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LIQUIVISC TM 2.5MG/G EYE GEL

Active substance(s): CARBOMER / CARBOMER / CARBOMER

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SUMMARY OF PRODUCT CHARACTERISTICS

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: 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
Benzalkonium chloride is commonly used as a preservative in ophthalmic
products and has been reported rarely to cause punctate keratopathy and/or
ulcerative keratopathy.
Contact Lenses:
Benzalkonium chloride may be absorbed by and discolour contact lenses and
therefore the patients should be instructed to wait until 30 minutes after
instillation of LIQUIVISC™ 2.5 mg/g, eye gel before inserting contact lenses.
If symptoms continue or worsen, the patient should be reviewed by a
physician.

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
Any ocular overdose or oral intake that could occur is of no clinical relevance.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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.

-

5.2

Its viscosity (700mPas) is greater than that of artificial tears, allowing less
frequent administration.

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
Data 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
No special requirements.

7

MARKETING AUTHORISATION HOLDER
LABORATOIRES THEA
12 RUE LOUIS-BLERIOT
Z.I. DU BREZET
63017 CLERMONT-FERRAND CEDEX 2
FRANCE

8

MARKETING AUTHORISATION NUMBER(S)
PL 20162/0009

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/06/2008

10

DATE OF REVISION OF THE TEXT
29/05/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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