This information is intended for use by health professionals

1. Name of the medicinal product

Vistamethasone 0.1% w/v Drops or Betamethasone 0.1% w/v Drops.

2. Qualitative and quantitative composition

Betamethasone Sodium Phosphate 0.1% w/v

Excipient with known effect

Benzalkonium Chloride - 0.02% w/v

Disodium Edetate – 0.1% w/v

Sodium Phosphate – 0.8% w/v

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Ear/eye/nasal drops, solution.

A clear and colourless solution.

4. Clinical particulars
4.1 Therapeutic indications

For the topical treatment of inflammatory non-infected conditions of the eye, ear or nose.

4.2 Posology and method of administration

The frequency of dosing depends on the clinical response. If there is no clinical response within 7 days of treatment, the drops 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 After more prolonged treatment (over 6 to 8 weeks), the drops should be withdrawn slowly to avoid relapse.

Dosage schedule:

Administration for topical ocular use.

Adults, Elderly and Children:

Initially one or two drops to be instilled into the affected eye(s) every two hours. Frequency of administration should be reduced once the condition is under control.

Administration for topical otic use.

Adults, Elderly and Children:

Initially two or three drops to be instilled into the affected ear(s) every three to four hours. Frequency of administration should be reduced once the condition is under control.

Administration for topical nasal use.

Adults, Elderly and Children:

Two or three drops to be instilled into each nostril twice daily as required.

4.3 Contraindications

Hypersensitivity to any of the preparations components. Bacterial, Viral, fungal, tuberculous or purulent conditions of the eye. Use is contraindicated if Glaucoma is present or Herpetic keratitis (e.g. dendritic ulcer), is considered a possibility. Use of topical steroids in this condition can lead to extension of the ulcer and marked visual deterioration. Otitis externa should not be treated when the eardrum is perforated due to the risk of ototoxicity.

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.

Prolonged use may lead to the risk of adrenal suppression in infants. Ophthalmological treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

Nasal administration of corticosteroids is not advised if an untreated nasal infection is present, or if the patient has pulmonary tuberculosis or following nasal surgery (until healing has occurred).

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, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

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.

This medicine contains 0.02 % w/v benzalkonium chloride in each 10 ml of solution which is equivalent to 0.2 mg/ml.

4.5 Interaction with other medicinal products and other forms of interaction

Vistamethasone / Betamethasone drops contain benzalkonium chloride as a preservative and therefore, should not be used 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

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 abnormal foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such defects in the human foetus.

4.7 Effects on ability to drive and use machines

May cause transient blurring of vision on instillation into the eye.

Betamethasone Sodium Phosphate has moderate influence on the ability to drive and use machine.

4.8 Undesirable effects

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

Use of topical corticosteroids 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 the 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.

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.

Following nasal administration, the most common effects are nasal irritation and dryness, although sneezing, headache, light headedness, urticaria, nausea, epistaxis, rebound congestion, bronchial asthma, perforation of the nasal septum, ulceration of the nasal septum, anosmia, parosmia and disturbance to sense of taste have also been reported.

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses.

It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid, if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should also be given to referring the patient to a paediatric specialist.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence of higher than recommended doses being used then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, ATC code: S03BA03

-

5.2 Pharmacokinetic properties

No data available.

5.3 Preclinical safety data

None available.

6. Pharmaceutical particulars
6.1 List of excipients

Benzalkonium Chloride Solution

Disodium Edetate

Sodium Phosphate

Purified Water

6.2 Incompatibilities

None Known.

6.3 Shelf life

24 months from date of manufacture.

28 days from first opening.

6.4 Special precautions for storage

Store upright below 25°C.

Store in original carton. Protect from light.

6.5 Nature and contents of container

5 or 10ml of the sterile solution is contained in a low density polythene bottle and dropper nozzle sealed by a tamper evident high density polythene cap.

Not all pack sizes may be marketed

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

7. Marketing authorisation holder

Martindale Pharmaceuticals Limited

Bampton Road,

Harold Hill,

Romford,

RM3 8UG

8. Marketing authorisation number(s)

PL 00156/0083

9. Date of first authorisation/renewal of the authorisation

26/11/2008

10. Date of revision of the text

August 2018