ROSACTA cream 50g
ROZAKTA cream 50 g
Rozacta® cream is a non-prescription medicinal product that has a pain-relieving effect while also improving peripheral blood circulation. Its main active ingredient is 10% rosemary essential oil. Rozacta® cream is suitable for the relief of various types of muscle or joint pain, and is also used to relieve symptoms such as cold and tired feet, heaviness in the legs or arms. Rozacta® cream is suitable for long-term use and can be combined with other drugs for local or oral administration.
Read the leaflet before use! Consult your doctor or pharmacist about risks and side effects. Rosacta ® is a traditional herbal medicinal product for use in the indicated indications, based on long-term use.
To report an adverse drug reaction or a complaint about the quality of the product, please contact your doctor or pharmacist, the Executive Agency for Medicines or use the link below: Medis Pharma Bulgaria EOOD, Sofia 1700, Prof. Atanas Ishirkov Street 31, office no. 6, Bulgaria,
ROZAKTA cream 50 g
Leaflet: user information
Rosacta cream
Rosacta cream
Rosemary oil / Rosemary oil
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, qualified healthcare professional or pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you need more information or advice, ask your pharmacist.• If you get any side effects, tell your doctor, qualified healthcare professional or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If after 4 weeks you do not feel better or your condition worsens, you should seek medical attention.
If symptoms persist while using this medicine or if you experience side effects not described in this leaflet, you should consult a doctor, qualified healthcare professional or pharmacist.
What this leaflet contains
1. What Rozagga Cream is and what it is used for
2. What you need to know» before using Rozacta cream
3. How to use Rozacta cream
4. Possible side effects
5. How to store Rozacta cream
6. Contents of the package and additional information
1. What Rozacta cream is and what it is used for
Rozact cream, which contains rosemary oil, is a traditional herbal medicinal product used in adults to relieve mild muscle and joint pain and mild peripheral circulatory disorders (with symptoms such as cold feet).
It is a traditional herbal medicinal product for use in specific indications based exclusively on long-term use.
If after 4 weeks you do not feel better or your condition worsens, you should seek medical attention.
2. What you should know before using Rozacta cream
Do not use Rozacta cream:
if you are allergic to rosemary oil or any of the other ingredients of this medicine (listed in section 6),
on injured or irritated skin.
Warnings and precautions
Talk to your doctor, qualified healthcare professional or pharmacist before using Rozacta Cream.
Discontinue use if redness, irritation or dryness of the skin occurs.
If you experience joint pain accompanied by joint swelling, redness or fever, you should see your doctor.
Tell your doctor if you have ever had or if you get any of these symptoms while taking this medicine:
inflammation of the skin or hardened areas under the skin leg ulcer
sudden swelling of one or both legs, if you notice that one or both legs are red or warm, or if you have kidney or heart problems
severe leg pain at rest.
Avoid contact with eyes. Do not apply the cream near mucous membranes.
Wash your hands before and after using the cream.
If the cream is accidentally swallowed, a doctor or pharmacist should be consulted.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended due to a lack of sufficient data.
Other medicines and Rozacta cream
Tell your doctor, qualified healthcare professional or pharmacist if you are using, have recently used or might use any other medicines.
No interactions with Rozacta Cream have been reported.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor, qualified healthcare professional or pharmacist for advice before using this medicine.
Pregnancy
Safety during pregnancy has not been established. In the absence of sufficient data, use during pregnancy is not recommended.
Breastfeeding
Safety during breastfeeding has not been established. In the absence of sufficient data, use during breastfeeding is not recommended.
Driving and using machines
Rozacta cream does not affect or negligibly affects the ability to drive and operate machinery.
Rosacta cream contains cetostearyl alcohol and ethanol (alcohol)
Rosacta cream contains 60 mg of cetostearyl alcohol in each dose of 2 g of cream. May cause local skin reactions (e.g. contact dermatitis).
Rosacta cream contains 0.3 g of ethanol (alcohol) in each dose of 2 g of cream. May cause a burning sensation on damaged skin.
3. How to use Rozacta cream
Always use this medicine exactly as your doctor, qualified healthcare professional or pharmacist has told you. If you are not sure, ask your doctor, qualified healthcare professional or pharmacist.
The recommended dose is:
Adults and people is old age
Apply approximately 3-6 cm of cream 2 to 3 times a day to the affected area and gently rub it into the skin. The amount of cream used will depend on the area being treated.
Application method:
Application to the skin.
Before use, pierce the tube by inverting the cap and twisting it to break the insulating barrier of the tube.
Duration of use:
If your symptoms get worse or last more than 4 weeks, you should talk to your doctor or a qualified healthcare professional.
Use in children and adolescents:
Use in children and adolescents under 18 years of age is not recommended due to a lack of sufficient data.
If you have used more than the required dose of Rozacta cream
No cases of overdose have been reported.
If you forget to use Rozacta cream
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor, qualified healthcare professional or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity (allergic reactions) may occur, such as contact dermatitis or asthma. The frequency is unknown.
If you get side effects not listed above, talk to your doctor, qualified healthcare professional or pharmacist.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system to
The Medicines Executive Agency,
"Damyan Gruev" Str. No. 8,
1303 Sofia
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Rozacta cream
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date corresponds to the last day of the month indicated.
To be stored below 25 °C.
Once opened, the cream should be used within 12 months.
Do not dispose of medicines down the drain or in the household waste container.
Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Rozacta cream contains
The active ingredient is Rosmarinus officinalis L, aetheroleum (Rosemary oil). 1 g of cream contains 100 mg of rosemary oil.
The other excipients are: medium chain triglycerides, octyldodecanol, ethanol (96 percent), glycerol (85 percent), emulsifying cetostearyl alcohol (type A), glycerol monostearate 40-55, trometamol, dimethicone, carbomers and purified water.
What Rozacta cream looks like and what it contains
Rozacta cream is a white glossy cream with a characteristic smell of rosemary oil.
Rosacta Cream is produced in aluminum tubes of 50 g and 90 g with an inner coating of epoxy phenolic resin and an HDPE screw cap.
Not all types of packaging can be put on sale.
Registration Certificate Holder and Manufacturer:
Holder of the certificate of registration:
Medis GmbH, Austria
Manufacturer:
Medis, doo, Slovenia
Date of last revision of the leaflet:
May, 2021
