This information is intended for use by health professionals

1. Name of the medicinal product

Betamethasone 0.1% w/w Eye Ointment

2. Qualitative and quantitative composition

Betamethasone sodium phosphate PhEur 0.1% w/w

For excipients, see 6.1

3. Pharmaceutical form

Eye Ointment.

4. Clinical particulars
4.1 Therapeutic indications

Short-term treatment of steroid responsive inflammatory conditions of the eye after clinical exclusion of bacterial, viral and fungal infections.

4.2 Posology and method of administration

Adults and children (including the elderly)

The frequency of dosing depends on the clinical response. If there is no clinical response within 7 days of treatment, the ointment should be discontinued.

Treatment should be the lowest effective dose for the shortest possible time. After more prolonged treatment (over 6 to 8 weeks), the ointment should be withdrawn slowly to avoid relapse.

An extrusion of the ointment about 1/4 inch long may be introduced beneath the lower lid two or three times daily and/or at night.

4.3 Contraindications

Bacterial, viral, fungal, tuberculous or purulent conditions of the eye. Use is contra indicated if glaucoma is present, or where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Use of topical steroids in the latter condition can lead to an extension of the ulcer and marked visual deterioration.

Hypersensitivity to any component of the preparation.

4.4 Special warnings and precautions for use

A patient information leaflet should be supplied with this product.

Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding.

Prolonged use may lead to the risk of adrenal suppression in infants.

Treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.

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 relevant to topical use.

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 Pregnancy and lactation

Safety for use in pregnancy and lactation has not been established. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

4.7 Effects on ability to drive and use machines

May cause transient blurring of vision on instillation. Patients should be warned not to drive or operate hazardous machinery unless vision is clear.

4.8 Undesirable effects

Hypersensitivity reactions, usually of the delayed type, may occur leading to irritation, burning, stinging, itching and dermatitis.

Topical corticosteroid use may result in corneal ulceration, increased intraocular pressure leading to optic nerve damage, reduced visual acuity and visual field defects.

Intensive or prolonged use of topical corticosteroids may lead to formation of posterior subcapsular cataracts.

In those diseases causing thinning of the cornea or sclera, corticosteroid therapy may result in thinning of the globe leading to perforation.

Mydriasis, ptosis, epithelial punctate keratitis and glaucoma have also been reported following ophthalmic use of corticosteroids.

Vision, blurred (see also section 4.4)

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 on the MHRA website (www.mhra.gov.uk/yellowcard).

4.9 Overdose

Oral ingestion of the contents of one tube (3g) of ointment is unlikely to lead to any serious adverse effects.

5. Pharmacological properties
5.1 Pharmacodynamic properties

ATC Code: S01B A06

Betamethasone is a glucocorticoid which has topical anti-inflammatory activity.

5.2 Pharmacokinetic properties

Not applicable as the ointment is applied topically to the eye.

5.3 Preclinical safety data

None stated.

6. Pharmaceutical particulars
6.1 List of excipients

White soft paraffin

Liquid paraffin

6.2 Incompatibilities

None known.

6.3 Shelf life

Unopened:

36 months

Opened:

4 weeks

6.4 Special precautions for storage

Store at a temperature below 30°C.

6.5 Nature and contents of container

Collapsible aluminium tubes with fine-bore extended nozzle tube fitted with a natural polyethylene cap containing 3 grams of ointment.

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

RPH Pharmaceuticals AB,

Lagervägen 7,

136 50 Jordbro,

Sweden

8. Marketing authorisation number(s)

PL 36301/0001

9. Date of first authorisation/renewal of the authorisation

02/12/1992

10. Date of revision of the text

06/10/2017