Rozex
Italy
Table of Contents
Package leaflet: Information for the patient
Rozex 0,75% cream
metronidazole
Please read all of this leaflet carefully before you start using this medicine because 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Rozex 0,75% cream is and what it is used for
- What you need to know before using Rozex 0,75% cream
- How to use Rozex 0,75% cream
- Possible side effects
- How to store Rozex 0,75% cream
- Contents of the pack and other information
1. What Rozex 0.75% cream is and what it is used for
Rozex 0.75% cream contains the active substance metronidazole, which belongs to a group of medicines
called topical chemotherapeutic agents, used to treat certain skin infections.
This medicine is indicated for the local treatment of rosacea, a skin condition characterized by
skin irritation (erythema), papules (small skin elevations), and pustules (small skin swellings
containing pus) in the central facial area.
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 to 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 develop 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 (haematological dyscrasia).
Avoid contact with eyes and mucous membranes (eyelids, lips, mouth, ears and inside of the nose).
During treatment with metronidazole, avoid exposure to UV rays (sunlight, sunbeds and solar lamps).
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 in this age group.
Other medicines and Rozex 0.75% cream
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Rozex 0.75% cream applied topically has minimal systemic absorption and is therefore unlikely to interact with other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
During pregnancy, use Rozex 0.75% cream only if clearly needed and under direct medical supervision.
Likewise, if you are breastfeeding, your doctor will need to evaluate whether to discontinue breastfeeding or treatment, depending on the actual therapeutic need.
Driving and using machines
Rozex 0.75% cream does not affect the ability to drive or operate machinery.
Rozex 0.75% cream contains:
- Cetylstearyl alcohol, which may cause localized 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 exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of Rozex 0.75% cream twice daily, in the morning and evening, to the affected area, gently massaging it into the skin. The skin should be thoroughly cleaned with a mild cleanser before applying the product.
Avoid applying the cream to the eyes, eyelids, lips, mouth, or inside the nose.
After applying Rozex 0.75% cream, you may use non-comedogenic (does not promote blackhead formation) and non-astringent cosmetics (do not have the effect of tightening skin pores).
The recommended duration of treatment is 3–4 months and should not be exceeded. However, if a clear benefit has been demonstrated, your doctor may extend your treatment for an additional period ranging from three to four months, depending on the severity of your condition. If no clear improvement is observed, treatment should be discontinued.
If you use more Rozex 0.75% cream than you should
There have been no reported cases of overdose with topical 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 apply a double dose to make up for a forgotten dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine may 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
- 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 sensation (paraesthesia)
- taste disturbance, metallic taste (dysgeusia)
- nausea
Not known (frequency cannot be estimated from the available data):
- contact dermatitis
- shedding of the outer layers of the skin (skin exfoliation)
- swelling of the face (tumefaction)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
This medicine requires no special storage conditions.
6. Package contents and other information
What Rozex 0.75% cream contains
- The active substance is metronidazole. 100 grams of cream contain 0.75 g of metronidazole.
- The other components are emulsifying waxes (cetyl stearyl alcohol and polysorbate 60), 70% non-crystalline sorbitol, glycerol, isopropyl palmitate, benzyl alcohol (E1519), lactic acid and/or sodium hydroxide to adjust pH, purified water.
Description of the appearance of Rozex 0.75% cream and package contents
Rozex 0.75% cream: Tube of 30 g or 50 g
Marketing Authorization Holder
Galderma Italia S.p.A. - Via dell'Annunciata, 21 - 20121 Milano
Manufacturer
Laboratoires GALDERMA
Z.I. Montdésir
74540 Alby-sur-Chéran
France
Patient Information Leaflet
Rozex 0.75% gel
metronidazole
Please read this leaflet carefully before using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Rozex 0.75% gel is and what it is used for
- What you need to know before using Rozex 0.75% gel
- How to use Rozex 0.75% gel
- Possible side effects
- How to store Rozex 0.75% gel
- Package contents and other information
1. What Rozex 0.75% gel is and what it is used for
Rozex 0.75% gel contains the active substance metronidazole, which belongs to a group of medicines called topical chemotherapeutic agents, used to treat certain skin infections.
This medicine is indicated for the local treatment of rosacea, a skin condition characterized by skin irritation (erythema), papules (small skin elevations), and pustules (small raised areas filled with pus) in the central facial region.
2 What you need to know before using Rozex 0.75% gel
Do not use Rozex 0.75% gel
- if you are allergic to metronidazole or to 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.
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.
Inform your doctor if you suffer from blood disorders (haematological dyscrasia).
Avoid contact with the eyes and mucous membranes (eyelids, lips, mouth, ears, and inside of the nose).
During treatment with metronidazole, avoid exposure to UV rays (sunlight, sunbeds, and solar lamps).
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, as safety and efficacy have not been established in this age group.
Other medicines and Rozex 0.75% gel
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Rozex 0.75% gel applied topically has minimal systemic absorption and is therefore unlikely to interact with other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
During pregnancy, use Rozex 0.75% gel only if clearly necessary and under direct medical supervision.
Similarly, if you are breastfeeding, your doctor will assess whether to discontinue breastfeeding or the treatment, depending on the therapeutic need.
Driving and operating machinery
Rozex 0.75% gel does not affect the ability to drive or operate machinery.
Rozex 0.75% gel contains:
- methyl 4-hydroxybenzoate (E218) and propyl 4-hydroxybenzoate (E216), which may cause allergic reactions (including delayed-type 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 exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of Rozex 0.75% gel twice daily, in the morning and evening, to the affected area, gently massaging it in. The skin must be thoroughly cleaned with a mild cleanser before applying the product.
