BLEPHADEMODEX

BLEPHADEMODEX sterile cleansing wipes

Product features

Blephademodex sterile cleaning wipes
For daily eyelid cleaning in case of Demodex blepharitis

This product is a medical device. Please read the instructions for use carefully before use. Keep this leaflet. You may want to read it again.

Indications

Blephademodex are sterile wipes soaked in a lotion for daily eyelid hygiene in case of Demodex infestation. For use on the skin only, avoid direct contact with the eyes.

Suitable for

Adults only.

Contraindications:

• Do not use if you are allergic to any of the ingredients of Blephademodex (see product description).
• Due to insufficient data, do not use Blephademodex if you are pregnant or breastfeeding unless your doctor advises you to do so.
• Due to insufficient data, Blephademodex should not be used in children unless your doctor advises you to do so.

Product description

Blephademodex are sterile wipes soaked in a lotion. The lotion contains: PEG-8, Polysorbate 80, Poloxamer 184, Terpinen-4-ol, PEG-6-glycerol caprylocaprat (i.e. Macrogol-6-glycerol caprylocaprat), Sodium hyaluronate, Dipotassium phosphate, Potassium dihydrogen phosphate, Purified water. Blephademodex is free of aggressive detergents and free of preservatives. Blephademodex has a fresh scent due to its natural ingredients, which disappears a few minutes after application. The colour of the wipes may vary. This is normal and due to natural plant extracts (Terpinen-4-ol, a purified tea tree oil extract).

Benefits, performance and mode of action

Blephademodex is recommended:

• For daily eyelid cleaning in case of Demodex infestation.
• For symptom relief in case of eyelid infections or inflammations (blepharitis) caused by Demodex infestation.

Demodex is the most common microscopic skin parasite, which, however, can lead to irritations such as itching, burning, inflamed eyelids, redness of the eyelid margins and a foreign body sensation if it occurs more frequently. Cylindrical scales at the base of the eyelashes are strong indications of a Demodex infestation. Demodex are not removed by the usual daily cleaning products and require special treatment. Blephademodex removes crusts, scales, impurities and infectious agents on the eyelids and eyelashes. Blephademodex relieves the symptoms of a Demodex infestation, such as itching, burning, dryness and inflammation of the eyelid margins. The redness of the eyelid margins and the foreign body sensation are reduced by the application. Blephademodex contains sodium hyaluronate, a natural skin moisturiser that soothes and regenerates sensitive skin. Blephademodex is well tolerated. The product has been tested under ophthalmological control.

General instructions for use

Dosage:

• Mild to moderate symptoms: Apply once a day for 4 weeks, preferably in the evening.
• Moderate to severe symptoms: Apply twice a day for 4 weeks, morning and evening.

Depending on the severity of the symptoms, the dosage and duration of treatment can be adjusted by your doctor. As with other similar blepharitis treatments, your doctor may recommend the simultaneous use of artificial tears. No special training is required to use Blephademodex. If you wear contact lenses, remove them before using Blephademodex. Wash your hands thoroughly before use. To open, tear open the packaging and unfold the enclosed wipe. Do not use any tools to open it. Wrap the wipe around the tip of your index finger. Keep your eyes closed and gently place the wipe on your eyelids and the base of your eyelashes. Massage gently in small circular movements and remove any crusts or secretions. Repeat the procedure with a new wipe on the other eye. Blephademodex is not oily and does not need to be rinsed off after use. Keep your eyes closed for 15 seconds after application.

Precautions for use

Check that the packaging is intact before using the product for the first time. Only use the product if the packaging is unopened. Use each wipe only once, otherwise it may not work properly and could lead to an increased risk of infection. If your symptoms worsen or do not improve, consult a healthcare professional.

Warnings

Keep out of reach of children. Avoid getting Blephademodex in your eyes. You may experience a burning sensation. If this happens, rinse your eyes with clean water or saline solution.

Side effects

The following side effects have been reported: burning sensation after application. In such cases, contact lens wearers should not reinsert their contact lenses. If you experience any side effects or unusual sensations after using this product, please contact a healthcare professional and provide the information to the local distributor, manufacturer or the competent health authority (see contact details at the end of the instructions for use).

Reporting of

side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this 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.

Storage and disposal:

• Store between 8°C and 25°C.
• Do not expose to direct sunlight or moisture.
• Dispose of the wipe immediately after use. Do not use the product after the expiry date printed on the packaging of the wipes and the outer carton.
• The expiry date refers to the last day of a month, provided that the packaging is undamaged and the product has been stored correctly.
• Dispose of the product responsibly in accordance with local guidelines (the packaging of the wipes and the wipes should be disposed of in household waste, the outer carton and the package leaflet are recyclable).

This leaflet was last revised in August 2020.

Manufacturer

Laboratoires Théa
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
www.laboratoires-thea.com

Distributor

Théa Pharma GmbH
Schillerstraße 3
10625 Berlin
Germany
www.theapharma.de
Phone 030/315 18 98-0

Ingredients

Sterile wipes soaked in a lotion containing: PEG-8, Polysorbate 80, Poloxamer 184, Terpinen-4-ol, PEG-6-glycerol caprylocaprat (Macrogol-6-glycerol caprylocaprat), Hyaluronic acid (as sodium hyaluronate), Potassium phosphate, Potassium dihydrogen phosphate, Purified water.

Source: Information from the package leaflet and the packaging
Status: 07/2023