Active ingredients: Procaine (procaine hydrochloride), Phenazone
Otalgan Ear drops
Why is Otalgan used? What is it for?
Antalgic and anti-inflammatory in ear affections
What it is: Otalgan is a pain reliever and anti-inflammatory in ear affections without tympanic perforation.
Contraindications When Otalgan should not be used
Otalgan must not be used in case of perforation of the tympanic membrane. Known individual hypersensitivity to the components of the product.
Precautions for use What you need to know before taking Otalgan
BEFORE USE, CAREFULLY READ ALL THE INFORMATION CONTAINED IN THE PACKAGE LEAFLET.
This is a SELF-MEDICATION medicine that you can use to treat mild and transient ailments that are easily recognizable and resolvable without resorting to your doctor's help.
It can therefore be purchased without a prescription but must be used correctly to ensure its effectiveness and reduce unwanted effects.
- For more information and advice, contact your pharmacist.
- Consult your doctor if the disorder does not go away after a short period of treatment.
Before administering the product, as a precautionary measure, make sure of the integrity of the eardrum membrane. In very early childhood the product must be administered under the direct supervision of the doctor and only in cases of real necessity. Do not extend the administration of the drug beyond 10 days; in any case, after a short period of treatment, 1-2 days, without appreciable results, consult your doctor.
Interactions Which drugs or foods can modify the effect of Otalgan
If you are using other medicines ask your doctor or pharmacist for advice.
Warnings It is important to know that:
What to do during pregnancy and lactation: during pregnancy and lactation OTALGAN should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
It is advisable to warm the bottle before use. The product can be used at any age.
Dosage and method of use How to use Otalgan: Dosage
Warning: do not exceed the indicated doses without medical advice and use only for short periods of treatment.
Instill in the external ear canal 2-4 times a day:
adults: 5 - 8 drops each time;
children: 4 - 5 drops each time.
Overdose What to do if you have taken too much Otalgan
In case of accidental intake of an excessive dose of OTALGAN, notify your doctor or go to the nearest hospital.
Side Effects What are the side effects of Otalgan
products for topical application can give rise to sensitization or irritation phenomena. In such cases, stop treatment and consult your doctor. In case of perforation of the eardrum, the product, in contact with the structure of the middle ear, can cause side effects of this level.
The use of phenazone, albeit systemically, has been associated with a high risk of agranulocytosis. This drug, like procaine, can cause allergic reactions in sensitized subjects and, following systemic adsorption, also anaphylactic manifestations.
Compliance with the instructions contained in the package leaflet reduces the risk of side effects which are generally transient. However, when they occur, it is advisable to consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet.
Request and fill in the Undesirable Effects report form available at the pharmacy (form B)
Expiry and Retention
Warning: do not use the medicine after the expiry date indicated on the package.
Keep this medicine out of the reach of children.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Do not store above 30 ° C, in a dry place away from light
Composition:
Active ingredient: 100g contain: 1g procaine hydrochloride, 5g phenazone.
Excipients: glycerol, butylhydroxyanisole.
What it looks like:
OTALGAN comes in the form of ear drops contained in a 6 g transparent bottle with dropper and safety closure.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
OTALGAN BERN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active principle:
100 g contain:
procaine hydrochloride 1 g
phenazone 5 g
03.0 PHARMACEUTICAL FORM
Ear drops, solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Otalgia.
04.2 Posology and method of administration
Instill into the external ear canal 2-4 times a day:
Adults: 5-8 drops each time.
Children: 4-5 drops each time.
Do not exceed the recommended dose.
04.3 Contraindications
Known individual hypersensitivity to the components of the product.
In case of perforation of the tympanic membrane, refrain from use.
04.4 Special warnings and appropriate precautions for use
It is advisable to warm the bottle before use.
As a precautionary measure, before administering the product, ensure the integrity of the eardrum membrane.
Do not extend the administration of the drug beyond 10 days; in any case, after a short period of treatment, 1-2 days, with no appreciable results, consult your doctor.
In very early childhood, the product must be administered under the direct supervision of the doctor and only in cases of actual need.
The product can be used at any age.
Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
Do not report.
04.6 Pregnancy and lactation
No particular risks are reported.
Administer under the direct supervision of the doctor and only in cases of real need.
04.7 Effects on ability to drive and use machines
No interference.
04.8 Undesirable effects
The products for topical application can give rise to sensitization or irritation phenomena.
In such cases, stop treatment and consult your doctor.
In case of perforation of the eardrum, the product in contact with the structure of the middle ear can cause side effects at this level.
The use of phenazone, albeit systemically, has been associated with a high risk of agranulocytosis; this drug, like procaine, can cause allergic reactions in sensitized subjects and, following systemic adsorption, also anaphylactic manifestations.
04.9 Overdose
Do not report overdose reactions.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Otalgan Berna has a prompt pain-relieving and anti-inflammatory action in ear affections without tympanic perforation.
05.2 Pharmacokinetic properties
Procaine hydrochloride has a rapid surface anesthetic action, is hydrolyzed by esterases and is well tolerated.
Phenazone exhibits topical anti-inflammatory activity and exhibits inhibitory effects on cyclooxygenase in vivo. With the instillation of Otalgan Berna in the external auditory canal, no systemic absorption of phenazone is found with highly sensitive methods.
05.3 Preclinical safety data
Otalgan Berna has proven to be safe: its tolerability is confirmed by its long-term clinical use.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Glycerol, butylhydroxyanisole.
06.2 Incompatibility
Do not report.
06.3 Period of validity
36 months in intact packaging.
06.4 Special precautions for storage
Close the bottle tightly after use.
06.5 Nature of the immediate packaging and contents of the package
6 g transparent, colorless, polyethylene bottle with polyethylene dropper and white polypropylene safety closure.
06.6 Instructions for use and handling
Warning: do not use the medicine after the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
07.0 MARKETING AUTHORIZATION HOLDER
Owner A.I.C. Vifor France SA
08.0 MARKETING AUTHORIZATION NUMBER
004398018
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
January 1951 - March 2000.
10.0 DATE OF REVISION OF THE TEXT
01/05/2000
