CLOZOL 2% Krem dopochwowy

Treść ulotki

1. CLOZOL 2% vaginal cream
   1. What is CLOZOL and what is it 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

CLOZOL 2% vaginal cream

clotrimazole

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 to.

• 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 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 is CLOZOL and what is it used for

CLOZOL contains clotrimazole, an antifungal agent that inhibits fungal growth.
CLOZOL is used, in adults and adolescents over the age of 12, for the treatment of localized symptoms
resulting from vulvovaginal and glans (distal portion of the penis) infections caused by candida,
previously diagnosed. These symptoms include itching, leukorrhea (whitish vaginal discharge),
redness and a feeling of swelling of the vaginal mucosa and glans, burning during urination.
See 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 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 already suffered from the same disorders less than 2 months ago
• you have a 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), can cause sensitization (acquisition of greater sensitivity); in this case it is necessary to interrupt the treatment and consult your doctor or pharmacist.
Avoid contact with eyes. Do not ingest.
It is preferable to start and end treatment during the intermenstrual period.
During the use of this medicine avoid vaginal intercourse, because the infection could be transmitted to your partner.
Furthermore, in order to avoid reinfection, particularly in the presence of vulvitis or balanitis due to Candida, local treatment of the partner is recommended.
During therapy with CLOZOL do not use tampons, vaginal douches, spermicides or other vaginal products.
During treatment with CLOZOL the effectiveness and safety of latex products, such as condoms and diaphragms, may be reduced.

Children and adolescents
This medicine should not be used by children under 12 years of age.

Other medicines and CLOZOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor in particular if you are being treated with sirolimusor oral tacrolimus(used to prevent organ transplant rejection) as CLOZOL may increase the levels of sirolimus and tacrolimus in the blood. In this case, your doctor will carefully monitor your condition.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Clinical data available regarding risk in pregnancy are limited. CLOZOL may be used during pregnancy only if necessary and under the supervision of a doctor.

Breastfeeding
CLOZOL can be used during breastfeeding.

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

Driving and operating machinery
The medicine does not impair or negligibly impairs the ability to drive vehicles or operate machinery.

CLOZOL contains cetostearyl alcohol and benzyl alcohol
This medicine contains cetostearyl alcohol: it may cause localized skin reactions (e.g. contact dermatitis).
This medicine contains 100 mg of benzyl alcoholper dose, equivalent to 20 mg/g.
Benzyl alcohol can cause allergic reactions and mild local irritation.

3. How to use CLOZOL

Use this medicine following 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 the age of 12 years
Introduce the contents of one applicator (approximately 5 g) as deeply as possible into the vagina, once a day, preferably in the evening, before bedtime, for 3 consecutive days.
If necessary, the treatment can be extended for another 3 days.
If your doctor has told you that you have vulvitisor Candida balanitis, apply a thin layer of CLOZOL 2-3 times a day to the entire urogenital and anal area.
To avoid reinfection, especially in the presence of vulvitis or Candida balanitis, the partner must be treated locally at the same time, applying the cream to the prepuce (the skin covering the glans, the most distal portion of the penis). Facilitate absorption of the cream locally with gentle massage.

Duration of treatment
The maximum duration of treatment is 7 days. If symptoms persist, consult your doctor.
In case of vulvitis or balanitis, the treatment should be prolonged for 1-2 weeks.

Method of use

• 1. Remove the plunger from the single-use applicator until it stops.
• 2. Open the tube. Screw the single-use applicator onto the tube and hold it firmly. Fill the applicator by applying gentle pressure to the tube.
• 3. Once you have assumed a supine position (lying on your back) with your legs slightly bent, remove the single-use applicator, insert it as deeply as possible into the vagina, and empty it by applying regular and continuous pressure to the plunger.
• 4. Remove the applicator and then discard it.

The applicator should be used only once and then discarded, in order to avoid possible reinfections.
Health education notes
It is important to follow some personal hygiene rules for prevention:

• avoid wearing overly tight clothing;
• avoid wearing nylon or other synthetic underwear: preferably use cotton or natural fiber clothing;
• avoid using alkaline pH soaps for intimate hygiene: the use of acidic pH (pH 5) detergents is recommended to respect the normal acidity of the vaginal environment;
• avoid using vaginal douches which can alter the vaginal environment and therefore promote

the establishment of infections;

• if using tampons, change them frequently and avoid using them during the night; it is still preferable to use external sanitary pads.

If you use more CLOZOL than you should
There is no risk of acute intoxication as it is unlikely to occur after a single vaginal or cutaneous application of an excessive dose (application to an extensive area under favorable absorption conditions) or due to involuntary oral intake. There is no specific antidote. In case of accidental ingestion/intake of an excessive dose of CLOZOL, immediately inform your doctor or go to the nearest hospital.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of this medicine, the following side effects may occur with unknown frequency (frequency cannot be
estimated based on available data):

• anaphylactic reaction (severe allergic reaction),
• angioedema (swelling of the face, lips, mouth, tongue and throat that can cause problems with breathing and
  swallowing),
• hypersensitivity (allergy),
• syncope (fainting),
• hypotension (low blood pressure).
• dyspnea (difficulty breathing),
• abdominal pain,
• nausea,
• skin 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 retention) and pain at the application site.

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.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help to 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 which is stated on the packaging. The expiry date refers to the last day of that month. The expiry date refers to the product in intact packaging, correctly stored.
Do not use CLOZOL 2% cream after 3 months from first opening.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 have the information about the medicine available, therefore keep both the box

6. Contents of the pack and other information

What CLOZOL contains

• The active ingredient is clotrimazole. 5 g of vaginal cream contains 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 contents of the pack
CLOZOL is presented in the form of a homogeneous vaginal cream, from white to off-white in color, for gynecological use.
The contents of the pack are an aluminum 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)