Summary of medicine characteristics - LIQUIVISC TM 2.5 MG / G EYE GEL
1 NAME OF THE MEDICINAL PRODUCT
LIQUIVISCTM 2.5 mg/g, eye gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbomer 974P 2.5 mg/g.
Excipient with known effect: benzalkonium chloride (0.06 mg/g).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye gel
Slightly yellow and opalescent gel.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic treatment of dry eye syndrome.
4.2 Posology and method of administration
Ocular use.
Adults (including the elderly):
Instil one drop of the gel into the inferior conjunctival cul-de-sac 1 to 4 times daily according to the degree of ocular trouble.
Children and adolescents aged to 18 years:
The safety and efficacy of LIQUIVISC 2.5 mg/g eye gel in children and adolescents at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available.
After instillation, the bottle should be stored vertically with the dropper downwards to facilitate the formation of drops when next used.
Do not touch the eye with the dropper tip. Replace the cap after use.
4.3 Contraindications
Hypersensitivity to any of the components of the product.
4.4 Special warnings and precautions for use
This medicine contains 0.0015 mg benzalkonium chloride in each drop.
Benzalkonium chloride is commonly used as a preservative in ophthalmic products and has been reported rarely to cause punctate keratopathy and/or ulcerative keratopathy.
Benzalkonium chloride has also 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.
Contact lenses:
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Patients should be advised to remove contact lenses before using this medicinal product and to wait at least 30 minutes before reinsertion.
4.5 Interaction with other medicinal products and other forms of interaction
In case of concomitant use with other eye drops, wait for 15 minutes between instillations.
LIQUIVISC™ 2.5 mg/g, eye gel should be the last medication instilled.
4.6 Pregnancy and lactation
LIQUIVISC™ 2.5 mg/g, eye gel was not studied in pregnant and breastfeeding women.
Caution should be exercised when prescribing to pregnant or breast-feeding women.
4.7 Effects on ability to drive and use machines
Vision may be blurred for a few minutes after the instillation.
If affected, the patient should be advised not to drive or operate hazardous machinery until normal vision is restored.
4.8 Undesirable effects
As for other eye drops, possibility of mild transient stinging or burning upon instillation.
Blurred vision may occur briefly after instillation until the gel is evenly distributed over the eye surface.
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.
Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
4.9 OverdoseAny ocular overdose or oral intake that could occur is of no clinical relevance.
5.1
TEAR SUBSTITUTE
(S : Sensory organ (eye))
Fluid eye gel based on a high molecular weight hydrophilic polymer (carbomer 974P).
Due to its physical properties, this gel forms a transparent lubricating and wetting film on the surface of the eye, temporarily compensating for tear insufficiency.
Its pH (7.3) and osmolality are similar to those of the normal tear film.
Its viscosity (700mPas) is greater than that of artificial tears, allowing less frequent administration.
5.2 Pharmacokinetic properties
Because of the relatively large size of the carbomer molecule, penetration through the cornea is unlikely.
The persistence time of the gel on the eye surface is about 30 minutes.
5.3 Preclinical safety data
5.3 Preclinical safety dataData from subacute toxicity and local tolerance studies do not show any relevant findings.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzalkonium chloride, sorbitol, lysine monohydrate, sodium acetate trihydrate, polyvinyl alcohol, water for injections.
6.2 Incompatibilities
Not applicable
6.3 Shelf life
Shelf life prior to opening 30 months
In-use shelf life
4 weeks
6.4 Special precautions for storage
Do not store above 25°C. Store container in the outer carton, in order to protect from light.
6.5 Nature and contents of container
10g in 10ml bottle (PE) with dropper (PE).
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.
7 MARKETING AUTHORISATION HOLDER
LABORATOIRES THEA
12 RUE LOUIS-BLERIOT
Z.I. DU BREZET
63017 CLERMONT-FERRAND CEDEX 2
FRANCE