This information is intended for use by health professionals

1. Name of the medicinal product

Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear Drops, Solution

2. Qualitative and quantitative composition

Prednisolone Sodium Phosphate 0.5% w/v

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Eye and ear drops, solution

Sterilised clear and colourless aqueous solution

4. Clinical particulars
4.1 Therapeutic indications

Prednisolone Sodium Phosphate Drops is indicated for short term treatment of steroid responsive inflammatory conditions of the eye after clinical exclusion of bacterial, viral and fungal infections and Non-infected inflammatory conditions of the ear.

4.2 Posology and method of administration

Adults and Children (including the Elderly)

Eyes

1 or 2 drops instilled into the eyes every one or two hours until control is achieved, when the frequency may be reduced.

Ears

2 or 3 drops instilled into the ear every two or three hours until control is achieved, when the frequency can be reduced.

Frequency of dosing depends on clinical response. If there is no clinical response within 7 days treatment, the drops should be discontinued. Treatment should be the lowest effective dose for the shortest possible time. After more prolonged treatment (over 6-8 weeks), the drops should be withdrawn slowly to avoid relapse.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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

In the ear, topical corticosteroids are contraindicated in patients with fungal diseases of the auricular structure, and in those with a perforated tympanic membrane.

4.4 Special warnings and precautions for use

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

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

The use of corticosteroids may reduce resistance to or mask the signs of infection. Appropriate anti-infective agents should be used if infection is present.

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders and anxiety.

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.

Paediatric population

Prolonged use may lead to the risk of adrenal suppression in infants. Potential systemic effects may include growth retardation in children and adolescents and more rarely a range of psychological or behavioural effects including depression or aggression (particularly in children).

4.5 Interaction with other medicinal products and other forms of interaction

Prednisolone Sodium Phosphate Drops contain benzalkonium chloride as a preservative and, therefore, should not be given to treat patients who wear soft contact lenses.

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

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 be a very small risk of such effects in the human foetus.

Breastfeeding

There is insufficient information on the excretion of Prednisolone sodium phosphate / metabolites in human milk. A risk to the newborns / infants cannot be excluded.

Fertility

No fertility data is available.

4.7 Effects on ability to drive and use machines

Prednisolone Sodium Phosphate Drops has moderate influence on the ability to drive and use machines.

It may cause transient blurring of vision on instillation, warn patients not to drive or operate hazardous machinery until vision is clear.

4.8 Undesirable effects

Very rare (<1/10,000)

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Not known (frequency cannot be estimated from the available data)

Not known: Immune system disorders

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

Not known: Skin and subcutaneous tissue disorders

Dermatitis

Not known: Eye disorders

Topical corticosteroid use may result in increased intraocular pressure leading to optic nerve damage, reduced visual acuity and visual field defects. Other side effects include Chorioretinopathy, mydriasis, ptosis, epithelial punctate keratitis and possible corneal or scleral malacia. Within a few days after discontinuing topical ophthalmic corticosteroid therapy and occasionally during therapy, acute anterior uveitis has occurred in patients (mainly blacks) without pre-existing ocular inflammation or infection.

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.

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

4.9 Overdose

Long term intensive topical use may lead to systemic effects. Oral ingestion of the contents of one bottle (up to 10ml) is unlikely to lead to any serious adverse effects.

5. Pharmacological properties
5.1 Pharmacodynamic properties

ATC code – S03D

Pharmacotherapeutic group – Ophthalmological and Otological preparations

5.2 Pharmacokinetic properties

Not available

5.3 Preclinical safety data

Not available

6. Pharmaceutical particulars
6.1 List of excipients

Benzalkonium chloride solution

Sodium chloride

Sodium acid phosphate

Disodium edetate

Sodium hydroxide

Phosphoric acid

Purified water

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

18 months unopened.

4 weeks after first opening.

6.4 Special precautions for storage

Store below 25°C. Do not freeze.

Store in the original package in order to protect from light.

Sterility of the drops is assured until cap seal is broken.

For storage conditions after first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Single 5ml or 10ml bottle with nozzle insert moulded in natural low density polyethylene closed with a tamper evident high density polyethylene cap.

Not all pack sizes are marketed.

6.6 Special precautions for disposal and other handling

No special requirement for disposal.

7. Marketing authorisation holder

RPH Pharmaceuticals AB,

Lagervägen 7,

136 50 Haninge,

Sweden

8. Marketing authorisation number(s)

PL 36301/0026

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 04 December 1992

Date of latest renewal: 30 May 2003

10. Date of revision of the text

28 November 2018