Package leaflet: Information for the user

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 remem ber 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 docto r or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Ca rd 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 StraRe 34/III 9020 Klagenfurt am Worthersee, Austria

Manufacturer

Medis, d.o.o., Brnciceva ulica 1 1231 Ljubljana-Crnuce, 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 krem United Kingdom (UK): Rowiren

This leaflet was last revised in 06/2016.

Certification

Mark