OTALGAN 1% + 5% Ear drops, solution

BEFORE USE, READ ALL INFORMATION CAREFULLY
This is a self-medication medicine that you can use to treat mild and transient disorders
easily recognizable and resolvable without resorting to the help of a doctor.
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 resolve after a short period of treatment.

®Otalgan
Analgesic and anti-inflammatory in ear conditions

Composition:Active ingredient: 100 g contain: procaine hydrochloride 1g, phenazone 5 g.
Excipients: glycerol, butylated hydroxyanisole.

What it looks like:OTALGAN is available in the form of ear drops contained in a
6 g transparent bottle with a dropper and safety closure.

What it is:S02DA99 – Otalgan is a pain reliever and anti-inflammatory in ear conditions
without tympanic perforation.

Holder of the marketing authorization
SWISS PHARMA GMBH- RHEINZABERNER STRASSE 8, DE-76761 - RÜLZHEIM (GERMANY).

Manufacturer and final controller
Vifor AG, Zweigniederlassung Medichemie Ettingen, Brühlstrasse 50, CH-4107 Ettingen,
Switzerland

Responsible for batch release
Vifor France SA, 7-13 boulevard Paul-Emile Victor, F-92521 Neuilly-sur-Seine cedex,
France

When it should not be used:Otalgan should not be used in case of perforation
of the tympanic membrane. Known individual hypersensitivity to the components of the
product.

What to do during pregnancy and breastfeeding:during pregnancy and breastfeeding
OTALGAN should be used only after consulting your doctor and evaluating with him the
risk/benefit ratio in your specific case.

Precautions for use:before administering the product, as a precaution,
ensure the integrity of the tympanic membrane. In early infancy, the product
should be administered under direct medical supervision and only in cases of actual
need. Do not prolong 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.

Which medicines or foods can alter the effect of the medicine:if you are
using other medicines, ask your doctor or pharmacist for advice.

It is important to know that:it is advisable to warm the bottle before use. The product
can be used at any age.

How to use OTALGAN:Caution: do not exceed the indicated doses without the advice of
your doctor and use only for short periods of treatment.
Instill into the external ear canal 2–4 times a day:
adults: 5 – 8 drops each time;
children: 4 – 5 drops each time.

What to do if you have taken an excessive dose of the medicine:in case of accidental
ingestion of an excessive dose of OTALGAN, inform your Doctor or go to the nearest
hospital.

Undesirable effects:topical products can cause sensitization or irritation.
In such cases, discontinue treatment and consult your doctor. In case of tympanic perforation, the product, in contact with the structures
of the middle ear, can determine side effects at that level.
The use of phenazone, even via systemic route, has been associated with a high risk of
agranulocytosis. This drug, like procaine, can cause allergic reactions in sensitized subjects and, following systemic absorption, even anaphylactic manifestations.
undesirable that 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 the occurrence of undesirable effects not
Report and complete the adverse reaction reporting form available in
pharmacy (form B).

Expiration and storage:Caution: do not use the medicine after the expiration date
indicated on the packaging.
Keep the medicine out of reach of children.
It is important to always have information about the medicine available, therefore
Do not store above 30°C, in a dry place and protected from light.