Package leaflet: Information for the user

CLOTRIMAZOLE DOC Generics 1% cream

Read this leaflet carefully before 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 information or advice, consult your pharmacist.
If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 3-4 weeks.

Contents of this leaflet:

What CLOTRIMAZOLE DOC Generics is and what it is used for
What you need to know before using CLOTRIMAZOLE DOC Generics
How to use CLOTRIMAZOLE DOC Generics
Possible side effects
How to store CLOTRIMAZOLE DOC Generics
Contents of the pack and other information

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

CLOTRIMAZOLO DOC Generici contains the active substance clotrimazole, which belongs to a group of
medicines called antifungals, effective against fungal growth.
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), tinea corporis.

2. What you need to know before using CLOTRIMAZOLE DOC Generics

Do not use CLOTRIMAZOLE DOC Generics

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 CLOTRIMAZOLE DOC Generics.
Do not swallow the cream and avoid contact with the eyes.
The use of CLOTRIMAZOLE DOC Generics, especially if used for prolonged periods, may cause allergic reactions (sensitization). If this occurs, treatment must be discontinued and you should consult your doctor.
Inform your doctor if you do not notice any improvement after 3–4 weeks, or if your symptoms worsen or recur (relapses).
Children
If the skin infection is in the diaper area (diaper dermatitis), it is not recommended to use an occlusive, non-breathable diaper after applying the cream.
Other medicines and CLOTRIMAZOLE DOC Generics
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
If you are in the first three months of pregnancy, use this medicine only if strictly necessary and after consulting your doctor.
Breastfeeding
Discontinue breastfeeding during treatment with CLOTRIMAZOLE DOC Generics.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
CLOTRIMAZOLE DOC Generics contains cetyl stearyl alcohol
It may cause local skin reactions (e.g. contact dermatitis).
Health education notes
To prevent fungal infections and their recurrence, it is helpful to follow certain hygienic and preventive measures, 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 wear breathable and comfortable footwear, and insoles should be changed or washed regularly.
Limit the use of clothing made of synthetic fibers.
In newborns, avoid prolonged contact of urine or feces with the skin by frequently changing diapers.
Have dogs and cats examined by a veterinarian before introducing them into the household.
If a family member develops a fungal infection, it is advisable to take additional hygiene precautions, such as keeping clothing separate and washing them at high temperatures.

3. How to use CLOTRIMAZOLE DOC Generics

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.
Before applying this medicine, wash and dry the affected area thoroughly.
Apply a small amount of cream to the affected area 2–3 times a day, gently massaging to aid absorption.
Half a centimetre of cream is sufficient to treat an area the size of the palm of your hand.
Do not exceed the recommended doses without consulting your doctor.
CLOTRIMAZOLE DOC Generics is particularly indicated for the treatment of skin infections in hairless (glabrous) areas.
In general, treatment lasts 3–4 weeks.
To prevent new infections from developing, it is recommended to continue treatment for at least 2 further weeks after symptoms have disappeared.
To avoid relapses, which are common in fungal infections (mycoses), follow the hygiene measures described in section 2, “Health education notes”.
If you use more CLOTRIMAZOLE DOC Generics than you should
In case of accidental ingestion of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use CLOTRIMAZOLE DOC Generics
Do not apply a double dose to make up for the missed application.
If you have any doubts about how to use 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)

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

Reporting of side effects
If you experience any side effects, 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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CLOTRIMAZOLE DOC Generici

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.
This medicine requires no special storage conditions.
Do not dispose of any medicine 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 CLOTRIMAZOLO DOC Generici 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 CLOTRIMAZOLO DOC Generici and contents of the pack
CLOTRIMAZOLO DOC Generici is a cream contained in a 30 g tube.
Marketing Authorization Holder
DOC Generici s.r.l. – Via Turati, 40 – 20121 Milan
Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy