OTOPROFEN

(BRUSCHETTİNİ S. r.l. ITALY)

Bottle 6 g

Composition.
100 ml of solution contain:
Active ingredients: procaine hydrochloride 1 g (equal to procaine base 0.866 g), phenazone 5 g
Excipients: glycerol.

Marketing authorization holder. BRUSCHETTINI S.r.l., Via Isonzo 6, Genova (Italy).

Manufacturing, packaging, chemical-physical and microbiological tests, release: Laboratorio Chimico Farmaceutico A. Sella S.r.l. – Via Vicenza 67, Schio (VI - Italy).

1. What is Otoprofen and what it is useful for?
OTOPROFEN is an ear drops, solution.
The content of the bottle is 6 g of solution.
OTOPROFEN is an otologic drug with analgesic and anaesthetic action.
OTOPROFEN is to be used in case of otalgias.

Before administering OTOPROFEN
Do not administer OTOPROFEN:
in case of hypersensitivity (allergy) to the components (procaine hydrochloride and/or phenazone) or to the excipient of OTOPROFEN or other chemically related substances.
It is advisable to consult the physician also in case such troubles were shown also in the past.

Pay attention above all:
if after a short period of treatment you do not have considerable results: in this case consult your physician.
Assumption of OTOPROFEN with food and drink
- Not relevant.
Pregnancy. Ask the physician or pharmacist for advice before taking whatever medicinal product.
Breast-feeding. Ask the physician or pharmacist for advice before taking whatever medicinal product
Driving and machinery use. OTOPROFEN does not interfere with driving ability or machinery actioning.
Important information on some excipients of OTOPROFEN. Not relevant.
Assumption of other medicinal products. Inform the physician or the pharmacist if you are assuming other medicinal products, also those without prescription.

How administer OTOPROFEN
Take always OTOPROFEN following exactly the physician instructions.
If you are not sure you must consult the physician or the pharmacist.
The usual dosage is:
Adults: 5 – 8 drops every time
Children: 4 – 5 drops every time
OTOPROFEN must be instilled into the external auditive duct
OTOPROFEN must be taken 2 - 4 times daily
If you feel that the effect of OTOPROFEN is too strong or too weak, ask the physician or the pharmacist for information.
Do not use OTOPROFEN for prolonged period of time if you do not have remarkable effects.
Consult the physician if illness relapses or if you noted whatever change of its characteristics.

If you take more OTOPROFEN than what it is needed:
advise immediately the physician or go to the nearest hospital.

If you forget to take OTOPROFEN:
do not take a double dose to compensate the eventual forgetfulness.
Effects when the treatment with OTOPROFEN is stopped: none

Possible undesirable effects
Like all the medicinal products, OTOPROFEN can have undesirable effects.
The respect of the instructions contained in the insert reduces the risk of undesirable effects. In case of eardrum perforation, the product, in contact with the mean ear structure, can cause undesirable effects at this level. The use of phenazone, even by systemic route, is associated to the high risk of agranulocytosis; this pharmaceutical product, like procaine, can cause allergic reactions in sensitized subjects and, after systemic absorbance, also anaphylactic manifestations.
If you note some undesirable effect not mentioned in this leaflet, inform the physician or the pharmacist.

How storing OTOPROFEN
Keep out of the reach of children.
Store in its original packaging.
Do not use the product after the expiry date imprinted on its package.

Other information
For other information on the product, please contact the marketing authorization holder.

Bruschettini S.r.l.
Via Isonzo 6 – 16147 Genova (Italy)