Consumer medicine information

Prednefrin Forte Eye Drops

Phenylephrine hydrochloride; Prednisolone acetate

BRAND INFORMATION

Brand name

Prednefrin Forte Eye drops

Active ingredient

Phenylephrine hydrochloride; Prednisolone acetate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Prednefrin Forte Eye Drops.

What is in this leaflet

This leaflet answers some common questions about PREDNEFRIN FORTE® eye drops, (including how to use the eye drops). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using PREDNEFRIN FORTE® eye drops against the benefits they expect it will have for you.

If you have any concerns about using/taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What PREDNEFRIN FORTE® eye drops are used for

PREDNEFRIN FORTE® eye drops are used for the immediate treatment of severe non infectious pain, swelling and redness (inflammation) of the eye, inflammation of the coloured part of the eye (iris), inflammation of the iris and ciliary body, inflammation of the white part of the eye and persistent allergy of the eye. PREDNEFRIN FORTE® eye drops can also be used for treatment of non infectious inflammation following surgery.

Mechanism of action:
The first active ingredient in PREDNEFRIN FORTE® eye drops prednisolone acetate belongs to a chemical group called the glucocorticoids which reduce pain, swelling and redness. The second active ingredient, phenylephrine hydrochloride is responsible for reducing swollen blood vessels in the eye and lid.

Your doctor may have prescribed PREDNEFRIN FORTE® eye drops for another reason. Ask your doctor if you have any questions about why PREDNEFRIN FORTE® eye drops have been prescribed for you.

Before you use PREDNEFRIN FORTE® eye drops

When you must not use it

Do not use PREDNEFRIN FORTE® eye drops if you have:

  1. an allergy to PREDNEFRIN FORTE® eye drops or any of the ingredients listed at the end of this leaflet.
  2. a severe untreated pus forming eye infection.
  3. Herpes simplex of the eye.
  4. an ulcer on the front layer of the eyeball.
  5. viral diseases of the eye.
  6. Tuberculosis (mycobacterial infection) of the eye.
  7. fungal infections of the eye.
  8. glaucoma

Check with your doctor if:

  1. you have a condition in which the pressure of fluid in the eye may be high (glaucoma).
  2. you have a disease which causes thinning of the front layer of the eyeball.
  3. you have a disease of the artery walls (arteriosclerosis).
  4. you have high blood pressure (hypertension).
  5. you have a condition where your thyroid gland is overactive (hyperthyroidism).
  6. you have an enlarged prostate.
  7. you have a condition where your blood sugar levels are too high (diabetes).
  8. you have received monoamine oxidase (MAO) inhibitor therapy or within 14 days of stopping such treatment.
  9. you are susceptible to allergies or are an asthmatic.
  10. you are pregnant or have the intention of becoming pregnant. Like most medicines, PREDNEFRIN FORTE® eye drops are not recommended during pregnancy unless the benefits outweigh the risks.
  11. you are breastfeeding or planning to start breastfeeding. It is not known whether your baby may absorb this medicine from breast milk and therefore there is a possibility of harm to the baby.

Do not use PREDNEFRIN FORTE® eye drops if:

  • the seal around the cap is broken,
  • the bottle/packaging shows signs of tampering,
  • the expiry date on the bottle or carton has passed.

If you use this medicine after the expiry date has passed, it may not work.

Do not put the eye drops into your eye(s) while you are wearing soft contact lenses. The preservative in PREDNEFRIN FORTE® eye drops (benzalkonium chloride) may be deposited in soft contact lenses. You can put your soft contact lenses back into your eyes 15 minutes after you have used PREDNEFRIN FORTE® eye drops.

It is not known if PREDNEFRIN FORTE® eye drops are safe and useful for children and adolescents under 18 years. It is not recommended to be used in children and adolescents under 18 years.

These drops are for topical use only.

If you are not sure whether you should start using PREDNEFRIN FORTE® eye drops, talk to your doctor.

Before you start to use it

Tell your doctor if:

  1. you have had an allergy to any other medicines or any other substances, such as foods, preservatives or dyes.
  2. you have or have had any medical conditions, especially a bacterial, viral or fungal disease.

