Patient Information Leaflet

Rowiren
cream
Rosmarini aetheroleum
Please read this leaflet carefully before using this medicine, as it contains
important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If you feel worse or if there is no improvement after 4 weeks of treatment, contact your doctor.

Table of contents

What Rowiren is and what it is used for
Important information before using Rowiren
How to use Rowiren
Possible side effects
How to store Rowiren
Contents of the pack and other information

1. What Rowiren is and what it is used for

Rowiren is a traditional herbal medicinal product intended for use in specific indications based solely on its long-standing traditional use.
The medicine contains rosemary essential oil, traditionally used in adults to relieve mild muscular and joint pain, as well as mild peripheral circulatory disorders (with symptoms such as cold feet).
If there is no improvement after 4 weeks of treatment or if you feel worse, contact your doctor.

2. Important information before using Rowiren

Do not use Rowiren:

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

Warnings and precautions
Before using this medicine, discuss it with your doctor or pharmacist.
Discontinue use if redness, irritation, or dryness of the skin occurs.
If joint pain is accompanied by joint swelling, redness, or fever, contact your doctor.
Inform your doctor if any of the following symptoms occur currently or during treatment with this medicine:

skin inflammation or subcutaneous hardening
leg ulcers
sudden swelling of one or both legs, redness or warmth 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 applying the cream.
In case of accidental ingestion, contact your doctor or pharmacist immediately.

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

Rowiren with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
No interactions have been reported with the use of Rowiren.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
The safety of use during pregnancy has not been established. Due to lack of sufficient data, use during pregnancy is not recommended.

Breastfeeding
The safety of use during breastfeeding has not been established. Due to lack of sufficient data, use during breastfeeding is not recommended.

Driving and operating machinery
This product has no effect or negligible effect on the ability to drive or operate machinery.

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 a burning sensation on damaged skin.

3. How to use Rowiren

This medicine should always be used exactly as described in this patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose is:
Adults and elderly patients
Apply approximately 3–6 cm of cream 2 to 3 times daily to the affected areas and gently massage into the skin. The amount of cream used depends on the size of the area being treated.
Method of administration
For topical use only.
Before first use, pierce the seal of the tube by reversing the cap and pressing it down to break the membrane sealing the tube.
Duration of treatment
If there is no improvement after 4 weeks, or if symptoms worsen, 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.
Use of more than the recommended dose of Rowiren
No cases of overdose have been reported.
Missed dose of Rowiren
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Hypersensitivity (allergic reactions) such as contact dermatitis or asthma may occur.
The frequency of these reactions is unknown. If any other adverse reactions not listed above occur,
consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 492 13 01; fax: +48 22 492 13 09; website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, additional information on the safety of using this medicine can be collected.

5. How to store Rowiren

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label following EXP.
The expiry date refers to the last day of the stated month.
Store below 25°C.
After opening the package, 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 is essential oil from Rosmarinus officinalis L., aetheroleum (rosemary essential oil).
Each 1 g of cream contains 100 mg of rosemary essential oil.
The other ingredients are: medium-chain saturated triglycerides, octyldodecanol, ethanol 96% V/V, glycerol 85%, cetostearyl alcohol emulsifying (type A), glycerol monostearate 40-55 (type II), tromethamol, dimethicone, carbomers and purified water.

What Rowiren looks like and contents of the pack
Rowiren is a white, shiny cream with a characteristic odour of rosemary essential oil.
The packaging consists of aluminium tubes with a capacity of 50 g and 90 g, internally coated with epoxy-phenolic resin and fitted with a cap made of HDPE, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised for sale in the European Economic Area countries 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 krém
Lithuania: Rosacta kremas
Romania: Rosacta cremă
Spain: Gelodol