of the cornea and conjunctiva, mycobacterial infection of the eye, fungal diseases of the eye, and sensitivity to any components of the formulation.

WARNINGS AND SPECIAL PRECAUTIONS
PRED FORTE, should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for intraocular pressure.
PRED FORTE contains benzalkonium chloride as a preservative, which is an irritant to the eye and could cause discolouration of soft (hydrophilic) contact lenses. The patient should avoid contact with contact lenses and therefore be instructed to remove them before PRED FORTE is used and then wait for at least 15 minutes before reinsertion.
PRED FORTE should not be administered while wearing soft (hydrophilic) contact lenses.
As the possibility of adverse effects on the corneal permeability and danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved preparations cannot be excluded, regular ophthalmological examination is required.
Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.
PRED FORTE contains sodium metabisulphite, a sulphite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes. Sulphite sensitivity is seen more frequently in asthmatic patients.
Posterior subcapsular cataract formation has been reported after prolonged use of the topical ophthalmic corticosteroids.
In those diseases causing thinning of the cornea or sclera, perforation has been reported with the use of PRED FORTE.
Prolonged use of corticosteroids may suppress the host immune response and thus increase the hazard of secondary ocular infections.
Patients with histories of herpes simplex should be treated with caution. Use of PRED FORTE in the presence of stromal herpes simplex requires caution and should be followed by frequent mandatory slit-lamp microscopy.
Acute purulent infections of the eye may be masked or enhanced by the use of PRED FORTE.
As fungal infections of the cornea have been reported coincidentally with long-term PRED FORTE applications, fungal invasion may be suspected in any persistent corneal ulceration where PRED FORTE has been used or is in use. Fungal cultures should be taken when appropriate.
Use of PRED FORTE may cause increased intraocular pressure. This may result in damage to the optic nerve with defects in the visual fields. PRED FORTE should be used with caution in the presence of glaucoma. It is advisable that the intraocular pressure be checked frequently. Because of the possibility of inducing corneal abscess, fungal keratopathy or glaucoma, the patient should be referred to an ophthalmologist if the eye has not responded within 48 hours.
Since PRED FORTE is not an anti-infective, if infection is present, appropriate measures must be taken to counteract the organism involved.
The use of PRED FORTE after cataract surgery may delay healing and increase the incidence of bleb formation.
To prevent eye injury or contamination, care should be taken to avoid touching the bottle to the eye or to any other surface. The use of the same bottle by more than one person may spread infection.
Systemic adverse events may occur with the use of PRED FORTE. The possibility of adrenal suppression should be considered with prolonged, frequent use of high doses of PRED FORTE, particularly in infants and children. Punctal occlusion may be recommended (see ‘DOSAGE AND DIRECTIONS FOR USE’).
Effects on ability to drive and use machines
Upon instillation, patients may experience transient blurred vision which may impair the ability to drive or use machinery. If affected, patients should not drive or use machinery until their vision has cleared.

INTERACTIONS
None known.

PREGNANCY AND LACTATION
Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE
PRED FORTE, should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for intraocular pressure (see ‘WARNINGS AND SPECIAL PRECAUTIONS’).
Adults: 1 to 2 drops instilled into the conjunctival sac two to four times daily. During the initial 24 to 48 hours the dosage may be increased to 2 drops every hour. Care should be taken not to discontinue therapy prematurely (i.e. not to stop PRED FORTE abruptly or taper off too quickly). Shake well before using.
Treatment should not exceed 10 days without reassessment.
Safety and efficacy in paediatric patients have not been established.
To reduce possible systemic absorption, it may be recommended that the lacrimal sac be compressed at the medial canthus (punctal occlusion) for 1 minute. This should be performed immediately following the instillation of each drop (see ‘WARNINGS AND SPECIAL PRECAUTIONS’).

SIDE EFFECTS
The following side-effects have been reported following use of PRED FORTE (frequencies unknown):

Immune system disorders
Hypersensitivity, urticaria
Nervous system disorders
Headache
Eye disorders
Increased intraocular pressure*, cataract (including subcapsular)*, eye penetration (scleral or corneal perforation)*, fungal eye infection*, viral eye infection*, bacterial eye infection*, ocular stinging, ocular hyperaemia, eye irritation, blurred vision / visual impairment, mydriasis, foreign body sensation
Gastrointestinal disorders
Dysgeusia
Skin and subcutaneous tissue disorders
Pruritus, rash

Systemic: extensive topical use of corticosteroids may lead to systemic side effects*.
* Refer to ‘WARNINGS AND SPECIAL PRECAUTIONS’for further information.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
There is no clinical experience of overdosage. Acute overdosage is unlikely to occur via the ophthalmic route.
If accidentally ingested, patients should be advised to drink fluids to dilute.
Refer to ‘SIDE EFFECTS’listed above.

IDENTIFICATION
Dense, white microfine suspension.

PRESENTATION
PRED FORTE Sterile Eye Suspension is supplied in sterile plastic dropper bottles containing 5 mL suspension. For topical use only, under supervision of a medical practitioner.

STORAGE INSTRUCTIONS
Store at or below 25ºC. Do not freeze. Do not use more than 30 days after opening. Store upright. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
J/15.2/77

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Allergan Pharmaceuticals (Pty) Ltd
30 New Road (entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
SOUTH AFRICA

DATE OF PUBLICATION OF THE PACKAGE INSERT
Date of registration: 23 December 1976
Date of most recent package insert as approved by Council: 28 November 2014

PATIENT INFORMATION LEAFLET

SCHEDULING STATUS
Schedule 4

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM

PRED FORTE Sterile Eye Suspension, prednisolone acetate 10 mg/mL sterile eye suspension

Read all of this leaflet carefully before you start using PRED FORTE Sterile Eye Suspension
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
PRED FORTE has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.
1. WHAT PRED FORTE CONTAINS
The active substance in PRED FORTE is prednisolone acetate 10 mg/mL.
The other ingredients are benzalkonium chloride 0,004% m/v as a preservative, disodium edetate, hypromellose, sodium chloride, sodium citrate dihydrate, sodium metabisulphite, polysorbate 80 and purified water.
2. WHAT PRED FORTE IS USED FOR
PRED FORTE belongs to a group of medicines known as steroids. PRED FORTE is used in adults for the short-term treatment of eye inflammation.

3. BEFORE YOU USE PRED FORTE
Do not use PRED FORTE:
If you are hypersensitive (allergic) to prednisolone acetate, benzalkonium chloride or any of the other ingredients of PRED FORTE;
If you have viral, fungal or bacterial eye infections;
If you have a mycobacterial infection or tuberculosis of the eye;
If you have injuries to or ulcers on the cornea;
If you have glaucoma;
If you have previously had herpes simplex.
Take special care with PRED FORTE
Talk to your doctor before using PRED FORTE if you suffer from, or have in the past suffered from:
Eye ulcers or have had a disease or treatment to the eye that caused the tissue of the cornea (the see-through layer covering the eye) to become thin;
You have glaucoma or are being treated for raised pressure within the eye;
You have had surgery for cataracts;
Bacterial, viral or fungal eye infections.
Tell your doctor:
If you are using or have used other steroid eye drops, as frequent or long-term use of steroids can result in additional side effects.
PRED FORTE should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for eye pressure.
PRED FORTE contains sodium metabisulphite, a sulphite that may cause allergic-type reactions, including anaphylactic symptoms, such as shortness of breath, difficulty breathing, hives and itching, and life-threatening or less severe asthmatic episodes. Sulphite sensitivity is seen more frequently in patients that suffer from asthma.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before using PRED FORTE.
The safety of PRED FORTE during pregnancy and breast-feeding has not been established.

Driving and using machinery
PRED FORTE may cause temporary blurred vision. Do not drive or use machinery until the symptoms have cleared.

Important information about some of the ingredients of PRED FORTE
PRED FORTE is preserved with benzalkonium chloride. You should undergo regular eye examinations if you are using PRED FORTE for a prolonged period of time. Benzalkonium chloride may cause side effects on your corneal permeability with prolonged or repeated use.
Contact lenses:
Do not use the drops while your contact lenses are in your eyes. Wait at least 15 minutes after using the eye drops before putting your lenses back in your eyes.
Benzalkonium chloride, the preservative in PRED FORTE may cause eye irritation and is also known to discolour soft contact lenses.
Using other medicines with PRED FORTE
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.)

