SIC OPHTAL

SIC OPHTAL N eye drops

Important notes (mandatory information)

Sic-Ophtal N, eye drops. Active ingredient: 1 ml of eye drops contains 3.20 mg of hypromellose. Areas of application: for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva due to impaired secretion and function of tears as a result of local or systemic diseases as well as in the case of insufficient or incomplete eyelid closure.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Sic-Ophtal N, eye drops
Active ingredient: 1 ml of eye drops contains 3.20 mg of hypromellose.

Please read all of this leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Sic-Ophtal N must be used as directed in order to be as effective as possible.

• Keep this 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, see a doctor in any case.
• If any of the side effects listed here affect you severely or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This leaflet contains

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

1. WHAT IS SIC-OPHTAL N AND WHAT IS IT USED FOR?

Sic-Ophtal N is a film former, tear substitute.
Sic-Ophtal N is used for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva due to impaired secretion and function of tears as a result of local or systemic diseases as well as in the case of insufficient or incomplete eyelid closure.

2. WHAT DO YOU NEED TO KNOW BEFORE USING SIC-OPHTAL N?

When should Sic-Ophtal N not be used?
Sic-Ophtal N must not be used if you are hypersensitive to any of the ingredients.

Special care is required when using Sic-Ophtal N

The preservative cetrimide contained in Sic-Ophtal N can cause irritation of the eye (burning, redness, foreign body sensation), especially with more frequent and prolonged use, and can damage the corneal epithelium. If you notice such irritation, you should use a preparation without preservatives. Wearers of soft contact lenses should remove them from the eye before using Sic-Ophtal N and only reinsert them about 15 minutes after application. Hard contact lenses can remain in the eye during the use of Sic-Ophtal N.

When using Sic-Ophtal N with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you are also using other eye drops/eye ointments, there should be an interval of about 10-15 minutes between applications, and Sic-Ophtal N should always be used last.

Pregnancy and breast-feeding

No special studies have been conducted with Sic-Ophtal N on pregnant patients. However, Sic-Ophtal N should only be used during pregnancy and breast-feeding after careful consideration of the benefits and risks by the doctor. There are no concerns about use during pregnancy and breast-feeding, as hypromellose is not absorbed and is therefore not systemically available.
Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

After instilling Sic-Ophtal N 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 and do not participate in road traffic for a few minutes after instilling Sic-Ophtal N.

3. HOW TO USE SIC-OPHTAL N?

Always use Sic-Ophtal N exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure.

How often should you use Sic-Ophtal N?
Unless otherwise prescribed, instill 1 drop into the conjunctival sac 3 to 5 times a day or more often as needed. The therapy of dry eye requires individual dosing. If you have used a larger amount of Sic-Ophtal N than you should have, this is not associated with any known risk. The therapeutic effect is not improved or worsened. Do not take a double dose if you have forgotten to take the previous dose.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Eye disorders

Hypersensitivity and intolerance reactions, e.g. burning, pain, increased tearing, foreign body sensation, conjunctival redness, eyelid swelling, itching.

Immune system

Skin rash, itching.

If you experience any side effects when using Sic-Ophtal N, please tell your doctor or pharmacist.

5. HOW TO STORE SIC-OPHTAL N?

The medicine must not be used after the expiry date (see folding box and label). The eye drops must not be used for more than 6 weeks after opening. Do not store above 30°C.

6. FURTHER INFORMATION

What does Sic-Ophtal N contain?
Active ingredient: 1 ml of eye drops contains 3.20 mg of hypromellose. The other ingredients are: cetrimide; sodium monohydrogen phosphate dodecahydrate (Ph.Eur.); sodium dihydrogen phosphate dihydrate; sodium edetate (Ph.Eur.); sorbitol (Ph.Eur.); water for injections.

What does Sic-Ophtal N look like and what do the packs contain?
Pack of 10 ml eye drops. Pack of 3 x 10 ml eye drops.

Please note!

Instructions for use

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 dropper bottle over the eye (without touching the eye) and now put a drop into the pulled down conjunctival sac. Close the eye slowly and move it back and forth so that the liquid is distributed well.

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 December 2014.

Active ingredient: 1 ml of eye drops contains 3.20 mg of hypromellose. Areas of application: for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva due to impaired secretion and function of tears as a result of local or systemic diseases as well as in the case of insufficient or incomplete eyelid closure.