If you have not told your doctor about any of the above, tell them before you use PREDNEFRIN FORTE® eye drops.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

There are no known drug interactions with PREDNEFRIN FORTE® eye drops.

How to use PREDNEFRIN FORTE® eye drops

How much to use

The usual dosage of PREDNEFRIN FORTE® eye drops is one to two drops in the eye(s) two to four times daily. During the initial 24 to 48 hours your doctor may increase the dosage to two drops every hour.

Do not stop using PREDNEFRIN FORTE® eye drops even if you feel well unless instructed by your doctor.

Your doctor will tell you how many drops you need to use each day. Use PREDNEFRIN FORTE® eye drops only as prescribed by your doctor.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Use PREDNEFRIN FORTE® eye drops every day, at about the same time each day, unless your doctor tells you otherwise. Using your eye drops at the same time each day will have the best effect on your condition. It will also help you remember when to use the eye drops.

If you are using more than one eye drop product, wait 5 minutes before using the second product.

If you are being changed from one eye drop to another, follow your doctor’s instructions carefully as to when to stop the old drops and when to start the new drops.

How to use it

You may find it easier to put drops in your eye while you are sitting or lying down.

If you are wearing soft contact lenses, remove them before putting the drops in your eye.

To open a new bottle of PREDNEFRIN FORTE® eye drops, first tear off the protective seal from the bottle. The seal will break and you can pull it off and then throw it away.

  1. Wash your hands well with soap and water.
  2. Shake the bottle gently.
  3. Remove the cap.
  4. Hold the bottle upside down in one hand between your thumb and forefinger or index finger.
  5. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
  6. Tilt your head back and look up.
  7. Put the tip of the bottle close to your lower eyelid. Do not let it touch your eye.
  8. Release one drop into the pouch or pocket formed between your eye and eyelid by gently squeezing the bottle.
  9. Close your eye. Do not blink or rub your eye.
  10. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body. Ask your doctor for more specific instructions on this technique.
  11. Replace the cap, sealing it tightly.
  12. Wash your hands again with soap and water to remove any residue.

Wait 15 minutes before replacing your contact lenses.

Be careful not to touch the dropper tip against your eye, eyelid or anything else to avoid contaminating the eye drops. Contaminated eye drops may give you an eye infection.

How long to use it

Continue using PREDNEFRIN FORTE® eye drops for as long as your doctor prescribes.

PREDNEFRIN FORTE® eye drops contain a corticosteroid. Corticosteroid eye drops should not be used for more than 10 days except under strict supervision by your doctor.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use the drops as soon as you remember, and then go back to using/taking them as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not use double the amount to make up for the dose that you missed.

If you use too much (overdose)

If you accidentally put several drops in your eye(s), immediately rinse your eye(s) with warm water.

If you think that you or anyone else may have swallowed any or all of the contents of a bottle of PREDNEFRIN FORTE® eye drops drink fluids to dilute and immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.

While you are using PREDNEFRIN FORTE® eye drops

Things you must do

If you develop an eye infection, receive an eye injury, or have eye surgery tell your doctor.

Your doctor may tell you to use a new container of PREDNEFRIN FORTE® eye drops because of possible contamination of the old one, or may advise you to stop your treatment with PREDNEFRIN FORTE® eye drops.

If you become pregnant while using PREDNEFRIN FORTE® eye drops tell your doctor immediately.

If you wear soft contact lenses, remove them before using PREDNEFRIN FORTE® eye drops. Leave your lenses out for at least 15 minutes after putting in the eye drops.

Tell your doctor if your condition gets worse or does not get better while using PREDNEFRIN FORTE® eye drops.

If you are about to be started on any new medicine tell your doctor and pharmacist that you are using PREDNEFRIN FORTE® eye drops.

Things you must not do

Do not give PREDNEFRIN FORTE® eye drops to anyone else, even if they have the same condition as you.

Do not stop using PREDNEFRIN FORTE® eye drops without first talking to your doctor.

