VAGISIL 2% Vaginal cream

Зміст інструкції

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

VAGISIL ANTIMICOTICO 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.

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

1. What is VAGISIL ANTIMICOTICO and what is it used for

VAGISIL ANTIMICOTICO contains clotrimazole, an antifungal agent that inhibits fungal growth.
VAGISIL ANTIMICOTICO is used, in adults and adolescents over the age of 12, for the treatment of
local symptoms resulting from vulvovaginal infections caused by candida. These symptoms include itching,
leucorrhea (whitish vaginal discharge), redness and a feeling of swelling of the vaginal mucosa, burning during
urination.
The cream can also be used to treat the partner's penis to prevent reinfection.
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 VAGISIL ANTIMICOTICO

Do not use VAGISIL ANTIMICOTICO

• 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 VAGISIL ANTIMICOTICO 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 (development of increased 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 the 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, in particular in the presence of Candida vulvitis, local treatment of the partner is recommended.
During therapy with VAGISIL ANTIMICOTICO, do not use tampons, vaginal douches, spermicides or other
vaginal products.
During treatment with VAGISIL ANTIMICOTICO, 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 VAGISIL ANTIMICOTICO
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 VAGISIL ANTIMICOTICO 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 with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

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

Breastfeeding
VAGISIL ANTIMICOTICO 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 alter or alters negligibly the ability to drive vehicles or operate machinery.

VAGISIL ANTIMICOTICO contains cetostearyl alcohol and benzyl alcohol
This medicine contains cetostearyl alcohol: 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 VAGISIL ANTIMICOTICO

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, at bedtime, for 3 consecutive days.
If the cream is used to treat the partner's penis, it should be applied two or three times a day for a maximum of two weeks.
If your doctor has told you that you have Candida vulvitis, apply a thin layer of VAGISIL ANTIMICOTICO 2-3 times a day to the entire urogenital and anal area.
To avoid reinfection, especially in the presence of Candida vulvitis, the partner should 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 a gentle massage.

Duration of treatment
The maximum duration of treatment is 3 days. If symptoms persist, consult your doctor.
If the cream is used to treat the sexual partner's penis, it should be applied two or three times a day for a maximum of two 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 (flexed), 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 very 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 attachment of infections;
• if using tampons, change them frequently and avoid use during the night; it is still preferable to use external sanitary pads.

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

If you forget to use VAGISIL ANTIMICOTICO
Continue treatment as recommended dosage.
If you have any doubts about the use of VAGISIL ANTIMICOTICO, ask 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
defined 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,
• pruritus (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 experience any side effects, including those not listed in this leaflet, please inform 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 VAGISIL ANTIMICOTICO

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 VAGISIL ANTIMICOTICO 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 eliminate the
medicines that 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 VAGISIL ANTIMICOTICO contains

• The active ingredient is clotrimazole. 5 g of vaginal cream contains 100 mg of clotrimazole.
• The other ingredients are: sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol, purified water.

Description of the appearance of VAGISIL ANTIMICOTICO and contents of the pack
VAGISIL ANTIMICOTICO is presented in the form of a homogeneous vaginal cream, from white to off-white in color,
for gynecological use.
The pack contains a 30 g aluminum tube of vaginal cream with 6 single-use applicators.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Combe EUROPA S.L.
Calle Orense 58 – 7 º - 28020
Madrid -Spain

Representative for Italy:
Combe ITALIA S.r.l.
Via Procaccini, 41

• 20154 - MILAN

Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)