Summary of Product Characteristics (SmPC) - Moistur-eyes dry eye drops
1 NAME OF THE MEDICINAL PRODUCT
Moistur-eyes ‘dry eye’ drops.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hypromellose eye drops contain 0.3% solution of hypromellose, buffered to pH 8.4
Excipients with known effect
Benzalkonium chloride solution
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Topical ophthalmic (drops).
4.1 Therapeutic indications
Hypromellose is used as artificial tears to prevent damage to the cornea in patients with kerato-conjunctivitis 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 e.g. air-conditioning, central heating, wind and sun).
4.2 Posology and method of administration
The recommended dosage for adults, children and the elderly is one or two drops topically instilled into the eyes three times daily as needed, or as directed by a physician.
Method of administration: For Ocular use only.
4.3 Contraindications
Hypersensitivity to the active substance, Hypromellose or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
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).
Label warning: The product contains benzalkonium chloride and should not be used if soft contact lenses are being worn.
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 has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.
4.5 Interaction with other medicinal products and other forms of interaction
Hypromellose prolongs the contact time of topically applied drugs commonly used in opthamology.
4.6 Fertility, 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 women 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 hypromellose.
Frequency cannot be estimated from the available data:
Eye disorders:
- transient mild stinging or temporarily blurred vision,
- 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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
Pharmacotherapeutic group: Ophthalmologicals - other ophthalmologicals
ATC code: S01XA20
Hypromellose is a soothing emollient solution with properties and uses similar to those of methylcellulose. Its advantages over methycellulose 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.
5.2 Pharmacokinetic properties
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
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 drugs studies because of the acknowledged low level of toxicity.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium Chloride EP
Potassium Chloride EP
Borax EP
Boric Acid EP
Benzalkonium Chloride Solution BP
Purified Water EP
6.2 Incompatibilities
None stated.
6.3 Shelf life
Unopened: 24 months
After first opening: 28 days
6.4 Special precautions for storage
Store below 25ºC, protect from light.
6.5 Nature and contents of container
A polypropylene dropper bottle fitted with a low density polyethylene nozzle and a high density polyethylene tamper evident cap.
6.6 Special precautions for disposal
- 1. Wash your hands
- 2. Tilt the head backwards and line up the eye dropper bottle over the eye
- 3. Squeeze the bottle gently to release a couple of drops into the eye
- 4. Blinking will insure the film of drops is distributed over the whole eye.
- 5. Repeat three times daily as needed
Warnings: This product contains benzalkonium chloride as a preservative and should not be used with soft contact lenses.
Do not allow the bottle to touch the eye as this can cause infection.
7. MARKETING AUTHORISATION HOLDER
Crescent Pharma Limited
Key House, Sarum Hill,
Basingstoke, RG21 8SR, UK.
8 MARKETING AUTHORISATION NUMBER(S)
PL 20416/0642
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/12/2008
10 DATE OF REVISION OF THE TEXT
24/07/2025