OTITEX

OTITEX ear drops

Product features

Otitex, 10 ml solution for instillation into the ear canal
For softening hardened earwax (cerumen)

Dear patient! Please read the following instructions for use carefully, as they contain important information on what to consider when using this medical product. If you have any questions, please contact your doctor or pharmacist.

Composition

Glycerol, ethanol, docusate sodium, buffer (sodium dihydrogen phosphate, sodium hydroxide), purified water.

Pharmaceutical entrepreneur

Südmedica GmbH
Ehrwalder Straße 21
81377 Munich
Tel.: 089/714 40 61
Fax: 089/719 29 50

Fields of application

For softening hardened earwax. Cerumen solution before medical ear examination and before local medicinal ear treatment. Otitex is well suited for keeping the ear canal clean in hearing aid wearers.

Contraindications

Otitex must not be used in the following cases:

• damaged (perforated) eardrum,
• in case of hypersensitivity reactions to one of the components,
• in case of hypersensitivity of the ear canal,
• in case of injuries or inflammations of the ear canal,
• in case of ear infection.

Side effects

Depending on the condition of the ear canal, such as injuries or inflammatory diseases in the ear canal, Otitex can cause painful discomfort. In this case, it is advisable to rinse the ear canal thoroughly with lukewarm water and to discontinue the use of Otitex.

Interaction with other agents

Otitex must not be used together with other medications for local treatment of the ear canal.

Dosage instructions

The following dosage information can serve as a general guideline

Single dose: Instill 10 - 15 drops into the ear canal.

Type of application

Instill Otitex lukewarm into the ear canal while lying on your side. A drop is released each time the bottle wall is pressed lightly. Then close the ear with cotton wool so that Otitex can act on the earwax. After approx. 5-10 minutes, rinse the softened earwax thoroughly with lukewarm water.

Duration of application

In case of heavily hardened earwax, a repetition of the application is indicated. In case of overproduction of earwax, regular application should be carried out according to the doctor's recommendation.

1. Open the safety cap on the bottle by turning it to the left.
2. After opening the bottle, the drops are instilled into the ear canal by pressing the plastic bottle according to the dosage instructions.
3. After use, close the bottle and store it at normal room temperature.

Warning:

• Medical devices do not belong in the hands of children.
• Keep Otitex out of reach of children.
• Do not let Otitex get into your eyes; rinse eyes immediately with plenty of tap water.

Shelf life notice:

• Maximum shelf life after opening: 6 months.
• Otitex should not be used after the expiry date stated on the packaging.

Special instructions

Due to the risk of injury, mechanical cleaning of the ear canal with pointed objects is not recommended. Similarly, aids that push the earwax into the back of the ear canal are not suitable for cleaning.

These instructions for use were last revised in November 2014.

Source: Information from the package insert
Status: 12/2017