ROZEX 0.75% Żel

Treść ulotki

1. Rozex 0.75% cream
   1. What is Rozex 0.75% cream and what is it used for
   2. What you need to know before using Rozex 0.75% cream
   3. How to use Rozex 0.75% cream
   4. Possible side effects
   5. How to store Rozex 0.75% cream
   6. Contents of the pack and other information
2. Rozex 0,75% gel
   1. What Rozex 0.75% gel is and what it is used for
   2. How to use Rozex 0.75% gel
   3. Possible side effects
   4. How to store Rozex 0,75% gel
   5. Contents of the pack and other information
3. Rozex 0.75% cutaneous emulsion
   1. What is Rozex 0.75% cutaneous emulsion and what is it used for?
   2. What you need to know before using Rozex 0.75% cutaneous emulsion
   3. How to use Rozex 0.75% cutaneous emulsion
   4. Possible side effects
   5. How to store Rozex 0.75% cutaneous emulsion
   6. Contents of the pack and other information

Rozex 0.75% cream

metronidazole
Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Rozex 0.75% cream is and what it is used for
• 2. What you need to know before you use Rozex 0.75% cream
• 3. How to use Rozex 0.75% cream
• 4. Possible side effects
• 5. How to store Rozex 0.75% cream
• 6. Contents of the pack and other information

1. What is Rozex 0.75% cream and what is it used for

Rozex 0.75% cream contains the active ingredient metronidazole, which belongs to a group of medicines
called topical chemotherapeutic agents, used to treat some skin infections.
This medicine is indicated in the local treatment of rosacea, a skin disease that manifests
with skin irritation (erythema), papules (small skin elevations) and pustules (small skin swellings
with pus) in the central part of the face.

2. What you need to know before using Rozex 0.75% cream

Do not use Rozex 0.75% cream

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

Warnings and precautions
Talk to your doctor or pharmacist before using Rozex 0.75% cream.
Contact your doctor if you experience a reaction due to local irritation during application
of the medicine, as it may be necessary to reduce the number of daily applications or discontinue
treatment.
Tell your doctor if you suffer from blood disorders (blood dyscrasia).
Avoid contact with eyes and mucous membranes (eyelids, lips, mouth, ears and the inside of the nose).
During therapy with metronidazole, avoid exposure to UV rays (sunlight, solariums and sunlamps).
Avoid unnecessary and prolonged use of this medicine.

Children
This medicine is not recommended for use in children as safety and efficacy have not been
established for this age group.

Other medicines and Rozex 0.75% cream
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Rozex 0.75% cream applied locally has poor systemic absorption and therefore this medicine is unlikely
to cause interactions when used with other drugs.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor for advice before using this medicine.
During pregnancy, use Rozex 0.75% cream only if absolutely necessary and under direct medical supervision.
Similarly, if you are breastfeeding, your doctor will need to assess the possibility of stopping
breastfeeding or treatment depending on the actual therapeutic need.

Driving and using machines
Rozex 0.75% cream does not impair the ability to drive vehicles or operate machinery.

Rozex 0.75% cream contains:

• cetyl stearyl alcohol which may cause localised skin reactions (e.g. contact dermatitis).
• 22 mg of benzyl alcohol(E1519) per gram, equivalent to 2.2% w/w, which may cause allergic reactions and mild local irritation.

3. How to use Rozex 0.75% cream

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Apply twice a day, morning and evening, a thin layer of Rozex 0.75% cream to the affected area,
massaging lightly. The skin must be thoroughly cleaned with a mild cleanser before
applying the product.
Avoid application to eyes, eyelids, lips, mouth and the inside of the nose.
After applying Rozex 0.75% cream you may use non-comedogenic (those that do not promote the
formation of blackheads) and non-astringent (those that do not have the effect of tightening the pores of the skin) cosmetics.
The recommended duration of treatment is 3 - 4 months, and should not be exceeded. However, if
an evident benefit is demonstrated, your doctor may prolong the treatment for a further period varying
from three to four months based on the severity of the condition. In the absence of evident improvement, therapy
must be discontinued.

If you use more Rozex 0.75% cream than you should
No cases of overdose have been reported during the local use of Rozex 0.75% cream in humans. If you have
any doubts about the use of Rozex 0.75% cream, consult your doctor or pharmacist.

If you forget to use Rozex 0.75% cream
Do not use a double dose to make up for a missed dose.
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.
The following side effects have been reported:
Common (may affect up to 1 in 10 people):

• dry skin
• redness of the skin (erythema)
• itching
• skin discomfort (burning, pain, stinging pain)
• skin irritation
• worsening of rosacea

Uncommon (may affect up to 1 in 100 people):

• decreased sensitivity (hypoesthesia)
• altered sensitivity (paresthesia)
• altered taste, metallic taste (dysgeusia)
• nausea

Not known (frequency cannot be estimated from available data)

• contact dermatitis
• shedding of the superficial layers of the skin (skin exfoliation)
• swelling of the face (tumefaction)

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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Rozex 0.75% cream

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 packaging 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.
This medicine does not require any particular storage conditions

6. Contents of the pack and other information

What Rozex 0.75% cream contains

• The active ingredient is metronidazole. 100 grams of cream contain 0.75 g of metronidazole.
• The other components are emulsifying waxes (cetylstearyl alcohol and polysorbate 60), 70% non-crystallized sorbitol, glycerol, isopropyl palmitate, benzyl alcohol (E1519), lactic acid and/or sodium hydroxide to adjust the pH, purified water.

Description of the appearance of Rozex 0.75% cream and pack contents
Rozex 0.75% cream: Tube of 30 g or 50 g

Marketing Authorisation Holder
Galderma Italia S.p.A. - Via dell'Annunciata, 21 - 20121 Milan

Manufacturer
Laboratoires GALDERMA
Z.I. Montdésir
74540 Alby-sur-Chéran
France

Rozex 0,75% gel

metronidazole
Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Rozex 0,75% gel is and what it is used for
• 2. What you need to know before you use Rozex 0,75% gel
• 3. How to use Rozex 0,75% gel
• 4. Possible side effects
• 5. How to store Rozex 0,75% gel
• 6. Contents of the pack and other information

1. What Rozex 0.75% gel is and what it is used for

Rozex 0.75% gel contains the active ingredient metronidazole, which belongs to a group of medicines called
topical chemotherapeutic agents, used to treat some skin infections.
This medicine is indicated for the local treatment of rosacea, a skin disease that manifests
with skin irritation (erythema), papules (small skin elevations) and pustules (small skin swellings
with pus) in the central part of the face.

2What you need to know before you use Rozex 0.75% gel
Do not use Rozex 0.75% gel

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

Warnings and precautions
Talk to your doctor or pharmacist before using Rozex 0.75% gel.
See your doctor if you experience a reaction due to local irritation during application
of the medicine, as it may be necessary to reduce the number of daily applications or discontinue the
treatment.
Tell your doctor if you suffer from blood disorders (blood dyscrasia).
Avoid contact with the eyes and mucous membranes (eyelids, lips, mouth, ears and the inside of the nose).
During therapy with metronidazole, avoid exposure to UV rays (sunlight, solariums and sunlamps).
Avoid unnecessary and prolonged use of this medicine.

Children and adolescents
This medicine is not recommended for use in children and adolescents under 14 years of age
because safety and efficacy have not been established for this age group.

Other medicines and Rozex 0.75% gel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Rozex 0.75% gel applied locally has poor systemic absorption and therefore this medicine is unlikely
to cause interactions when used with other drugs.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding
ask your doctor for advice before using this medicine.
During pregnancy, use Rozex 0.75% gel only if absolutely necessary and under the direct supervision of your
doctor.
Similarly, if you are breastfeeding, your doctor will need to assess the possibility of stopping
breastfeeding or treatment depending on the actual therapeutic need.

Driving and using machines
Rozex 0.75% gel does not impair the ability to drive vehicles or operate machinery.

Rozex 0.75% gel contains:

• methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (including delayed reactions)
• 30 mg of propylene glycol(E1520) per gram, equivalent to 3% w/w, which may cause skin irritation.

3. How to use Rozex 0.75% gel

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Apply a thin layer of Rozex 0.75 % gel to the affected area twice a day, morning and evening,
massaging lightly. The skin must be thoroughly cleaned with a mild cleanser before
applying the product.
Avoid application to eyes, eyelids, lips, mouth and the inside of the nose.
After applying Rozex 0.75% gel you can use non-comedogenic (that do not promote the
formation of blackheads) and non-astringent (that do not have the effect of tightening the pores of the skin) cosmetics.
The recommended average duration of treatment is 3-4 months, and should not be exceeded. However, if
an evident benefit is demonstrated, your doctor may prolong the treatment for a further period of
three to four months depending on the severity of the condition. In the absence of evident improvement the
therapy must be discontinued.

If you use more Rozex 0.75% gel than you should
No cases of overdose have been reported during the local use of Rozex 0.75% gel in humans. If you have
any doubts about the use of Rozex 0.75% gel, consult your doctor or pharmacist.

If you forget to use Rozex 0.75% gel
Do not use a double dose to make up for a missed dose.
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.
The following side effects have been reported:
Common (may affect up to 1 in 10 people):

• dry skin
• redness of the skin (erythema)
• itching
• skin discomfort (burning, pain, stinging pain)
• skin irritation
• worsening of rosacea

Uncommon (may affect up to 1 in 100 people):

• decreased sensitivity (hypoesthesia)
• altered sensitivity (paresthesia)
• altered taste, metallic taste (dysgeusia)
• nausea

Not known (frequency cannot be estimated from available data)

• contact dermatitis
• shedding of the superficial layers of the skin (skin exfoliation)
• swelling of the face (tumefaction)

Cases of tearing have been reported when the gel was applied too close to the eyes.

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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Rozex 0,75% gel

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 packaging after Exp. The expiry
date refers to the last day of that month.
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.
This medicine does not require any particular storage conditions

6. Contents of the pack and other information

What Rozex 0.75% gel contains

• The active ingredient is metronidazole. 100 grams of gel contain 0.75 g of metronidazole.
• The other ingredients are carbomer 940, disodium edetate, methyl parahydroxybenzoate (E218), propylene glycol (E1520), propyl parahydroxybenzoate (E216), sodium hydroxide (for pH adjustment), purified water.

Description of the appearance of Rozex 0.75% gel and pack contents
Tube containing 30 g

Marketing Authorisation Holder
Galderma Italia S.p.A. - Via dell'Annunciata, 21 – 20121 Milano

Manufacturer
Laboratoires GALDERMA
Z.I. Montdésir
74540 Alby-sur-Chéran
France

Rozex 0.75% cutaneous emulsion

metronidazole
Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1.What Rozex 0.75% cutaneous emulsion is and what it is used for
• 2. What you need to know before you use Rozex 0.75% cutaneous emulsion
• 3. How to use Rozex 0.75% cutaneous emulsion
• 4. Possible side effects
• 5. How to store Rozex 0.75% cutaneous emulsion
• 6. Contents of the pack and other information

1. What is Rozex 0.75% cutaneous emulsion and what is it used for?

Rozex 0.75% cutaneous emulsion contains the active substance metronidazole, which belongs to a group of
medicines called topical chemotherapeutic agents, used to treat some skin infections.
This medicine is indicated for the local treatment of rosacea, a skin disease that manifests
with skin irritation (erythema), papules (small skin elevations) and pustules (small skin swellings
with pus) in the central part of the face.

2. What you need to know before using Rozex 0.75% cutaneous emulsion

Do not use Rozex 0.75% cutaneous emulsion

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

Warnings and precautions
Consult your doctor or pharmacist before using Rozex 0.75% cutaneous emulsion.
Consult your doctor if you experience a reaction due to local irritation during application
of the medicine, as it may be necessary to reduce the number of daily applications or discontinue
treatment.
Inform your doctor if you suffer from blood disorders (blood dyscrasia).
Avoid contact with the eyes and mucous membranes (eyelids, lips, mouth, ears and the inside of the nose).
During therapy with metronidazole, avoid exposure to UV rays (sunlight, solariums and sunlamps).
Avoid unnecessary and prolonged use of this medicine.

Children
This medicine is not recommended for use in children as safety and efficacy have not been
established for this age group.

Other medicines and Rozex 0.75% cutaneous emulsion
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Rozex 0.75% cutaneous emulsion applied locally has poor systemic absorption and therefore
this medicine is unlikely to cause interactions when used with other drugs.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor for advice before using this medicine.
During pregnancy, use Rozex 0.75% cutaneous emulsion only if absolutely necessary and under the
direct supervision of your doctor.
Similarly, if you are breastfeeding, your doctor will need to assess the possibility of interrupting
breastfeeding or treatment depending on the actual therapeutic need.

Driving and using machines
Rozex 0.75% cutaneous emulsion does not impair the ability to drive vehicles or operate machinery.

Rozex 0.75% cutaneous emulsion contains:

• stearyl alcohol and potassium sorbatewhich may cause localized skin reactions (e.g. contact dermatitis (skin inflammation)).
• 13 mg of benzyl alcohol(E1519) per gram equivalent to 1.3% w/w which may cause allergic reactions and mild local irritation.

3. How to use Rozex 0.75% cutaneous emulsion

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Apply a thin layer of Rozex 0.75% cutaneous emulsion to the affected area twice a day, morning and evening, massaging lightly. The skin must be thoroughly cleaned with a mild
cleanser before applying the product.
Avoid application to eyes, eyelids, lips, mouth and the inside of the nose.
After applying Rozex 0.75% cutaneous emulsion, you may use non-comedogenic (that do not
promote the formation of blackheads) and non-astringent (that do not have the effect of tightening skin pores) cosmetics.
The recommended duration of treatment is 3-4 months, and should not be exceeded. However, if
an evident benefit is demonstrated, your doctor may prolong the treatment for a further period varying
from three to four months depending on the severity of the condition. If there is no evident improvement, therapy
should be discontinued.

If you use more Rozex 0.75% cutaneous emulsion than you should
No cases of overdose have been reported during the local use of Rozex 0.75% cutaneous emulsion
in humans. If you have any doubts about the use of Rozex 0.75% cutaneous emulsion, consult your doctor or
pharmacist.

If you forget to use Rozex 0.75% cutaneous emulsion
Do not use a double dose to make up for a missed dose.
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.
During the local use of Rozex 0.75% cutaneous emulsion, only mild local reactions have occurred.
The following side effects have been reported:
Common (may affect up to 1 in 10 people):

• skin dryness
• skin redness (erythema)
• itching
• skin discomfort (burning, pain, stinging pain)
• skin irritation
• worsening of rosacea

Uncommon (may affect up to 1 in 100 people):

• decreased sensitivity (hypoesthesia)
• altered sensitivity (paresthesia)
• altered taste, metallic taste (dysgeusia)
• nausea

Not known (frequency cannot be estimated from available data)

• contact dermatitis
• shedding of the superficial layers of the skin (skin exfoliation)
• facial swelling (tumefaction)

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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Rozex 0.75% cutaneous emulsion

Keep this medicine out of the sight and reach of children.
Store this medicine at a temperature not exceeding 25° C.
Do not use this medicine after the expiry date which is reported on the packaging after Exp. The expiry
date refers to the last day of that month.
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 Rozex 0.75% cutaneous emulsion contains

• The active ingredient is metronidazole. 100 grams of cutaneous emulsion contain 0.75 g of metronidazole.
• The other ingredients are Carbomer 941, benzyl alcohol (E1519), glycerol, macrogol 400, steareth-21, glyceryl stearate/PEG-100 stearate, stearyl alcohol, light liquid paraffin, cyclomethicone, potassium sorbate (E202), lactic acid and/or sodium hydroxide for pH adjustment, and purified water.

Description of the appearance of Rozex 0.75% cutaneous emulsion and contents of the pack
Rozex 0.75% cutaneous emulsion: Tube of 30 g

Marketing Authorisation Holder
Galderma Italia S.p.A. - Via dell'Annunciata, 21 – 20121 Milano

Manufacturer
Laboratoires GALDERMA
Z.I. Montdésir
74540 Alby-sur-Chéran
France