Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pred Forte 1% w/v, Eye Drops Suspension
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Prednisolone acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
PRED FORTE belongs to a group of medicines known as steroidal anti-inflammatory drugs. PRED FORTE is used in adults for the short-term treatment of eye inflammation. It reduces the irritation, burning, redness and swelling of eye inflammation caused by chemicals, heat, radiation, allergy, or foreign objects in the eye. 2.
What you need to know before you take it
e PRED FORTE
Do not use PRED FORTE If you are allergic to prednisolone acetate, benzalkonium chloride or any of the other ingredients of this medicine (listed in section 6) If you suffer from viral, fungal or bacterial eye infections If you suffer from tuberculosis of the eye If you have injuries to or ulcers on the cornea If you have previously had herpes simplex Warnings and precautions 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 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 Contact your doctor if you experience blurred vision or other visual disturbances. Children PRED FORTE has not been tested in children under the age of 18 and therefore should not be used by patients under 18 years. Tell your doctor before using PRED FORTE, 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. Other medicines and Pred Forte Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines may increase the effects of PRED FORTE and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). Pregnancy and breast-feeding If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine as steroids may be harmful to the baby. Use of PRED FORTE is not recommended if you are breast-feeding. Driving and using machines PRED FORTE may cause temporary blurred vision. Do not drive or use machinery until the symptoms have cleared. PRED FORTE contains benzalkonium chloride This medicine contains 0.06 mg benzalkonium chloride in each 1 ml. Contact lenses Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor. 3.
How to take it
PRED FORTE Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 1 or 2 drops into the affected eye(s) 2 to 4 times a day. During the first two days of treatment you may be asked to apply the drops as often as every hour.
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:
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 eye injury and contamination, do not let the tip of the dropper touch your eye or anything else. Replace and tighten the cap straight after use. Wipe off any excess liquid from your cheek with a clean tissue. If you use this medicine for more than 10 days, your doctor may ask you to have checkups. These are to make sure that your medicine 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 Putting too many drops in your eye(s) is unlikely to lead to unwanted side effects. 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, contact your doctor straight away. If you forget to use PRED FORTE
If you forget 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 the forgotten dose. Then apply your next dose as usual and continue with your normal routine. Do not take a double dose to make up for a forgotten dose. If you stop using PRED FORTE 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 medicine, ask your doctor or pharmacist. 4. Possible Side Effects Like all medicines, this medicine can cause side effects, although not everybody gets them. You should see your doctor immediately if you experience: ulcers on the surface of the eye severe pain in the eye allergic reaction You should see your doctor if any of the following effects prove troublesome or if they are long-lasting: Frequency not known (cannot be estimated from the available data) headache increased pressure within the eye centre of the eye becomes cloudy (cataracts) a feeling that something is in your eye eye infections (bacterial, fungal or viral) mild stinging or irritation red eye blurred or poor vision droopy eyelids pupil dilation change in sense of taste rash or itching Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
PRED FORTE Keep this medicine out of the sight and reach of children. Discard the bottle 28 days after opening, even if there is solution remaining. Do not use this medicine after the expiry date which is stated on the bottle label and the bottom of the carton after EXP. The expiry date refers to the last day of that month for an unopened bottle. Do not store above 25°C (room temperature). Do not freeze. Do not use this medicine if you notice the tamper-proof seal is broken. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What PRED FORTE contains
- The active substance is Prednisolone acetate 1.0% w/v.
- The other ingredients are benzalkonium chloride, edetate disodium, sodium chloride, hypromellose, boric acid, sodium citrate dihydrate, polysorbate 80, sodium hydroxide, hydrochloric acid, purified water.
What PRED FORTE looks like and contents of the pack PRED FORTE is a sterile eye drop suspension in a plastic bottle. Each carton contains 1 plastic bottle with a screw cap. Each bottle is about half full and contains 5 ml or 10 ml of the eye drops as written on the front of the carton. Marketing Authorisation Holder AbbVie Ltd. Maidenhead SL6 4UB UK Tel: 01628 561090 Manufacturer Allergan Pharmaceuticals Ireland Westport Co Mayo Ireland This leaflet was last revised in November 2024.
To listen to or request a copy of this leaflet in Braille, large print or audio please contact the Marketing Authorisation Holder.
Frequently asked questions about Pred Forte 1% w/v, Eye Drops Suspension
How do I take Pred Forte 1% w/v, Eye Drops Suspension?
Pred Forte 1% w/v, Eye Drops Suspension comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Pred Forte 1% w/v, Eye Drops Suspension?
