CANFORA TSETA 10% Roztwór do stosowania na skórę

Treść ulotki

1. CANFORA ZETA 10 % hydroalcoholic, oily cutaneous solution
   1. What is CANFORA ZETA and what is it used for
   2. What you need to know before using CANFORA ZETA
   3. How to use CANFORA ZETA
   4. Possible side effects
   5. How to store CANFORA ZETA
   6. Contents of the pack and other information

CANFORA ZETA 10 % hydroalcoholic, oily cutaneous solution

Canfora

Read this leaflet carefully before using this medicine as 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.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

• 1. What CANFORA ZETA is and what it is used for
• 2. What you need to know before using CANFORA ZETA
• 3. How to use CANFORA ZETA
• 4. Possible side effects
• 5. How to store CANFORA ZETA
• 6. Contents of the pack and other information

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

CANFORA ZETA contains the active ingredient canfora, which belongs to a group of medicines
used for muscle and joint pain.
CANFORA ZETA relieves the 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 skin itching.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days
of using the medicine.

2. What you need to know before using CANFORA ZETA

Do not use CANFORA ZETA

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

Warnings and precautions
Consult your doctor or pharmacist before using CANFORA ZETA.
Do not use concentrated camphor-based 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 more than 3 days and at doses higher than those
recommended.
Avoid using medicines and cosmetics containing substances called terpene derivatives because together with
CANFORA ZETA they may cause you serious problems.
Avoid bringing this medicine close to heat sources such as flames as it is flammable.

Children
Do not apply CANFORA ZETA to the nostrils of your child as it may cause serious damage
(shock). CANFORA ZETA, if used in excessive doses, may cause problems, such as convulsions, in
newborns and children (see section “Do not use CANFORA ZETA”).

Other medicines and CANFORA ZETA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
During treatment with CANFORA ZETA, do not use all 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 by different
routes such as mouth, rectum or nose.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Avoid using CANFORA ZETA if you are pregnant, planning a pregnancy or
breastfeeding.

Driving and operating machinery
CANFORA ZETA may cause headache or dizziness. If this happens, avoid driving vehicles and
operating machinery.

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

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

3. How to use CANFORA ZETA

Use this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply the solution with a light massage to the affected area and rub for 3-5 minutes.
Do not exceed the maximum recommended dose of 6.5 ml for CANFORA ZETA oily cutaneous solution
and 7 ml for CANFORA ZETA hydroalcoholic cutaneous solution.
Do not ingest this medicine.
Avoid using this medicine for more than 3 days.

Use in children
CANFORA ZETA is contraindicated in children under 30 months of age and in children who have
a history of epilepsy and convulsions (see section “Do not use CANFORA ZETA”).

If you use more CANFORA ZETA than you should
In case of overdose due to application of an excessive amount of camphor, skin irritation may occur.
If you accidentally ingest this medicine, however, nausea, vomiting, abdominal pain, diarrhea, headache, dizziness, sensations of heat/flushing, convulsions, respiratory arrest and coma may occur. If you experience severe symptoms, you should consult a doctor for diagnosis and
treatment.
If you have ingested CANFORA ZETA hydroalcoholic solution, vomiting should be induced, while if you have
ingested CANFORA ZETA oily solution, vomiting should not be induced. If your child has
accidentally ingested CANFORA ZETA, problems with the nervous system may occur.
In case of accidental ingestion/intake of CANFORA ZETA, immediately notify your doctor
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 gets them.
The following side effects may occur:

Not known frequency(frequency cannot be estimated from available data)

• delirium, central nervous system depression, coma, convulsions, headache, dizziness, collapse (shock);
• asthma, breathing problems (respiratory failure);
• burning (pyrosis) and stomach pain, vomiting, nausea;
• failure of urine secretion (anuria);
• skin irritation (urticaria, erythema). CANFORA ZETA if used in excessive doses can cause convulsions in newborns and children.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 ZETA

Keep this medicine out of 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.
Keep the container in the original packaging tightly closed to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CANFORA ZETA hydroalcoholic cutaneous solution contains

• The active ingredient is camphor. 100 g of solution contains 10 g of camphor.
• The other ingredients are: ethanol, purified water.

What CANFORA ZETA oily cutaneous solution contains

• The active ingredient is camphor. 100 g of solution contains 10 g of camphor.
• The other ingredients are: peanut oil, butylated hydroxyanisole.

Description of the appearance of CANFORA ZETA and contents of the pack
CANFORA ZETA 10 % hydroalcoholic cutaneous solution – bottle of 100 and 1000 ml
CANFORA ZETA 10 % oily cutaneous solution – bottle of 100 and 1000 ml

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Zeta Farmaceutici S.p.A., Via Mentana, 38 – 36100 Vicenza – Italy.

Manufacturer
Zeta Farmaceutici S.p.A., via Galvani, 10 – 36066 Sandrigo (Vi) – Italy.