ABIMONO 1% Cream

Зміст інструкції

1. ABIMONO 1 % cream
   1. What ABIMONO is and what it is used for
   2. What you need to know before using ABIMONO
   3. How to use ABIMONO
   4. Possible side effects
   5. How to store ABIMONO
   6. Contents of the pack and other information
2. ABIMONO 600 mg vaginal ovule, 1 % vaginal cream
   1. What is ABIMONO and what is it used for
   2. What you need to know before you use ABIMONO
   3. How to use ABIMONO
   4. Possible side effects
   5. How to store ABIMONO
   6. Contents of the pack and other information

ABIMONO 1 % cream

Isoconazole nitrate

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 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 get worse

Contents of this leaflet:

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

1. What ABIMONO is and what it is used for

ABIMONO contains isoconazole nitrate, an antifungal agent for local use, meaning it works by eliminating fungi from the skin.
ABIMONO is indicated in adultsfor the local treatment of superficial mycoses (superficial infections caused by fungi) that affect skin that is either bare or covered with hair, such as:

• dermatophytoses (skin infections covered with hair that manifests as an inflamed, scaly patch, with broken hairs, and may also be covered with pustules);
• candidiasis (a fungal infection caused by a fungus called Candida that affects the superficial layers of the skin and mucous membranes);
• pityriasis versicolor (a fungal infection characterized by a change in skin color, with irregular, well-defined, flat, light brown patches on light skin or lighter than the surrounding healthy skin if dark-skinned, as the yeast interferes with melanin production). See your doctor if you do not feel better or if your symptoms worsen.

2. What you need to know before using ABIMONO

Do not use ABIMONO

• if you are allergic to isoconazole nitrate or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines used to treat fungal infections.

Warnings and precautions
Consult your doctor or pharmacist before using ABIMONO.
ABIMONO is for external use only. Do not ingest.

Avoid contact with eyes.
Wash your hands thoroughly after using the medicine
Use, especially if prolonged, of topical products may cause allergic reactions (see section
“Possible side effects”). In this case, stop treatment and consult your doctor who will establish the appropriate
therapy.
During the use of this medicine, fungi and/or bacteria against which this medicine is not
able to act may develop. Therefore, consult your doctor if you do not notice any improvement or if you notice a worsening of
symptoms after the treatment period prescribed by the doctor.

Other medicines and ABIMONO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Cross-sensitivity reactions between isoconazole, miconazole, econazole and tioconazole are possible.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine. If you are pregnant or breastfeeding
use this medicine only if absolutely necessary and under direct medical supervision.
The infant must not come into contact with the treated skin of the breast.

Driving and operating machinery
ABIMONO does not affect the ability to drive vehicles or operate machinery.

ABIMONO 1 % cream contains cetyl stearyl alcohol
It may cause local skin reactions (e.g. contact dermatitis).

3. How to use ABIMONO

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.

Unless otherwise prescribed by your doctor, the recommended dose is 2 applications per day.
The duration of treatment is generally 2-3 weeks, sometimes also 4 weeks in difficult cases,
especially at the level of the interdigital spaces. On specific medical prescription, treatments of
longer duration are also possible.
To prevent relapses, it is advisable that the treatment be continued for at least 2 weeks after clinical
healing.
In case of interdigital lesions, insert a gauze pad soaked in Abimono cream between the toes.
To ensure the successful outcome of the treatment, strictly observe certain hygienic precautions, including
carefully drying the interdigital spaces in case of fungal infection localized to the feet.

If you use more ABIMONO than you should
No cases of isoconazole nitrate overdose are known. In case of accidental intake/ingestion of
this medicine, contact your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Skin irritations may occur, very rarely contact dermatitis, and allergic reactions.
If you experience an allergic reaction during treatment with ABIMONO STOPtreatment and
consult your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store ABIMONO

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not take this medicine after the expiry date that is stated on the pack after Scad. The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Do not dispose of any medicine in 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 pack and other information

What ABIMONO 1% cream contains

• the active ingredient is isoconazole nitrate. 100 g of cream contains 1.00 g of isoconazole nitrate;
• the other components are: polysorbate 60, sorbitan monostearate, cetyl stearyl alcohol(see the paragraph “ABIMONO contains cetyl stearyl alcohol”), liquid paraffin, white petrolatum, distilled water.

Description of the appearance of ABIMONO and contents of the pack
It is presented as a white cream for local use packaged in a 20 g tube.

Marketing Authorisation Holder
Farmitalia S.r.l.
Viale Alcide De Gasperi 165/B
95127 Catania

Manufacturer
Special Product’s Line S.p.A.
Via Campobello, 15
00040 Pomezia (RM)

ABIMONO 600 mg vaginal ovule, 1 % vaginal cream

Isoconazole nitrate

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 want more information or advice, ask your doctor or pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ABIMONO and what is it used for

ABIMONO contains isoconazole nitrate, an antimicrobial for gynaecological use.
ABIMONO is indicated in womenadultsfor the local treatment of infections caused by fungi such as vulvo-vaginal infections, even if associated with infections caused by bacteria. See your doctor if you do not feel better or
if you feel worse.

2. What you need to know before you use ABIMONO

Do not use ABIMONO

• if you are allergic to isoconazole nitrate or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines used to treat fungal infections.

Warnings and precautions
Talk to your doctor or pharmacist before using ABIMONO.
ABIMONO is for local vaginal use only. Do not ingest.
When using Abimono it is important to know:
avoid contact with the eyes.
Wash your hands thoroughly after using the medicine.

• During the treatment of vaginal fungal infections and in the days immediately following, to avoid re-infection, change towels and underwear daily and sterilize them by boiling (preferably cotton).
• For the same reason, consult your doctor about the possibility of simultaneous local treatment of your partner.
• The use, especially if prolonged, of products for local use can give rise to allergic reactions (see section “Possible side effects”). In this case, stop treatment and consult your doctor who will establish the appropriate therapy.

During the use of this medicine, fungi and/or bacteria may develop against which this medicine is not
able to act. Therefore, see your doctor if you do not notice any improvement or if you notice a worsening of
symptoms after the treatment period prescribed by your doctor.

Other medicines and ABIMONO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions of Abimono with other medicines are known to date. However, it is advisable to inform your doctor if
you are taking:

• Medicines to thin the blood (anticoagulants) such as warfarin.

Cross-sensitivity reactions between isoconazole, miconazole, econazole and tioconazole are possible.
Pregnancy, breastfeeding and fertility
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
If you are pregnant, the applicator for administering ABIMONO must be
used with caution (see section 3 “How to use ABIMONO”).
Breastfeeding
It is not known whether the active ingredient of Abimono passes into breast milk. The risk to the infant cannot be
excluded.
Fertility
There is no data to demonstrate that fertility is impaired by the use of Abimono

Driving and using machines
ABIMONO does not affect the ability to drive vehicles or use machines.

ABIMONO 1 % vaginal cream contains cetyl stearyl alcohol
May cause local skin reactions (e.g. contact dermatitis).

3. How to use ABIMONO

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.
The single-use applicator is used to insert the cream deeply into the vagina. This is preferable before bedtime and in a supine position, with legs slightly bent.
Do not use ABIMONO during your menstrual period.
If you are pregnant, use the applicator device with caution and only as directed by your doctor.
During treatment with this medicine, your partner should also use ABIMONO 1% cream. The cream should be applied to the genital organ, in particular on the glans and foreskin, twice a day for about a week.
The simultaneous use of latex condoms or diaphragms with vaginal antimicrobial preparations may decrease the effectiveness of latex contraception. Therefore, products like Abimono should not be used together with diaphragms or latex condoms. Patients who use spermicides should consult their doctor as any local vaginal treatment may inactivate the spermicide.

ABIMONO 600 mg vaginal ovule

How much
The recommended dose is 1 ovule.

How
Insert the ovule deeply into the vagina.

ABIMONO 1% vaginal cream

How much
The recommended dose is 1 application per day, for one week.

Instructions for use

• Remove the cap from the tube and screw the applicator onto the tube
• Push the plunger progressively until it stops
• Fill the applicator with cream by applying gentle pressure to the tube
• remove the applicator from the tube and replace the cap
• Insert the filled applicator deeply into the vagina and empty it into the cavity by pushing the plunger
• Remove the applicator and discard it.

If you think that the effect of Abimono is too strong or too weak, contact your doctor or pharmacist.

If you use more ABIMONO than you should
In case of accidental ingestion/ingestion or excessive application of Abimono, contact your doctor or pharmacist or go to the nearest hospital.

If you forget to use ABIMONO
Do not use a double dose to make up for a forgotten dose when you remember, simply use the next dose and continue treatment as prescribed.
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 gets them.
If you experience any of the following side effects during treatment with ABIMONO STOPthe
treatment and consult your doctor:

• allergic reaction
• burning and irritation and vaginal pain
• cramps in the lower abdomen
• skin rash
• headache

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store ABIMONO

Keep this medicine out of the sight and reach of children.

ABIMONO 600 mg vaginal ovule
Store at a temperature not exceeding 30 °C.

ABIMONO 1% vaginal cream
This medicine does not require special storage conditions.
Do not take this medicine after the expiry date which is stated on the package after Exp.
The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ABIMONO 600 mg vaginal ovule contains

• the active ingredient is isoconazole nitrate. Each ovule contains 0.6 g of isoconazole nitrate;
• the other ingredients are: boric acid, semi-synthetic glycerides.

What ABIMONO 1% vaginal cream contains

• the active ingredient is isoconazole nitrate. 100 g of cream contain 1 g of isoconazole nitrate;
• the other ingredients are: sorbitan monostearate, polyoxyethylene sorbitan monostearate, cetyl stearyl alcohol(see paragraph “ABIMONO contains cetyl stearyl alcohol”), white petrolatum, isopropyl myristate, boric acid, purified water.

Description of the appearance of ABIMONO and contents of the pack

ABIMONO 600 mg vaginal ovule
It is presented in an ovule for gynaecological use packaged in blisters in packs of 1 ovule.

ABIMONO 1% vaginal cream
It is presented as a white cream for gynaecological use packaged in a 30 g tube. Each pack
contains the tube and 6 single-use applicators.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Farmitalia S.r.l.
Viale Alcide De Gasperi 165/B
95127 Catania

Manufacturer

ABIMONO 600 mg vaginal ovule
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR)

ABIMONO 1% vaginal cream
Special Product's Line s.p.a.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR).