0.75% gel
metronidazole
What Rozex gel is and what it is used for
Rozex gel contains metronidazole, which is an antibiotic that is active against only a few types of bacteria.
Rozex gel is used for redness and rashes in the skin disease rosacea. Rosacea is a skin disease that affects the central parts of the face (forehead, nose, cheeks, and chin) with redness, bumps, and blisters.
A doctor should have diagnosed rosacea before starting treatment with Rozex gel.
It is not clear if the gel acts against rosacea by affecting the bacterial flora of the skin or by any other effect on the skin. Metronidazole is not effective against other skin diseases or skin infections.
Metronidazole contained in Rozex gel may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Rozex gel
Do not use Rozex gel
- if you are allergic (hypersensitive) to metronidazole or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Rozex gel.
- Contact with eyes and mucous membranes should be avoided.
- If the skin becomes irritated, you can either use Rozex gel less often or pause the treatment. Contact a doctor in case of severe skin irritation.
- UV exposure (sunbathing, solarium, UV lamp) should be avoided during treatment.
- Tell your doctor if you suffer or have suffered from any blood disease.
- Prolonged or unnecessary use of Rozex gel should be avoided.
Children
This medicine should not be used in children because of a lack of experience.
Other medicines and Rozex gel
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is no experience of use during pregnancy. Rozex gel should only be used during pregnancy if your doctor deems it necessary. Therefore consult a doctor before use during pregnancy.
Rozex gel passes into breast milk. Consult a physician before use during breastfeeding.
Driving and using machines
Rozex gel does not affect your ability to drive or use machines.
Rozex gel contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and propylene glycol (E1520)
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed). This medicine also contains 30 mg of propylene glycol (E1520) per gram, equivalent to 3% w / w, which may cause skin irritation.
How to use Rozex gel
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 2 applications on the skin daily (morning and evening). Apply a gel in a thin layer on the skin areas of the face to be treated. Before use, clean the skin with a mild soap. You can use cosmetics that are not opaque, dehydrating, or astringent once you have applied Rozex gel.
The normal treatment time is three to four months. Contact your doctor if you feel that the treatment does not help.
If you use more Rozex gel than you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor or hospital for risk assessment and advice.
If you forget to use Rozex gel
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (affects more than 1 user in 100):
Skin side effects such as burning and stinging pain, dryness, redness, irritation, itching, and worsening of rosacea.
Uncommon (affects 1 in 100 and 1 in 1000 users):
Metal taste in the mouth, tingling or numbness of the arms and legs, and nausea.
No known frequency (cannot be calculated from the available data):
Contact dermatitis, swelling of the face, dandruff.
How to store Rozex gel
- Keep this medicine out of the sight and reach of children.
- Store in a cold place. Do not freeze.
- Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is metronidazole. 1 gram of gel contains metronidazole 7.5 mg (0.75%).
- The other ingredients are carbomer, propylene glycol (E1520), sodium edetate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide, and purified water.
What the medicine looks like and the contents of the pack
The clear or light yellow gel can change to slightly brownish over time.
Rozex gel is supplied in an aluminum tube containing 30 g.
Marketing Authorization Holder and Manufacturer
Manufacturer
Galderma Laboratories
ZI Montdésir
74540 Alby-Sur-Chéran
France