OTOWAXOL

OTOWAXOL solution

Product features

Otowaxol ear drops, solution

Read the entire instructions for use carefully before you start using this medical device, as they contain important information. Always use this medical device exactly as described in these instructions for use or exactly as instructed by your doctor or pharmacist.

• Keep the instructions for use. You may want to read them again later
• Ask your pharmacist if you need more information or advice
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in these instructions for use. See section 4.
• If you do not feel better or even worse after 2–3 applications, contact your doctor.

What these instructions for use contain

1. WHAT IS OTOWAXOL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING OTOWAXOL?
3. HOW IS OTOWAXOL USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD OTOWAXOL BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION
7. INSTRUCTIONS FOR USE FOR THE EAR SYRINGE

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

Otowaxol is a solution for instillation into the ear to remove excess earwax (cerumen) and earwax plugs.

2. WHAT SHOULD YOU CONSIDER BEFORE USING OTOWAXOL?

Otowaxol must not be used:

• if you are allergic to any of the ingredients of this medical device listed in section 6.
• in case of a damaged eardrum and existing ear infection. An indication of a damaged (perforated) eardrum is the Valsalva test: If you hold your nose and then blow as if to blow your nose, you will hear a whistling sound in addition to the normal crackling.

Warnings and precautions

Please talk to your doctor or pharmacist before using Otowaxol. Painful symptoms may occur in case of existing injuries and inflammations in the ear canal. In this case, treatment with Otowaxol is contraindicated. If you have already received treatment, rinse the ear canal with lukewarm water and discontinue the use of Otowaxol. If Otowaxol accidentally gets into your eyes, rinse your eyes immediately with plenty of water.

Special notes

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

Children and adolescents

Otowaxol is suitable for use in children and adolescents.

Interactions with other agents

Otowaxol must not be used at the same time as other agents for local treatment of the ear canal.

Pregnancy and breast-feeding

There are no concerns about using Otowaxol during pregnancy and breast-feeding.

3. HOW IS OTOWAXOL USED?

Always use Otowaxol exactly as described in these instructions for use or exactly as instructed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Dosage:

• Adults and elderly patients: 10 drops are instilled into the ear to be treated.
• Children and adolescents: The dosage for children and adolescents is the same as for adults and elderly patients.

Type of application

Otowaxol solution is instilled into the ear canal of the ear to be treated by gently squeezing it directly from the bottle with the head tilted. The ear canal is then closed with cotton wool. After 5 to 10 minutes, the softened or dissolved earwax is flushed out with lukewarm water using the ear syringe. For more detailed instructions on how to use the ear syringe, see section 7. In case of hard and solidified earwax, this procedure can be repeated and the exposure time extended. Consult an ENT specialist if the ear canal is still blocked after 2 - 3 applications.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines and medical devices, Otowaxol can have side effects, although not everybody gets them.

The following side effects have been reported

Frequency not known (cannot be estimated from the available data):
Hypersensitivity/allergic reactions, inflammation of the outer ear (otitis externa), hearing loss (hypoacusis), ear discomfort, earache, dizziness, allergic skin reactions, contact dermatitis, reactions at the application site such as inflammation, swelling, irritation.

If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in these instructions for use By reporting side effects, you can help provide more information about the safety of this product.

5. HOW SHOULD OTOWAXOL BE STORED?

Keep Otowaxol out of the reach of children. Do not use Otowaxol after the expiry date stated on the bottle and the folding box. Do not use for more than 6 months after opening. Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Composition

Ethanol 96%, glycerol 85%, docusate sodium, sodium dihydrogen phosphate dihydrate, sodium monohydrogen phosphate dihydrate, purified water.

Otowaxol is available in the following pack sizes

Pack of 10 ml Otowaxol solution and pack of 10 ml Otowaxol solution + ear syringe.

MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg
Germany
Tel.: (06172) 888-01
Fax: (06172)888-2740
E-Mail: medinfo@medapharma.de

7. INSTRUCTIONS FOR USE FOR THE EAR SYRINGE

This combination pack contains an ear syringe for rinsing the ear canal with lukewarm water after treatment with Otowaxol.

Application:

• After using Otowaxol and the corresponding exposure time, fill the ear syringe with lukewarm water by hand.
• Carry out the next steps over a bowl, a sink or a towel (which may get dirty).
• Carefully insert the ear syringe into the ear canal, not too deeply
• To allow the water to enter the ear canal, gently squeeze the bulbous end of the ear syringe until there is no more liquid in the ear syringe. Tilt your head to the side while flushing out the softened or dissolved earwax.
• Carefully remove the ear syringe from the ear canal in a squeezed state (to avoid an unwanted suction and pressure effect).

Note

The ear syringe is only used to rinse the ear with water, but not to suck up the dissolved earwax.

Disinfection and care:

• Before the first and each subsequent use, the ear syringe should be cleaned inside and outside with soap solution and plenty of water and boiled briefly. Prolonged temperatures above 80°C will destroy the product, but a short-term temperature increase to 100°C (max. 1 min) in boiling water is possible. Make sure that the ear syringe can move freely in sufficiently bubbling water.
• After boiling, place the ear syringe with the opening facing downwards so that the remaining liquid can drain away.

Warnings and precautions

• Do not use a defective product.
• Not suitable for microwaves.
• Do not use aggressive cleaning or disinfecting agents for cleaning.
• Do not expose to direct sunlight.

These instructions for use were last revised in September 2017.

Source: Information from the package leaflet
Status: 02/2018