CLOTRIMAZOLO 1 % Cream

Зміст інструкції

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

CLOTRIMAZOLO DOC Generici 1% cream

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 3-4 weeks.

Contents of this leaflet:

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

1. What is CLOTRIMAZOLO DOC Generici and what is it used for?

CLOTRIMAZOLO DOC Generici contains the active ingredient clotrimazole, belonging to a group of
medicines called antifungals, active against the growth of fungi.
This medicine is indicated for the treatment of skin and skin fold infections caused
by fungi (mycoses), such as pityriasis versicolor, cutaneous candidiasis, tinea pedis(athlete's foot), tinea corporis.

2. What you need to know before using CLOTRIMAZOLO DOC Generici

Do not use CLOTRIMAZOLO DOC Generici

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

Warnings and precautions
Consult your doctor or pharmacist before using CLOTRIMAZOLO DOC Generici.
Do not ingest the cream and avoid contact with the eyes.
Use of CLOTRIMAZOLO DOC Generici, especially if for prolonged periods, may cause allergic-type reactions
(sensitization). In this case, it is necessary to interrupt the treatment and consult
your doctor.
Inform your doctor if you do not notice any improvement after 3-4 weeks or if you experience a
worsening or recurrence of symptoms (relapses).

Children
If the skin infection is in the diaper area (diaper rash), it is not recommended to use
a non-breathable diaper (with an "occlusive" effect) after applying the cream.

Other medicines and CLOTRIMAZOLO DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
If you are in the first three months of pregnancy, use this medicine only in cases of real need and after
consulting your doctor.
Breastfeeding
Stop breastfeeding during treatment with CLOTRIMAZOLO DOC Generici.

Driving and using machines
This medicine does not impair the ability to drive vehicles or operate machinery.

CLOTRIMAZOLO DOC Generici contains cetostearyl alcohol
It may cause local skin reactions (e.g. contact dermatitis).

Health education notes
To prevent fungal infection and its recurrences, it is useful to follow some hygienic-health rules, such as:

• In public places such as swimming pools, gyms, hotel rooms etc. avoid walking barefoot.
• For those who practice sports, it is important to use breathable and comfortable footwear, the whose insoles should be changed or washed periodically.
• Limit the use of clothing containing synthetic fibers.
• In newborns, avoid stagnation of urine or feces on the skin by changing the diaper frequently.
• Subject dogs and cats to a veterinary examination before welcoming them into the home environment.
• If a family member shows signs of fungal infection, it is advisable to observe further hygiene precautions, such as keeping clothes separate and washing them at high temperature.

3. How to use CLOTRIMAZOLO DOC Generici

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.
Before using this medicine, wash and dry the area to be treated thoroughly.
Apply a small amount of cream to the affected area 2-3 times a day, massaging gently
to promote absorption.
Half a centimetre of cream is sufficient to treat an area the size of a hand.
Do not exceed the indicated doses without your doctor's advice.
CLOTRIMAZOLO DOC Generici is particularly indicated for the treatment of infections of skin areas
free of hair (glabrous).
In general, the duration of treatment is 3-4 weeks.
To avoid the appearance of new infections, it is recommended to continue treatment for at least another 2
weeks after the symptoms have disappeared.
To avoid relapses, which are very common in fungal infections (mycoses), observe the hygiene rules reported in
paragraph 2 “Health education notes”.

If you use more CLOTRIMAZOLO DOC Generici than you should
In case of accidental ingestion of this medicine, immediately inform your doctor or go to the nearest
hospital.

If you forget to use CLOTRIMAZOLO DOC Generici
Do not apply a double dose to compensate for a missed application.
If you have any doubts about using 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(frequency cannot be estimated from available data)

• allergic reactions with symptoms such as temporary loss of consciousness (syncope), low blood pressure (hypotension), difficulty breathing (dyspnea), urticaria;
• skin disorders such as blisters, discomfort and pain, swelling, irritation, erythema, loss of the upper skin layer (desquamation), itching, rash, burning sensation.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help to provide more
information on the safety of this medicine.

5. How to store CLOTRIMAZOLO DOC Generici

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 “Scad.”. The expiry date
refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 CLOTRIMAZOLO DOC Generici contains

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

Description of the appearance of CLOTRIMAZOLO DOC Generici and contents of the pack
CLOTRIMAZOLO DOC Generici is a cream contained in a tube of 30 g.

Marketing Authorisation Holder
DOC Generici s.r.l. –Via Turati, 40 – 20121 Milano

Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italia