BRUMIXOL 30 G Крем

Содержание инструкции

1. BRUMIXOL 1% cutaneous solution, 1% dermatological cream
   1. What is BRUMIXOL and what is it used for
   2. What you need to know before using BRUMIXOL
   3. How to use BRUMIXOL
   4. Possible side effects
   5. How to store BRUMIXOL
   6. Contents of the pack and other information
2. BRUMIXOL 1% vaginal cream, 100 mg vaginal suppositories
   1. What is BRUMIXOL and what is it used for
   2. What you need to know before using BRUMIXOL
   3. How to use BRUMIXOL
   4. Possible side effects
   5. How to store BRUMIXOL
   6. Contents of the pack and other information

BRUMIXOL 1% cutaneous solution, 1% dermatological cream

ciclopiroxolamine

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 worsen after a few days.

Contents of this leaflet:

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

1. What is BRUMIXOL and what is it used for

BRUMIXOL contains the active ingredient ciclopiroxolamine which belongs to a group of medicines
called dermatological antifungals that slow down or block the growth of fungi.
This medicine is indicated for the treatment of skin mycoses caused by fungi sensitive to it.
See your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using BRUMIXOL

Do not use BRUMIXOL

• if you are allergic to ciclopiroxolamine or to any of the other ingredients of this medicine (listed in section 6). The product should not be used in case of ophthalmic affections.

Warnings and precautions
Consult your doctor or pharmacist before using BRUMIXOL.
During therapy, follow the hygienic rules recommended by your doctor.
If you use this medicine for prolonged periods of time, you may experience allergic reactions (of
hypersensitivity).
If you experience allergic reactions or notice that the therapy with BRUMIXOL is no longer effective (development of
microorganisms not sensitive to it), stop treatment and consult your doctor who will prescribe you adequate therapy
.

Other medicines and BRUMIXOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, 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 strict medical supervision.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.

BRUMIXOL 1% dermatological cream contains benzyl alcohol
This medicine contains 50 mg of benzyl alcohol per dose equivalent to 10 mg/g.
Benzyl alcohol may cause allergic reactions
Benzyl alcohol may cause mild local irritation.

BRUMIXOL 1% dermatological cream contains cetyl alcohol and stearyl alcohol
This medicine contains cetyl alcohol and stearyl alcohol which may cause skin reactions
localized (e.g. contact dermatitis).

3. How to use BRUMIXOL

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 dose varies according to the severity of the symptoms and according to the doctor's judgement.
The suggested initial dose is two applications daily of a few grams of cream or lotion in relation to the extent of the affected area.
In severe cases, the dose should be increased according to the doctor's judgement.
For correct use, previously cleanse the affected areas with sterile gauze.
After applying the cream or lotion in the doses indicated above, massage gently.
In nail mycoses, occlusive bandaging is appropriate.
The application of the cream or lotion should be continued for a few days after clinical healing and negative culture.
Average treatment duration: 3/4 weeks.

If you use more BRUMIXOL than you should
Cases of overdose are not known.
In case of ingestion/accidental intake of BRUMIXOL, immediately inform your doctor or go to the nearest hospital.

If you forget to use BRUMIXOL
Do not use a double dose to make up for a missed dose.
If you have any doubts about 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 following side effects may occur:

Rare frequency (may affect up to 1 in 1,000 people)

• itching;
• burning;
• skin irritation

These effects are generally transient.
The use of topical products, especially if prolonged, can lead to sensitization phenomena. In the
event of hypersensitivity reactions and if fungi insensitive to treatment develop, treatment should be
discontinued and appropriate therapy initiated (see the section “Warnings and
precautions”).
Following the instructions contained in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 BRUMIXOL

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, in intact packaging, correctly
stored.
Store at a temperature not exceeding 25 °C.
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

WhatBRUMIXOL 1% cutaneous solution contains

• The active ingredient is ciclopiroxolamine. 100 ml of solution contains 1 g of ciclopiroxolamine.
• The other ingredients are: macrogol 400, lactic acid, purified water.

WhatBRUMIXOL 1% dermatological cream contains

• The active ingredient is ciclopiroxolamine. 100 g of cream contains 1 g of ciclopiroxolamine.
• The other ingredients are: 2-octyldodecanol, liquid paraffin, cetyl alcohol, stearyl alcohol, myristyl alcohol, diethanolamide of coconut fatty acids, polysorbate 60, sorbitan monostearate, benzyl alcohol, lactic acid, purified water.

Description of the appearance of BRUMIXOL and contents of the pack
BRUMIXOL 1% cutaneous solution
30 ml bottle

BRUMIXOL 1% dermatological cream
30 g tube

Marketing Authorisation Holder and manufacturer
Bruschettini S.r.l. - Via Isonzo 6 – 16147 Genova - Italy

BRUMIXOL 1% vaginal cream, 100 mg vaginal suppositories

ciclopiroxolamine

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 worsen after a few days.

Contents of this leaflet:

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

1. What is BRUMIXOL and what is it used for

BRUMIXOL contains the active substance ciclopiroxolamine, which belongs to a group of medicines
called gynecological antimicrobials and antiseptics.
This medicine is indicated for the treatment of infections caused by microorganisms including microorganisms
of the Candida genus that infect the internal and external areas of the vagina (vulvovaginal candidiasis).
See your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using BRUMIXOL

Do not use BRUMIXOL

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

Warnings and precautions
Talk to your doctor or pharmacist before using BRUMIXOL.
Avoid using BRUMIXOL during your menstrual period.
During the course of therapy, follow the hygiene rules recommended by your doctor.
As it is possible to transmit or re-acquire (re-infection) the infection from your partner, your “healthy”
partner should also undergo medical check-ups.
Also, it is recommended to abstain from sexual intercourse for the entire duration of therapy.
If you use this medicine for prolonged periods of time, you may experience allergic (hypersensitivity)
reactions.
If you experience allergic reactions or if you notice that the therapy with BRUMIXOL is no longer effective (development of
microorganisms that are not susceptible), stop treatment and consult your doctor who will prescribe you appropriate
therapy.

Other medicines and BRUMIXOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding with
breast milk, 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 strict medical supervision.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.

BRUMIXOL 1% vaginal cream contains cetyl alcohol and stearyl alcohol
This medicine contains cetyl alcohol and stearyl alcohol which may cause localized skin reactions
(e.g. contact dermatitis).

BRUMIXOL 1% vaginal cream contains benzyl alcohol
This medicine contains 50 mg of benzyl alcohol per application equivalent to 1 g per 100 g of
product.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol may cause mild local irritation.

BRUMIXOL 100 mg vaginal suppositories contains benzoic acid
This medicine contains 25 mg of benzoic acid per suppository equivalent to 9.259 mg/g.
Benzoic acid may cause local irritation.

3. How to use BRUMIXOL

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 dose varies according to the severity of the symptoms and according to the doctor's judgement.

Cream
The recommended dose is 1 dose (5 g) of cream once a day, to be inserted into the vagina
(intravaginally), using the appropriate applicator-doser, preferably in the evening before bedtime.
It may be useful to apply the cream also to the areas near the vagina and anus (peri-vulvar and peri-
anal level).
For correct use of the medicine, carefully follow these instructions:

• pierce the opening of the tube using the appropriate tip in the plastic cap;
• screw the single-use applicator onto the open tube;
• press the tube until the applicator is completely filled;
• detach the applicator from the tube;
• lie on your back and bend your legs slightly;
• insert the applicator deeply into the vagina;
• press the plunger until the applicator is completely emptied. The duration of treatment is approximately 6-7 days. The maximum duration, unless otherwise prescribed by the doctor, is 14 days.

Pessaries
The recommended dose is 1 pessary (100 mg), to be inserted deeply into the vagina, once a day,
preferably in the evening before bedtime.
The duration of treatment is 3 days.
The maximum duration, unless otherwise prescribed by the doctor, is 6 days.

If you use more BRUMIXOL than you should
No cases of overdose are known.
In case of accidental ingestion/intake of BRUMIXOL, immediately inform your doctor or go to the
nearest hospital.

If you forget to use BRUMIXOL
Do not use a double dose to make up for a missed dose.
If you have any doubts about using 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 following side effects may occur:

Rare frequency (may affect up to 1 in 1,000 people)

• itching;
• burning;
• skin irritation;

These effects are generally transient.
The use of topical products, especially if prolonged, may give rise to sensitization phenomena. In the
event of hypersensitivity reactions and if fungi insensitive to treatment develop, treatment should be
discontinued and appropriate therapy initiated (see section “Warnings and
precautions”).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 BRUMIXOL

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, in intact packaging, correctly
stored.
Store at a temperature not exceeding 25 °C.
It is recommended to store the suppositories in a refrigerator.
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

WhatBRUMIXOL 1% vaginal cream contains

• The active ingredient is ciclopiroxolamine. 100 g of cream contains 1 g of ciclopiroxolamine.
• The other ingredients are: 2-octyldodecanol, liquid paraffin, cetyl alcohol, stearyl alcohol, myristyl alcohol, coconut fatty acid diethanolamide, polysorbate 60, sorbitan monostearate, benzyl alcohol, lactic acid, purified water.

WhatBRUMIXOL 100 mg vaginal suppositories contains

• The active ingredient is ciclopiroxolamine. One suppository contains 0.1 g of ciclopiroxolamine.
• The other ingredients are: suppocire BS-2X, benzoic acid.

Description of the appearance of BRUMIXOL and contents of the pack
BRUMIXOL 1% vaginal cream
Tube of 30 g with single-use applicators.
Tube of 78 g with single-use applicators.

BRUMIXOL 100 mg vaginal suppositories
Pack of 6 suppositories.

Marketing Authorisation Holder and Manufacturer
Bruschettini S.r.l. - Via Isonzo 6 – 16147 Genova - Italy