VISC OPHTAL

VISC OPHTAL eye gel

Important notes (mandatory information)

Visc-Ophtal, eye gel. Active ingredient: 1 g of eye gel contains 2 mg of carbomer. Areas of application: as a substitute for tear fluid in the event of impaired tear production and for the symptomatic treatment of dry eyes.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Visc-Ophtal, eye gel
Active ingredient: 1 g of eye gel contains 2 mg of carbomer.

Please read the entire package leaflet carefully, as it contains important information for you. This medicine is available without a prescription. However, Visc-Ophtal must be used as directed in order to achieve the best possible treatment results.

• Please keep the package leaflet. You may want to read it again later.
• Ask your doctor or pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, be sure to see a doctor.
• If any of the side effects listed here affect you significantly or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This package leaflet contains

1. WHAT IS VISC-OPHTAL AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE USING VISC-OPHTAL?
3. HOW TO USE VISC-OPHTAL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE VISC-OPHTAL?
6. FURTHER INFORMATION

1. WHAT IS VISC-OPHTAL AND WHAT IS IT USED FOR?

Visc-Ophtal is a tear substitute. It is used as a substitute for tear fluid in the event of impaired tear production and for the symptomatic treatment of dry eyes.

2. WHAT YOU NEED TO KNOW BEFORE USING VISC-OPHTAL?

Visc-Ophtal must not be used if you are hypersensitive to any of the ingredients. Special care must be taken when using Visc-Ophtal if you wear contact lenses. Contact lenses should be removed before use. They can be reinserted 15 minutes after instilling Visc-Ophtal. No specific interactions have been reported to date when using Visc-Ophtal with other medicines.

Note

However, if you are also using other eye drops/eye ointments, there should be a time interval of about 5 minutes between their use and Visc-Ophtal should always be used last. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before using any medicine. Although no studies have been conducted on pregnant patients with Visc-Ophtal, there are no suspicions that would argue against its use during pregnancy and breastfeeding, especially since carbomer is absorbed only to a very small extent (< 2% from the gastrointestinal tract) and is therefore practically unavailable to the body. In general, medicines should only be used during pregnancy and breastfeeding after careful consideration of the benefits and risks by the doctor.

Driving and operating machinery

After instilling Visc-Ophtal into the conjunctival sac of the eye, visual acuity may be impaired for a few minutes. This is because a relatively large amount of fluid is present on the eye after instillation, which can lead to blurred vision. Due to the impairment of visual acuity, we recommend that you do not work without a secure hold, operate machinery or participate in road traffic for a few minutes after instilling Visc-Ophtal.

3. HOW TO USE VISC-OPHTAL?

Always use Visc-Ophtal exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure. Please follow the instructions for use, otherwise Visc-Ophtal will not work properly.

Dosage

The treatment of dry eyes requires individual dosing. Depending on the severity and intensity of the symptoms, instill 1 drop into the conjunctival sac 3 to 5 times a day or more often and 1 drop before going to bed.

Note

To avoid contamination of the dropper tip and eye gel, neither the eyelid nor the eye area or other surfaces should come into contact with the dropper tip.

Type of application

For use on the eye.

Duration of use

An ophthalmologist should be consulted for the treatment of dry eyes, which is usually a long-term or permanent therapy. Visc-Ophtal is suitable for long-term therapy. Please talk to your doctor or pharmacist if you have the impression that the effect of Visc-Ophtal is too strong or too weak.

If you have used more Visc-Ophtal than you should

No specific overdose reactions are known and are not to be expected with this type of application.

If you forget to use Visc-Ophtal

Do not use a double dose. Continue therapy with the same dosage at the next scheduled time. If necessary, you can also use Visc-Ophtal between two scheduled times.

If you stop using Visc-Ophtal

You must expect that the typical symptoms of dry eyes will soon reappear. Do not discontinue treatment with Visc-Ophtal without consulting your doctor.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Visc-Ophtal can have side effects, although not everybody gets them. In individual cases, an intolerance reaction to one of the ingredients may occur. Visc-Ophtal contains the preservative cetrimide, which can cause eye irritation (burning, redness, foreign body sensation), especially with more frequent use, and can damage the corneal epithelium. If you notice such an intolerance, you should prefer a preparation without preservatives. In the case of known intolerances to preservatives, we also recommend using an unpreserved preparation.

Note

If you experience any side effects, please tell your doctor or pharmacist.

5. HOW TO STORE VISC-OPHTAL?

Keep out of reach of children! Do not use the medicine after the expiry date (see folding box and tube fold).

Note on shelf life after opening

The eye gel must not be used for more than 6 weeks after opening.

Storage conditions

This medicine does not require any special storage conditions.

6. FURTHER INFORMATION

What Visc-Ophtal contains

The active ingredient is: Carbomer (viscosity 40,000-60,000 mPa·s) in a concentration of 2.0 mg/g eye gel. The other ingredients are: Cetrimide; sorbitol (Ph.Eur.), sodium hydroxide (for pH adjustment), water for injections.

What Visc-Ophtal looks like and contents of the pack

Visc-Ophtal is a clear, colourless eye gel.
Pack of tubes with 10 g or 3 x 10 g eye gel.

Properties and instructions for use

Visc-Ophtal is a droppable eye gel and is therefore easy and convenient to use. Please hold the tube upright when dropping. This creates a small drop that easily detaches from the tip of the tube. Due to its high viscosity, Visc-Ophtal is particularly suitable for treating even severe symptoms of dry eyes. It forms a protective film with high adhesion and long-lasting effect and moistens the cornea and conjunctiva for a long time, so that in severe cases only relatively few applications (on average 3 - 5/day) are sufficient to relieve the symptoms and improve the condition. Visc-Ophtal is very well tolerated and has a refreshing, cooling effect. It can also be used more frequently, depending on the need.

Please note the following handling instructions

A pleasant and therapeutic drop size is achieved when the tube is held vertically over the eye when dropping (see also the direction of the arrow under the tube fold). To use Visc-Ophtal, gently pull the eyelid down and look up.

Pharmaceutical entrepreneur

Dr. Winzer Pharma GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Phone 030 - 33093 - 5070
Fax 030 - 33 093 - 305
e-mail: service@drwinzer.de

This leaflet was last revised in June 2007.

Source: Information from the package leaflet
Status: 02/2016
Active ingredient: 1 g of eye gel contains 2 mg of carbomer. Areas of application: as a substitute for tear fluid in the event of impaired tear production and for the symptomatic treatment of dry eyes.