Phenol Marco Viti
Italy
Table of Contents
Package leaflet: Information for the user
FENOLO MARCO VITI 1% ear drops, solution
Phenol
Read all of this leaflet carefully before using this medicine because it contains important information for you.
- Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after a few days.
Contents of this leaflet:
- What FENOLO MARCO VITI is and what it is used for
- What you need to know before using FENOLO MARCO VITI
- How to use FENOLO MARCO VITI
- Possible side effects
- How to store FENOLO MARCO VITI
- Contents of the pack and other information
1. What FENOLO MARCO VITI is and what it is used for
FENOLO MARCO VITI contains the active substance phenol, which belongs to a group of medicines called antiseptics and disinfectants used against bacterial infections.
FENOLO MARCO VITI is indicated for disinfecting the ears (auditory canal).
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after several days of using the medicine.
2. What you need to know before using FENOLO MARCO VITI
Do not use FENOLO MARCO VITI
- If you are allergic to phenol or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using FENOLO MARCO VITI.
Do not ingest this medicine as it is poisonous if swallowed.
Avoid using FENOLO MARCO VITI for prolonged periods. Prolonged use may cause sensitization and irritation; in such cases, contact your doctor for advice on the most appropriate treatment.
Do not apply the medicine to the eyes or mucous membranes.
To reduce the risk of irritation, you may dilute FENOLO MARCO VITI with glycerin. Do not dilute with water, as dilution with water may make the medicine irritating.
Thoroughly dry the area where the drops are to be applied.
Other medicines and FENOLO MARCO VITI
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 and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine may be used only if necessary and under the direct supervision of a doctor during pregnancy or while breastfeeding.
Driving and using machines
FENOLO MARCO VITI does not affect the ability to drive vehicles or operate machinery.
3. How to use FENOLO MARCO VITI
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply 1 - 2 drops into the ear 1 - 2 times a day.
Use this medicine only on external areas and do not mix it with other medicines.
If you use more FENOLO MARCO VITI than you should
If you use a high amount of phenol or use this medicine for prolonged periods, you may experience skin reactions such as irritation and sensitization, or toxic effects on the brain, heart, blood vessels, lungs and kidneys.
In case of accidental ingestion/usage of FENOLO MARCO VITI, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)
- Skin irritation.
- Sensitisation. Following the instructions provided in this leaflet reduces the risk of side effects.
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 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 FENOLO MARCO VITI
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp." which refers to the product in its original, unopened packaging. The expiry date refers to the last day of that month.
After first opening, any remaining medicine should be used within 6 months. After this period, any unused medicine must be discarded.
Store the container in its original packaging, tightly closed, to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What FENOLO MARCO VITI contains
- The active substance is phenol. 100 g of solution contain 1 g of liquid phenol (equivalent to 0.85 g of phenol).
- The other components are: glycerol, purified water.
Description of the appearance of FENOLO MARCO VITI and package contents
Packaging containing one 10 g bottle.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Marco Viti Farmaceutici S.p.A. - Via Mentana, 38 - 36100 Vicenza – Italy.
Manufacturer
Zeta Farmaceutici S.p.A. - Via Galvani, 10 - 36066 Sandrigo (VI) - Italy.