The active substance in Pred Forte 1% w/v, Eye Drops Suspension is prednisolone acetate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Pred Forte 1% w/v, Eye Drops Suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Pred Forte 1% w/v, Eye Drops Suspension without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: prednisolone acetate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For short-term treatment of steroid-responsive inflammatory conditions of the eye, after excluding the presence of viral, fungal and bacterial pathogens in adults.
4.2. Posology and method of administration
Posology
Adults
One to two drops instilled into the conjunctival sac two to four times daily. During the initial 24 to 48 hours the dosing frequency may be safely increased to 2 drops every hour. Care should be taken not to discontinue therapy prematurely.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Paediatric population
The safety and efficacy in paediatric population have not yet been established.
No posology can be recommended.
Method of administration
Route of administration is by ocular instillation.
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.
Shake well before use.
4.3. Contraindications
Acute untreated purulent ocular infections. Acute superficial herpes simplex (dendritic keratitis); vaccinia, varicella and most other viral diseases of the cornea and conjunctiva. Fungal diseases of the eye. Mycobacterial infection such as tuberculosis of the eye.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Acute purulent infections of the eye may be masked or enhanced by the use of topical steroids. Pred Forte contains no antimicrobial agent. If infection is present, appropriate measures must be taken to counteract the infective organisms.
Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.
Fungal infections of the cornea have been reported coincidentally with long-term steroid application and fungal invasion may be suspected in any persistent corneal ulceration where a steroid has been used, or is in use.
Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal or scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.
The preservative in Pred Forte, benzalkonium chloride, may be absorbed by and cause discoloration of soft contact lenses. Patients wearing soft contact lenses should be instructed to remove contact lenses prior to administration of the solution and wait at least 15 minutes after instilling Pred Forte before reinserting soft contact lenses.
Use of intraocular steroids may prolong the course and may exacerbate the severity of many viral infections on the eye (including herpes simplex). Patients with a history of herpes simplex keratitis should be treated with caution. Use of steroid medication in the presence of stromal herpes simplex requires caution and should be followed by frequent, mandatory, slit-lamp microscopy.
Prolonged use of topical corticosteroids may cause an increase in intraocular pressure in certain individuals. This may result in glaucoma with damage to the optic nerve with resultant defects in visual acuity and visual fields. Steroids should be used with caution in the presence of glaucoma. It is advisable that intraocular pressure be checked frequently during treatment with Pred Forte.
Eye drops containing corticosteroids should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for intraocular pressure.
Posterior subcapsular cataract formation has been reported after heavy or protracted use of topical ophthalmic corticosteroids.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Systemic adverse events may occur with extensive use of topical steroids; punctal occlusion may be recommended (see Section 4.2).
The possibility of adrenal suppression should be considered with prolonged, frequent, use of high dose topical steroids, particularly in infants and children.
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, 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.
4.5. Interaction with other medicinal products and other forms of interaction
None known.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such defects in the human foetus. Therefore this product should be used with caution during pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Breast-feeding
It is not known whether topical administration of Pred Forte 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
Pred Forte may cause short-lasting blurring of vision upon instillation. If affected, the patient should not use machinery/electric tools or drive until vision has returned to normal.
4.8. Undesirable effects
The following undesirable effects have been reported following use of Pred Forte.
Frequency categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from available data).
Immune system disorders
Not known:
Hypersensitivity, Urticaria
Nervous system disorders
Not known:
Headache
Eye disorders
Not known:
Intraocular pressure increased*
Cataract (including subcapsular)*
Eye penetration (scleral or corneal perforation)*
Foreign body sensation
Ocular infection (including bacterial*, fungal*, and viral* infections)
Ocular stinging
Eye irritation
Eye pain
Ocular hyperemia
Vision blurred* /Visual impairment
Mydriasis
Eyelid ptosis
Gastrointestinal disorders
Not known:
Dysgeusia
Skin and subcutaneous tissue disorders
Not known:
Pruritus, Rash
Systemic: extensive topical use of corticosteroids may lead to systemic side effects*.
* See Section 4.4 for further information.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There is no clinical experience of overdosage. Acute overdosage is unlikely to occur via the ophthalmic route.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- ULTRACORTENOL 5 mg/g prescriptionPREDNISOLONUM · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- EncortolonPrednisolonum · taken by mouth
- Cortico VeyxinPrednisoloni acetas · injection / infusion
- EquisolonPrednisolonum · taken by mouth
- DermipredPrednisolonum · taken by mouth
- PrednicortonePrednisolonum · taken by mouth
- HedylonPrednisolonum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Pred Forte 1% w/v, Eye Drops Suspension. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.