Summary of Product Characteristics Updated 18-Jun-2018 | Martindale Pharma, an Ethypharm Group Company
Hypromellose 0.3% w/v Eye Drops
Hypromellose 0.3% w/v
Excipients of known effect:
For the full list of excipients, see section 6.1
Eye drops, Solution.
Clear to slightly opalescent colourless, slightly viscous solution.
To provide tear-like lubrication for the symptomatic relief of dry eyes and eye irritation associated with deficient tear production.
As an ocular lubricant for artificial eyes.
Adults, children and the elderly
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.
Method of administration
For ocular use only.
Hypersensitivity to the 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 continuous redness occur, patients should discontinue use and consult a physician or pharmacist.
In order to preserve the sterility, the dropper should not be allowed to touch any part of the eye or any other surface.
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.
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.
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.
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 blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.
Adverse events which have been associated with Hypromellose are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
System Organ Class
transient mild stinging or vision blurred,
foreign body sensation in eyes,
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Ophthalmologicals: other ophthalmologicals
ATC code: SO1X A20
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.
This product is a sterile, isotonic, buffered solution of Hypromellose. It is used as a substitute for natural tears.
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.
Benzalkonium Chloride solution
May contain sodium hydroxide or hydrochloric acid.
36 months unopened.
28 days after opening.
Store below 25°C.
Plastic tamper evident eye drop assembly. Fill volume 10ml.
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.
Martindale Pharmaceuticals Ltd
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