Lipovisc
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Package leaflet: information for the user
Lipovisc 2 mg/g, ophthalmic gel
Carbomer
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen.
Contents of this leaflet:
- What Lipovisc is and what it is used for
- What you need to know before using Lipovisc
- How to use Lipovisc
- Possible side effects
- How to store Lipovisc
- Package contents and other information
1. What Lipovisc is and what it is used for
Lipovisc is a whitish, highly viscous gel containing a lubricant used as a substitute for natural tears. Normally, the eyes produce enough tear fluid to allow smooth and comfortable eye movement. If the eyes do not produce a sufficient amount of tears, they may become dry and red, causing discomfort and pain. Lipovisc may help prevent such discomfort.
Lipovisc is a highly viscous gel that forms a protective film over the eye, keeping its surface moist.
It is easy and convenient to use, and is particularly suitable for the symptomatic treatment of dry eye syndrome.
Consult your doctor if you do not feel better or if you feel worse.
2. What you need to know before using Lipovisc
Do not use Lipovisc:
if you are allergic to carbomer or to any of the other ingredients of this medicine (listed
in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Lipovisc 2 mg/g, ophthalmic gel.
Children and adolescents up to 18 years of age
In children and adolescents, the safety and efficacy of Lipovisc at the recommended dosage for adults have been established based on clinical experience, but clinical studies are not available.
Other medicines and Lipovisc
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you use Lipovisc together with other eye drops/eye ointments, there must be an interval of at least 15 minutes between the application of each other medication and Lipovisc; Lipovisc should always be applied last.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
Ask your doctor for advice before taking any medicine. You may be able to continue using it, but you might also need to use an alternative.
Contact lenses
To avoid formation of filaments or gel deposits on contact lenses, remove them before applying Lipovisc ophthalmic gel. They may be reinserted after 30 minutes.
Driving and using machines
As with any ophthalmic product, you may experience temporary blurred vision after application. Wait until your vision returns to normal before driving or using machinery.
- How to use Lipovisc Always use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The recommended dose is one drop of gel applied into the inner corner of the eye closest to the nose, 3 to 5 times daily and approximately 30 minutes before going to bed.
Follow these instructions carefully:
- Wash your hands thoroughly before use
- Remove the protective cap by twisting it
- Look upward and gently pull down the lower eyelid
- Hold the Lipovisc tube just above the eye and apply slight pressure until a small amount of gel flows between the eye and the lower eyelid
- Release the lower eyelid and move your eye while open to ensure even distribution of the gel over the eye
- Repeat the process for the other eye, if necessary.
Children and adolescents up to 18 years of age
In children and adolescents, the safety and efficacy of Lipovisc at the recommended dosage for adults have been established based on clinical experience, but clinical studies are not available.
If you use more Lipovisc than you should
If you have instilled an excessive amount of Lipovisc ophthalmic gel, rinse your eyes.
If you forget to use Lipovisc
Do not apply a double dose to make up for a forgotten dose.
If you stop using Lipovisc
Dry eye syndrome may worsen if treated incorrectly or inadequately.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
- Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. You may experience mild eye burning after application, with blurred vision. These effects will disappear within a few minutes. Cases of allergy (hypersensitivity) have been reported following use of Lipovisc (may affect up to 1 in 10,000 people), due to one of the components. Other rare side effects (may affect up to 1 in 10,000 people) include sticky eyelids, conjunctivitis (eye redness), appearance of spots (or dots) on the cornea (the surface of the eye), swollen eyes, burning, itching, and eye irritation. If any of these side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
- How to store Lipovisc
Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton and tube after “Expiry date”. The expiry date refers to the last day of that month.
- Store Lipovisc at a temperature not exceeding 25°C (room temperature).
- Lipovisc is sterile until first opening. It is important to keep the tube as clean as possible after opening.
- The tube is equipped with a flat cap allowing it to be stored in an upright position.
- Discard 28 days after first opening. It is advisable to write down the date of first opening.
- Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
- This medicine is for personal use only. Do not give it to others.
- Contents of the pack and other information
What Lipovisc contains
The active substance is carbomer. Each tube contains 2.0 mg of carbomer per gram of gel.
The other ingredients are cetrimide, sorbitol, medium-chain triglycerides, sodium hydroxide (for pH adjustment), and purified water.
Lipovisc contains the preservative cetrimide.
Description of the appearance of Lipovisc and contents of the pack
Lipovisc is a white, highly viscous gel.
Pack sizes:
5 g tube of gel. Packs containing 1 or 3 tubes of 5 g ophthalmic gel.
10 g tube of gel. Packs containing 1 or 3 tubes of 10 g ophthalmic gel.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Bausch & Lomb-IOM S.p.A.
Viale Martesana, 12
20090 Vimodrone (MI),
Italy
Manufacturer
Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH
Brunsbutteler Damm 165-173
Berlin
Germany
This medicine is authorized in the European Economic Area member states under the following names:
United Kingdom: Liposic Eye Gel
Belgium: Liposic
Greece: Liposic, Eye gel
Spain: Lipolac, gel oftalmico
France: Liposic, Gel ophtalmique
Ireland: Liposic Eye gel
Italy: Lipovisc
Portugal: Liposic
This leaflet was last updated on: