Patient leaflet - ROWIREN CREAM
Rowiren
Rosemary oil
cream
1 VMEDIS
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 practitioner or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor, a qualified healthcare practitioner or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after 4 weeks.
If the symptoms persist during the use of the medicinal product or if adverse effect not mentioned in the package leaflet occur, a doctor or pharmacist or a qualified health care practitioner should be consulted.
What is in this leaflet
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1. What Rowiren is and what it is used for
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2. What you need to know before you use Rowiren
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3. How to use Rowiren
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4. Possible side effects
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5. How to store Rowiren
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6. Contents of the pack and other information
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 rowirendo 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.
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 informationwhat rowiren containsthe 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.
Brnciceva ulica 3
1231 Ljubljana-Crnuce
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 crema
Slovakia: Rowiren krem
Spain: Gelodol
United Kingdom: Rowiren
This leaflet was last revised in 05/2021.
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