Patient leaflet - Rowiren cream
1. What Rowiren is and what it is used for
Rowiren which contains rosemary oil is a traditional herbal medicinal product used in adults for relief of minor muscular and articular pain and minor peripheral circulatory disorders (with symptoms such as cold feet), based on traditional use only.
2. What you need to know before you use Rowiren
Do not use Rowiren:
- if you are allergic to rosemary oil or any of the other ingredients of this medicine (listed in section 6),
- on broken or irritated skin.
Warnings and precautions
If you are not sure if this product is suitable for you, talk to your doctor, qualified healthcare practitioner or pharmacist before using Rowiren.
Discontinue use if redness, irritation or dry skin occurs. If you experience joint pain accompanied by swelling of joint, redness or fever, you should visit your doctor.
Tell your doctor if either you have any of the following already, or you experience any of these symptoms while using this medicine:
- inflammation of your skin or a hard area under your skin
- an ulcer forming on your legs
- sudden swelling of one or both of your legs, you notice one or both of your legs is red or hot or you have kidney or heart problems
- severe pain in your leg when you are at rest.
Avoid contact with eyes. Do not apply 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 contacted for advice.
Children and adolescents
The use in children and adolescents under 18 years of age is not recommended due to lack of adequate data.
Other medicines and Rowiren
Tell your doctor, qualified healthcare practitioner or pharmacist if you are using, have recently used or might use any other medicines.
No interaction is reported for Rowiren.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, qualified healthcare practitioner or pharmacist for advice before using this medicine.
Pregnancy
Safety during pregnancy has not been established. In the absence of sufficient data, the use during pregnancy is not recommended. Breast-feeding
Safety during breast-feeding has not been established. In the absence of sufficient data, the use during breast-feeding is not recommended.
Driving and using machines
Rowiren has no or negligible influence on the ability to drive and use machines.
Rowiren contains cetostearyl alcohol and ethanol (alcohol)
Rowiren contains 60 mg cetostearyl alcohol in each dose of 2 g cream.
May cause local skin reactions (e.g. contact dermatitis). Rowiren contains 0.3 g ethanol (alcohol) in each dose of 2 g cream. It may cause burning sensation on damaged skin.
3. How to use Rowiren
Always use this medicine exactly as described in this leaflet or as your doctor, qualified healthcare practitioner or pharmacist has told you. Check with your doctor, qualified healthcare practitioner or pharmacist if you are not sure.
The recommended dose is
Adults and elderly
Apply approximately 3 - 6 cm of cream 2 to 3 times daily to the affected area and gently massage it into the skin. The amount of cream used will depend on the area being treated.
Method of administration
Cutaneous use. Use this medicine only on your skin. Before use, pierce the tube by reversing the cap and screwing down to break the seal on the tube.
Duration of use
If your symptoms worsen, or persist longer than 4 weeks during the use of the medicinal product, you must talk to your doctor or a qualified healthcare practitioner.
Use in children and adolescents
The use in children and adolescents under 18 of age is not recommended due to lack of adequate data.
If you use more Rowiren than you should
No case of overdose has been reported.
If you forget to use Rowiren
Do not apply a double dose to make up for a forgotten application. If you have any further questions on the use of this medicine, ask your doctor, qualified healthcare practitioner or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity (allergic reactions) such as contact dermatitis or asthma may occur. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor, qualified healthcare practitioner or pharmacist should be consulted.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly the Yellow Card Scheme at: www. mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
Store below 25 °C.
Once opened, the cream should be used within 12 months.
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. Contents of the pack and other information
What Rowiren contains
The active substance is Rosmarinus officinalis L, aetheroleum (rosemary oil).
1 g of cream contains 100 mg of rosemary oil.
The other ingredients are: medium-chain triglycerides, octyldodecanol, ethanol (96 per cent), glycerol (85 per cent), emulsifying cetostearyl alcohol (Type A), glycerol monostearate 40–55, trometamol, dimeticone, carbomers and purified water.
What Rowiren looks like and contents of the pack
Rowiren is a white shiny cream with characteristic odour of rosemary oil.
Rowiren is available in aluminium tubes of 50 g and 90 g coated internally with an epoxy-phenolic resin and fitted with an HDPE screw cap.
Not all pack sizes may be marked.
Traditional Herbal Registration Holder and Manufacturer Traditional Herbal Registration Holder
Medis GmbH
Europaring F15
2345 Brunn am Gebirge
Austria
Manufacturer
Medis, d.o.o.
Brnčičeva ulica 3
1231 Ljubljana-Črnuče
Slovenia
This medicine product is authorised in the Member States of the European Economic Area and in the United Kingdom under the following names:
Austria, Bulgaria, Croatia, Estonia, Hungary, Latvia, Slovenia: Rosacta
Czech Republic, Denmark, Finland, Norway, Poland, Sweden: Rowiren
Lithuania: Rosacta kremas
Romania: Rosacta cremă
Slovakia: Rowiren krém
Spain: Gelodol
United Kingdom: Rowiren
This leaflet was last revised in 05/2021.
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