Ecorex

Package leaflet: Information for the user

ECOREX 1% vaginal cream, 150 mg ovules

Econazole nitrate
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 instructed you.
• Keep this leaflet. You may need to read it again.
• If you need more advice or information, 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 your symptoms worsen.

Contents of this leaflet:

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

1. What ECOREX is and what it is used for

ECOREX contains the active substance econazole nitrate, which belongs to a group of medicines called
antifungal agents, used to prevent the growth of fungi.
ECOREX is indicated for the treatment of the following symptoms affecting the internal and external areas of the vagina, when these are caused by fungal infections due to Candida species previously diagnosed by the physician:

• itching, white discharge (leucorrhoea), redness, and sensation of swelling of the vaginal mucosa;
• burning during urination.

Consult your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you should know before using ECOREX

Do not use ECOREX

• if you are allergic to econazole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Apply ECOREX only in the vaginal area.
Children
This medicine may be administered to children only when strictly necessary and under direct medical supervision.
Other medicines and ECOREX
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Interactions with other medicines and ECOREX are unlikely; however, use caution and inform your doctor if you are taking medicines to treat blood clotting disorders (oral anticoagulants) such as warfarin and acenocoumarol, as the anticoagulant effect of these medicines may be altered.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use ECOREX only when strictly necessary and under direct medical supervision.
Driving and using machines
ECOREX does not affect the ability to drive or operate machinery.
ECOREX 1% vaginal cream contains parahydroxybenzoates and propylene glycol
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains propylene glycol, which may cause skin irritation.

3. How to use ECOREX

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

ECOREX 1% vaginal cream: Fill the applicator with cream and insert it completely into the vagina, preferably while lying down. Repeat the application for 15 days, every evening before going to bed.
Continue the treatment even after symptoms have disappeared (such as itching, whitish discharge).

ECOREX 150 mg vaginal ovules: Insert one 150 mg ovule completely into the vagina, preferably while lying down. Repeat the application every evening before going to bed for three consecutive days.

The treatment should be repeated in the following cases:

• In case of recurrence (reappearance of a previous infection)
• If, one week after completion of treatment, your doctor determines that the infection has not been eliminated

Do not exceed the recommended doses.

If you use more ECOREX than you should
It is extremely unlikely that an overdose will occur with this medicine; any effects would be limited to local irritation.

ECOREX is intended for vaginal use only.

In case of accidental ingestion, contact your doctor or the nearest hospital for treatment of symptoms, which may include nausea, vomiting, and diarrhea.

If the medicine comes into contact with the eyes, rinse the affected area thoroughly with water or a physiological solution and consult a doctor if symptoms persist.

If you forget to use ECOREX
Do not use a double dose to make up for the forgotten dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
The frequency of the following side effects is not known because it cannot be estimated based on the available data:

• burning and irritation of the vagina;
• cramps affecting the pelvis and lower abdomen (pelvic cramps);
• skin irritation (rash);
• headache (cephalalgia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ECOREX

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 product in its original, undamaged packaging and properly stored.
Store ECOREX 150 mg ovules at a temperature not exceeding 25°C.
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.

6. Contents of the package and other information

Product composition
ECOREX 1% vaginal cream

• The active substance is econazole. 100 g of cream contain 1 g of econazole nitrate.
• The other ingredients are: polyglycolyzed fatty acid esters, propylene glycol, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), deionized water.

ECOREX 150 mg vaginal ovules

• The active substance is econazole. Each ovule contains 150 mg of econazole nitrate.
• The other ingredients are: solid semisynthetic glycerides and polycarbophil.

Packaged contents
ECOREX 1% vaginal cream – 78 g tube with applicator.
ECOREX 150 mg ovules – pack of 6 ovules.
Marketing Authorization Holder
Teofarma s.r.l.
Via Fratelli Cervi, 8 – 27010 – Valle Salimbene, PAVIA (PV)
Manufacturers
ECOREX 1% vaginal cream: Sofar S.p.A. – via Firenze 40 – Trezzano Rosa (MI) – Italy
ECOREX 150 mg ovules: Lamp S.Prospero S.p.A. - via della Pace 25/A – S. Prospero S/S (Modena) – Italy