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ROWIREN CREAM

Active substance(s): ROSEMARY OIL

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Package leaflet: Information for the user

Rosemary oil

cream

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,
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 feel worse, or do
not feel better after 4 weeks.
If the symptoms persist during the use of the
medicinal product or if adverse effects 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
1. What Rowiren is and what it is used for
2. What you need to know before you use Rowiren
3. How to use Rowiren
4. Possible side effects
5. How to store Rowiren
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
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.

If symptoms worsen or symptoms persist longer
than 4 weeks, consult your doctor or qualified
healthcare practitioner.
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 taking 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.
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.
Medicinal products may affect each other if used
simultaneously. No such interaction is reported for
Rowiren.
Pregnancy, breast-feeding and fertility
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.
Due to lack of adequate data, Rowiren is not
recommended if you are pregnant or
breast-feeding.
Driving and using machines
Rowiren has no or negligible influence on the
ability to drive and use machines.

Rowiren contains cetostearyl alcohol
May cause local skin reactions (e.g. contact
dermatitis).
3. How to use Rowiren
Always use this medicine exactly as described in
this leaflet or as your doctor, qualified healthcare
practitioner or pharmacisthas told you. Check with
your doctor, qualified healthcare practitioner or
pharmacist if you are not sure.
Before use, pierce the tube by reversing the cap
and screwing down to break the seal on the tube.
Cutaneous use. Use this medicine only on your skin.
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.
Wash hands before and after using the cream.
Use the cream as often as the leaflet tells you to.
Use in children and adolescents
The use in children and adolescents under 18 years
of age is not recommended due to lack of
adequate data.
If your symptoms worsen, or persist longer than 4
weeks during the use of the medicinal product, you
must talk to your doctor or qualified healthcare
practitioner.
If you use more Rowiren than you should
No case of overdose has been reported.
If you accidentally apply too much cream, it can be
wiped off with a tissue.
If you forget to use Rowiren
If you miss your application of Rowiren at the
correct time, apply it as soon as you remember and
then carry on as normal.
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 via the Yellow Card Scheme Website:
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
1 g of cream contains 100 mg of Rosmarinus officinalis L,
aetheroleum (Rosemary oil). The other excipients
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, St. Veiter Straße 34/III, 9020
Klagenfurt am Wörthersee, Austria
Manufacturer
Medis, d.o.o., Brnčičeva ulica 3, 1231
Ljubljana-Črnuče, Slovenia
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria, Bulgaria, Croatia, Estonia, Hungary,
Latvia, Slovenia: Rosacta
Czech Republic, Denmark, Finland, Norway, Poland,
Spain, Sweden, United Kingdom: Rowiren
Lithuania: Rosacta kremas
Romania: Rosacta cremă
Slovakia: Rowiren krém
This leaflet was last revised in 11/2017.
Certification Mark

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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