4. HOW TO USE PRED FORTE
Do not share medicines prescribed for you with any other person.
PRED FORTE should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for eye pressure.
Always use PRED FORTE exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Your doctor will tell you how long your treatment with PRED FORTE will last. Do not stop treatment early because PRED FORTE should be used as instructed by your doctor to work properly. Do not use PRED FORTE more or less often, or for a longer period, than you are told to by your doctor or pharmacist.
If you have the impression that the effect of PRED FORTE is too strong or too weak, tell your doctor or pharmacist.

Instructions for use
You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.

Apply your eye drops in the following way:
Illustrated here [Ed]
1. Wash your hands. Shake the bottle well before use
Tilt your head back and look at the ceiling
2. Gently pull the lower eyelid down until there is a small pocket.
3. Turn the bottle upside down and squeeze it to release one or two drops into each eye that needs treatment.
4. Let go of the lower lid, and close your eye.
Press your finger against the corner of your eye (the side where your eye meets your nose) for one minute.
If a drop misses your eye, try again.
To avoid contamination with germs, do not let the tip of the dropper touch your eye or anything else.
To avoid spreading the infection, do not share the same bottle with another person.
Replace and tighten the cap straight after use.
Wipe off any excess liquid from your cheek with a clean tissue.
If you use PRED FORTE for more than 10 days, your doctor may ask you to have check-ups.
These are to make sure that PRED FORTE is working properly and that the dose you are taking is right for you. Your doctor will check your eyes for:
An increase in pressure;
Cataracts;
Infection.
The proper application of your eye drops is very important. If you have any questions ask your doctor or pharmacist.

If you use more PRED FORTE than you should
If you have placed too many drops in your eye(s), wash your eye(s) with clean water. Apply your next dose at the normal time.
If, by accident, anyone drinks this medicine, the person should drink fluids to dilute it. Consult your doctor or pharmacist straight away.
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to use PRED FORTE
If you forget to apply a dose, apply it as soon as you remember, unless it is almost time for your next dose, in which case you should miss out on the forgotten dose. Then apply your next dose as usual and continue with your normal routine.
Do not use a double dose to make up for forgotten individual doses.

Effects when treatment with PRED FORTE is stopped
PRED FORTE should be used as advised by your doctor.
Do not stop using PRED FORTE until your doctor has told you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

5. POSSIBLE SIDE EFFECTS
PRED FORTE can have side effects. Not all side effects reported for PRED FORTE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using PRED FORTE, please consult your doctor, pharmacist or other health care professional for advice.

You should see your doctor immediately if you experience:
Ulcers on the surface of the eye (symptoms include eye pain, light sensitivity, involuntary closing of the eyes and tearing);
Severe pain in the eye.
You should see your doctor if any of the following effects prove troublesome or if they are long-lasting:
Allergic reaction (symptoms may include rash and itching of the surrounding skin);
Headache;
Glaucoma (increased pressure within the eye);
Cataracts (centre of the eye becomes cloudy);
Eye infections;
Redness of the eye(s);
Foreign body sensation;
Stinging or irritation;
Blurred or poor vision;
Pupil dilation;
Change in sense of taste;
Rash or itching.
If you notice any side effects not mentioned in this leaflet, please inform your doctor pharmacist.

6. STORING AND DISPOSING OF PRED FORTE
Store at or below 25°C. Do not freeze.
Store in an upright position.
Store all medicines out of reach of children.
Do not use the product after the expiry date. This is the date printed on the label of the bottle and on the bottom of the outer carton. The expiry date refers to the last day of that month for an unopened bottle.
Do not use the product if the bottle has been open for longer than 30 days, even if there is solution remaining.
Do not use PRED FORTE if you notice the tamper-proof seal is broken.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
7. PRESENTATION OF PRED FORTE
PRED FORTE Sterile Eye Suspension is supplied in sterile plastic dropper bottles containing 5 mL suspension.
For topical use only, under supervision of a medical practitioner.

8. IDENTIFICATION OF PRED FORTE
Dense, white microfine suspension.

9. REGISTRATION NUMBER
J/15.2/77

10. NAME AND ADDRESS OF REGISTRATION HOLDER
Allergan Pharmaceuticals (Pty) Ltd
30 New Road (entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
South Africa

11. DATE OF PUBLICATION
Date of registration: 23 December 1976
Date of revision of the patient information leaflet: 28 November 2014

Updated on this site: September 2017
Source: Pharmaceutical Industry

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