1. What this product is and what it is used for
This medicine is a topical cream that contains an antibiotic that kills certain bacteria on the skin.
It is used to locally treat rosacea, a skin condition characterized by redness on the face.
2. What you need to know before you use this product
a. 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.
b. Take special care with Rozex 0.75% Gel
Do not get the gel in your eyes or on other mucous membranes (e.g. inside the mouth, nose or lips). If you do, rinse the area(s) thoroughly with water.
If you experience any local skin irritation, stop using Rozex either temporarily or completely.
Do not go out into strong sunlight (including sun-bathing) and avoid exposure to ultra-violet light (e.g. solariums, sun-lamps) while you are using this product.
Rozex should be used with caution in patients suffering from or with history of blood disorders.
Due to a lack of available data, this medicine should not be used in children.
Avoid prolonged and unnecessary use of Rozex.
If in doubt, ask your doctor or pharmacist for advice.
c. 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.
- Using Rozex could interfere with drugs used to reduce blood clotting (anticoagulants) such as warfarin and dicoumarin.
- Contact your doctor for advice if you are taking medicines to reduce blood clotting, or if you suffer from any other blood disorders.
d. Pregnancy and breast-feeding
Talk to your doctor or pharmacist before taking any medicines. Rozex 0.75% Gel may be used during pregnancy. Due to the weak passage of metronidazole after applying to the skin, its use in women who are breast-feeding may be considered.
e. Important information about some of the ingredients of Rozex 0.75% Gel
Rozex 0.75% Gel contains propylene glycol that may cause skin irritation. It contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
3. How to use this product.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Apply a thin layer of gel to the affected areas of the skin twice daily, morning and evening after washing with mild soap. Use only non-comedogenic and non-astringent cosmetics after applying Rozex.
If you feel that the effect of Rozex is too strong or too weak, talk to your doctor or pharmacist.
Instructions for proper use: Wash your hands after use
Method of administration: Topical application.
Duration of treatment: The usual duration of treatment is 3 to 4 months.
If you use more Rozex 0.75% Gel than you should: Talk to your doctor or pharmacist immediately.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Common (may affect up to 1 in 10 people): Skin reactions such as burning and stinging of the skin, redness of the skin (erythema), dry skin, irritation and itching (pruritus) of the skin and worsening of rosacea.
• Uncommon (may affect up to 1 in 100 people): Feeling sick (nausea), metallic taste (dysgeusia), numbness (hypoesthesia) and tingling or “pins and needles” (paraesthesia).
· Unknown (frequency cannot be estimated from the available data): contact dermatitis (eczema), peeling skin (exfoliation) and swelling of the face (facial edema).
5. How to store this product
Keep this medicine out of the sight and reach of children.
Do not store above 300C.
Store at room temperature.
Do not use this medicine after the expiry date indicated on the box next to “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Further information
a. What this product contains
• The active substance is metronidazole.