Hypromellose Eye Drops BP

Active Ingredient

Hypromellose Ph Eur 0.3g in 100ml

Eye Drops

Hypromellose is used as artificial tears to prevent damage to the cornea in patients with kerato-conjunctivitis sicca accompanying rheumatoid arthritis, or keratitis or during gonioscopy procedures. It is also used to moisten hard contact lenses and to lubricate artificial eyes.

Hypromellose provides immediate relief of dry eye conditions (including dry eye conditions associated with the use of VDUs and TVs, infrequent blinking, certain medical treatments, atmospheric pollution and drying atmospheres eg air-conditioning, central heating, wind and sun.

The recommended dosage for adults, children and infants of all age groups is one or two drops topically instilled into the eye three times daily as needed, or as directed by a physician.

Hypersensitivity to any component of the preparation.

May cause transient stinging or temporary blurred vision. If irritation persists or worsens, or headache, eye pain, vision changes or continued redness occur, patients should discontinue use and consult a physician or pharmacist (see section 4.8).

In order to help preserve sterility the dropper should not be allowed to touch the eyelids or any other surface. (Label warning: do not touch the eyelid with the dropper). The product contains benzalkonium chloride and should not be used if soft contact lenses are being worn.

Hypromellose prolongs the contact time of topically applied drugs commonly used in ophthalmology.

Safety for use in pregnancy and lactation has not been established. Therefore, use only when considered essential by the physician.

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

May cause transient mild stinging or temporarily blurred vision.

Not applicable

Hypromellose is a soothing emollient solution with properties and uses similar to those of methylcellulose. Its advantages over methylcellulose are that mucilages of hypromellose have greater clarity and fewer undispersed fibres are usually present. It prolongs the action of medicated eye drops and is used as artificial tears to prevent damage to the cornea in dry eye syndromes.

Not applicable to topical (ophthalmic) preparations.

Hypromellose is not systemically absorbed.

Nothing of relevance which is not included in other sections of the SPC

Sodium chloride

Potassium chloride

Borax

Boric acid

Benzalkonium chloride solution

Purified water

Sodium hydroxide solution (to adjust pH)

Hydrochloric acid (to adjust pH)

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

Protect from light.

Store below 25°C

A slight haziness which may develop in the unopened product is normal and does not adversely affect the product. Discard within four weeks of opening.

10ml polypropylene dropper bottle fitted with a low density polyethylene nozzle and a high density polyethylene tamper evident cap.

FDC International Ltd

Unit 6 Fulcrum 1

Solent Way

Whiteley

Fareham

Hants

PO15 7FE

United Kingdom

15872/0005

Not applicable

14 June 2010