Lenirit micosi
Italy
Table of Contents
Package leaflet: Information for the user
CLOTRIMAZOLE EG 1% cream
Please read this leaflet carefully before using 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 instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult 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 improvement or if you notice worsening of symptoms after 3–4 weeks.
Contents of this leaflet:
- What CLOTRIMAZOLE EG is and what it is used for
- What you need to know before using CLOTRIMAZOLE EG
- How to use CLOTRIMAZOLE EG
- Possible side effects
- How to store CLOTRIMAZOLE EG
- Contents of the pack and other information
1. What CLOTRIMAZOLE EG is and what it is used for
CLOTRIMAZOLE EG 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 (mycoses), such as pityriasis versicolor, cutaneous candidiasis, tinea pedis (athlete's foot), tinea corporis.
Consult your doctor if you do not feel better or if you feel worse after 3–4 weeks, or if you notice recurrence of symptoms (relapses).
2. What you need to know before using CLOTRIMAZOLE EG
Do not use CLOTRIMAZOLE EG
- 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 EG.
Do not swallow the cream and avoid contact with the eyes.
The use of CLOTRIMAZOLE EG, especially if prolonged, may cause sensitization reactions. In such cases, treatment must be discontinued and medical advice should be sought.
Children
If the skin infection affects the diaper area (diaper dermatitis), it is not recommended to use an impermeable diaper (occlusive effect) after applying the cream.
Other medicines and CLOTRIMAZOLE EG
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 currently known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are in the first three months of pregnancy, use this medicine only when strictly necessary and under close medical supervision.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
CLOTRIMAZOLE EG 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 measures, such as:
- Avoid walking barefoot in public places such as swimming pools, gyms, hotel rooms, etc.
- For people 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 containing synthetic fibres.
- In newborns, avoid prolonged contact of urine or faeces 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, additional hygienic precautions are recommended, such as keeping clothing separate and washing it at high temperatures.
3. How to use CLOTRIMAZOLO EG
Use this medicine exactly as described 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 it to promote absorption.
Half a centimetre of cream is sufficient to treat an area the size of a hand.
Do not exceed the recommended doses without consulting your doctor.
CLOTRIMAZOLO EG is particularly indicated for the treatment of infections on hairless (glabrous) skin areas.
Generally, treatment lasts 3–4 weeks.
To prevent new infections from occurring, it is recommended to continue treatment for at least 2 further weeks after symptoms have disappeared.
To avoid relapses, which are very common in fungal infections (mycoses), follow the hygiene measures described in section 2, “Hygiene education notes”.
If you use more CLOTRIMAZOLO EG 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 apply CLOTRIMAZOLO EG
Continue treatment as directed according to the recommended dosage.
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 everyone 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 due to fluid accumulation (oedema), irritation, loss of the upper 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 EG
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 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 no longer required. This will help protect the environment.
6. Package contents and other information
What CLOTRIMAZOLE EG 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 CLOTRIMAZOLE EG and package contents
CLOTRIMAZOLE EG is a cream contained in a 30 g tube.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 – 20136 Milan
Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy