Hypromellose Eye Drops BP

Hypromellose 0.3% w/vFor the full list of excipients, see section 6.1

Eye drops, Solution.Clear to slightly opalescent colourless, slightly viscous solution.

Hypromellose is used as artificial tears to prevent damage to the cornea in patients with keratoconjunctivitis sicca accompanying rheumatoid arthritis, xerophthalmias 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 elderly is one or two drops topically instilled into the eye three times daily as needed, or as directed by a physician.Administration : For ocular use only.

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

May cause transient mild 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 preserve the sterility, the dropper should not be allowed to touch any part of the eye or any other surface. (Label warning: Do not touch any part of the eye with the dropper). The product contains benzalkonium chloride and should not be used if soft contact lenses are being worn.Remove contact lenses prior to application and wait at least 15 minutes before reinserting. Benzalkonium chloride is known to discolour soft contact lenses.

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

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 women to hypromellose is negligible. In addition to this, hypromellose is pharmacologically inert.

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

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

Eye disorder:

• transient mild stinging or vision blurred, • eye pain, • foreign body sensation in eyes, • eye irritation, • ocular hyperaemia.

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 Yellow card scheme at www.mhra.gov.uk/yellowcard.

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

Pharmacotherapeutic group: Ophthalmologicals: other ophthalmologicals ATC code: SO1X A20Hypromellose 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 an inert substance. It has no pharmacological activity and not absorbed systemically. Hence, the pharmacokinetic properties have not been studied.

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 drugs studies because of the acknowledged low level of toxicity.

Sodium chloridePotassium chlorideBoraxBoric acidBenzalkonium chloride solutionPurified waterSodium hydroxide solution (for pH adjustment)Hydrochloric acid ( for pH adjustment)

Not known

Unopened: 24 monthsAfter first opening: 1 month

Protect from light.Do not store above 25°CA slight haziness which may develop in the unopened product is normal and does not adversely affect the product. Discard after four weeks of opening.

Pack Type A

Low density polyethylene bottle with polystyrene spiked cap.

Pack size: 10 ml

Pack Type B

Low density polyethylene (LDPE) vial with insert cap assembly, comprising of white coloured HDPE screw cap over a LDPE nozzle with tamper-evident LDPE dust cover sealing the vial cap.

Pack size: 10 ml

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.

FDC International Ltd.Unit 6, Fulcrum 1Solent WayWhiteley FarehamHampshirePO15 7FEUnited Kingdom

PL 15872/0005

16^th January 1998 / 01^st July 2008

24 June 2017