Things to be careful of

Your vision may blur for a short time after you put in your PREDNEFRIN FORTE® eye drops. If this happens you should wait until you can see well again before you drive or use machinery.

PREDNEFRIN FORTE® eye drops may cause the pupils to get dilated (get bigger) or transient blurring of vision which may impair the ability to drive a car or operate machinery. Wait until your vision has cleared. Be careful driving or operating machinery until you know how PREDNEFRIN FORTE® eye drops affect you.

Use of PREDNEFRIN FORTE® eye drops after cataract surgery may delay healing and increase the likelihood of blister formation on the eye.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using PREDNEFRIN FORTE® eye drops. PREDNEFRIN FORTE® eye drops help most people with severe inflammation of the eye, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.

Some side effects of PREDNEFRIN FORTE® eye drops are:

  • increased pressure in the eye
  • formation of cataract, ie blurred vision
  • viral, bacterial or fungal infections of the eye
  • perforation of the tissues of the eye
  • eye irritation
  • vision blurred/vision disturbances
  • dilation of the pupil
  • dry eye
  • eye discharge
  • eye pain
  • foreign body sensation
  • eye pruritus (itchy eye)
  • increased flow of tears
  • ocular hyperemia (red eye)

There can also be effects on the body as a whole such as allergy, rash, headache, altered taste and itching.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects and they worry you.

After using PREDNEFRIN FORTE® eye drops

Storage

Keep your eye drops in a cool place where the temperature stays below 25°C. Store upright. Do not freeze the eye drops.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Do not carry the eye drops in pockets of your clothes. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not leave the top/lid off the bottle for any length of time to avoid contaminating the eye drops.

Disposal

Write the date on the bottle when you open the eye drops and throw out any remaining solution after four weeks.

Eye drops contain a preservative which helps prevent germs growing in the solution for the first four weeks after opening the bottle. After this time there is a greater risk that the drops may become contaminated and cause an eye infection. A new bottle should be opened.

If your doctor tells you to stop using the eye drops or they have passed their expiry date, ask your pharmacist what to do with any remaining solution.

Product description

What it looks like

The eye drops come in a 10 mL sterile plastic bottle.

Ingredients

Active ingredients: Prednisolone acetate 10mg/mL (1%) and phenylephrine hydrochloride 1.2mg/mL (0.12%).

Inactive ingredients:
benzalkonium chloride 0.04mg/mL (0.004%), phenazone, polysorbate 80, boric acid, sodium citrate, sodium chloride, sodium metabisulfite, disodium edetate, hypromellose, and purified water.

Manufacturer/Supplier

Allergan Australia Pty Ltd
810 Pacific Highway,
Gordon, NSW 2072

ARTG number: AUST R 23235

Date of preparation: November 2017

® Registered trademark of Allergan, Inc.

BRAND INFORMATION

Brand name

Prednefrin Forte Eye drops

Active ingredient

Phenylephrine hydrochloride; Prednisolone acetate

Schedule

S4

 

1 Name of Medicine

Phenylephrine hydrochloride and prednisolone acetate.

2 Qualitative and Quantitative Composition

Prednefrin Forte eye drops contains prednisolone acetate (microfine suspension) 10 mg (1%) and phenylephrine hydrochloride 1.2 mg (0.12%).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Prednefrin Forte eye drops is a sterile ophthalmic suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

Severe inflammation (non-infectious) of the eye, such as acute iritis, iridocyclitis, scleritis, episcleritis, uveitis, resistant ocular allergy and inflammation following surgery (where no infectious aetiology is suspected), particularly where unusually rapid control of the inflammation is desired.

4.2 Dose and Method of Administration

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 safely increased to 2 drops every hour. The physician may choose the dosage which affords optimal therapeutic effect in each case.
In order to minimise systemic absorption of Prednefrin Forte eye drops, apply pressure to the tear duct immediately following administration of the drug.
Care should be taken not to discontinue therapy prematurely.

4.3 Contraindications

Prednefrin Forte eye drops is contraindicated in:
Acute untreated purulent infections, such as superficial (or epithelial) Herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and most other viral diseases of the cornea and conjunctiva.
Ocular tuberculosis and fungal infections of the ocular structures of the eye.
Mycobacterial infection of the eye.
Narrow angle glaucoma.
Hypersensitivity to prednisolone acetate, phenylephrine hydrochloride, benzalkonium chloride or any of the other constituents.

4.4 Special Warnings and Precautions for Use

In diseases due to microorganisms, acute untreated infection may be masked, enhanced or activated by the steroid. Since Prednefrin Forte eye drops is not an anti-infective, if infection is present, appropriate measures must be taken to counteract the organisms involved. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. As fungal infections of the cornea are particularly prone to develop with long-term local steroid application, fungal invasion must be suspected in any persistent corneal ulceration where a steroid has been used, or is in use. Fungal cultures should be taken when appropriate. Use of intraocular steroid medication in the presence of stromal Herpes simplex may prolong the course and may exacerbate the severity of many viral infections of the eye. Use of corticosteroid medication in the treatment of patients with a history of Herpes simplex requires caution and should be followed by frequent mandatory slit lamp microscopy (see Section 4.3 Contraindications). Prednefrin Forte eye drops contains benzalkonium chloride as a preservative.
Eye drops containing corticosteroids should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for intraocular pressure. Extended use of topical corticosteroids may cause increased intraocular pressure in susceptible individuals resulting in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision. Prolonged use may result in posterior subcapsular cataract formation.
In diseases causing thinning of the cornea, perforation has been known to have occurred with the use of topical steroids. Reports in the literature indicate that posterior subcapsular lenticular opacities have been reported to occur after heavy or protracted use of topical ophthalmic corticosteroids.
Prednefrin Forte eye drops contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic patients.
The possibility of adrenal suppression should be considered with prolonged, frequent use of high dose topical steroids, particularly in infants and children.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
If patient experiences eye pain, changes in vision, ocular irritation or if eye irritation and redness persist over 72 hours, discontinue use and consult a doctor.

Potential systemic effects.

Prednefrin Forte eye drops should be used with caution in patients with arteriosclerosis, hypertension, hyperthyroidism, prostatic enlargement, or diabetes.
Treatment should be used with caution in patients receiving monoamine oxidase (MAO) inhibitor therapy or within 14 days of stopping such treatment as patients may experience hypertensive crisis.
To minimise risk of potential systemic effects, the puncta should be depressed after instillation of drops to reduce drainage through the nasolacrimal duct to the oral and nasal mucosa.

Eye inflammation.

Use Prednefrin Forte eye drops with caution on an inflamed eye, as hyperaemia greatly increases the rate of systemic absorption through the conjunctiva.

Use with contact lenses.

Prednefrin Forte eye drops contain the preservative benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Patients wearing soft (hydrophilic) contact lenses should be instructed to remove contact lenses prior to administration of Prednefrin Forte eye drops and wait at least 15 minutes following administration before reinserting soft contact lenses.

Potential for eye injury or contamination.

To prevent eye injury or contamination, care should be taken to avoid touching the bottle tip to the eye or to any other surface.

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, consider evaluating for 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.

Information for patients.

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.

Use in the elderly.

No data available.

Paediatric use.

Safety and effectiveness have not been demonstrated with Prednefrin Forte eye drops in paediatric patients. Prednefrin Forte eye drops is not recommended to be used in pediatric patients.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed. Concurrent use of MAOI, tricyclic antidepressants, guanethidine or systemic adrenergic blockers may alter the effects of Prednefrin Forte eye drops.
Although the systemic exposure is expected to be low with topical ophthalmic corticosteriod administration, co-treatment with CYP3A inhibitors may increase the risk of systemic corticosteroid-related adverse effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
In animal experiments, corticosteroids have been found to cause malformations of various kinds (cleft palate, skeletal malformations) and abortion. These findings do not seem to be relevant to humans. Reduced intrauterine growth and lower birth weight have been recorded in animals and humans after long-term or high dose treatment. Suppression of the adrenal cortex in the newborn baby may occur after long-term treatment. The short-term use of corticosteroids prior to delivery for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or the newborn infant.
There are no adequate and well controlled studies in pregnant women. Prednefrin Forte should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Maternal pulmonary oedema has been reported with tocolysis and fluid overload.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore, use is not recommended in women breast feeding infants.

