Clotrimazole IpsO Pharma
Italy
Table of Contents
Package leaflet: Information for the user
CANDAZOL 2% vaginal cream
clotrimazole
Please read 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.
- 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 you notice worsening of symptoms after 7 days.
Contents of this leaflet:
- What CANDAZOL is and what it is used for
- What you need to know before using CANDAZOL
- How to use CANDAZOL
- Possible side effects
- How to store CANDAZOL
- Contents of the pack and other information
1. What CANDAZOL is and what it is used for
CANDAZOL contains clotrimazole, an antifungal agent that inhibits the growth of fungi.
CANDAZOL is used in adults and adolescents over the age of 12 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, leucorrhea (whitish vaginal discharge), redness and swelling of the vaginal mucosa and glans, and burning sensation during urination.
Contact 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 CANDAZOL
Do not use CANDAZOL
- 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 CANDAZOL 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 (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 could 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 CANDAZOL, do not use tampons, vaginal douches, spermicides, or other vaginal products.
During treatment with CANDAZOL, 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 CANDAZOL
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 CANDAZOL 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 might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Clinical data available on pregnancy risk are limited. CANDAZOL may be used during pregnancy only if clearly needed and under medical supervision.
Breastfeeding
CANDAZOL 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 has negligible effect on the ability to drive or operate machinery.
CANDAZOL contains cetyl stearyl alcohol and benzyl alcohol
This medicine contains cetyl stearyl 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 CANDAZOL
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 aged over 12 years
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, the treatment may be extended for another 3 days.
If your doctor has diagnosed you with Candida vulvitis or Candida balanitis, apply a thin layer of CANDAZOL 2–3 times daily to the entire urogenital and anal area.
To prevent reinfection, particularly in cases of Candida 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). Facilitate local absorption of the cream with gentle massage.
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 hold it firmly in place. Fill the applicator by gently squeezing the tube.
- Once lying in a supine position (on your back) with legs slightly bent, remove the single-use applicator, insert it 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.
Health education notes
It is important to follow certain personal hygiene measures for prevention:
- avoid wearing tight-fitting clothing;
- avoid wearing nylon or other synthetic fiber underwear: cotton or natural fiber garments are preferable;
- avoid using alkaline pH intimate soaps: acidic pH cleansers (pH 5) are recommended to maintain the normal acidic environment of the vagina;
- avoid vaginal douching, which may disrupt the vaginal environment and thereby favor the establishment of infections;
- if using internal sanitary pads, change them frequently and avoid using them at night; external sanitary pads are generally preferable.
If you use more CANDAZOL than you should
Acute intoxication is unlikely, as it is improbable that toxicity 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. If an excessive dose of CANDAZOL is accidentally ingested or swallowed, contact your doctor immediately or go to the nearest hospital.
If you forget to use CANDAZOL
Continue treatment as directed in the recommended dosage.
If you have any doubts about the use of CANDAZOL, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets 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 the 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 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 effects, 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 CANDAZOL
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 CANDAZOL 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 carton
and the package leaflet.
6. Package contents and other information
What CANDAZOL 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 CANDAZOL and contents of the pack
CANDAZOL is a vaginal cream, homogeneous, 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
Ipso Pharma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)
Distribution Licensee
PHARMEXTRACTA S.P.A.
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)