PAN OPHTAL

PAN OPHTAL Gel

Important notes (mandatory information)

Pan-Ophtal Gel, eye gel. Active ingredient: 1 g eye gel contains 50 mg dexpanthenol.

Indications

Treatment of non-inflammatory corneal diseases of the eye (keratopathies), e.g. corneal dystrophies (nutritional disorders), corneal degenerations (regressions), recurrent corneal erosions (exfoliations) and corneal lesions (injuries) in contact lens wearers. Additional medication to support the healing process in case of corneal and conjunctival damage, chemical burns and burns. Additional medication to a specific therapy of infectious corneal processes of bacterial, viral or mycogenic (caused by fungi) origin.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Pan-Ophtal Gel, eye gel
Active ingredient: 1 g eye gel contains 50 mg dexpanthenol.

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

• 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 occur to a significant extent or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet contains

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

1. WHAT IS PAN-OPHTAL GEL AND WHAT IS IT USED FOR?

Pan-Ophtal Gel is a wound healing agent.

Indications

Treatment of non-inflammatory corneal diseases of the eye (keratopathies), e.g. corneal dystrophies (nutritional disorders), corneal degenerations (regressions), recurrent corneal erosions (exfoliations) and corneal lesions (injuries) in contact lens wearers. Additional medication to support the healing process in case of corneal and conjunctival damage, chemical burns and burns. Additional medication to a specific therapy of infectious corneal processes of bacterial, viral or mycogenic (caused by fungi) origin.

Note

Pan-Ophtal Gel is not suitable for healing infectious corneal processes of bacterial, viral or mycotic origin, but only as an additional medication to a specific therapy of these corneal diseases.

2. WHAT YOU NEED TO KNOW BEFORE USING PAN-OPHTAL GEL

Contraindications

When should you not use Pan-Ophtal Gel?
You should not use Pan-Ophtal Gel if you are known to be hypersensitive to any of the ingredients.

Precautions for use and

Warnings

What should contact lens wearers consider when using Pan-Ophtal Gel?
As a contact lens wearer, you should not use Pan-Ophtal Gel while wearing the lenses, as this could smear the contact lens and lead to incompatibilities with the lens material.

What do you need to consider in road traffic and when working with machinery and when working without a secure hold?
Since this medicine, even when used as intended, temporarily affects vision and thus reaction time due to the formation of streaks, you should not participate in road traffic, work without a secure hold or operate machinery during this time.

Interactions with other medicines or other agents, insofar as they can affect the effect of the medicine

Which other medicines are affected in their effect by Pan-Ophtal Gel or in turn affect the effect of Pan-Ophtal Gel?
No specific interactions with other agents are known, but if additional treatment with other eye drops/eye ointments is necessary, there should be a period of at least 15 minutes between the application of the different medications. In any case, you should administer Pan-Ophtal Gel last.

Warnings

None known.

Pregnancy and breastfeeding

During pregnancy and breastfeeding, the benefit of use must be carefully weighed against any possible risk by a doctor. Ask your doctor or pharmacist for advice before using any medicine.

3. HOW TO USE PAN-OPHTAL GEL

Dosage, type and duration of use

How and for how long should you use Pan-Ophtal Gel?
Depending on the severity and extent of the disease, instill one drop into the conjunctival sac 4 times a day and before bedtime. The duration of use is not limited. The application should be continued until the symptoms subjectively improve.

Application errors and overdose

What should you do if Pan-Ophtal Gel has been used in excessive amounts (accidental or intentional overdose)?
Overdosing with Pan-Ophtal Gel is not associated with any known risks. The therapeutic effect is not improved or worsened.

What should you do if you have used too little Pan-Ophtal Gel or have missed an application?
In this case, do not double the dose the next time, but make up for the application as soon as possible, and then continue dosing with the same amount and at the same time interval/rhythm as indicated above or as prescribed by your doctor.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

What side effects can occur when using Pan-Ophtal Gel?
Eye disorders: Eye irritation, e.g. redness, pain, foreign body sensation, increased tearing, itching, conjunctival swelling.
Immune system: Very rare (less than 1 in 10,000 treated): Hypersensitivity reactions (e.g. itching, rash)
If you experience any side effects when using Pan-Ophtal Gel, please tell your doctor or pharmacist.

5. HOW TO STORE PAN-OPHTAL GEL

The medicine must not be used after the expiry date (see folding box and tube fold). Pan-Ophtal Gel must not be used for more than 6 weeks after opening. Do not store above +25°C!

6. FURTHER INFORMATION

What does Pan-Ophtal Gel contain?
Active ingredient: 1 g eye gel contains 50 mg dexpanthenol. The other ingredients are: Cetrimide; Carbomer (viscosity 40,000-60,000 mPa·s); Sodium edetate (Ph.Eur.); Sodium hydroxide (for pH adjustment); Water for injections.

Dosage form and contents

Packs of 10 g and 3 x 10 g eye gel in tubes.

Handling instructions

Pan-Ophtal Gel is highly viscous to improve the gliding ability of the eyelids. This relieves the symptoms of corneal and conjunctival lesions and thus promotes healing. Pan-Ophtal Gel is manufactured sterile and is subject to strict quality criteria. Therefore, when handling the tubes, please note that you do not touch the tip of the tube with your fingers and that the tip of the tube does not come into contact with the eyes. Please close the tube again with the protective cap after use.

Dropping instructions

Tilt your head back. With the index finger of one hand, pull the lower eyelid of the eye down, with the other hand hold the tube vertically above the eye (without touching the eye) and now drop one drop into the pulled down conjunctival sac. Try to keep the eye open and move it so that the liquid is distributed well. A pleasant and therapeutic drop size is achieved when the tube is held vertically above the eye when dropping - see also the direction of the arrow under the tube fold.

Note

The screw cap is also suitable as a stand and allows you to place the tube vertically. This way you can always apply Pan-Ophtal® Gel quickly and easily.

Pharmaceutical entrepreneur and manufacturer

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 package leaflet was last revised in January 2011.

Source: Information from the package leaflet
Status: 02/2016
Active ingredient: 1 g eye gel contains 50 mg dexpanthenol. Indications: Treatment of non-inflammatory corneal diseases of the eye (keratopathies), e.g. corneal dystrophies (nutritional disorders), corneal degenerations (regressions), recurrent corneal erosions (exfoliations) and corneal lesions (injuries) in contact lens wearers. Additional medication to support the healing process in case of corneal and conjunctival damage, chemical burns and burns. Additional medication to a specific therapy of infectious corneal processes of bacterial, viral or mycogenic (caused by fungi) origin.