Ganazolo

Package leaflet: Information for the user

Ganazolo 10 mg/g cream, 10 mg/g cutaneous emulsion

Econazole nitrate
Equivalent medicine
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 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 any improvement or if you notice a worsening of symptoms.

Contents of this leaflet:

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

1. What Ganazolo is and what it is used for

Ganazolo contains econazole nitrate, which belongs to a group of medicines called "antifungals",
used to treat infections caused by fungi.
Ganazolo is indicated for the treatment of:

• skin infections (cutaneous mycoses) caused by fungi, yeasts, and molds;
• skin infections caused by bacteria known as "Gram-positive", such as streptococci and staphylococci;
• fungal infections of the external ear canal (fungal external otitis) and infections of the ear canal caused by fungi (mycosis) (only for the "cutaneous emulsion" form);
• fungal infections of the nails (onychomycosis);
• a particular superficial skin infection caused by a fungus, characterized by skin discoloration with irregular patches that may be lighter or darker than the surrounding skin (Pityriasis Versicolor).

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Ganazolo

Do not use Ganazolo

• if you are allergic to econazole nitrate or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other substances chemically similar to econazole (such as imidazoles).

Warnings and precautions
Talk to your doctor or pharmacist before using Ganazolo.
Ganazolo is intended for external use only.
Ganazolo is not intended for ophthalmic or oral use.
If allergic reactions or irritation occur, stop treatment and contact your doctor.

Children and adolescents

Other medicines and Ganazolo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking oral anticoagulants (medicines to thin the blood) such as warfarin or acenocoumarol, as Ganazolo may alter their effect.
Ganazolo should be used with caution if you are being treated with anticoagulants: your doctor will monitor your blood tests more frequently and may consider adjusting the dose of your oral anticoagulant medicine during and after treatment with econazole.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use Ganazolo during the first trimester of pregnancy unless your doctor considers it necessary for your health.
Ganazolo may be used during the second and third trimesters of pregnancy only if your doctor determines that the potential benefit to the mother outweighs the possible risks to the baby.

Breastfeeding
Ganazolo should be used with caution during breastfeeding and only under medical supervision.

Driving and using machines
The effects of Ganazolo on the ability to drive vehicles and operate machinery are unknown.

Ganazolo contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate and propylene glycol
Methyl p-hydroxybenzoate and propyl p-hydroxybenzoate may cause allergic reactions (including delayed reactions).
Ganazolo 10 mg/g cream contains 150 mg of propylene glycol in 1.5 g of cream equivalent to 100 mg/g.
Ganazolo 10 mg/g cutaneous emulsion contains 8.5 mg of propylene glycol in 2 drops of emulsion equivalent to 100 mg/g.
Propylene glycol may cause skin irritation.

3. How to use Ganazolo

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.
Unless otherwise prescribed by your doctor, Ganazolo should be applied to the infected skin areas, with gentle massage, twice daily, in the morning and evening, until the infection has completely disappeared (which generally occurs within 1–3 weeks).
It is advisable to continue applying Ganazolo for a few days after the infection has cleared.
If you notice exudate (fluid or blood) in skin folds, clean the area (for example, spaces between the toes, gluteal folds) with gauze or bandages before applying Ganazolo.
For ear infections (only if there is no lesion of the eardrum), the recommended dose is 1–2 drops of Ganazolo cutaneous emulsion instilled into the ear canal 1–2 times a day.
Alternatively, you may insert into the external ear canal a strip of gauze soaked in the cutaneous emulsion.
For the treatment of nail infections (onychomycosis), an occlusive dressing is recommended (bandaging the infected skin area with a bandage or gauze after application of the medicine to prevent its leakage).

If you use more Ganazolo than you should
Ganazolo is for external use only.
If it comes into contact with the eyes, rinse thoroughly with clean water or physiological saline solution and consult your doctor if symptoms persist.
In case of accidental ingestion, nausea, vomiting, and diarrhea may occur.
In the event of accidental ingestion/ingestion of Ganazolo, contact your doctor immediately or go to the nearest hospital.

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

If you stop using Ganazolo
If you need to discontinue treatment with Ganazolo, contact your doctor.
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 use of topical products, especially if prolonged, may lead to sensitisation; if this occurs, discontinue treatment and consult your doctor.
If particularly intense local reactions occur, treatment must be discontinued and medical advice sought.

The following side effects may occur:

Common side effects (may affect up to 1 in 10 people)

• itching,
• skin burning sensations,
• pain.

Uncommon side effects (may affect up to 1 in 100 people)

• skin redness (erythema),
• malaise (feeling unwell),
• swelling.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• swelling of the legs, arms, face, mucous membranes, mouth, lips and/or tongue (angioedema),
• allergic skin inflammation caused by contact with substances of various kinds (contact dermatitis),
• skin rash,
• urticaria,
• blister formation,
• skin peeling.

In very rare cases, local irritation has been observed, for example areas of skin affected by intense redness with blistering, which upon rupture lead to the formation of small crusts (eczema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://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 Ganazolo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.”
The expiry date refers to the last day of that month.
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. Package contents and other information

What Ganazolo 10 mg/g cream contains

• The active substance is econazole nitrate. 100 g of cream contain 1.00 g of econazole nitrate.
• The other components are: polyglycol ester of saturated fatty acids, propylene glycol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, deionized water.

What Ganazolo 10 mg/g cutaneous emulsion contains

• The active substance is econazole nitrate. 100 g of cutaneous emulsion contain 1.00 g of econazole nitrate.
• The other components are: polyglycol ester of saturated fatty acids, propylene glycol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, distilled water.

Description of the appearance of Ganazolo and contents of the pack
Ganazolo 10 mg/g cream
tube of 30 g.
Ganazolo 10 mg/g cutaneous emulsion
bottle of 30 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Istituto Ganassini S.p.A. di Ricerche Biochimiche
Via P. Gaggia 16 – 20139 Milano (MI)
Tel: 02 53570 41
Fax: 02 534106
e-mail: [email protected]

Manufacturer
Ganazolo 10 mg/g cream:
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe 1 – 29016 Cortemaggiore (PC)
Ganazolo 10 mg/g cutaneous emulsion:
Sofar S.p.A. Via Firenze 40 – 20060 Trezzano Rosa (MI)

Patient information leaflet

Ganazolo 10 mg/g vaginal cream, 150 mg ovules

Econazole nitrate
Generic medicine
Please read this entire 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.

• 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 any improvement or if your symptoms worsen.

Contents of this leaflet:

1. What Ganazolo is and what it is used for
2. What you need to know before using Ganazolo
3. How to use Ganazolo
4. Possible side effects
5. How to store Ganazolo
6. Package contents and other information

1. What Ganazolo is and what it is used for

Ganazolo contains econazole nitrate, which belongs to a class of medicines called "antifungals", used to treat fungal infections (mycoses).
Ganazolo is used for the treatment of:

• fungal infections of the vaginal (internal) and genital (external) area in women (vulvovaginal mycoses);
• fungal infection of the external genitals in men (fungal balanitis).

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Ganazolo

Do not use Ganazolo:

• if you are allergic to econazole nitrate or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other substances chemically similar to econazole (such as imidazoles).

Warnings and precautions
Talk to your doctor or pharmacist before using Ganazolo.
Ganazolo 10 mg/g vaginal cream and Ganazolo 150 mg ovules are for vaginal use only.
Ganazolo 10 mg/g vaginal cream and Ganazolo 150 mg ovules are not for ophthalmic or oral use: avoid contact with the eyes and do not swallow the medicine.
Avoid concomitant use of latex condoms or diaphragms for contraception with Ganazolo, as simultaneous use may reduce the effectiveness of the contraceptive. Therefore, Ganazolo must not be used simultaneously with latex condoms or diaphragms.
If you use spermicide products as contraceptives, consult your doctor, because Ganazolo may reduce the effectiveness of the spermicide.
Do not use Ganazolo concomitantly with other products for internal or external treatment of the genital area.
If you experience severe irritation or sensitization (allergic) reaction during use of Ganazolo, stop treatment and consult your doctor.

Other medicines and Ganazolo
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Inform your doctor if you are taking oral anticoagulants (medicines to thin the blood) such as warfarin or acenocoumarol, as Ganazolo may alter their effect.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use Ganazolo during the first trimester of pregnancy unless your doctor considers it necessary for your health. Ganazolo may be used during the second and third trimesters of pregnancy only if your doctor determines that the potential benefit to the mother outweighs the possible risks to the fetus.

Breastfeeding
It is not known whether Ganazolo passes into breast milk. Therefore, Ganazolo should be used with caution during breastfeeding and only under medical supervision.

Driving and use of machines
No effects of Ganazolo on the ability to drive vehicles or operate machinery are known.

Ganazolo 10 mg/g vaginal cream contains methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, and
propylene glycol.
Methyl p-hydroxybenzoate and propyl p-hydroxybenzoate may cause allergic reactions (including delayed reactions).
This medicine contains 500 mg of propylene glycol per applicator, equivalent to 100 mg/g.
Propylene glycol may cause skin irritation.

3. How to use Ganazolo

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

Ganazolo 10 mg/g vaginal cream
The recommended dose is: 1 applicator filled with cream to be used every evening before going to bed for 15 days.
Insert the applicator deeply into the vagina, preferably while lying in a supine position.
Continue the treatment for the full duration even after symptoms such as itching and whitish vaginal discharge (leucorrhoea) have disappeared.

Treatment of partner: Clean the glans and foreskin with warm water and apply the cream once daily for 15 consecutive days.

Ganazolo 150 mg ovules
The recommended dose is:
1 ovule every evening before going to bed, for 3 consecutive days.
Insert the ovule deeply into the vagina, preferably while lying in a supine position.
If the infection recurs or if a follow-up examination one week after treatment still confirms the presence of infection, repeat a second course of treatment.

If you use more Ganazolo than you should
In case of accidental ingestion, nausea, vomiting, and diarrhoea may occur.
If Ganazolo is accidentally ingested or taken orally, inform your doctor immediately or go to the nearest hospital.

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

If you stop using Ganazolo
If you need to stop treatment with Ganazolo, contact your doctor.
If you have any doubts 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.

Side effects at the application site:

• skin burning sensation and prickling sensation (prickling feeling);
• itching;
• skin irritation (erythema).

Side effects with unknown frequency (frequency cannot be established based on available data):

• swelling of the legs, arms, face, mucous membranes, mouth, lips or tongue (angioedema);
• skin rash;
• urticaria;
• allergic reactions (hypersensitivity).

Other side effects reported with the same type of medicines are:

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

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 https://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 Ganazolo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp." or "Expiry". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ganazolo 10 mg/g vaginal cream contains

• The active substance is econazole nitrate. 1 g of vaginal cream contains 10 mg of econazole nitrate.
• The other components are: polyglycolized esters of saturated fatty acids, propylene glycol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, deionized water.

What Ganazolo 150 mg Ovules contain

• The active substance is econazole nitrate. Each ovule contains 150 mg of econazole nitrate.
• The other components are semisynthetic triglycerides.

Description of the appearance of Ganazolo and package contents

• Ganazolo 10 mg/g vaginal cream: pack containing 1 tube of 78 g with applicator
• Ganazolo 150 mg ovules: pack containing 6 ovules

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Istituto Ganassini S.p.A. di Ricerche Biochimiche - Via P. Gaggia 16 – 20139 Milan.
Tel: 02 5357041
Fax: 02 534106
e-mail: [email protected]

Manufacturer
Ganazolo 10 mg/g Vaginal Cream
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe 1 – 29016 Cortemaggiore (PC)
Ganazolo 150 mg ovules
Temmler Italia S.r.l. - Via delle Industrie 2 – 20061 Carugate (MI)

Patient Information Leaflet

Ganazolo 1 mg/ml vaginal solution

Econazole
Equivalent medicine
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 you notice worsening of symptoms.

Contents of this leaflet:

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

1. What Ganazolo is and what it is used for

Ganazolo contains econazole, which belongs to a group of medicines called "antifungals", used to treat fungal infections (mycoses).
Ganazolo is used as an adjunct (coadjuvant) to therapy for infections of the vulva and vagina (vulvovaginal conditions) caused by fungi and/or by bacteria sensitive to econazole.
If you do not feel better or feel worse, consult your doctor.

2. What you need to know before using Ganazolo

Do not use Ganazolo:

• if you are allergic to econazole or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other substances chemically similar to econazole (such as imidazoles).

Warnings and precautions
Talk to your doctor or pharmacist before using Ganazolo.
Ganazolo vaginal solution is for vaginal use only.
Ganazolo vaginal solution is not for ophthalmic or oral use: avoid contact with the eyes and do not ingest the medicine.
Avoid using latex condoms or diaphragms for contraception together with Ganazolo, as concomitant use may reduce the effectiveness of the contraceptive.
Therefore, Ganazolo should not be used at the same time as latex condoms or diaphragms.
If you use sperm-killing products (spermicides) as contraceptives, consult your doctor, as Ganazolo may reduce the effectiveness of the spermicide.
Do not use Ganazolo together with other products for internal or external treatment of the genital area.
If during the use of Ganazolo you experience severe irritation or a sensitization reaction (allergy), stop treatment and consult your doctor.

Other medicines and Ganazolo
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Inform your doctor if you are taking oral anticoagulants (blood-thinning medicines) such as warfarin or acenocoumarol, as Ganazolo may alter their effect.
Ganazolo should be used with caution if you are being treated with anticoagulants: your doctor will monitor your blood tests more frequently and may consider adjusting the dose of your oral anticoagulant during and after treatment with econazole.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Do not use Ganazolo during the first trimester of pregnancy unless your doctor considers it necessary for your health.
Ganazolo may be used during the second and third trimesters of pregnancy only if your doctor determines that the potential benefit to the mother outweighs the possible risks to the unborn child.

Breastfeeding
It is not known whether Ganazolo passes into breast milk. Therefore, Ganazolo should be used with caution during breastfeeding and only under strict medical supervision.

Driving and using machines
No effects of Ganazolo on the ability to drive or operate machinery are known.

Ganazolo contains methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, and propylene glycol
Methyl p-hydroxybenzoate and propyl p-hydroxybenzoate may cause allergic reactions (including delayed reactions).
This medicine contains 10 g of propylene glycol per bottle, equivalent to 66.67 mg/ml.
Propylene glycol may cause skin irritation.

3. How to use Ganazolo

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.

Ganazolo is a ready-to-use solution, and each single-dose container comes with an individually packaged vaginal irrigation cannula.
The recommended dose is:
1 vaginal douche per day for 5 consecutive days, followed by 1 vaginal douche per day on alternate days, for a total of 5 additional douches.

To perform the douche, use the single-dose container and cannula, both of which must be discarded after use. For each douche, use the entire contents of the single-dose container.

How to perform the douche:

• Use the solution at room temperature or warm the closed container slightly under a stream of warm water;
• Hold the neck of the container with one hand and, with the other hand, gently press outward on the closure tab located on top of the cap to remove it;
• Remove a cannula from its packaging and insert its base into the opening in the cap, applying slight pressure to secure it in place;
• The douche is now ready for use, and you may proceed with the irrigation.

Perform the vaginal douche by gently inserting the cannula into the vagina and slowly squeezing the solution into the vaginal cavity by gently pressing the container. After use, discard both the cannula and the container.

If you use more Ganazolo than you should
In case of accidental ingestion, nausea, vomiting, and diarrhea may occur.
If Ganazolo is accidentally ingested or swallowed, contact your doctor immediately or go to the nearest hospital.

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

If you stop using Ganazolo
If you need to discontinue treatment with Ganazolo, contact your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Side effects at the application site:

• burning sensation of the skin and prickling sensation (prickling feeling);
• itching;
• skin irritation (erythema).

Side effects with unknown frequency (frequency cannot be estimated from the available data) are:

• swelling of the legs, arms, face, mucous membranes, mouth, lips and/or tongue (angioedema);
• skin rash;
• hives;
• allergic reactions (hypersensitivity).

Other side effects:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website https://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 Ganazolo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ganazolo contains

• The active substance is econazole. 150 ml of vaginal solution contain 150 mg of econazole.
• The other components are propylene glycol, lactic acid, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, trimethylcetylammonium p-toluenesulphonate, lavender fragrance, deionized water.

Description of the appearance of Ganazolo and contents of the pack
Pack containing 5 vials of 150 ml vaginal solution and 5 disposable applicators.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Istituto Ganassini S.p.A. di Ricerche Biochimiche - Via P. Gaggia 16 – 20139 Milan.
Tel: 02 5357041
Fax: 02 534106
e-mail: [email protected]
Manufacturer
Sofar S.p.A. - Via Firenze 40 – 20060 Trezzano Rosa (MI)