4.7 Effects on Ability to Drive and Use Machines

Prednefrin Forte eye drops may cause pupillary dilation, transient blurring of vision, which may impair the ability to drive or operate machines. The patient should wait until their vision has cleared before driving or using machinery.

4.8 Adverse Effects (Undesirable Effects)

Immune system disorders.

Hypersensitivity, urticaria.

Nervous system disorders.

Headache.

Eye disorders.

Adverse reactions include increased intraocular pressure, which may be associated with optic nerve damage and defects in the visual fields; posterior subcapsular cataract formation; eye penetration (sclera or corneal perforation), ocular infections from bacteria, fungi or viruses liberated from ocular tissues and perforation of the globe when used in conditions where there is thinning of the cornea or sclera, eye irritation, vision blurred/visual disturbances and mydriasis.

Gastrointestinal disorders.

Dysgeusia.

Skin and subcutaneous tissue disorders.

Pruritus and rash.

General disorders and administration site conditions.

Systemic side effects may occur rarely with extensive use of topical steroids.

Post-marketing experiences.

The following adverse reactions have been identified during post-marketing use of Prednefrin Forte eye drops. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

Eye disorders.

Dry eye, eye discharge, cataract subcapsular, eye Irritation, eye pain, eye penetration (scleral or corneal perforation), foreign body sensation, intraocular pressure increased, ocular infection (including bacterial, fungal, and viral infections), eye pruritus, lacrimation increased, mydriasis, ocular hyperemia, vision blurred.

Immune system disorders.

Hypersensitivity reaction including symptoms or signs of eye allergy and skin allergy.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Although overdose by the topical ophthalmic route will not ordinarily cause acute problems, it may cause systemic sympathomimetic effects (e.g. palpitation, headache and hypertension). In case of overdose, immediately flush eyes with water or normal saline. If accidentally ingested, drink fluids to dilute.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Prednisolone acetate is a glucocorticoid that, on the basis of weight, has 3 to 5 times the anti-inflammatory potency of hydrocortisone. Glucocorticoids inhibit the oedema, fibrin deposition, capillary dilation and phagocytic migration of the acute inflammatory response as well as capillary proliferation, deposition of collagen and scar formation. The phenylephrine component of Prednefrin Forte eye drops constricts the engorged vessels of the eye and lid.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Preservative.

Benzalkonium chloride 0.04 mg (0.004%) per 1 mL.

Inactives.

Hypromellose, phenazone, polysorbate 80, boric acid, sodium citrate, sodium metabisulfite, sodium chloride, disodium edetate and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

3 years.
Contents are sterile if seal is intact.
AUST R23235.

6.4 Special Precautions for Storage

Store below 25°C. Protect from freezing. Store upright.
Shake well before using.

6.5 Nature and Contents of Container

A sterile suspension in 10 mL dropper bottles.
To avoid contamination of the suspension, keep container tightly closed.
Do not touch dropper tip to any surface.

6.6 Special Precautions for Disposal

Discard unused contents 4 weeks after opening.
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Prednisolone acetate is an odourless, white or almost white, crystalline powder. Practically insoluble in water, soluble 1 in 120 of alcohol; slightly soluble in acetone and chloroform.
Molecular Weight: 402.5.
Chemical Name: 11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione.
Empirical formula: C21H28O5.

Chemical structure.

Structure of prednisolone acetate.

CAS number.

52-21-1.
Phenylephrine hydrochloride is white or almost white, odourless crystals or crystalline powder. Soluble 1 in 2 of water, and 1 in 4 of alcohol; practically insoluble in chloroform.
Molecular Weight: 203.7.
Chemical Name: (R)-3-hydroxy- α-[(methylamino)methyl]benzenemethanol hydrochloride.
Empirical formula: C9H14ClNO2.

Chemical structure.

Structure of phenylephrine hydrochloride.

CAS number.

61-76-7.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes