Clotrimazole Doc Generici

CLOTRIMAZOLE PHARMEG – Transfer of Marketing Authorization
Change of name to CLOTRIMAZOLE DOC var.4

Package leaflet: Information for the user

CLOTRIMAZOLO DOC 2% vaginal cream

clotrimazole
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always 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 any of the side effects occur, 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 CLOTRIMAZOLO DOC is and what it is used for
2. What you need to know before using CLOTRIMAZOLO DOC
3. How to use CLOTRIMAZOLO DOC
4. Possible side effects
5. How to store CLOTRIMAZOLO DOC
6. Package contents and other information

1. What CLOTRIMAZOLO DOC is and what it is used for

CLOTRIMAZOLO DOC contains clotrimazole, an antifungal agent that inhibits the growth of fungi.
CLOTRIMAZOLO DOC 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.
Such 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 CLOTRIMAZOLE DOC

Do not use CLOTRIMAZOLE DOC

• 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 CLOTRIMAZOLE DOC 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.

Use, especially if prolonged, of topical products (applied to the skin) may cause sensitization (development of increased sensitivity); in such cases, treatment must be discontinued and a doctor or pharmacist should be consulted.
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.
Moreover, to prevent reinfection, particularly in cases of Candida vulvitis or balanitis, local treatment of the partner is recommended.
During treatment with CLOTRIMAZOLE DOC, do not use tampons, vaginal douches, spermicides, or other vaginal products.
During treatment with CLOTRIMAZOLE DOC, 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 CLOTRIMAZOLE DOC
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 CLOTRIMAZOLE DOC may increase blood levels of sirolimus and tacrolimus. In this case, your doctor will closely monitor your condition.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Available clinical data on the risk during pregnancy are limited. CLOTRIMAZOLE DOC may be used during pregnancy only if clearly needed and under medical supervision.
Breastfeeding
CLOTRIMAZOLE DOC may be used during breastfeeding.
Fertility
No studies have been conducted in humans on the effects of clotrimazole on fertility; 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 machinery.
CLOTRIMAZOLE DOC 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 CLOTRIMAZOLE DOC

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 necessary, 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 CLOTRIMAZOLE DOC 2–3 times a day over the entire urogenital and anal area.
To prevent reinfection, particularly in cases of Candida vulvitis or balanitis, the partner should also be treated locally at the same time by applying the cream to the foreskin (the skin covering the glans, the most distal part of the penis). Facilitate local absorption of the cream with gentle massage.

Duration of treatment
The maximum duration of treatment 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 out until it stops.
2. Open the tube. Screw the single-use applicator onto the tube and press firmly. Fill the applicator by gently squeezing the tube.
3. Once lying in a supine position (on your back) 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.
4. Remove the applicator and then discard it.

The applicator should be used only once and then discarded to avoid possible reinfection.

Hygiene advice
It is important to follow certain personal hygiene practices 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 (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 favor infection;
• If using internal sanitary pads, change them frequently and avoid using them at night; external sanitary pads are preferable.

If you use more CLOTRIMAZOLE DOC than you should
Acute intoxication is unlikely, as it is improbable to 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 oral intake of an excessive dose of CLOTRIMAZOLE DOC, contact your doctor immediately or go to the nearest hospital.

If you forget to use CLOTRIMAZOLE DOC
Continue treatment as recommended.
If you have any doubts about how to use CLOTRIMAZOLE DOC, 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 face, lips, mouth, tongue and throat which may cause breathing and swallowing difficulties),
• hypersensitivity (allergy),
• syncope (fainting),
• hypotension (low blood pressure),
• dyspnoea (difficulty in 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, 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 CLOTRIMAZOLE DOC

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 and properly stored.
Do not use CLOTRIMAZOLE DOC 2% cream after 3 months from the 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 package leaflet.

6. Package contents and other information

What CLOTRIMAZOLO DOC 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 CLOTRIMAZOLO DOC and contents of the pack
CLOTRIMAZOLO DOC is a homogeneous vaginal cream, white to almost 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
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan, Italy
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)