Vagisil antifungal
Italy
Package leaflet: Information for the user
VAGISIL ANTIMYCOTIC 2% vaginal cream
clotrimazole
Please read all of this leaflet carefully before you start 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 told you to.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, consult your pharmacist.
- If you experience any side effects, including any 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 VAGISIL ANTIMYCOTIC is and what it is used for
- What you need to know before using VAGISIL ANTIMYCOTIC
- How to use VAGISIL ANTIMYCOTIC
- Possible side effects
- How to store VAGISIL ANTIMYCOTIC
- Contents of the pack and other information
1. What VAGISIL ANTIMYCOTIC is and what it is used for
VAGISIL ANTIMYCOTIC contains clotrimazole, an antifungal agent that inhibits the growth of fungi.
VAGISIL ANTIMYCOTIC is used in adults and adolescents over 12 years of age for the treatment of
localized symptoms due to vulvovaginal infections caused by Candida. These symptoms include itching,
leucorrhea (whitish vaginal discharge), redness and a sensation of swelling of the vaginal mucosa, and burning during
urination.
The cream may also be used for treatment of 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 ANTIMYCOTIC
Do not use VAGISIL ANTIMYCOTIC
- 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 VAGISIL ANTIMYCOTIC if:
- you have already 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 (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 treatment with this medicine, avoid vaginal intercourse, as the infection could be transmitted to your partner.
Furthermore, to prevent reinfection, particularly in cases of Candida vulvitis, local treatment of the partner is recommended.
During treatment with VAGISIL ANTIMYCOTIC, do not use tampons, vaginal douches, spermicides, or other vaginal products.
During treatment with VAGISIL ANTIMYCOTIC, 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 VAGISIL ANTIMYCOTIC
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 VAGISIL ANTIMYCOTIC 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, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Clinical data on the risk during pregnancy are limited. VAGISIL ANTIMYCOTIC may be used during pregnancy only if clearly needed and under medical supervision.
Breastfeeding
VAGISIL ANTIMYCOTIC 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 machines.
VAGISIL ANTIMYCOTIC 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 alcohol per dose, equivalent to 20 mg/g.
Benzyl alcohol may cause allergic reactions and mild local irritation.
3. How to use VAGISIL ANTIMYCOTIC
Use this medicine exactly as stated 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 the cream is used for treatment of the partner's penis, it should be applied two or three times a day for up to two weeks.
If your doctor has diagnosed you with Candida vulvitis, apply a thin layer of VAGISIL ANTIMYCOTIC 2-3 times a day to the entire urogenital and anal area.
To prevent reinfection, particularly in cases of Candida vulvitis, the partner should be treated simultaneously with local application of the cream to the foreskin (the skin covering the glans, the most distal portion of the penis). Facilitate local absorption of the cream with gentle massage.
Duration of treatment
The maximum treatment duration is 3 days. If symptoms persist, consult your doctor.
If the cream is used for treatment of the sexual partner's penis, it should be applied two or three times a day for up to two 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. Fill the applicator by carefully squeezing the tube.
- Once in the supine position (lying on your back with your abdomen facing upwards), with 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 should 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 underwear or other synthetic fibres: prefer cotton or natural fibre garments;
- Avoid using alkaline pH intimate soaps: acidic pH (pH 5) cleansers are recommended to maintain the normal acidic environment of the vagina;
- Avoid vaginal douching, which may disrupt the vaginal environment and thus promote infection;
- If using internal sanitary pads, change them frequently and avoid using them at night; external sanitary pads are preferable.
If you use more VAGISIL ANTIMYCOTIC than you should
Acute intoxication is unlikely, as it is improbable that this would occur following a single vaginal or cutaneous application of an excessive dose (application over a large area under conditions favourable to absorption) or after accidental oral ingestion. There is no specific antidote. In case of accidental ingestion/overdose of VAGISIL ANTIMYCOTIC, contact your doctor immediately or go to the nearest hospital.
If you forget to use VAGISIL ANTIMYCOTIC
Continue treatment as recommended.
If you have any doubts about the use of VAGISIL ANTIMYCOTIC, 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 with 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 and 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, talk to your doctor or pharmacist. You can also report side effects directly via 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 VAGISIL ANTIMYCOTIC
Keep this medicine out of 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 VAGISIL ANTIMYCOTIC 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 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 leaflet.
6. Package contents and other information
What VAGISIL ANTIMICOTICO 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 VAGISIL ANTIMICOTICO and package contents
VAGISIL ANTIMICOTICO is a homogeneous vaginal cream, white to off-white in colour, for gynaecological use.
The pack contains one 30 g aluminium 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 in 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)