Package leaflet: Information for the user

CANFORA SELLA 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 advice or information, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

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

1. What CANFORA SELLA is and what it is used for

CANFORA SELLA contains the active substance camphor, which belongs to a group of medicines used for muscle and joint pain.
CANFORA SELLA relieves symptoms of inflammation and pain, and is indicated for the treatment of mild pain, joint and muscle pain, gout, skin irritations, and cutaneous pruritus.
Consult your doctor if you do not feel better or if you feel worse after 3 days of using this medicine.

2. What you need to know before using CANFORA SELLA

Do not use CANFORA SELLA

if you are allergic to camphor or to any of the other ingredients of this medicine (listed in section 6);
if you have skin wounds or abrasions;
if the person who is to use the medicine is a child under 30 months of age or who has suffered from epilepsy and seizures;
CANFORA SELLA 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 SELLA.
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.
Avoid using this medicine for longer than 3 days or at doses higher than those recommended.
Avoid exposing this medicine to sources of heat such as open flames, as it is flammable.
Children
Do not apply CANFORA SELLA near your child's nostrils, as it may cause serious harm (shock).
CANFORA SELLA, when used in excessive doses, may cause nervous system problems such as seizures in newborns and children.
Other medicines and CANFORA SELLA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
During treatment with CANFORA SELLA, do not use any medicines containing substances known as terpene derivatives, such as camphor, cineole, niaouli, wild thyme, terpineol, terpin, citral, menthol, and essential oils of pine needles, eucalyptus, and turpentine, because, even if administered via different routes (e.g. oral, rectal, or nasal), they may cause you serious problems when used together with CANFORA SELLA.
Pregnancy and breastfeeding
Avoid using CANFORA SELLA if you are pregnant, planning to become pregnant, or breastfeeding.
Driving and using machines
Due to the possible occurrence of headache or dizziness, CANFORA SELLA may impair your ability to drive or operate machinery.
CANFORA SELLA oily cutaneous solution contains peanut oil
Do not use it if you are allergic to peanuts or soy.
CANFORA SELLA hydroalcoholic cutaneous solution contains ethanol.
It may cause a burning sensation on damaged skin.

3. How to use CANFORA SELLA

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.
Avoid exceeding the maximum recommended dose of 0.6 grams of camphor.
Do not swallow this medicine.
Avoid using this medicine for more than 3 days.

Children
CANFORA SELLA is contraindicated in children up to 30 months of age (see section "Do not use CANFORA SELLA").

If you use more CANFORA SELLA than you should
In case of overdose due to application of an excessive amount of camphor, skin irritation may occur.
However, if this medicine is accidentally ingested, symptoms such as nausea, vomiting, abdominal pain, diarrhea, headache, dizziness, sensations of heat/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 SELLA, vomiting should be induced.
If you have ingested the oily solution of CANFORA SELLA, vomiting must not be induced.
If your child has accidentally ingested CANFORA SELLA, neurological problems may occur.
In case of accidental ingestion/overdose of CANFORA SELLA, immediately inform a doctor 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)

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

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 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 SELLA

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.
Store the container in the original packaging, tightly closed, to protect the medicine from light and heat.
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 SELLA 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 SELLA oily cutaneous solution contains

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

Description of the appearance of CANFORA SELLA and contents of the pack
CANFORA SELLA 10% hydroalcoholic cutaneous solution – bottle of 100 g or 1000 ml.
CANFORA SELLA 10% oily cutaneous solution – bottle of 100 g or 1000 ml.
Marketing Authorization Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI) – Italy.