SICCA STULLN eye drops

Important information (mandatory information):

Sicca-Stulln eye drops. Active ingredient: Hypromellose. Areas of use: For the symptomatic treatment of dry eyes (drying symptoms of the cornea and conjunctiva due to tear secretion and tear function disorders as a result of local or systemic diseases as well as insufficient or incomplete eyelid closure).

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Sicca-Stulln eye drops, 1 ml eye drops contains 3.0 mg hypromellose (2% solution: 3500 - 5600 mPa.s at +20°C)
Active ingredient: Hypromellose

Please read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment success, Sicca-Stulln must be used as directed.

• Please keep this leaflet. You may want to read it again later.
• If you need any further information or advice, ask your doctor or pharmacist.
• If your symptoms worsen or do not improve, please consult a doctor.
• If any of the side effects listed gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

This leaflet contains:

1. WHAT IS SICCA&ndash%%%STULLN AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING SICCA&ndash%%%STULLN?
3. HOW TO USE SICCA&ndash%%%STULLN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SICCA&ndash%%%STULLN BE STORED?
6. MORE INFORMATION

1. WHAT IS SICCA-STULLN AND WHAT IS IT USED FOR?

Sicca-Stulln is a tear substitute, artificial tear fluid.

Areas of application:
For the symptomatic treatment of dry eyes (drying of the cornea and conjunctiva due to tear secretion and tear function disorders as a result of local or systemic diseases, as well as insufficient or incomplete eyelid closure).

2. WHAT MUST YOU CONSIDER BEFORE USING SICCA-STULLN?

Sicca-Stulln must not be used if you are hypersensitive to any of the ingredients. Particular caution is required when using Sicca-Stulln, as this medicine, even when used as intended, temporarily affects vision and thus reaction time by causing streaking. During this time, you should not drive, work without a secure footing, or operate machinery.

Important information about certain other ingredients of Sicca-Stulln:
Benzalkonium chloride can cause eye irritation. Avoid contact with soft contact lenses. Benzalkonium chloride can cause discoloration of soft contact lenses. Contact lenses must be removed before use and must not be reinserted until at least 15 minutes after use.

When using Sicca-Stulln with other medicines:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including non-prescription medicines. If other eye drops/eye ointments are used in addition, the effect of the previous medicine may be impaired, as it may be diluted or displaced from the conjunctival sac by the introduction of the subsequent medicine. For this reason, an interval of around 15 minutes should be observed between the applications of the various preparations. Sicca-Stulln should always be used last, as it is important that the eye drops remain in the eye for as long as possible and thus have a long moisturizing effect. There is an intolerance to phenols, tannins, oxidizing agents (particularly in alkaline environments) and ammonium bituminosulfonate.

Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before using any medicine. There are no concerns about using it during pregnancy and breast-feeding, as hypromellose is not absorbed and is therefore not available systemically.

Driving and using machines:
You must not drive a vehicle or operate any tools or machines, because this medicine, even when used as intended, temporarily affects your vision and thus your ability to react by causing streaks.

3. HOW TO USE SICCA-STULLN?

Always use Sicca-Stulln exactly as directed in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is 1 drop into the conjunctival sac 3 to 5 times a day up to every hour, depending on individual requirements. Treatment of dry eyes requires individual dosing. When using to treat dry eyes, which is usually long-term or continuous therapy, an ophthalmologist should always be consulted.

Method of use Eye drops:
Please talk to your doctor or pharmacist if you have the impression that the effect of Sicca-Stulln is too strong or too weak.

Instructions for use:
Opening the bottle: The bottle is sealed with a safety ring. Open the bottle by turning the cap to the right.
Instilling the eye drops: Bend your head slightly backwards, look up and pull the lower eyelid of your eye slightly downwards with your index finger. With your other hand, hold the dropper bottle vertically with the opening facing downwards over your eye (without touching the eye with the dropper tip). Gently squeeze the dropper bottle until a drop forms, which is then dripped into the pulled-down conjunctival sac. Close your eye slowly and move it back and forth so that the liquid can be distributed well.

Duration of use
The product is usually used as long-term or continuous therapy.

Note:
An ophthalmologist should always be consulted for long-term or continuous use to treat dry eyes.

If you forget to use Sicca-Stulln:
Do not use a double dose if you have forgotten to use the previous dose.

If you stop using Sicca-Stulln:
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, Sicca-Stulln can cause side effects, although not everybody gets them. The following frequency information is used to assess side effects:

The following categories are used to indicate the frequency of side effects:
Very common:	more than 1 in 10 patients
Frequently:	1 to 10 treated patients out of 100
Occasionally:	1 to 10 patients treated in 1,000
Rarely:	1 to 10 treated patients out of 10,000
Very rare:	less than 1 in 10,000 patients
Not known:	Frequency cannot be estimated based on the available data.

Possible side effects:
In rare cases, hypersensitivity reactions in the eye can occur when using Sicca-Stulln. Ophthalmic drugs often contain preservatives that can lead to taste irritations or sensitization. If such hypersensitivity reactions or irritations in the eye occur, please interrupt treatment and consult your doctor. Patients who are particularly sensitive to preservatives are recommended to switch to preparations without preservatives. Please inform your doctor or pharmacist if any of the side effects listed affect you seriously, or if you notice side effects that are not listed in this leaflet. If you notice any side effects that are not listed in this leaflet, please inform your doctor or pharmacist.

Reporting suspected side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW SHOULD SICCA-STULLN BE STORED?

Keep medicines out of the reach of children! Do not use this medicine after the expiry date which is stated on the label and carton after “Use by”. The expiry date refers to the last day of that month.

Storage conditions:
Do not store above 25°C. Keep container in the outer carton to protect the contents from light.

Note on shelf life after opening:
The eye drops must not be used for longer than 4 weeks after opening.

6. FURTHER INFORMATION:

What Sicca-Stulln contains:
The active ingredient is: 1 ml of solution contains hypromellose 3.0 mg (2% solution: 3500 - 5600 mPa.s at +20°C). The viscosity of the solution is between 6 and 8 mPa.s. The other ingredients are: benzalkonium chloride, boric acid, sodium tetraborate 10 H20, sodium chloride, potassium chloride, water for injections.

What Sicca-Stulln looks like and contents of the pack:
Eye drops in LDPE dropper bottles. Packs of 10 ml and 3 x 10 ml solution.

Pharmaceutical company:
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln


This leaflet was last revised in February 2014.

Source: Information in the package leaflet
as of: 05/2016

Active ingredient: Hypromellose. Indications: For the symptomatic treatment of dry eyes (drying of the cornea and conjunctiva due to tear secretion and tear function disorders as a result of local or systemic diseases as well as insufficient or incomplete eyelid closure).