SICCAPROTECT

SICCAPROTECT eye drops

Important notes (mandatory information)

Siccaprotect eye drops. Areas of application: for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva due to tear secretion disorders caused by local or systemic (affecting the entire body) underlying diseases as well as in the case of insufficient eyelid closure and for rewetting hard contact lenses while wearing them.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Siccaprotect eye drops
Active ingredients: dexpanthenol 30 mg/ml and polyvinyl alcohol 14 mg/ml

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after a few days, contact your doctor.

What this package leaflet contains

1. WHAT IS SICCAPROTECT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING SICCAPROTECT?
3. HOW TO USE SICCAPROTECT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE SICCAPROTECT?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS SICCAPROTECT AND WHAT IS IT USED FOR?

Siccaprotect is a tear substitute for local application to the eye. Siccaprotect is used for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva due to tear secretion disorders caused by local or systemic (affecting the entire body) underlying diseases as well as in the case of insufficient eyelid closure and for rewetting hard contact lenses while wearing them.

2. WHAT SHOULD YOU CONSIDER BEFORE USING SICCAPROTECT?

Siccaprotect must not be used:

• if you are allergic to dexpanthenol, polyvinyl alcohol or any of the other ingredients of this medicine listed in section 6.
• while wearing soft (hydrophilic) contact lenses.

Using Siccaprotect with other medicines

No interactions are known. Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines, even if they are non-prescription medicines. Note: If you are also using other eye drops or eye ointments, you should allow a time interval of 15 minutes between the applications of the individual preparations. You should always use eye ointments last.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery

You must not drive a vehicle immediately after using Siccaprotect, because this medicine, even when used as intended, temporarily and briefly affects visual acuity and thus the ability to react in road traffic. You must then also temporarily not operate tools or machines.

Important information about certain other ingredients of Siccaprotect

Benzalkonium chloride can cause irritation to the eye. Avoid contact with soft contact lenses. Benzalkonium chloride can cause soft contact lenses to discolour. You must remove contact lenses before use and may not reinsert them for at least 15 minutes after use.

3. HOW TO USE SICCAPROTECT?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the recommended dose is to instill one drop into the conjunctival sac up to 6 times a day. Spread the applications of Siccaprotect evenly throughout the day. The exact duration of treatment depends on the individual clinical picture and is determined by the doctor. In general, treatment with tear substitutes such as Siccaprotect is a long-term therapy. Eye drops should always be used in such a way that contact between the dropper tip and the eye or facial skin is avoided. Unscrew the protective cap, tilt your head back slightly, pull the lower eyelid away from the eye a little and apply a drop to the conjunctival sac by gently pressing the bottle. Slowly close your eyelids. The bottle should be carefully closed again after use. Please talk to your doctor or pharmacist if you have the impression that the effect of Siccaprotect is too strong or too weak.

Use in children and adolescents

Use in children and adolescents has not yet been studied.

If you have used more Siccaprotect than you should

No special measures are necessary. Continue your treatment at the usual dose.

If you forget to use Siccaprotect

Do not use double the amount to make up for the missed application, but catch up on the application as soon as possible, and then continue dosing with the same amount and at the same time interval/rhythm as specified above or prescribed by your doctor.

If you stop using Siccaprotect

Consult your doctor or pharmacist.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Eye disorders:

• Rare (in one to 10,000 people treated): Hypersensitivity reactions, e.g. burning, pain, increased tearing.
• In very rare cases, patients with pronounced corneal defects developed corneal opacities due to the formation of calcium phosphate during therapy with phosphate-containing eye drops.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of 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 TO STORE SICCAPROTECT?

Do not store above 25°C. Store the bottle in the outer carton in order to protect the contents from light. Keep this medicine out of the reach of children. You must not use the medicine after the expiry date which is stated on the label. The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment. Note on shelf life after opening: You may only use Siccaprotect for 6 weeks after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Siccaprotect contains

The active ingredients are dexpanthenol 30 mg/ml and polyvinyl alcohol 14 mg/ml. The other ingredients are benzalkonium chloride (preservative), potassium hydrogen phosphate, potassium monohydrogen phosphate, purified water.

What Siccaprotect looks like and contents of the pack

Siccaprotect are clear, colourless eye drops, which are filled in 10 ml plastic bottles. Each pack contains either 1 or 3 plastic bottles, each with a screw cap.

General information for the patient

In severe cases and in the case of persistent local irritation, especially in wearers of hard contact lenses, regular ophthalmological check-ups are necessary.

Properties

The active ingredient dexpanthenol contained in Siccaprotect belongs to the group of B vitamins. It has a key function in cell metabolism and is an indispensable component of healthy tissue. Dexpanthenol has an anti-inflammatory, antipruritic and regenerating effect on the cornea and conjunctiva of the eye, so that irritation caused by insufficient tear flow and its complications heal quickly and are prevented by permanent use of Siccaprotect. In addition, dexpanthenol is able to bind water and thus achieve a moisturising effect. Especially in the elderly, the daily requirement for dexpanthenol cannot always be met through diet due to changed eating habits. The polyvinyl alcohol contained in Siccaprotect increases the viscosity (viscosity) of the eye drops and thus enables a long-lasting protective film. Siccaprotect largely corresponds to the physiological tear film in pH value and viscosity. The natural regeneration of the cells of the cornea is not delayed and the vision is not impaired.

Pharmaceutical entrepreneur and manufacturer

Ursapharm
Industriestraße
D-66129 Saarbrücken
Tel.: 06805/92 92-0,
Fax: 06805/92 92-88
E-mail: info@ursapharm.de

This package leaflet was last revised in March 2014.

Source: Information from the package leaflet
Status: 04/2018
Areas of application: for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva due to tear secretion disorders caused by local or systemic (affecting the entire body) underlying diseases as well as in the case of insufficient eyelid closure and for rewetting hard contact lenses while wearing them.