Liposic

1. Name Of The Medicinal Product

Liposic^®, eye gel

2. Qualitative And Quantitative Composition

Each 1g of gel contains 2mg of carbomer

For excipients see 6.1

3. Pharmaceutical Form

Eye gel; white, turbid, highly viscous, dripable

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic treatment of dry eye syndrome

4.2 Posology And Method Of Administration

Therapy of dry eye conditions requires an individual dosage regimen.

According to the severity and intensity of the symptoms, instill one drop into the conjunctival sac 3

Generally, an ophthalmologist should be consulted when treating keratoconjunctivitis sicca, which normally turns out to be long-term or permanent therapy.

An appropriate drop size is obtained when the tube is held in a vertical position above the eye during instillation.

4.3 Contraindications

Hypersensitivity to any component of this product

4.4 Special Warnings And Precautions For Use

Contact lenses should be removed prior to administration, and may be inserted again 30 minutes after Liposic has been instilled. Concomitant ocular medication should be administered 15 minutes prior to instillation of Liposic (see 4.5).

No specific studies with Liposic have been performed in children.

If the symptoms of the dry eye continue or worsen, treatment should be stopped and an ophthalmologist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

Please note:

Liposic may prolong the contact-time of topically applied drugs in ophthalmology. Concomitant ocular medication should be administered 15 minutes prior to instillation of Liposic.

4.6 Pregnancy And Lactation

Clinical data regarding the safety of Liposic in human pregnancy or lactation are not available. Preclinical data predict that the risk of Liposic use in human pregnancy or lactation is very low. But due to the lack of clinical data the use of Liposic during pregnancy or lactation can not be recommended.

4.7 Effects On Ability To Drive And Use Machines

Even when used as indicated, this medicinal product may impair visual acuity for about five minutes due to the formation of streaks after gel application, and patients should exercise caution when driving vehicles or operating machinery.

4.8 Undesirable Effects

Ocular irritation may occur in rare cases due to the preservative contained. Intolerance reactions to one of the ingredients may be seen in isolated cases. Observed undesirable effects include burning, reddening of the eyes, sticky eyelids, palpebral giant papillary conjunctivitis, corneal stipples, episcleritis, blurred vision, itching, discomfort

4.9 Overdose

Any ocular overdosage or oral intake which might occur is of no clinical relevance. However, care should be taken to administer small drops to the eye to avoid sticky eyelids.

5. Pharmacological Properties

ATC code S01XA20

5.1 Pharmacodynamic Properties

Liposic eye gel is based on a high molecular weight hydrophilic polymer. Its pH and osmolality are similar to those of the normal tear film. Due to its physical properties, the eye gel binds water and forms a translucent lubricating and wetting film on the surface of the eye. The gel structure is destroyed by the salts contained in the lacrimal fluid and releases moisture. A study in 54 patients with keratoconjunctivitis sicca found that Liposic therapy prolonged tear break-up time from a mean of 5.3 seconds to 11.2 seconds after 6 weeks. Schirmer I-test values were increased from a mean of 4.8 mm to 10.7 mm after 6 weeks.

5.2 Pharmacokinetic Properties

No controlled animal nor human pharmacokinetic studies with this product are available. However, absorption or accumulation in eye tissues can presumably be excluded due to the high molecular weight of carbomer. Clinical studies performed with an essentially similar product have shown that ocular residence time can be assumed to be approximately up to 90 minutes.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity and pharmacological safety.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Cetrimide, sorbitol, medium-chain triglycerides, sodium hydroxide (for pH adjustment), purified water

6.2 Incompatibilities

None known so far.

6.3 Shelf Life

3 years

28 days after opening of the container

6.4 Special Precautions For Storage

Do not store above 25ºC

6.5 Nature And Contents Of Container

Tubes of 5 g eye gel. Packs with one or three tubes of 5 g eye gel.

Tubes of 10 g eye gel. Packs with one or three tubes of 10 g eye gel.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Dr. Gerhard Mann

Chem.-Pharm. Fabrik GmbH

Brunsbuetteler Damm 165-173

13581 Berlin (Germany)

8. Marketing Authorisation Number(S)

PL 13757/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

21 March 2000

10. Date Of Revision Of The Text

26 October 2001

11. Legal Category

P