This information is intended for use by health professionals

1. Name of the medicinal product

ISOPTO PLAIN 0.5% eye drops, solution

2. Qualitative and quantitative composition

Hypromellose Ph.Eur. 0.5% w/v.

For excipients see 6.1.

3. Pharmaceutical form

Eye Drops, Solution

4. Clinical particulars
4.1 Therapeutic indications

Used topically to provide tear-like lubrication for the symptomatic relief of dry eyes and eye irritation associated with deficient tear production. (Usually in cases of rheumatoid arthritis, keratoconjunctivitis sicca and xerophthalmia).

Also used as an ocular lubricant for artificial eyes.

4.2 Posology and method of administration

Adults, children and the elderly. The dose depends on the need for lubrication. Usually one to two drops to each eye three times daily or as prescribed.

4.3 Contraindications

Hypersensitivity to any component of the product.

4.4 Special warnings and precautions for use

If irritation persists or worsens, or headache, eye pain, vision changes or continued redness occur, discontinue use and consult a physician.

To preserve sterility do not allow the dropper to touch the eye or any other surface.

The product contains benzalkonium chloride and should not be used when soft contact lenses are worn.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

Fertility

Studies have not been performed to evaluate the effect of topical ocular administration of hypromellose on fertility. Hypromellose is a pharmacologically inert compound and it would not be expected to have any effect on fertility.

Pregnancy

There are no or limited amount of data from the use of ophthalmic hypromellose in pregnant women. Systemic exposure to hypromellose following topical ocular administration is negligible and the product has no pharmacological properties.

Lactation

It is unknown whether topical hypromellose/metabolites are excreted in human milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to hypromellose is negligible. In addition to this, hypromellose is pharmacologically inert.

4.7 Effects on ability to drive and use machines

May cause transient blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.

4.8 Undesirable effects

The following adverse reactions have been reported following administration of ISOPTO PLAIN. Frequency cannot be estimated from the available data.

System Organ Classification

Adverse Reaction

Eye disorders

Vision blurred, eye pain, foreign body sensation in eyes, eye irritation, ocular hyperaemia

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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of benefit/risk balance of the medicinal product. Health care professionals are asked to report any suspected adverse reactions via their national reporting system:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

4.9 Overdose

Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, nor in the event of accidental ingestion of the contents of one bottle.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Ophthalmologicals: Other ophthalmologicals

ATC code: SO1X A20

Hypromellose is an inert substance. It has no pharmacological activity.

5.2 Pharmacokinetic properties

Hypromellose is an inert substance. It has no pharmacological activity and, hence, the pharmacokinetic properties have not been studied.

5.3 Preclinical safety data

Hypromellose is an inert substance and is not expected to be absorbed systemically. Hence, although no systemic toxicity studies have been conducted it is not expected to demonstrate any systemic toxicity or to have any effect on reproductive processes.

Similarly no specific local ocular toxicity or irritation studies have been conducted, however, no adverse effects are anticipated. Indeed, hypromellose ophthalmic solution is used as a control in some ophthalmic drug studies because of the acknowledged low level of toxicity.

6. Pharmaceutical particulars
6.1 List of excipients

Sodium citrate dihydrate Ph.Eur., Disodium hydrogen phosphate anhydrous BP, Sodium dihydrogen phosphate monohydrate BP, Sodium chloride Ph.Eur., Benzalkonium chloride Ph.Eur, Purified water Ph.Eur.

6.2 Incompatibilities

None known

6.3 Shelf life

36 months (unopened), 1 month (after first opening).

6.4 Special precautions for storage

Do not store above 25°C. Do not refrigerate.

Keep container tightly closed.

Discard 1 month after opening.

6.5 Nature and contents of container

10 ml Drop-Tainer - Natural Low Density Polyethylene Bottle and Plug.

Polystyrene or Polypropylene cap.

6.6 Special precautions for disposal and other handling

Do not touch dropper tip to any surface as this may contaminate the contents.

If the drop of medication is not retained in the eye upon dosing for any reason, instill another drop.

7. Marketing authorisation holder

Alcon Eye Care UK Limited

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey, GU15 3YL

United Kingdom

8. Marketing authorisation number(s)

PL 41809/0002

9. Date of first authorisation/renewal of the authorisation

14 May 2002

10. Date of revision of the text

January 2020

LEGAL CATEGORY

P