CERULISINA 1% + 5% Ушные капли, раствор

Содержание инструкции

1. CERULISINA DOLORE 1% + 5% ear drops, solution
   1. What is CERULISINA DOLORE and what is it used for
   2. What you need to know before using CERULISINA DOLORE
   3. How to use CERULISINA DOLORE
   4. Possible side effects
   5. How to store CERULISINA DOLORE
   6. Contents of the pack and other information

CERULISINA DOLORE 1% + 5% ear drops, solution

Procaine hydrochloride and phenazone

Read this leaflet carefully before you use this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms get worse after 1-2 days.

Contents of this leaflet:

• 1. What CERULISINA DOLORE is and what it is used for
• 2. What you need to know before you use CERULISINA DOLORE
• 3. How to use CERULISINA DOLORE
• 4. Possible side effects
• 5. How to store CERULISINA DOLORE
• 6. Contents of the pack and other information

1. What is CERULISINA DOLORE and what is it used for

CERULISINA DOLORE is a combination of two active ingredients: procaine hydrochloride and phenazone. Procaine hydrochloride belongs to a group of medicines called local anesthetics, which relieve pain in the area where they are applied, while phenazone, which belongs to a group of medicines called anti-inflammatory and analgesic drugs, reduces inflammation and pain.
This medicine is indicated for the treatment of ear pain (otalgia).
Consult your doctor if you do not feel better or if you feel worse after 1-2 days.

2. What you need to know before using CERULISINA DOLORE

Do not use CERULISINA DOLORE

• if you are allergic or have previously shown allergy to procaine hydrochloride, phenazone, other substances chemically similar to these or to any of the other components of this medicine (listed in section 6);
• if you have or have had a perforated eardrum, as adverse effects at the level of the middle ear may occur.

Warnings and precautions
Consult your doctor or pharmacist before using CERULISINA DOLORE.
In particular, before using this medicine, consult your doctor who, as a precaution, will verify that
there are no damages to the eardrum.
CERULISINA DOLORE may cause allergic reactions and irritation in the application area. In this case,
discontinue treatment and inform your doctor who will establish appropriate therapy.
Do not use this medicine for prolonged treatments. If you do not notice appreciable results after a short period of
treatment (1-2 days), consult your doctor.

Children
In early infancy, CERULISINA DOLORE is recommended only in case of actual need and not for
prolonged treatments.

Other medicines and CERULISINA DOLORE
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if absolutely necessary and
for short-term treatments.

Driving and operating machinery
This medicine does not alter the ability to drive vehicles or operate machinery.

3. How to use CERULISINA DOLORE

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose for an adult is 5-8 drops, 2-4 times a day.
Instill the drops into the outer part of the ear (external auditory canal).
It is recommended to warm the bottle before use.
Use CERULISINA DOLORE for short periods and, if you do not experience an improvement in symptoms,
consult your doctor.
If you feel that the effect of CERULISINA DOLORE is too strong or too weak, consult your
doctor or pharmacist.
Consult your doctor if the condition recurs or if you have noticed any change in its
characteristics.

Use in children
The recommended dose is 4-5 drops, 2-4 times a day.

If you use more CERULISINA DOLORE than you should
Cases of overdose are not known.
In case of ingestion/taking of an excessive amount of this medicine, seek immediate medical attention
or go to the nearest hospital.

If you forget to use CERULISINA DOLORE
Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
They can occur with unknown frequency(frequency cannot be estimated from available data):

• undesirable effects at the level of the middle ear, if a tympanic perforation is present;
• reduction in the number of a type of white blood cells (agranulocytosis) and allergic reactions, including severe ones (anaphylactic reactions), following the passage of this medicine into the blood (systemic absorption).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor
or pharmacist. You can also report side effects directly through the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
contribute to providing more information on the safety of this medicine.

5. How to store CERULISINA DOLORE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

WhatCERULISINA DOLOREcontains

• The active ingredients are: procaine hydrochloride and phenazone. 100 g contain 1 g of procaine hydrochloride (equivalent to 0.866 g of procaine base) and 5 g of phenazone.
• The other component is: glycerol.

Description of the appearance of CERULISINA DOLORE eye drops and contents of the pack
Bottle with dropper containing 6 g of ear drops, solution.

Marketing Authorisation Holder
IBSA FARMACEUTICI ITALIA S.R.L.
VIA MARTIRI DI CEFALONIA, 2, 26900 - LODI (LO).

Manufacturer
Laboratorio Chimico Farmaceutico A. Sella S.r.l. – Via Vicenza, 67 – Schio (VI) – Italy