Dexagel 0,985 mg Gel

DEXAGEL is an eye gel which contains a substance called dexamethasone. This substance is a corticosteroid which inhibits inflammatory symptoms.

DEXAGEL is indicated to reduce ocular inflammation after cataract surgery.

Do not use DEXAGEL:

• if you are hypersensitive (allergic) to dexamethasone or any of the other ingredients of DEXAGEL (listed in section 6)
• if you are suffering from an ocular infection which could be bacterial (acute purulent infection) fungal, or viral (e.g. herpetic virus)
• if you have ocular tuberculosis
• if you have glaucoma
• if you have had previous ocular hypertension induced by corticosteroid treatment
• if you have corneal damages (perforation, ulcerations or lesions associated with incomplete healing).

Warnings and precautions

Talk to your doctor or pharmacist before using DEXAGEL.

Close ophthalmic monitoring is required during the use of DEXAGEL. Tell your doctor:

• if you are an elderly person (e.g. over 65 years of age), as more frequent ophthalmic monitoring is recommended.
• if you have an ocular infection.
• if you have a history of herpetic disease (disease caused by the herpes simplex virus, e.g. cold sores or genital herpes).
• if you are suffering from a corneal ulcer.
• if you suffer from increased intraocular pressure (glaucoma).
• if you have already experienced adverse reactions to local steroids treatment.
• if you suffer from diabetes.

Contact your doctor if you experience blurred vision or other visual disturbances.

Talk to your doctor if you experience swelling and weight gain around the trunk and in the face as these are usually the first manifestations of a syndrome called Cushing’s syndrome.

Severe allergic conjunctivitis: if you have severe allergic conjunctivitis, tell your doctor.

Red eye: if you have a red eye, do not use DEXAGEL and tell your doctor.

Contact lenses: you should avoid wearing contact lenses during treatment with DEXAGEL.

Children and adolescents

The safety and efficacy in children have not been established.

Other medicines and DEXAGEL

Always tell your health care provider if you are using, or have recently used, any other medicine. (This includes all complementary or traditional medicines).

Tell your doctor if you are taking ritonavir or cobicistat (medicines for the treatment of HIV), as this may increase the amount of dexamethasone in the blood.

Tell your doctor if you are taking any of the following medicines, as they may reduce the effect of DEXAGEL:

• phenytoin (to treat epilepsy),
• phenobarbitone (for the treatment of epilepsy or anxiety),
• ephedrine (used to treat breathing problems, nasal congestion, low blood pressure problems, or myasthenia gravis),
• rifampicin (medicine for the treatment of tuberculosis).

DEXAGEL may increase the need for salicylates (aspirin), talk to your doctor if you are on treatment with aspirin.

Talk to your doctor if you take anticholinergic medicines (e.g. atropine), you may be at greater risk of increased intraocular pressure.

The use of topical steroids (like DEXAGEL) together with topical non-steroidal anti-inflammatories (NSAIDs) (e.g. diclofenac) may increase the potential for corneal healing problems.

If you are using any other medicine to be applied in the eye, you should wait 15 minutes between each application. DEXAGEL should be administered last.

Do not share medicines prescribed for you with any other person.

Always use DEXAGEL exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is 1 drop every 4 hours. Later this can be reduced to 1 drop 3 to 4 times a day.

DEXAGEL should be used in your eye(s) only.

You should press lightly in the corner of your eye for a minute following the instillation of the gel. This reduces the systemic absorption of DEXAGEL.

Your doctor will tell you how long the treatment with DEXAGEL will last, but this should not exceed 4 weeks.

If you have the impression that the effect of X is too strong or too weak, tell your doctor or pharmacist.

If you use more DEXAGEL than you should

Rinse the eye with water if you have applied too much product to your eye and there is prolonged irritation.

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to use DEXAGEL

Do not use a double dose to make up for a forgotten dose.

DEXAGEL can have side effects. Not all side effects reported for DEXAGEL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using DEXAGEL, please consult your health care provider for advice.

If any of the following happens, stop using DEXAGEL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting

These are all very serious side effects. If you have them, you may have had a serious reaction to DEXAGEL. You may need urgent medical attention or hospitalisation.

DEXAGEL can have the following side effects in your eyes. Tell your doctor if you notice any of the following:

Frequent side effects

• cataract
• increased intraocular pressure (with long term use)

Less frequent side effects

• opportunistic infections
• conjunctivitis (inflammation of the eye membranes)
• corneal oedema
• corneal thinning
• eye irritation
• drooping eyelids (ptosis)
• eye itching (pruritus)
• foreign body sensation in the eye
• keratitis (inflammation of the cornea – the clear layer at the front of the eye)
• dilation of the pupil (mydriasis)
• ocular discomfort
• corneal deposits

Side effects with unknown frequency

• eye infection
• blurred vision

DEXAGEL can also have side effects that affect other parts of your body. Tell your doctor if you notice any of the following:

Less frequent side effects

• hypersensitivity (allergic reactions)
• facial oedema (swelling)

Side effects with unknown frequency

• adrenal suppression (which can result in hormone problems)
• Cushing’s syndrome (swelling and weight gain of the body and face – see section 2 Warnings and precautions)
• increased blood glucose levels

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

You can also report side effects directly to the company, using the following e-mail address: [email protected]

By reporting side effects, you can help provide more information on the safety of DEXAGEL.

• Store all medicines out of reach of children.
• Store at or below 25 °C.
• Discard any remaining eye gel after 6 weeks of first opening the tube.
• Do not use after the expiry date stated on the tube or carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).