GANAZOLO 10 mg /G Крем

Содержание инструкции

1. Ganazolo 10 mg/g cream, 10 mg/g cutaneous emulsion
   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
2. Ganazolo 10 mg/g vaginal cream, 150 mg vaginal suppositories
   1. What is Ganazolo and what is it 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
3. Ganazolo 1 mg/ml vaginal solution
   1. What is Ganazolo and what is it used for
   2. What you need to know before you use Ganazolo
   3. How to use Ganazolo
   4. Possible side effects
   5. How to store Ganazolo
   6. Contents of the pack and other information

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

Econazole nitrate
Generic medicine

Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms do not improve or if they get worse.

Contents of this leaflet:

• 1. What Ganazolo is and what it is used for
• 2. What you need to know before you use 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 for the treatment of 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 called "Gram positive", such as streptococci and staphylococci;
• infections of the external ear canal caused by fungi (otitis externa mycotica) and infections of the ear canal caused by fungi (mycosis) (only for the “cutaneous emulsion” form);
• nail infections caused by fungi (onychomycosis);
• a particular superficial skin infection due to infection by a fungus and characterized by a change in skin color, with irregular patches that may be lighter or darker than the surrounding skin (Pityriasis Versicolor).

See 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 any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other substances similar to econazole from a chemical point of view (such as imidazole).

Warnings and precautions
Consult your doctor or pharmacist before using Ganazolo.
Ganazolo is indicated only for external use.
Ganazolo is not indicated for ophthalmic or oral use.
If allergic reactions occur or irritation appears, 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.
Tell 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 must be used with caution if you are being treated with anticoagulants: your doctor will monitor your blood tests more
frequently and assess a possible adjustment of the dosage of the oral anticoagulant medicine during treatment with econazole and after its discontinuation.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Do not use Ganazolo in the first trimester of pregnancy unless your doctor considers it necessary for your
health.
Ganazolo may be used in 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 must be used with caution during breastfeeding and only under medical supervision.

Driving and operating machinery
The effects of Ganazolo on the ability to drive vehicles and operate machinery are not known.

Ganazolo contains methyl p-hydroxybenzoateand propyl p-hydroxybenzoate and propylene glycol
Methyl p-hydroxybenzoate and propyl p-hydroxybenzoate may cause allergic reactions (even delayed).
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 following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Unless otherwise prescribed by your doctor, Ganazolo should be applied to the infected skin areas, with a light
massage, 2 times a day, morning and evening until the infection has completely disappeared (which generally
occurs in 1 - 3 weeks).
It is recommended to continue applying Ganazolo for a few days after the infection has disappeared.
If you notice the presence of exudate (fluid or blood) in the skin folds, clean the area (for example 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 can insert a strip of gauze soaked in cutaneous emulsion into the external ear canal.
In the treatment of nail infection (onychomycosis) an occlusive dressing is recommended (bandaging
the infected skin area with a bandage or gauze after applying the medicine to prevent it from
leaking out).

If you use more Ganazolo than you should
Ganazolo is for external use only.
In case of contact with eyes, rinse with clean water or saline solution and consult your doctor if the
symptoms persist.
In case of accidental ingestion, nausea, vomiting and diarrhea may occur.
If you accidentally ingest/take Ganazolo, 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 a missed dose.

If you stop using Ganazolo
If you need to stop treatment with Ganazolo, contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The use of topical products, especially if prolonged, may give rise to sensitization phenomena; if this occurs, stop
treatment and consult your doctor.
In case of particularly intense local reactions, it is necessary to stop treatment and consult your
doctor.
The following side effects may occur:

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

• itching,
• burning sensation of the skin,
• pain.

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

• redness of the skin (erythema),
• feeling unwell,
• swelling.

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

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

In very rare cases, local irritations have occurred, for example, areas of skin affected by intense
redness with the presence of blisters that, when broken, lead to the formation of crusts (eczema).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
You can also report side effects directly through 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 which is stated on the pack after “Exp.”
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 pack and other information

What Ganazolo 10 mg/g cream contains

• The active ingredient is econazole nitrate. 100 g of cream contains 1.00 g of econazole nitrate.
• The other ingredients are: saturated fatty acid polyglycol esters , propylene glycol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate,deionised water.

What Ganazolo 10 mg/g cutaneous emulsion contains

• The active ingredient is econazole nitrate. 100 g of cutaneous emulsion contains 1.00 g of econazole nitrate.
• The other ingredients are: saturated fatty acid polyglycol esters ,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 Authorisation Holder and Manufacturer
Marketing Authorisation 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)

Ganazolo 10 mg/g vaginal cream, 150 mg vaginal suppositories

Econazole nitrate
Generic medicine

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse.

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 is Ganazolo and what is it used for

Ganazolo contains econazole nitrate which belongs to a class of medicines called “antifungals”, used
to treat fungal infections (infections caused by fungi).
Ganazolo is used for the treatment of:

• infections of the vaginal region (internal) and the genital region (external) of women caused by fungi (vulvovaginal mycoses);
• infection of the external genitals of men caused by fungi (Mycotic 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 useGanazolo:

• if you are allergic to econazole nitrate or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other substances similar to econazole from a chemical point of view (such as imidazole).

Warnings and precautions
Consult your doctor or pharmacist before using Ganazolo.
Ganazolo 10 mg/g vaginal cream and Ganazolo 150 mg pessaries are for vaginal use only.
Ganazolo 10 mg/g vaginal cream and Ganazolo 150 mg pessaries are not for ophthalmic or oral use: avoid contact
with the eyes and do not ingest the medicine.
Avoid the concomitant use of latex condoms or diaphragms for contraception with Ganazolo because simultaneous
use may reduce the effectiveness of the contraceptive. Therefore Ganazolo should not be used
simultaneously with latex condoms or diaphragms.
If you are using products to destroy sperm as contraceptives (spermicides) you should consult your doctor
because Ganazolo may reduce the effectiveness of the spermicide.
Do not use Ganazolo in conjunction with other products for the internal or external treatment of the genitals.
If you experience severe irritation or sensitization reaction (allergy) during the use of Ganazolo, discontinue the
treatment and consult your doctor.

Other medicines and Ganazolo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are taking oral anticoagulants (blood thinners) such as warfarin or
acenocoumarol, as Ganazolo may modify their effect.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

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

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 operating machinery
No effects of Ganazolo on the ability to drive and 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 following exactly as stated in this leaflet or as instructed 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 every evening before going to bed for 15 days.
You should insert the applicator deep into the vagina, preferably in a supine position.
You should continue with the treatment even after the disappearance of symptoms such as itching and whitish vaginal discharge (leucorrhea).

Partner treatment:clean the glans and foreskin with warm water and apply the cream once a day for
15 consecutive days.

Ganazolo 150 mg pessaries
The recommended dose is:
1 pessary every evening before going to bed, for 3 consecutive days.
You should insert the pessary deep into the vagina, preferably in a supine position.
If the infection recurs or if, one week after treatment, the control examination confirms the presence of the
infection, you should repeat a second course of treatment.

If you use more Ganazolo than you should
In case of accidental ingestion, nausea, vomiting and diarrhea may occur.
In case of accidental ingestion/administration of Ganazolo, immediately inform your doctor or go to the nearest
hospital.

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

If you stop using Ganazolo
If you need to stop the treatment with Ganazolo, contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects at the application site:

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

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

• swelling of the legs, arms, face, mucous membranes, mouth, lips or tongue (angioedema);
• skin rash (rash);
• urticaria (hives);
• 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through 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 which is stated on the pack after “Scad.” or “Scadenza”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ganazolo 10 mg/g vaginal cream contains

• The active ingredient is econazole nitrate. 1 g of vaginal cream contains 10 mg of econazole nitrate.
• The other ingredients are: polyglycol esters of saturated fatty acids, propylene glycol,methyl p-hydroxybenzoate,propyl p-hydroxybenzoate,deionised water.

What Ganazolo 150 mg Suppositories contains

• The active ingredient is econazole nitrate. Each suppository contains 150 mg of econazole nitrate.
• The other ingredients are semi-synthetic triglycerides.

Description of the appearance of Ganazolo and contents of the pack

• Ganazolo 10 mg/g vaginal cream pack of 1 tube of 78 g with applicator
• Ganazolo 150 mg suppositoriespack of 6 suppositories

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Istituto Ganassini S.p.A. di Ricerche Biochimiche - Via P. Gaggia 16 – 20139 Milano.
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 suppositories
Temmler Italia S.r.l. - Via delle Industrie 2 – 20061 Carugate (MI)

Ganazolo 1 mg/ml vaginal solution

Econazole
Generic medicine

Read this leaflet carefully before you use 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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 you use 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 is Ganazolo and what is it used for

Ganazolo contains econazole which belongs to a group of medicines called “antifungals”, used to
treat fungal infections (infections caused by fungi).
Ganazolo is used in addition (as an adjunct) to the therapy of infections of the vulva and vagina (vulvovaginal
conditions) caused by fungi and/or bacteria sensitive to econazole.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before you use 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 similar to econazole from a chemical point of view (such as imidazole).

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 the concomitant use of latex condoms or diaphragms for contraception with Ganazolo because the
simultaneous 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 are using products to destroy sperm as contraceptives (spermicides) consult your doctor because
Ganazolo may reduce the effectiveness of the spermicide.
Do not use Ganazolo in conjunction with other products for the internal or external treatment of the genitals.
If you experience severe irritation or sensitization reaction (allergy) during the use of Ganazolo, stop the
treatment and consult your doctor.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

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

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
There are no known effects of Ganazolo on the ability to drive vehicles and operate machinery.

Ganazolo contains methyl p-hydroxybenzoate, propyl p-hydroxybenzoate andpropylene 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 following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist .
Ganazolo is in a ready-to-use solution and each single-dose container is supplied with a vaginal irrigation cannula individually packaged.
The recommended dose is:
1 douche daily for 5 consecutive days and then 1 douche daily on alternate days for a total of 5 douches.
You must use the single-dose container and the cannula for the douche and discard them after use. For each douche, you must use the entire contents of the single-dose container.
How to perform the douche:

• Use the douche at room temperature or by warming the closed container under a stream of warm water;
• Hold the neck of the container with one hand and with the other hand press outwards on the closing stem located above the cap in order to remove it;
• Remove a cannula from the package and insert the bottom of it into the hole in the cap, pressing it in with light pressure;
• The douche is now ready and you can perform the irrigation.

You must perform the vaginal douche by gently inserting the cannula into the vagina and pushing the liquid into the vagina by gently pressing on the container. After use, discard 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 you accidentally ingest/take Ganazolo, immediately inform your doctor or go to the nearest hospital.

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

If you stop using Ganazolo
If you need to stop treatment with Ganazolo, contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects at the application site:

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

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

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

Other side effects:

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
You can also report side effects directly through 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 which is stated on the pack after “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 pack and other information

What Ganazolo contains

• The active ingredient is econazole. 150 ml of vaginal solution contains 150 mg of econazole.
• The other ingredients are propylene glycol, lactic acid, methyl parahydroxybenzoate, propyl parahydroxybenzoate, trimethylcetylammonium p-toluenesulfonate, lavender fragrance, deionised water.

Description of the appearance of Ganazolo and contents of the pack
Pack of 5 bottles of 150 ml of vaginal solution and 5 single-use applicators.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Istituto Ganassini S.p.A. di Ricerche Biochimiche - Via P. Gaggia 16 – 20139 Milano.
Tel: 02 5357041
Fax: 02 534106
e-mail: [email protected]
Manufacturer
Sofar S.p.A.- Via Firenze 40 – 20060 Trezzano Rosa (MI)