Package leaflet: Information for the user

CANFORA MARCO VITI 10% hydroalcoholic, oily cutaneous solution

Camphor
Please read 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 you.
Keep this leaflet. You may need to read it again.
If you need more 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 any improvement or if you notice a worsening of symptoms after 3 days.

Contents of this leaflet:

What CANFORA MARCO VITI is and what it is used for
What you need to know before using CANFORA MARCO VITI
How to use CANFORA MARCO VITI
Possible side effects
How to store CANFORA MARCO VITI
Contents of the pack and other information

1. What CANFORA MARCO VITI is and what it is used for

CANFORA MARCO VITI contains the active substance camphor, which belongs to a group of
medicines used for muscle and joint pain.
CANFORA MARCO VITI relieves symptoms of inflammation and pain and is indicated for the
treatment of pain due to mild neuralgia, joint and muscle pain, gout, superficial skin irritations, and cutaneous pruritus.
Consult your doctor if you do not notice any improvement or if you observe a worsening of symptoms after 3 days
of using the medicine.

2. What you need to know before using CANFORA MARCO VITI

Do not use CANFORA MARCO VITI

if you are allergic to camphor or to any of the other ingredients of this medicinal product (listed in section 6);
if you have skin wounds or abrasions;
if the person using the medicine is a child under 30 months of age or who has suffered from epilepsy or febrile convulsions. CANFORA MARCO VITI oily cutaneous solution contains peanut oil. If you are allergic to peanuts or soy, do not use this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before using CANFORA MARCO VITI.
Do not use concentrated camphor solutions containing more than 11% camphor, as they may be irritating and dangerous.
Do not ingest this medicine, as serious effects may occur, including death.
Avoid using this medicine for longer than 3 days or in doses higher than those recommended.
Avoid using medicines and cosmetics containing substances called terpene derivatives, as they may cause serious problems when used together with CANFORA MARCO VITI.
Avoid bringing this medicine close to heat sources such as flames, as it is flammable.

Children
Do not apply CANFORA MARCO VITI to your child's nostrils, as it may cause serious harm (shock). CANFORA MARCO VITI, when used in excessive doses, may cause nervous system problems such as convulsions in newborns and children (see section "Do not use CANFORA MARCO VITI").

Other medicines and CANFORA MARCO VITI
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
During treatment with CANFORA MARCO VITI, do not use any medicines containing substances called terpene derivatives (such as camphor, cineole, niaouli, wild thyme, terpineol, terpin, citral, menthol, and essential oils of pine needles, eucalyptus, and turpentine), even if administered via different routes such as oral, rectal, or nasal.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Avoid using CANFORA MARCO VITI if you are pregnant, planning a pregnancy, or breastfeeding.

Driving and using machines
CANFORA MARCO VITI may cause headache or dizziness. If this occurs, avoid driving vehicles or operating machinery.

CANFORA MARCO VITI oily cutaneous solution contains peanut oil and butylated hydroxyanisole (BHA)
CANFORA MARCO VITI contains peanut oil. Do not use it if you are allergic to peanuts or soy.
CANFORA MARCO VITI contains butylated hydroxyanisole (BHA), which may cause localized skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.

CANFORA MARCO VITI hydroalcoholic cutaneous solution contains ethanol: may cause a burning sensation on damaged skin.

3. How to use CANFORA 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 the solution with a gentle massage to the affected area and rub for 3–5 minutes.
Do not exceed the maximum recommended dose of 6.5 ml for CANFORA MARCO VITI oily cutaneous solution and 7 ml for CANFORA MARCO VITI hydroalcoholic cutaneous solution.
Do not swallow this medicine.
Do not use this medicine for more than 3 days.

Use in children
CANFORA MARCO VITI is contraindicated in children under 30 months of age and in children with a history of epilepsy or febrile seizures (see section "Do not use CANFORA MARCO VITI").

If you use more CANFORA MARCO VITI than you should
In case of overdose due to excessive application of camphor, skin irritation may occur.
If this medicine is accidentally ingested, symptoms such as nausea, vomiting, abdominal pain, diarrhoea, headache, dizziness, sensations of warmth/flushing, convulsions, respiratory depression, and coma may occur. If you experience severe symptoms, seek medical advice immediately for diagnosis and treatment.
If you have ingested the hydroalcoholic solution of CANFORA MARCO VITI, vomiting should be induced. However, if you have ingested the oily solution of CANFORA MARCO VITI, vomiting must not be induced.
If your child has accidentally ingested CANFORA MARCO VITI, neurological problems may occur.
In case of accidental ingestion/overdose of CANFORA MARCO VITI, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of 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)

delirium, central nervous system depression, coma, convulsions, headache (cephalalgia), dizziness, collapse (shock);
asthma, breathing problems (respiratory failure);
stomach burning (pyrosis) and stomach pain, vomiting, nausea;
failure to secrete urine (anuria);
skin irritations (urticaria, erythema). CANFORA MARCO VITI, if used in excessive doses, may cause convulsions in neonates and children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report side effects directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CANFORA MARCO VITI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Store the container in the original packaging, tightly closed, to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What CANFORA MARCO VITI hydroalcoholic cutaneous solution contains

The active substance is camphor. 100 g of solution contain 10 g of camphor.
The other components are: ethanol, purified water.

What CANFORA MARCO VITI oily cutaneous solution contains

The active substance is camphor. 100 g of solution contain 10 g of camphor.
The other components are: peanut oil, BHA.

Description of the appearance of CANFORA MARCO VITI and contents of the pack
CANFORA MARCO VITI 10% hydroalcoholic cutaneous solution – 100 g bottle.
CANFORA MARCO VITI 10% oily cutaneous solution – 100 ml bottle.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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.