Ellecos
ItalyTable of Contents
Package leaflet: Information for the user
ELLECOS 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.
- Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days.
Contents of this leaflet:
- What ELLECOS is and what it is used for
- What you need to know before using ELLECOS
- How to use ELLECOS
- Possible side effects
- How to store ELLECOS
- Contents of the pack and other information
1. What ELLECOS is and what it is used for
ELLECOS contains clotrimazole, an antifungal agent that inhibits the growth of fungi.
ELLECOS is used in adults and adolescents over 12 years of age for the treatment of local symptoms
associated with vulvovaginal and glans (distal portion of the penis) infections caused by Candida,
previously diagnosed. These 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 ELLECOS
Do not use ELLECOS
- 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 ELLECOS 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 prolonged use, of topical products (applied to the skin) may cause sensitization reactions (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.
Moreover, to prevent reinfection, particularly in cases of vulvitis or balanitis caused by Candida, local treatment of the partner is recommended.
During treatment with ELLECOS, do not use tampons, vaginal douches, spermicides, or other vaginal products.
During treatment with ELLECOS, 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 ELLECOS
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 ELLECOS may increase blood levels of sirolimus and tacrolimus. In such cases, your doctor will monitor your condition closely.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breast-feeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Available clinical data on the risk during pregnancy are limited. ELLECOS may be used during pregnancy only if clearly needed and under medical supervision.
Breast-feeding
ELLECOS may be used during breast-feeding.
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 a negligible effect on the ability to drive or operate machinery.
ELLECOS 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 ELLECOS
Use this medicine exactly as stated 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 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 ELLECOS cream 2–3 times a day 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 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 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 outwards 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 lying in a supine position (on your back) with knees slightly bent, remove the applicator from the tube, 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 practices for prevention:
- Avoid wearing tight-fitting clothing;
- Avoid wearing nylon or other synthetic fiber underwear: prefer cotton or natural fiber garments;
- Avoid using alkaline pH intimate soaps: use acidic pH (pH 5) cleansers 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 preferable.
If you use more ELLECOS 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 ELLECOS is accidentally ingested or swallowed, inform your doctor immediately or go to the nearest hospital.
If you forget to use ELLECOS
Continue treatment as recommended in the prescribed dosage.
If you have any doubts about the use of ELLECOS, 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, with frequency not known (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),
- 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 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 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 ELLECOS
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, stored under
correct conditions.
Do not use ELLECOS 2% cream more than 3 months after first opening.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 information about the medicine available; therefore, retain both the
packaging and the package leaflet.
6. Package contents and other information
What ELLECOS contains
- The active substance is clotrimazole. 5 g of vaginal cream contains 100 mg of clotrimazole.
- The other components are: sorbitan stearate, polysorbate 60, cetyl palmitate, cetyl stearyl alcohol, octyldodecanol, benzyl alcohol, purified water.
Description of the appearance of ELLECOS and contents of the pack
ELLECOS 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
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)