Canfora Zeta

Patient Information Leaflet: Information for the User

CANFORA ZETA 10% hydroalcoholic, oily cutaneous solution

Camphor
Please read all of this leaflet carefully before you use this medicine because 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 to do.
• Keep this leaflet. You may need to read it again.
• If you need more information or advice, contact 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 any improvement or if you notice worsening of symptoms 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 CANFORA ZETA is and what it is used for

CANFORA ZETA contains the active substance canfora, which belongs to a group of medicines used for muscle and joint pain.
CANFORA ZETA relieves symptoms of inflammation and pain, and is indicated for the treatment of mild neuralgic pain, 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 skin wounds or abrasions;
• if the person who will use the medicine is a child under 30 months of age or who has suffered from epilepsy or febrile seizures. CANFORA ZETA oily cutaneous solution contains peanut oil. If you are allergic to peanuts or soya, do not use this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before using CANFORA ZETA.
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 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 ZETA.
Avoid bringing this medicine close to sources of heat such as open flames, as it is flammable.
Children
Do not apply CANFORA ZETA to your child's nostrils, as it may cause serious harm (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
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other
medicines.
During treatment with CANFORA ZETA, 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, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Avoid using CANFORA ZETA if you are pregnant, planning a pregnancy, or breastfeeding.
Driving and using machines
CANFORA ZETA may cause headache or dizziness. If this occurs, avoid driving or operating machinery.
CANFORA ZETA oily 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 soya.
CANFORA ZETA contains butylated hydroxyanisole (BHA), 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 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 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 ZETA oily cutaneous solution and 7 ml for CANFORA ZETA hydroalcoholic cutaneous solution.
Do not swallow 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 with a history of epilepsy and seizures (see section "Do not use CANFORA ZETA").

If you use more CANFORA ZETA 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, diarrhea, headache, dizziness, sensations of warmth/flushing, seizures, respiratory depression, and coma may occur. If you experience severe symptoms, seek medical attention immediately for diagnosis and treatment.
If CANFORA ZETA hydroalcoholic solution has been ingested, vomiting should be induced. However, if CANFORA ZETA oily solution has been ingested, vomiting must not be induced. If your child has accidentally ingested CANFORA ZETA, neurological problems may occur.
In case of accidental ingestion or intake of CANFORA ZETA, contact your doctor immediately or go to the nearest hospital.

If you have any questions 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 experiences 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);
• burning sensation (pyrosis) and stomach pain, vomiting, nausea;
• failure to secrete urine (anuria);
• skin irritations (urticaria, erythema). CANFORA ZETA, when 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, 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 ZETA

Keep this medicine out of the 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.
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. Package contents and other information

What CANFORA ZETA 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 ZETA oily cutaneous solution contains

• The active substance is camphor. 100 g of solution contain 10 g of camphor.
• The other components 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 ml and 1000 ml
CANFORA ZETA 10% oily cutaneous solution – bottle of 100 ml and 1000 ml

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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.