Roviren

B. PATIENT LEAFLET

Leaflet attached to the packaging: information for the user

Rowiren

cream
Rosmariniaetheroleum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If the patient feels worse or if no improvement occurs after 4 weeks, consult a doctor.

Table of contents of the leaflet

• 1. What is Rowiren and what is it used for
• 2. Important information before using Rowiren
• 3. How to use Rowiren
• 4. Possible side effects
• 5. How to store Rowiren
• 6. Contents of the packaging and other information

1. What is Rowiren and what is it used for

Rowiren is a traditional herbal medicinal product for use in specific indications, resulting solely from its long-term use.
The medicine contains rosemary essential oil traditionally used in adults to relieve mild muscle and joint pain and mild peripheral circulation disorders (with symptoms such as cold feet).
If no improvement occurs after 4 weeks or the patient feels worse, consult a doctor.

2. Important information before using Rowiren

When not to use Rowiren:

• if the patient is allergic to the active substance rosemary essential oil or any of the other ingredients of this medicine (listed in section 6),
• on damaged or irritated skin.

Warnings and precautions

Before starting to use the medicine, discuss it with your doctor or pharmacist.
Stop using it if redness, irritation, or dryness of the skin occurs.
If joint pain occurs, accompanied by swelling of the joints, redness, or fever, consult a doctor.
Tell your doctor if you are currently experiencing or have experienced any of the following symptoms while using this medicine:

• skin inflammation or hardening under the skin
• leg ulcers
• sudden swelling of one or both legs, redness, or a feeling of heat in one or both legs, or 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 swallowed, consult a doctor or pharmacist.

Children and adolescents

Use in children and adolescents under 18 years of age is not recommended due to insufficient data.

Rowiren and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take.
No interactions have been found with the use of Rowiren.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
The safety of use during pregnancy has not been established. Due to insufficient data, use during pregnancy is not recommended.
Breastfeeding
The safety of use during breastfeeding has not been established. Due to insufficient data, use during breastfeeding is not recommended.

Driving and using machines

The product has no influence or negligible influence on the ability to drive and use machines.

Rowiren contains cetearyl alcohol and ethanol (alcohol)

Rowiren contains 60 mg of cetearyl alcohol in each 2 g dose of cream.
It may cause local skin reactions (e.g., contact dermatitis).
Rowiren contains 0.3 g of ethanol (alcohol) in each 2 g dose of cream.
It may cause burning of damaged skin.

3. How to use Rowiren

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose is
Adults and elderly
Apply 3-6 cm of cream to the affected areas 2-3 times a day and gently massage into the skin. The amount of cream used depends on the surface area being treated.
Method of administration
Apply to the skin.
Before use, pierce the tube by turning the cap and pressing it to break the membrane sealing the tube.
Duration of use
If no improvement occurs after 4 weeks or the patient feels worse, consult a doctor or pharmacist.

Use in children and adolescents

Use in children and adolescents under 18 years of age is not recommended due to insufficient data.

Using more than the recommended dose of Rowiren

No cases of overdose have been reported.

Missing a dose of Rowiren

Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It may cause hypersensitivity (allergic reactions), such as contact dermatitis or asthma.
The frequency of these reactions is unknown. If other side effects occur that are not listed above, consult a doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 492 13 01; fax: +48 22 492 13 09; website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rowiren

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after EXP.
The expiry date refers to the last day of the month.
Store below 25°C.
After opening the packaging, the shelf life is 12 months.
Medicines should not be disposed of 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 packaging and other information

What Rowiren contains

The active substance of the medicine is rosemary essential oil from Rosmarinus officinalisL. ,aetheroleum (rosemary essential oil).
1 g of cream contains 100 mg of rosemary essential oil.
The other ingredients are: triglycerides of saturated fatty acids of medium chain length, octyldodecanol, ethanol 96% V/V, glycerol 85%, cetearyl alcohol, emulsifier (type A), glyceryl monostearate 40-55 (type II), tromethamine, dimethicone, carbomers, and purified water.

What Rowiren looks like and what the packaging contains

Rowiren is a white, shiny cream with a characteristic rosemary essential oil smell.
The packaging consists of aluminum tubes with a capacity of 50 g and 90 g, internally coated with epoxy-phenolic resin with an HDPE cap, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medis GmbH
Europaring F15
2345 Brunn am Gebirge
Austria

Manufacturer

Medis, d.o.o.
Brnčičeva ulica 3
1231 Ljubljana-Črnuče
Slovenia

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Bulgaria, Croatia, Estonia, Latvia, Slovenia, Hungary: Rosacta
Czech Republic, Denmark, Finland, Norway, Poland, Sweden, United Kingdom (Northern Ireland): Rowiren
Slovakia: Rowiren cream
Lithuania: Rosacta cream
Romania: Rosacta cream
Spain: Gelodol

Date of last revision of the leaflet: