Cangil

Package leaflet: Information for the user

CANGIL 1% cream

Clotrimazole
Please read all of this leaflet carefully before you start 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, talk to your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3-4 weeks.

Contents of this leaflet:

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

1. What CANGIL is and what it is used for

CANGIL contains the active substance clotrimazole, which belongs to a group of medicines called antifungal agents, effective against the growth of fungi.
This medicine is indicated for the treatment of skin and skin fold infections caused by fungi (fungal infections), such as pityriasis versicolor, cutaneous candidiasis, tinea pedis (athlete's foot), and tinea corporis.

2. What you need to know before using CANGIL

Do not use CANGIL

• if you are allergic to clotrimazole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using CANGIL.
Do not swallow the cream and avoid contact with the eyes.
The use, especially prolonged, of topical skin products (applied to the skin) may lead to sensitization reactions such as erythema (localized redness in the area of skin where the medicine is applied) and itching. In such cases, discontinue treatment and consult your doctor or pharmacist.
If the skin infection is in the diaper area (diaper dermatitis), the use of non-breathable diapers is not recommended after applying the medicine.
Inform your doctor if you do not notice improvement after 3–4 weeks, or if symptoms worsen or recur (relapses).
Other medicines and CANGIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No medicines are known to affect the action of CANGIL.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
If you are in the first three months of pregnancy, you must consult your doctor before using CANGIL.
Breastfeeding
CANGIL may be used during breastfeeding. If applied locally to the nipple area, wash the breast before breastfeeding.
Driving and using machines
This medicine does not affect, or has a negligible effect on, the ability to drive or operate machinery.
CANGIL contains cetyl stearyl alcohol, benzyl alcohol, and polysorbate 60
This medicine contains cetyl stearyl alcohol, which may cause localized skin reactions (e.g. contact dermatitis).
This medicine contains 10 mg/g of benzyl alcohol. Benzyl alcohol may cause allergic reactions and mild local irritation.
This medicine contains polysorbate 60. Polysorbates may cause allergic reactions.

3. How to use CANGIL

Use this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
CANGIL is particularly suitable for treating hairless (glabrous) skin areas.
Before using this medicine, thoroughly wash and dry the area to be treated.
Apply a small amount of cream to the affected area, 2–3 times daily, gently massaging it to promote absorption.
Do not apply large amounts of the product; for example, half a centimeter of cream is sufficient to treat an area the size of a hand.
Do not exceed the recommended doses without medical advice.

Duration of treatment
In general, a treatment period of three to four weeks is sufficient for symptoms to disappear.
To prevent the appearance of new infections, it is recommended to continue treatment for at least two further weeks after symptoms have resolved.
To prevent recurrence of infection, which is very common in fungal infections (mycoses), observe the hygiene measures described below under “Hygiene advice”.

Hygiene advice
To prevent mycosis and recurrence of infection, it is helpful to follow certain hygiene measures, such as:

• Avoid walking barefoot in public places such as swimming pools, gyms, hotel rooms, etc.
• If you practice sports, wear breathable and comfortable footwear, and periodically replace or wash the insoles.
• Limit the use of clothing containing synthetic fibres.
• Change the baby’s diaper frequently to avoid urine or faeces remaining in contact with the skin.
• Have dogs and cats examined by a veterinarian before introducing them into the household.
• Observe additional hygiene precautions, such as changing underwear and towels frequently, and keeping clothes separate and washing them at high temperatures, if a family member has a fungal infection (mycosis).

If you use more CANGIL than you should
In case of accidental ingestion of this medicine, contact your doctor immediately or go to the nearest hospital.
Acute poisoning is unlikely following excessive topical application or accidental ingestion of this medicine.

If you forget to apply CANGIL
Do not use a double dose to make up for the forgotten dose.
Continue treatment as advised in the section “How to use CANGIL”.
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 gets them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

• angioedema (swelling), anaphylactic reaction, hypersensitivity
• syncope (temporary loss of consciousness), hypotension (lowering of blood pressure)
• dyspnea (difficulty breathing)
• skin disorders such as blisters, contact dermatitis, erythema (redness of the skin), paresthesia, desquamation of the skin (loss of cells from the outermost layer of the skin), pruritus, rash, urticaria, stinging pain of the skin, burning sensation of the skin
• irritation at the application site, reaction at the application site, edema, pain.

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 CANGIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 CANGIL contains

• The active substance is clotrimazole. 100 g of cream contain 1 g of clotrimazole.
• The other components are: sorbitan monostearate, polysorbate 60, spermaceti, cetostearyl alcohol, 2-octyldodecanol, benzyl alcohol, purified water.

Description of the appearance of CANGIL and package contents
CANGIL is a homogeneous cream, white to off-white in colour. The pack contains one 30 g tube.
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – Episcopia (Potenza)
Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy