PURADEX 1 MG / ML EYE DROPS SOLUTION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Puradex 1mg/ml eye drops solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of solution contains 1 mg of dexamethasone phosphate as dexamethasone sodium phosphate.

Excipient(s) with known effect:

1 ml of solution contains 1.093 mg dexamethasone sodium phosphates equivalent to 1.000 mg dexamethasone phosphate.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Eye drops, solution.

Clear colourless solution, with no visible particles.

Osmolality: 230 to 300 mOsmol/Kg

pH: 7.2 – 8.2

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For treatment of non-infectious inflammatory conditions affecting the anterior segment of the eye.

4.2 Posology and method of administration

Puradex 1mg/ml eye drops solution is for ocular use only.

This product should be used only under close ophthalmic supervision.

Posology

The usual posology is of 1 drop 4 to 6 times daily in the affected eye.

In severe cases, treatment may be started with 1 drop every hour but dosage should be reduced to one drop every 4 hours when favourable response is observed. Gradual tapering off is recommended in order to avoid a relapse.

The duration of treatment will generally vary from a few days to a maximum of 14 days.

Elderly patients

There has been wide experience with the use of dexamethasone eye drops in elderly patients. The dose recommendations given above reflect the clinical data derived from this experience.

Paediatric population

Efficacy and safety has not been established in the paediatric population.

In children, long-term continuous corticosteroid therapy should be avoided due to possible adrenal suppression (see section 4.4).

Method of administration

Ocular use.

Puradex 1mg/ml eye drops solution is a sterile solution that does not contain a preservative.

Patients should be instructed:

-to wash their hands carefully prior to instillation,

-to avoid contact between the tip of the dispenser and the eye or eyelids.

Nasolacrimal occlusion by compression of lacrimal ducts may reduce systemic absorption.

4.3 Contraindications

Eye infections not controlled by anti-infectious treatment, such as:

o Acute purulent bacterial infections including Pseudomonas and mycobacterial infections,

o Fungal infections,

o Epithelial Herpes simplex keratitis (dendritic keratitis), vaccinia, varicella zoster and most other viral infections of the cornea and conjunctiva,

o Amoebic Keratitis,

Perforation, ulceration and injury of cornea with uncompleted epithelialisation (see also section 4.4),

Known glucocorticosteroid-induced ocular hypertension.

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

4.4 Special warnings and precautions for use

Cushing’s syndrome and/or adrenal suppression associated with systemic absorption of ocular dexamethasone may occur after intensive or long-term continuous therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat). In these cases, treatment should be progressively discontinued.

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

CYP3A4 inhibitors (including ritonavir and cobicistat ): may decrease dexamethasone clearance resulting in increased effects and adrenal suppression/Cushin­g’s syndrome. 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 effects.

No interaction studies have been performed.In case of concomitant treatment with other eye drops, solution, instillations should be spaced out by 15 minutes.

Superficial stromal corneal precipitations of calcium phosphate have been reported under combined use of corticosteroids and topical beta-blockers.

4.6 Fertility, pregnancy and lactation

Pregnancy

Insufficient data are available on the use of Puradex 1mg/ml eye drops solution in human pregnancy to assess possible harmful effects. Corticosteroids cross the placenta. Teratogenic effects have been observed in animals (see section 5.3). However, there is no evidence to date that teratogenic effects are induced in humans. After systemic use of corticosteroids, at higher doses, effects on the unborn/neonate (intrauterine growth inhibition, inhibition of the function of the adrenal cortex) have been reported. However, these effects have not been reported for ocular use.

As a precautionary measure, it is preferable to avoid the use of Puradex 1mg/ml eye drops solution during pregnancy.

Breast-feeding

It is not known whether this medicine is excreted in breast milk. However, the total dose of dexamethasone is low.

Puradex 1mg/ml eye drops solution can be used during lactation.

Fertility

There are no data on potential effects of dexamethasone 1 mg/ml on fertility.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

As with any eye drops, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs, the patient must wait until the vision is clear before driving or using machines.

4.8 Undesirable effects

4.9 Overdose

In the case of topical overdosage, the treatment should be stopped. In case of prolonged irritation, the eye(s) should be rinsed with sterile water.

The symptomatology due to accidental ingestion is not known. As with other corticosteroids however, the physician may consider gastric lavage or emesis.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals, anti-inflammatory agents, Corticosteroids, plain, ATC code: S01B A01

Dexamethasone sodium phosphate is a hydrosoluble inorganic ester of dexamethasone. It is a synthetic corticosteroid with an anti-inflammatory and anti- allergic action. Dexamethasone has more potent anti-inflammatory action compared to hydrocortisone (approximately 25:1) and prednisolone (approximately 5:1).

5.2 Pharmacokinetic properties

Due to its hydrophilic properties, dexamethasone sodium phosphate is barely absorbed by the intact epithelium of the cornea.

Following absorption via the eye and the nasal mucosa, dexamethasone sodium phosphate is hydrolyzed in the system to dexamethasone.

Afterwards, dexamethasone and its metabolites are mainly eliminated via the kidneys.

5.3 Preclinical safety data

6   PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Disodium edetate

Sodium chloride

Disodium hydrogen phosphate anhydrous

Water for injection

6.2 Incompati­bilities

Not applicable.

6.3 Shelf life

30 months

After first opening, the product may be stored for a maximum of 28 days and it does not require any special storage conditions.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

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

6.5 Nature and contents of container

5 ml solution in a white opaque 5 ml LDPE bottle with white Novelia nozzle (HDPE and silicone) and a white HDPE cap.

Pack sizes: 1 bottle.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

RAFARM UK LIMITED

6th Floor, 2 Kingdom Street

W2 6BD, London, United Kingdom

+44 (0) 203 580 4282

regulatory@ra­farm.uk