Hypromellose Eye Drops Bp 0.3% W/V
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hypromellose Eye Drops BP 0.3% w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: Hypromellose 0.3% w/v
Preservative: Benzalkonium chloride 0.01% w/v
For other excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye Drops, Solution
4 CLINICAL PARTICULARS
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, 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 airconditioning, central heating, wind and sun.
4.2
Posology and method of administration
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.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
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).
This formulation of Hypromellose Eye Drops contains benzalkonium chloride as a preservative. Benzalkonium chloride may be deposited in soft contact lenses and cause eye irritation and discoloration of the lenses. Hence, avoid contact with soft contact lenses. The lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after 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 ophthalmology.
4.6 Pregnancy and lactation
Safety for use in pregnancy and lactation has not been established. Therefore, use only when considered essential by the physician.
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. Frequency cannot be estimated from the available data.
Eye disorders: - 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 the Yellow Card Scheme at:
4.9 Overdose
Not applicable to topical (ophthalmic) preparations. Hypromellose is not systemically absorbed.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
ATC Code: S01KA02 viscoelastic substances.
5.2 Pharmacokinetic properties
Not applicable to topical (ophthalmic) preparations. Hypromellose is not systemically absorbed.
5.3 Preclinical safety data
Nothing of relevance which is not included in other sections of the SPC
6.1 List of excipients
Sodium chloride Potassium chloride Borax Boric acid Purified water
Sodium hydroxide solution (to adjust pH) Hydrochloric acid (to adjust pH)
6.2 Incompatibilities
The product contains benzalkonium chloride and should not be used if soft contact lenses are worn.
6.3 Shelf life
Polypropylene bottle
Unopened: 24 months
Opened: 28 days
Polyethylene bottle
Unopened: 36 months
Opened: 28 days
6.4 Special precautions for storage
Protect from light.
Do not store above 25°C
6.5 Nature and contents of container
10ml polypropylene dropper bottle fitted with a low density polyethylene nozzle and a high density polyethylene tamper evident cap.
Or
10ml low density polyethylene bottle with low density polyethylene dropper and high density polyethylene cap.
6.6 Special precautions for disposal
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
7 MARKETING AUTHORISATION HOLDER
Medicom Healthcare Limited
Office 1, 235 Pond Road
Titchfield Common
Fareham
Hampshire
PO14 4PJ
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 18956/0007
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23/01/2009
10 DATE OF REVISION OF THE TEXT
02/06/2014