Cerulisina for pain
Italy
Table of Contents
Package leaflet: Information for the user
CERULISINA DOLORE 1% + 5% ear drops, solution
Hydrochloride procaine and phenazone
Please read this leaflet carefully before using this medicine because 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, consult your pharmacist.
- If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
- Talk to your doctor if you do not notice any improvement or if you notice a worsening of symptoms after 1-2 days.
Contents of this leaflet:
- What CERULISINA DOLORE is and what it is used for
- What you need to know before using CERULISINA DOLORE
- How to use CERULISINA DOLORE
- Possible side effects
- How to store CERULISINA DOLORE
- Contents of the pack and other information
1. What CERULISINA DOLORE is and what it is used for
CERULISINA DOLORE is a combination of two active substances: 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 agents, 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 an allergy to procaine hydrochloride, phenazone, other substances chemically similar to these, or to any of the other ingredients of this medicine (listed in section 6);
- if you have or have previously had a perforation of the eardrum, as adverse effects in the middle ear may occur.
Warnings and precautions
Talk to 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 is no damage to the eardrum membrane.
CERULISINA DOLORE may cause allergic reactions and irritation at the site of application. In such cases,
discontinue treatment and inform your doctor, who will establish an appropriate therapy.
Do not use this medicine for prolonged treatments. If you do not observe noticeable improvement after a short period of treatment (1-2 days), consult your doctor.
Children
In early infancy, CERULISINA DOLORE is recommended only when strictly necessary and not for prolonged treatments.
Other medicines and CERULISINA DOLORE
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine.
No interactions with other medicines are known.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only when strictly necessary and for short-term treatment.
Driving and using machines
This medicine does not impair the ability to drive vehicles or operate machinery.
3. How to use CERULISINA DOLORE
Use this medicinal product 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 adults is 5-8 drops, 2-4 times daily.
Apply the drops into the external part of the ear (external auditory canal).
It is advisable to warm the bottle slightly before use.
Use CERULISINA DOLORE for short periods only. If you do not experience an improvement in symptoms, consult your doctor.
If you feel the effect of CERULISINA DOLORE is too strong or too weak, talk to your doctor or pharmacist.
Consult your doctor if the condition recurs repeatedly or if you have noticed any change in its characteristics.
Use in children
The recommended dose is 4-5 drops, 2-4 times daily.
If you use more CERULISINA DOLORE than you should
There are no known cases of overdose.
In case of accidental ingestion/overdose of this medicinal product, seek immediate advice from your doctor or the nearest hospital.
If you forget to use CERULISINA DOLORE
Do not use a double dose to make up for the missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with unknown frequency (frequency cannot be estimated from the available data):
- side effects affecting the middle ear, if a perforation of the eardrum is present;
- decrease in the number of a type of white blood cells (agranulocytosis) and allergic reactions, including severe reactions (anaphylactic reactions), following systemic absorption of this medicine into the bloodstream.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide 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 packaging after "Exp.".
The expiry date refers to the last day of that month and to the product in its original, unopened packaging,
correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What CERULISINA DOLORE contains
- The active substances 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 package contents
Dropper bottle containing 6 g of ear drops, solution.
Marketing Authorization 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