1% Cream
metronidazole
What Rosazol is and what it is used for
Rosazol cream contains metronidazole, which is an antibiotic that is active against only a few types of bacteria.
Rosazol cream is used for redness and rash 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. Rosacea is most common in women aged 30-50 years. A doctor should have determined the diagnosis of rosacea before starting treatment with Rosazol cream.
It is not clear if the cream 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.
What you need to know before you use Rosazol
Do not use Rosazol
- if you are allergic (hypersensitive) to metronidazole or any of the other ingredients of Rosazol.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Rosazol.
- Contact with eyes and mucous membranes should be avoided.
- If the skin becomes irritated, you can either use Rosazol less often or take a temporary break from 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.
- This medicine should not be used in children because of a lack of experience.
- Prolonged or unnecessary use of Rosazol should be avoided.
Other medicines and Rosazol
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
There is limited experience with the use of the drug during pregnancy. Consult a physician before use during pregnancy.
Metronidazole passes into breast milk but is unlikely to affect the breastfeeding baby. However, consult a physician if more than occasional use of Rosazol cream during breastfeeding.
Driving and using machines
Rosazol cream does not affect your ability to drive or use machines.
Rosazol contains sodium lauryl sulfate, cetyl alcohol, and cetostearyl alcohol
This medicine contains 8 mg of sodium laurilsulfate per gram of cream.
Sodium lauryl sulfate may cause local skin reactions (stinging or burning) or increase skin reactions caused by other products used on the same skin surface.
This medicine contains 145 mg of cetyl alcohol per gram of cream. Cetyl alcohol may cause local skin reactions (eg contact dermatitis).
This medicine contains 50 mg of cetostearyl alcohol per gram of cream. Cetostearyl alcohol may cause local skin reactions (eg contact dermatitis).
How to use Rosazol
Use Rosazol according to your doctor’s prescription or the instructions on the package. Ask your doctor or pharmacist if you are unsure.
The usual dosage is 2 applications on the skin daily (morning and evening) on the skin areas of the face to be treated. Apply the cream in a thin layer on well-cleansed skin. Use a mild soap. You can use cosmetics that do not cause acne and that are not dehydrating or astringent after you have applied Rosazol cream.
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 Rosazol than you should
If you have used too much Rosazol cream or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
Possible side effects
Like all medicines, Rosazol can cause side effects, although not everybody gets them.
Common ( may affect up to 1 in 10 people):
- Skin side effects such as burning and stinging pain, dryness, redness, irritation, itching, and worsening of rosacea.
Uncommon ( may affect up to 1 in 100 people):
- Metal taste in the mouth,
- Knitting or numbness of arms and legs as well
- Nausea.
Has been reported (occurs in an unknown number of users):
- Contact dermatitis
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Rosazol
Store at a maximum of 25 o C. Store in a cool place.
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.
Keep out of sight and reach of children.
Medicines 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.
Other information
Content declaration
- the active substance is metronidazole. 1 g of cream contains 10 mg of metronidazole.
- The other ingredients are lactic acid, sodium lauryl sulfate, cetyl alcohol, cetostearyl alcohol, and sterile water.
What the medicine looks like and the contents of the pack
Plasttub.
Pack size: 25 g
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland