Abimono
Italy
Table of Contents
Package leaflet: Information for the patient
ABIMONO 1% cream
Isoconazole nitrate
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 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:
- What ABIMONO is and what it is used for
- What you need to know before using ABIMONO
- How to use ABIMONO
- Possible side effects
- How to store ABIMONO
- Contents of the pack and other information
1. What ABIMONO is and what it is used for
ABIMONO contains isoconazole nitrate, a topical antifungal agent that works by eliminating skin fungi.
ABIMONO is indicated in adults for the local treatment of superficial mycoses (superficial fungal infections) affecting hairy or non-hairy skin, such as:
- dermatophytoses (fungal infections of hairy skin appearing as inflamed, scaly patches with broken hairs, sometimes covered with pustules);
- candidiasis (fungal infection caused by a fungus called Candida, affecting the superficial layers of the skin and mucous membranes);
- pityriasis versicolor (a fungal infection characterized by skin discoloration, with irregular, well-demarcated, flat patches of light brown color on light skin or lighter than surrounding healthy skin on dark skin, since the yeast interferes with melanin production).
Consult your doctor if you do not feel better or if you notice worsening of symptoms.
2. What you should know before using 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 topical use only. Do not swallow.
Avoid contact with the eyes.
Wash your hands thoroughly after using the medicine.
The use, especially if prolonged, of topical products may lead to allergic reactions (see section "Possible side effects"). If this occurs, stop treatment and consult your doctor, who will initiate appropriate therapy.
During the use of this medicine, fungi and/or bacteria may develop that are not susceptible to this medicine. Therefore, consult your doctor if you do not notice improvement or if you observe worsening of symptoms after the treatment period prescribed by your doctor.
Other medicines and ABIMONO
Inform 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 may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine. If you are pregnant or breastfeeding, use this medicine only if clearly needed and under direct medical supervision.
The infant must not come into contact with treated breast skin.
Driving and using machines
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 exactly as described 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 a doctor, the recommended dose is 2 applications per day.
The duration of treatment is generally 2–3 weeks; sometimes up to 4 weeks in difficult cases, especially involving interdigital spaces. Longer treatment periods may be possible upon specific medical instruction.
To prevent recurrence, treatment should continue for at least 2 weeks after clinical healing has occurred.
In case of interdigital lesions, insert a gauze compress soaked with Abimono cream between the toes.
To ensure successful treatment, strictly follow certain hygiene measures, including carefully drying the interdigital spaces in case of foot mycosis.
If you use more ABIMONO than you should
There are no known cases of overdose with isoconazole nitrate. In case of accidental ingestion/ingestion of this medicine, consult your doctor or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you forget to use ABIMONO
Do not use a double dose to make up for the missed dose.
4. Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Skin irritation may occur; very rarely, contact dermatitis and allergic reactions may develop.
If you experience an allergic reaction while using ABIMONO, STOP treatment and consult your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor.
You may also report side effects directly via the national reporting system at the website
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 use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the last day of that month. The expiry date applies to the product in its original, unopened packaging, correctly stored.
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 ABIMONO 1% cream contains
- The active substance is isoconazole nitrate. 100 g of cream contain 1.00 g of isoconazole nitrate;
- The other components are: polysorbate 60, sorbitan monostearate, cetylstearyl alcohol (see section “ABIMONO contains cetylstearyl alcohol”), liquid paraffin, white vaseline, distilled water.
Description of the appearance of ABIMONO and contents of the pack
It is a white cream for topical use, packaged in a 20 g tube.
Marketing Authorisation Holder
Farmitalia S.r.l.
Via Pinciana, 25
00198 Rome
Manufacturer
Special Product’s Line S.p.A.
Via Campobello, 15
00040 Pomezia (RM)
Package leaflet: Information for the patient
ABIMONO 600 mg vaginal suppository, 1 % vaginal cream
Isoconazole nitrate
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 doctor or pharmacist.
- If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What ABIMONO is and what it is used for
- What you need to know before using ABIMONO
- How to use ABIMONO
- Possible side effects
- How to store ABIMONO
- Contents of the pack and other information
1. What ABIMONO is and what it is used for
ABIMONO contains isoconazole nitrate, an antimicrobial for gynaecological use.
ABIMONO is indicated in adult women for the local treatment of infections caused by fungi, such as vulvo-vaginal infections, even when associated with bacterial infections. Consult your doctor if you do not feel better or if you feel worse.
2. What you should know before using 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 vaginal use only. Do not swallow.
When using Abimono, it is important to know:
avoid contact with the eyes.
Wash your hands thoroughly after using the medicine.
- During treatment for vaginal mycosis and in the days immediately following, to avoid reinfection, change your towels and underwear daily and sterilize them by boiling (preferably cotton garments).
- For the same reason, consult your doctor about whether your partner should also receive concurrent local treatment.
- The use, especially prolonged use, of topical products may lead to allergic reactions (see section "Possible side effects"). If this occurs, discontinue treatment and consult your doctor, who will initiate appropriate therapy.
During the use of this medicine, fungi and/or bacteria may develop against which this medicine is ineffective. Therefore, consult your doctor if you do not notice any improvement or if your symptoms worsen after the treatment period prescribed by your doctor.
Other medicines and ABIMONO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between Abimono and other medicines are currently known. 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, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
If you are pregnant, the applicator for the administration of ABIMONO should 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. Risk to the breastfed infant cannot be ruled out.
Fertility
There are no data showing that fertility is impaired by the use of Abimono.
Driving and use of machinery
ABIMONO does not affect the ability to drive or operate machinery.
ABIMONO 1% vaginal cream contains cetyl stearyl alcohol
It may cause local skin reactions (e.g. contact dermatitis).
3. How to use ABIMONO
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.
The single-use applicator is used to insert the cream deeply into the vagina. It is preferable to do this before going to bed, while lying on your back with knees slightly bent.
Do not use ABIMONO during menstruation.
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 area, particularly on the glans and foreskin, twice daily for approximately one week.
The simultaneous use of latex condoms or diaphragms with vaginal antimicrobial preparations may reduce the effectiveness of latex contraceptives. Therefore, products such as Abimono must not be used together with latex diaphragms or latex condoms. Patients using spermicides should consult their doctor, as any local vaginal treatment may inactivate the spermicide.
ABIMONO 600 mg vaginal ovule
Dosage
The recommended dose is 1 ovule.
How to use
Insert the ovule deeply into the vagina.
ABIMONO 1% vaginal cream
Dosage
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
- Gradually push the plunger to the stop position
- Fill the applicator with cream by gently squeezing the tube
- Remove the applicator from the tube and replace the cap
- Insert the filled applicator deeply into the vagina and empty it by pushing the plunger
- Remove the applicator and dispose of 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 or excessive application of Abimono, consult 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; simply use the next dose as scheduled 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, STOP the treatment and consult your doctor:
- allergic reaction
- burning, irritation, and vaginal pain
- cramps in the lower abdomen
- skin rash
- headache
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor.
You may also report side effects directly via 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 any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, unopened packaging, stored correctly.
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 ABIMONO 600 mg vaginal ovule contains
- The active substance is isoconazole nitrate. Each ovule contains 0.6 g of isoconazole nitrate;
- The other ingredients are: boric acid, semisynthetic glycerides.
What ABIMONO 1% vaginal cream contains
- The active substance 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 section “ABIMONO contains cetyl stearyl alcohol”), white vaseline, isopropyl myristate, boric acid, purified water.
Description of the appearance of ABIMONO and the contents of the pack
ABIMONO 600 mg vaginal ovule
Presented as a gynecological ovule, packaged in a blister pack containing 1 ovule.
ABIMONO 1% vaginal cream
Presented as a white cream for gynecological use, packaged in a 30 g tube. Each package contains the tube and 6 single-use applicators.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome, Italy
Manufacturer
ABIMONO 600 mg vaginal ovule
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR), Italy
ABIMONO 1% vaginal cream
Special Product's Line s.p.a.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR), Italy.