CANFORA 10% Topical solution

Зміст інструкції

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

CANFORA NEW.FA.DEM.

10 % alcoholic cutaneous solution
10% 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 to.
• 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.

Contents of this leaflet:

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

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

CANFORA NEW.FA.DEM. contains the active ingredient camphor, which belongs to a group of medicines
used for muscle and joint pain.
CANFORA NEW.FA.DEM. relieves the symptoms of inflammation and pain and is indicated for the
treatment of mild pain, joint and muscle pain, gouty joint inflammation, superficial skin irritations and skin itching.
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 and deep and abrasive skin wounds;
• if the person who needs 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 convulsions.

Warnings and precautions
Consult your doctor or pharmacist before using CANFORA NEW.FA.DEM.
Do not use camphor-based solutions that are concentrated, containing more than 11% camphor, because 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. to the nostrils of your child as it may cause serious damage
(shock). CANFORA NEW.FA.DEM. if used in excessive doses can cause problems with the nervous system,
such as convulsions, in newborns and children.

Other medicines and CANFORA NEW.FA.DEM.
Tell 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 by different routes such as orally, rectally or nasally.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, 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 if you are breastfeeding.

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

CANFORA NEW.FA.DEM. oily cutaneous solution contains soybean oil
This medicine contains soybean 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 medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask 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 ml of the medicine.
Do not ingest this medicine.
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 application of an excessive amount of camphor, skin irritation may occur.
If you accidentally ingest this medicine, nausea, vomiting, abdominal pain, diarrhea, headache, dizziness, sensations of heat/flushing, convulsions, respiratory arrest and coma may occur.
If you experience severe symptoms, seek medical attention for diagnosis and treatment.
If your child has accidentally ingested CANFORA NEW.FA.DEM., they may experience problems with the
nervous system.
In case of accidental ingestion/intake of CANFORA NEW.FA.DEM., immediately notify your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, ask 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:

Frequency not known(the frequency of which cannot be estimated based on available data)

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

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 NEW.FA.DEM.

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.
Keep the container in the original packaging tightly closed to protect the medicine from light and from
heat.
Store at a temperature not exceeding 30 °C.
Use this medicine within 6 months of first opening the bottle. After this period, discard any
remaining medicine.
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 NEW.FA.DEM. cutaneous solution contains
The active ingredient is camphor. 100 g of solution contain 10 g of camphor.

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

Description of the appearance of CANFORA NEW.FA.DEM. and contents of the pack
CANFORA NEW.FA.DEM. 10 % hydroalcoholic cutaneous solution – bottle of 100 ml or 1000 ml.
CANFORA NEW.FA.DEM. 10 % oily cutaneous solution – bottle of 100 ml or 1000 ml.

Marketing Authorisation Holder
New.Fa.Dem. srl Farmaceutici e Chimici with registered office and production facility in Viale Ferrovia dello Stato,
zona A.S.I., Giugliano in Campania NA.

Manufacturer
New.Fa.Dem. srl Farmaceutici e Chimici with registered office and production facility in Viale Ferrovia dello Stato,
zona A.S.I., Giugliano in Campania NA.