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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 your symptoms
worsen or persist longer than 4 weeks.
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 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.
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 pharmacist has 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.
Use this medicine only on your skin.
Adults and elderly
Apply cream, approximately 3 - 6 cm, 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.
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.
Cutaneous use.
Children and adolescents
The use in children and adolescents under
18 years 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 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 (cannot be estimated
from available data).
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. 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.
Store below 25 °C.

Once opened, the cream should be used within
12 months.
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.
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: triglycerides,
medium-chain, octyldodecanol, ethanol (96 per
cent), glycerol (85 per cent), cetostearyl alcohol
(Type A) emulsifying, glycerol monostearate
40–55, trometamol, dimeticone, carbomers and
water, purified.
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 tube of 90 g
coated internally with an epoxy-phenolic resin and
fitted with an HDPE screw cap.
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 1
1231 Ljubljana-Črnuče, Slovenia
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Austria (AT): Rosacta
Czech Republic (CZ): Rowiren
Spain (ES): Rowiren
Croatia (HR): Rosacta
Hungary (HU): Rosacta
Poland (PL): Rowiren
Sweden (SE): Rowiren
Slovenia (SI): Rosacta
Slovakia (SK): Rowiren krém
United Kingdom (UK): Rowiren
This leaflet was last revised in 06/2016.

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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