Apicort 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.

Always use Apicort Forte exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose of Apicort Forte 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:

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 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 check-ups. 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 Apicort Forte than you should Putting too many drops in your eye(s) is unlikely to lead to unwanted side-effects

-Do not use Apicort Forte -If you are allergic (hypersensitive) to: prednisolone acetate, benzalkonium chloride or other ingredients 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

Take special care with Apicort Forte

 

Talk to your doctor before using Apicort 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.

 

Tell your doctor before using Apicort 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.

 

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

• A preservative in Apicort Forte (benzalkonium chloride) may cause eye irritation. Apicort Forte should not be used whilst soft contact lenses are in place, as it may discolour them.

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

Tell your doctor before you start using Apicort Forte if you are pregnant or if you are breast-feeding as steroids may be harmful to the baby.

Ask your doctor or pharmacist for advice before using any medicine.

Apicort 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 Apicort Forte.

Like all medicines, Apicort Forte can cause side effects. But not everyone gets them.

You should see your doctor immediately if you experience:

-Ulcers on the surface of the eye .   -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

-Headache                                                            -increased pressure within the eye

-Centre of the eye becomes cloudy (cataracts)    -eye infections

-Mild stinging or irritation                                      -blurred or poor vision

-Pupil dilation                                                        -change in sense of taste     

-Rash or itching

 

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

 

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 Apicort 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 use a double dose to make up for a Forgotten dose.

-If you stop using Apicort Forte

Apicort Forte should be used as advised by your doctor. Do not stop using Apicort 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.

Pharmacotherapeutic group: corticosteroids, ATC code: S01BA04

Prednisolone acetate is a synthetic adrenocorticoid with the general properties of prednisolone. Adrenocorticoids diffuse across cell membranes to complex with cytoplasmic receptors and subsequently stimulate synthesis of enzymes with anti-inflammatory effects. 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.

Prednisolone acetate has, on a weight to weight basis, a potency three to five times that of hydrocortisone.

Prednisolone acetate has been shown to penetrate rapidly the cornea after topical application of a suspension preparation. Aqueous humour Tmax occurs between 30 and 45 minutes after installation. The half life of prednisolone acetate in human aqueous humour is approximately 30 minutes

Not applicable

Sodium edetate

Sodium metabisulphite

Sodium phosphate monobasic

 Sodium phosphate dibasic

Tween 80

Sodium chloride

Methylcellulose.

    Benzalkonium chloride                                 

None

3 years

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Apicort Forte is a sterile eye drop suspension in a plastic bottle. Each carton contains 1 plastic bottle with a screw cap. Each bottle contains 5 ml or 10 ml of the eye drops as written on the front of the carton

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