OTALGAN

BEFORE USE, CAREFULLY READ ALL INFORMATION CONTAINED IN THIS LEAFLET.
This is a SELF-MEDICATION medicine that can be used to treat mild and transient disorders
which are easily recognizable and resolvable without medical assistance.
It may therefore be purchased without a prescription, but must be used correctly to ensure
its effectiveness and reduce the risk of adverse effects.

• For further information and advice, consult your pharmacist.
• Consult a doctor if the condition does not resolve after a short period of treatment.

® Otalgan
Analgesic and anti-inflammatory for ear conditions
Composition: Active ingredients: 100 g contain: procaine hydrochloride 1 g, phenazone 5 g.
Excipients: glycerol, butylated hydroxyanisole.
Presentation: OTALGAN is available as ear drops in a transparent 6 g bottle with dropper and child-resistant cap.
What it is: S02DA99 – Otalgan is an analgesic and anti-inflammatory agent for ear conditions without tympanic membrane perforation.
Marketing Authorization Holder
SWISS PHARMA GMBH - RHEINZABERNER STRASSE 8, DE-76761 - RÜLZHEIM (GERMANY).
Manufacturer and Final Control
Vifor AG, Zweigniederlassung Medichemie Ettingen, Brühlstrasse 50, CH-4107 Ettingen,
Switzerland
Batch Release Responsible
Vifor France SA, 7-13 boulevard Paul-Emile Victor, F-92521 Neuilly-sur-Seine cedex,
France
When not to use: Otalgan must not be used in case of perforation of the tympanic membrane. Known hypersensitivity to any component of the product.
Pregnancy and breastfeeding: During pregnancy and breastfeeding, OTALGAN should only be used after consulting a doctor and evaluating the individual risk/benefit ratio.
Precautions for use: Before administering the product, as a precautionary measure, ensure the integrity of the tympanic membrane. In very young infants, the product should be administered only under direct medical supervision and only when strictly necessary. Do not extend treatment beyond 10 days; in any case, if no improvement is observed after a short treatment period of 1–2 days, consult a doctor.
Which medicines or foods may affect the medicine’s action: If you are taking other medicines, consult your doctor or pharmacist.
Important information: It is advisable to warm the bottle slightly before use. The product may be used at any age.
How to use OTALGAN: Warning: Do not exceed the recommended doses without medical advice and use only for short treatment periods.
Instill into the external auditory canal 2–4 times daily:
Adults: 5–8 drops each time;
Children: 4–5 drops each time.
What to do if you have taken an excessive dose: In case of accidental ingestion of an excessive dose of OTALGAN, contact a doctor or go immediately to the nearest hospital.
Undesirable effects: Topically applied products may cause sensitization or irritation reactions. In such cases, discontinue treatment and consult a doctor. If the eardrum is perforated, contact of the product with the structures of the middle ear may lead to adverse effects.
The use of phenazone, even by systemic route, has been associated with a high risk of agranulocytosis. This medicine, like procaine, may cause allergic reactions in sensitized individuals and, following systemic absorption, even anaphylactic reactions.
Following the instructions in this leaflet reduces the risk of undesirable effects, which are generally transient. However, if such effects occur, consult a doctor or pharmacist.
It is important to inform your doctor or pharmacist of any undesirable effects not described in this leaflet.
Request and complete the adverse reaction reporting form available at pharmacies (Form B).
Expiry and storage: Warning: Do not use the medicine after the expiry date stated on the packaging.
Keep the medicine out of the reach of children.
It is important to always have the medicine information available; therefore, retain both the outer packaging and the leaflet.
Do not store above 30°C. Store in a dry place and protect from light.
Leaflet revision by the Ministry of Health: .