Avoid applying the gel near the eyes, eyelids, lips, mouth, or inside the nostrils.
After applying Rozex 0.75% gel, you may use non-comedogenic (products that do not promote blackheads) and non-astringent cosmetics (those that do not cause pore tightening).
The recommended average duration of treatment is 3–4 months and should not be exceeded. However, if a clear benefit has been demonstrated, your doctor may extend your treatment for an additional period ranging from three to four months, depending on the severity of your condition. If there is no evident improvement, treatment should be discontinued.
If you use more Rozex 0.75% gel than you should
No cases of overdose have been reported with topical 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 apply a double dose to make up for a missed dose.
If you have any doubts about using 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 sensation (paresthesia)
- taste disturbance, metallic taste (dysgeusia)
- nausea
Not known (frequency cannot be estimated from the available data):
- contact dermatitis
- shedding of the outer 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 via 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 special storage conditions.
6. Package contents and other information
What Rozex 0.75% gel contains
- The active substance is metronidazole. 100 grams of gel contain 0.75 g of metronidazole.
- The other ingredients are carbomer 940, disodium edetate, methyl 4-hydroxybenzoate (E218), propylene glycol (E1520), propyl 4-hydroxybenzoate (E216), sodium hydroxide (to adjust pH), purified water.
Description of the appearance of Rozex 0.75% gel and contents of the pack
30 g tube
Marketing Authorization Holder
Galderma Italia S.p.A. - Via dell'Annunciata, 21 – 20121 Milano
Manufacturer
Laboratoires GALDERMA
Z.I. Montdésir
74540 Alby-sur-Chéran
France
Patient Information Leaflet
Rozex 0.75% cutaneous emulsion
metronidazole
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Rozex 0.75% cutaneous emulsion is and what it is used for
- What you need to know before using Rozex 0.75% cutaneous emulsion
- How to use Rozex 0.75% cutaneous emulsion
- Possible side effects
- How to store Rozex 0.75% cutaneous emulsion
- Contents of the pack and other information
1. What Rozex 0.75% cutaneous emulsion is and what it is 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 certain skin infections.
This medicine is indicated for the local treatment of rosacea, a skin condition characterised by skin irritation (erythema), papules (small raised areas of skin), and pustules (small swollen areas of skin containing 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 to 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% cutaneous emulsion.
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.
Inform your doctor if you suffer from blood disorders (haematological dyscrasia).
Avoid contact with the eyes and mucous membranes (eyelids, lips, mouth, ears, and inside of the nose).
During treatment with metronidazole, avoid exposure to UV radiation (sunlight, sunbeds, 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 in 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 medicines.
Rozex 0.75% cutaneous emulsion, when applied topically, is poorly absorbed systemically and therefore is unlikely to cause interactions with other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
During pregnancy, use Rozex 0.75% cutaneous emulsion only if strictly necessary and under direct medical supervision.
Likewise, if you are breastfeeding, your doctor will assess whether to discontinue breastfeeding or the treatment, depending on the therapeutic need.
Driving and using machines
Rozex 0.75% cutaneous emulsion does not affect the ability to drive or operate machinery.
Rozex 0.75% cutaneous emulsion contains:
- cetyl alcohol and potassium sorbate, which 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 exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of Rozex 0.75% cutaneous emulsion twice daily, in the morning and evening, to the affected area, gently massaging it in. The skin must be thoroughly cleaned with a mild cleanser before applying the product.
Avoid applying it to the eyes, eyelids, lips, mouth, or inside the nose.
After applying Rozex 0.75% cutaneous emulsion, you may use non-comedogenic (do not promote blackheads) and non-astringent cosmetics (do not have the effect of tightening skin pores).
The recommended duration of treatment is 3–4 months and should not be exceeded. However, if a clear benefit has been demonstrated, your doctor may extend the treatment for an additional period ranging from three to four months, depending on the severity of the condition. If there is no clear improvement, treatment should be discontinued.
If you use more Rozex 0.75% cutaneous emulsion than you should
Cases of overdose have not been reported with topical 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 apply a double dose to make up for the 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 everyone experiences them.
Only mild local reactions have been observed during the topical use of Rozex 0.75% cutaneous emulsion.
The following adverse effects have been reported:
Common (may affect up to 1 in 10 people):
- dry skin
- skin redness (erythema)
- itching
- skin discomfort (burning, stinging, pain)
- skin irritation
- worsening of rosacea
Uncommon (may affect up to 1 in 100 people):
- decreased sensitivity (hypoesthesia)
- altered sensation (paresthesia)
- taste disturbance, metallic taste (dysgeusia)
- nausea
Not known (frequency cannot be estimated from available data):
- contact dermatitis
- shedding of the outer layers of the skin (cutaneous exfoliation)
- facial swelling (tumefaction)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report side effects directly via 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 stated on the pack after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What Rozex 0.75% cutaneous emulsion contains
- The active substance is metronidazole. 100 grams of cutaneous emulsion contain 0.75 g of metronidazole.
- The other components are Carbomer 941, benzyl alcohol (E1519), glycerol, macrogol 400, steareth-21, glyceryl stearate/PEG-100 stearate, stearyl alcohol, liquid paraffin, cyclomethicone, potassium sorbate (E202), lactic acid and/or sodium hydroxide to adjust pH, 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 Authorization Holder
Galderma Italia S.p.A. - Via dell'Annunciata, 21 – 20121 Milano
Manufacturer
Laboratoires GALDERMA
Z.I. Montdésir
74540 Alby-sur-Chéran
France