Clozol

Package leaflet: Information for the user

CLOZOL 2% vaginal cream

clotrimazole
Please read all of 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 to do.

• 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 your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What CLOZOL is and what it is used for

CLOZOL contains clotrimazole, an antifungal agent that inhibits the growth of fungi.
CLOZOL 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 swelling sensation 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 CLOZOL

Do not use CLOZOL

• 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 CLOZOL 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.

The use, especially if prolonged, of topical products (applied to the skin) may cause sensitization reactions (development of increased sensitivity); in such cases treatment must be discontinued and medical advice sought.
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 could be transmitted to your partner.
Furthermore, to prevent reinfection, particularly in cases of Candida-related vulvitis or balanitis, local treatment of the partner is recommended.
During treatment with CLOZOL, do not use tampons, vaginal douches, spermicides, or other vaginal products.
During treatment with CLOZOL, 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 CLOZOL
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 organ transplant rejection), as CLOZOL may increase blood levels of sirolimus and tacrolimus. In such cases, your doctor will closely monitor your condition.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Clinical data on the risk during pregnancy are limited. CLOZOL may be used during pregnancy only if clearly needed and under medical supervision.

Breastfeeding
CLOZOL may be used during breastfeeding.

Fertility
No studies in humans have been conducted on the effects of clotrimazole on fertility; however, animal studies have not shown any reproductive toxicity.

Driving and operating machinery
This medicine does not affect, or has a negligible effect on, the ability to drive vehicles or operate machinery.

CLOZOL contains cetyl stearyl alcohol and benzyl alcohol
This medicine contains cetyl stearyl alcohol, which may cause localized 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 CLOZOL

Use this medicine exactly as described in this leaflet or as instructed 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 Candidal balanitis, apply a thin layer of CLOZOL cream 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 cream applied to the foreskin (the skin covering the glans, the most distal portion of the penis). Gently massage the cream locally to enhance absorption.

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

1. Pull the plunger of the single-use applicator outwards until it stops.
2. Open the tube. Screw the single-use applicator onto the tube and hold it firmly in place. Fill the applicator by gently squeezing the tube.
3. Once lying in a supine position (on your back) with knees slightly bent, remove the applicator from the tube, insert it as deeply as possible into the vagina, and empty it by steadily and continuously pressing the plunger.
4. Remove the applicator and then discard it.

The applicator must be used only once and then discarded to avoid possible reinfections.

Health education notes
It is important to follow certain personal hygiene practices for prevention:

• Avoid wearing tight-fitting clothing;

• Avoid wearing nylon or other synthetic fiber underwear: prefer cotton or natural fiber garments;

• Avoid using alkaline pH intimate soaps: acidic pH detergents (pH 5) are recommended to maintain the normal acidic environment of the vagina;

• Avoid using vaginal douches, which may disrupt the vaginal environment and thereby promote the establishment of infections;

• if using internal sanitary pads, change them frequently and avoid using them at night; external sanitary pads are preferable.

If you use more CLOZOL than you should
Acute intoxication is unlikely, as it is improbable that it would occur after a single vaginal or cutaneous application of an excessive dose (application over a large area under conditions favorable for absorption) or after accidental oral ingestion. There is no specific antidote. In case of accidental ingestion or overdose of CLOZOL, contact your doctor immediately or go to the nearest hospital.

If you forget to use CLOZOL
Continue treatment as per the recommended dosage.
If you have any doubts about using CLOZOL, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur with this medicine at an unknown frequency (frequency cannot be estimated from the available data):

• anaphylactic reaction (severe allergic reaction),
• angioedema (swelling of face, lips, mouth, tongue and throat which may cause breathing or swallowing difficulties),
• hypersensitivity (allergy),
• syncope (fainting),
• hypotension (low blood pressure),
• dyspnea (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, edema (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, talk to your doctor or pharmacist. You can 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 CLOZOL

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, stored correctly.
Do not use CLOZOL 2% cream more than 3 months after first opening.
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.
It is important to always keep the medicine information available; therefore, retain both the packaging and the package leaflet.

6. Package contents and other information

What CLOZOL 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, cetostearyl alcohol, octyldodecanol, benzyl alcohol, purified water.

Description of the appearance of CLOZOL and package contents
CLOZOL is a homogeneous white to off-white vaginal cream for gynaecological use.
The pack consists of an aluminium tube containing 30 g of vaginal cream with 6 single-use applicators.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)