Clotrimazole Eg
Italy
Table of Contents
Package leaflet: Information for the user
CLOTRIMAZOLE EG 2% vaginal cream
clotrimazole
Please read all of this leaflet carefully before you use 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 told you to.
- 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, talk to your doctor or pharmacist. See section 4.
- Talk to your doctor if you do not notice improvement or if your symptoms worsen after 7 days.
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
- Package contents and other information
1. What CLOTRIMAZOLO EG is and what it is used for
CLOTRIMAZOLO EG contains clotrimazole, an antifungal agent that inhibits the growth of fungi.
CLOTRIMAZOLO EG is used in adults and adolescents over 12 years of age for the treatment of localized symptoms due to vulvovaginal and glans (distal portion of the penis) infections caused by Candida, previously diagnosed. These symptoms include itching, leucorrhoea (whitish vaginal discharge), redness and a sensation of swelling of the vaginal mucosa and glans, and burning during urination.
Consult your doctor if you do not feel better or if you feel worse after 7 days of treatment.
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 if:
- you have previously suffered from the same symptoms less than 2 months ago
- you have fever, lower abdominal pain, back pain, foul-smelling vaginal discharge, nausea, vaginal bleeding and/or shoulder pain.
Use, especially if prolonged, of topical products (applied to the skin) may cause sensitization reactions (development of increased sensitivity); if this occurs, treatment must be discontinued and you should consult your doctor or pharmacist.
Avoid contact with the eyes. Do not swallow.
It is preferable to start and complete treatment during the intermenstrual period.
During use of this medicine, avoid vaginal intercourse, as the infection may be transmitted to your partner.
Furthermore, to prevent reinfection, particularly in cases of Candida vulvitis or balanitis, local treatment of the partner is recommended.
During treatment with CLOTRIMAZOLE EG, do not use tampons, vaginal douches, spermicides or other vaginal products.
During treatment with CLOTRIMAZOLE EG, the effectiveness and safety of latex-based products such as condoms and diaphragms may be reduced.
Children and adolescents
This medicine must not be used in children under 12 years of age.
Other medicines and CLOTRIMAZOLE EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are being treated with sirolimus or oral tacrolimus (used to prevent rejection of organ transplants), as CLOTRIMAZOLE EG may increase blood levels of sirolimus and tacrolimus. In this case, your doctor will closely monitor your condition.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Available clinical data on the risk during pregnancy are limited. CLOTRIMAZOLE EG may be used during pregnancy only if clearly needed and under medical supervision.
Breastfeeding
CLOTRIMAZOLE EG may be used during breastfeeding.
Fertility
No studies on the effects of clotrimazole on fertility in humans have been conducted; however, animal studies have not shown any reproductive toxicity.
Driving and using machines
This medicine does not affect or affects negligibly the ability to drive or use machinery.
CLOTRIMAZOLE EG contains cetyl stearyl alcohol and benzyl alcohol
This medicine contains cetyl stearyl alcohol: it may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 100 mg of benzyl alcohol per dose, equivalent to 20 mg/g.
Benzyl alcohol may cause allergic reactions and mild local irritation.
3. How to use CLOTRIMAZOLE 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.
Adults and adolescents over 12 years of age
Insert the contents of one applicator (approximately 5 g) as deeply as possible into the vagina once daily, preferably in the evening before going to bed, for 3 consecutive days.
If necessary, treatment may be extended for another 3 days.
If your doctor has diagnosed you with Candidal vulvitis or balanitis, apply a thin layer of CLOTRIMAZOLE EG 2–3 times a day to the entire urogenital and anal area.
To prevent reinfection, particularly in cases of Candidal vulvitis or balanitis, the partner should also be treated simultaneously with topical application of the cream to the foreskin (the skin covering the glans, the most distal part of the penis). Enhance local absorption by gently massaging the cream into the skin.
Duration of treatment
The maximum treatment duration is 7 days. If symptoms persist, consult your doctor.
In cases of vulvitis or balanitis, treatment should be continued for 1–2 weeks.
Instructions for use
- Pull the plunger of the single-use applicator out until it stops.
- Open the tube. Screw the single-use applicator onto the tube and press firmly to ensure it is securely attached. Fill the applicator by carefully squeezing the tube.
- Lie on your back (supine position) with your legs slightly bent. Insert the single-use applicator as deeply as possible into the vagina and empty it by steadily and continuously pressing the plunger.
- Remove the applicator and then discard it.
The applicator must be used only once and then discarded to avoid possible reinfections.
Hygiene advice
It is important to follow certain personal hygiene practices for prevention:
- Avoid wearing tight-fitting clothing;
- Avoid wearing nylon or other synthetic fibre underwear: prefer cotton or natural fibre garments;
- Avoid using alkaline pH intimate soaps: use acidic pH (pH 5) cleansers to maintain the natural acidity of the vaginal environment;
- Avoid vaginal douching, which may disrupt the vaginal environment and promote infection;
- If using internal sanitary pads, change them frequently and avoid using them overnight; external sanitary pads are preferable.
If you use more CLOTRIMAZOLE EG than you should
Acute intoxication is unlikely, as systemic toxicity is improbable following a single excessive vaginal or cutaneous application (e.g. application over a large area under conditions favouring absorption) or accidental oral ingestion. There is no specific antidote. If an excessive dose of CLOTRIMAZOLE EG is accidentally ingested or swallowed, contact your doctor immediately or go to the nearest hospital.
If you forget to use CLOTRIMAZOLE EG
Continue treatment as directed with the recommended dosage.
If you have any doubts about how to use CLOTRIMAZOLE EG, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur with this medicine at an unknown frequency (the frequency cannot be estimated from the available data):
- anaphylactic reaction (severe allergic reaction),
- angioedema (swelling of the face, lips, mouth, tongue, and throat that may cause breathing or swallowing difficulties),
- hypersensitivity (allergy),
- syncope (fainting),
- hypotension (low blood pressure),
- dyspnoea (difficulty breathing),
- abdominal pain,
- nausea,
- rash,
- urticaria (hives),
- exfoliation in the genital area,
- vaginal discharge,
- vaginal bleeding,
- discomfort in the genital area,
- erythema (redness) in the genital area,
- burning sensation in the genital area,
- itching in the genital area,
- pain in the genital area,
- irritation, oedema (fluid accumulation), and pain at the application site.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at 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 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. The expiry date refers to the last
day of that month. The expiry date applies to the product in its original, unopened packaging, correctly stored.
Do not use CLOTRIMAZOLE EG 2% cream after 3 months from first opening.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.
It is important to always keep the information about the medicine available; therefore, retain both the
packaging and the leaflet.
6. Package contents and other information
What CLOTRIMAZOLE EG contains
- The active substance is clotrimazole. 5 g of vaginal cream contain 100 mg of clotrimazole.
- The other components are: sorbitan stearate, polysorbate 60, cetyl palmitate, cetylstearyl alcohol, octyldodecanol, benzyl alcohol, purified water.
Description of the appearance of CLOTRIMAZOLE EG and contents of the package
CLOTRIMAZOLE EG is a homogeneous vaginal cream, white to off-white in colour, for gynaecological use.
The package contains an aluminium tube with 30 g of vaginal cream and 6 single-use applicators.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR), Italy