Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Otinum
0.2 g/g (200 mg/g), ear drops, solution
Choline salicylate
Please read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by the physician.
Keep this leaflet so that it can be read again if necessary.
If advice or further information is needed, please contact the pharmacist.
If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
If there is no improvement within 3 days or if the patient feels worse, consult a doctor.

Contents of the leaflet:

What Otinum is and what it is used for
Important information before using Otinum
How to use Otinum
Possible side effects
How to store Otinum
Contents of the pack and other information

1. What Otinum is and what it is used for

Otinum is a medicine indicated for short-term use in inflammatory conditions of the external auditory canal associated with pain, itching, and redness.
The medicine is also recommended for softening earwax prior to irrigation of the external auditory canal.
The active substance in Otinum ear drops is a derivative of salicylic acid – choline salicylate.
When applied locally, choline salicylate has analgesic and anti-inflammatory properties. Thus, it reduces pain and inflammation associated with external otitis. The glycerol contained in the medicine softens earwax, facilitating its removal. After local administration into the ear, the medicine does not exert systemic effects.

2. Important information before using Otinum

When not to use Otinum

if the patient is allergic (hypersensitive) to the active substance (choline salicylate), to other salicylates (e.g. acetylsalicylic acid/aspirin), or to any of the other ingredients of this medicine (listed in section 6);
if the patient has bleeding or discharge from the ear;
if the patient experiences severe ear pain accompanied by hearing loss;
if the patient has previously been diagnosed with a perforated eardrum (rupture or discontinuity of the eardrum);
in individuals under 18 years of age.

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Signs suggestive of eardrum perforation include: acute ear pain (gradually decreasing), tinnitus (which may indicate damage to deeper ear structures), hearing loss, dizziness, and/or ear discharge. Causes of eardrum damage (perforation) include: infections, injuries (e.g. due to improper ear cleaning with cotton swabs), and causes related to medical procedures (e.g. improper ear irrigation due to earwax impaction).

Warnings and precautions

Any ear pain should prompt consultation with a physician.
This medicine, used for the treatment of inflammatory conditions of the external auditory canal without prior medical consultation, should only be used temporarily and for no longer than 3 days. If there is no improvement or if symptoms worsen despite using Otinum as directed for 3 days, medical advice should be sought.
If additional symptoms appear, indicating a developing illness (e.g. fever, malaise, weakness, dizziness, ear discharge), medical advice should be sought immediately.
In case of recurrent illness, the decision to use Otinum should be made by a physician.
Otinum may mask symptoms of other ear diseases and may complicate or delay their correct diagnosis.
The patient should inform the physician about using this medicine.
Otinum contains a preservative – chlorobutanol.
Otinum must not be used in ways other than those indicated in the leaflet or by alternative routes of administration (e.g. orally, on open wounds, particularly within the auricle, or into the eyes).

Otinum and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. This includes medicines obtained without a prescription.
Otinum is used topically and does not exhibit systemic effects.
Concomitant use with non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen) may intensify local effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

Otinum does not affect the ability to drive motor vehicles or operate machinery.

3. How to use Otinum medicine

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Otinum medicine is intended for topical use in the ear only. Otinum is intended for use in adults.
If you feel that the effect of Otinum is too strong or too weak, consult your physician.
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Recommended dosage:

For short-term treatment of local symptoms of acute external otitis: usually 3 to 4 drops into the external auditory canal every 6 to 8 hours. Otinum should not be used for longer than 3 days without medical advice.
For softening hardened cerumen prior to its removal from the ear: usually 3 to 4 drops into the external auditory canal every 12 hours for four days.

Elderly patients:
Dosage adjustment is not required.
Patients with hepatic and/or renal impairment:
Dosage adjustment is not required.
Instructions for administering Otinum medicine:

Wash your hands and then unscrew the cap from the bottle.
Tilt your head or lie on your side so that the affected ear faces upward.
Gently pull the earlobe (lower part of the auricle) in the direction away from the neck.
Turn the opened Otinum bottle upside down and, by gently squeezing it on both sides, administer 3–4 drops of the medicine into the affected ear.
Keep your head tilted for several minutes to allow the drops to flow into the ear canal.
Wipe away any excess liquid with a clean tissue.
Screw the cap back onto the Otinum bottle.

Additional tips for administering Otinum medicine:

Assistance from another person when administering drops into the ear or using a mirror may make administration easier.
Take care to avoid water entering the ear into which the medicine has previously been administered.
Do not share Otinum medicine with other people.

Use of a higher than recommended dose of Otinum medicine
Overdose is not possible when the medicine is administered into the ear. Symptoms of overdose that may occur following accidental oral ingestion include: disorientation, dizziness, excessive sweating, vomiting, tinnitus, and abnormally rapid breathing (hyperventilation). Ingestion of very large oral doses may lead to central nervous system disturbances, resulting, among others, in respiratory and circulatory disorders.
In case of accidental oral ingestion, seek immediate medical advice.
Missed dose of Otinum medicine
If you miss a dose at the scheduled time, administer it as soon as possible.
However, if it is almost time for the next dose, skip the missed dose. Do not use a double dose to make up for a missed dose.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.
The frequency of the adverse effects listed below is unknown (cannot be determined from the available data).
Local hypersensitivity reactions (skin redness and itching).
In patients with perforation of the tympanic membrane, use of this medicine may lead to hearing damage.
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Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: + 48 22 49 21 301, fax: + 48 22 49 21 游戏副本

6. Contents of the pack and other information

What Otinum contains

The active substance is choline salicylate.
The other ingredients are: glycerol, 96% ethanol, chlorobutanol, purified water.

What Otinum looks like and contents of the pack
The medicine is packed in a polyethylene bottle with a dropper and a cap, placed in a cardboard box.
The pack contains 10 g of medicine.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Latvia, country of export:
SIA Meda Pharma, Mūkusalas 101, Riga LV-1004, Latvia
Manufacturer:
ICN Polfa Rzeszów S.A., Przemysłowa 2, 35-959 Rzeszów, Poland
Parallel Importer:
Delfarma Sp. z o.o., Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged by:
Delfarma Sp. z o.o., Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in Latvia, country of export: 96-0162
Parallel Import Licence number: 26/17
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