Package leaflet: Information for the user

CANFORA NEW.FA.DEM.

10% alcoholic cutaneous solution
10% oily cutaneous solution
Camphor
Please read this leaflet carefully before you use 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, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. What CANFORA NEW.FA.DEM. is and what it is used for

CANFORA NEW.FA.DEM. contains the active substance camphor, which belongs to a group of medicines
used for muscle and joint pain.
CANFORA NEW.FA.DEM. relieves symptoms of inflammation and pain, and is indicated for the
treatment of mild pain, joint and muscle pain, articular inflammation due to gout, superficial skin irritations, and skin pruritus.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before using CANFORA NEW.FA.DEM.

Do not use CANFORA NEW.FA.DEM.

if you are allergic to camphor or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to peanuts or soy;
if you have severely damaged skin, deep wounds, or skin abrasions;
if the person who is to use the medicine is a child under 2 years of age, due to the risk of uncontrolled and repeated contractions of the laryngeal muscles (laryngospasm) and seizures.

Warnings and precautions
Talk to your doctor or pharmacist before using CANFORA NEW.FA.DEM.
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, including death, may occur.
Children
Do not apply CANFORA NEW.FA.DEM. near your child's nostrils, as it may cause severe harm (shock).
CANFORA NEW.FA.DEM., if used in excessive doses, may cause nervous system problems such as
seizures in newborns and children.
Other medicines and CANFORA NEW.FA.DEM.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
During treatment with CANFORA NEW.FA.DEM., do not use any medicines containing substances
called terpene derivatives, even if administered via different routes such as oral, rectal, or nasal.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, ask your
doctor or pharmacist for advice before using this medicine.
Avoid using CANFORA NEW.FA.DEM. if you are pregnant, planning a pregnancy, or breastfeeding.
Driving and using machines
CANFORA NEW.FA.DEM. may cause headache or dizziness. If this occurs, avoid driving vehicles
and using machinery.
CANFORA NEW.FA.DEM. oily cutaneous solution contains soybean seed oil
This medicine contains soybean seed oil. Do not use it if you are allergic to peanuts or soy.
CANFORA NEW.FA.DEM. alcoholic cutaneous solution contains ethanol
This medicine contains 4320 mg of alcohol (ethanol) in 0.60 g (6 ml).
It may cause a burning sensation on damaged skin.

3. How to use CANFORA NEW.FA.DEM.

Use this medicinal product 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 ml of medicinal product.
Do not ingest this medicinal product.
CANFORA NEW.FA.DEM. is contraindicated in children under 2 years of age (see section "Do not use
CANFORA NEW.FA.DEM.").
If you use more CANFORA NEW.FA.DEM. than you should
In case of overdose due to excessive application of camphor, skin irritation may occur.
If this medicinal product is accidentally ingested, symptoms such as nausea, vomiting, abdominal pain,
diarrhea, headache, dizziness, sensations of heat/hot flushes, convulsions, respiratory depression, and coma may occur.
If you experience severe symptoms, consult a doctor immediately for diagnosis and treatment.
If your child has accidentally ingested CANFORA NEW.FA.DEM., neurological problems may occur.
In case of accidental ingestion/overdose of CANFORA NEW.FA.DEM., contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

nervous system disorders: delirium, central nervous system depression, coma, convulsions, headache, dizziness,
collapse (shock);
asthma, breathing problems (respiratory failure);
stomach burning and pain, vomiting, nausea;
failure to excrete urine (anuria);
skin irritations (urticaria, erythema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report side effects directly via the national reporting system at 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 NEW.FA.DEM.

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".
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 and heat.
Store at a temperature not exceeding 30 °C.
Use this medicine within 6 months after first opening the bottle. After this period, dispose of any remaining medicine.
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 CANFORA NEW.FA.DEM. cutaneous solution contains
The active substance is camphor. 100 g of solution contain 10 g of camphor.

Hydroalcoholic solution: the other components are purified water, 96% ethanol.
Oily solution: the other component is soybean seed oil.

Description of the appearance of CANFORA NEW.FA.DEM. and contents of the pack
CANFORA NEW.FA.DEM. 10% hydroalcoholic cutaneous solution – 100 ml bottle or 1000 ml bottle.
CANFORA NEW.FA.DEM. 10% oily cutaneous solution – 100 ml bottle or 1000 ml bottle.
Marketing Authorization Holder
New.Fa.Dem. srl Farmaceutici e Chimici, with registered office and manufacturing site at Viale Ferrovia dello Stato,
zona A.S.I., Giugliano in Campania NA.
Manufacturer
New.Fa.Dem. srl Farmaceutici e Chimici, with registered office and manufacturing site at Viale Ferrovia dello Stato,
zona A.S.I., Giugliano in Campania NA.