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ROWIREN CREAM - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

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

  • 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 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.

Certification Mark

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

M MUSCULO-SKELETAL SYSTEM DRUGS

M02 TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

M02A TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

M02AX Other topical products for joint and muscular pain in ATC

Frequently Asked Questions

What is Rowiren Cream used for?

Rowiren Cream is used to relieve joint and muscular pain, helping to soothe discomfort associated with conditions like arthritis, muscle strains, and sprains.

How does Rowiren Cream work?

Rowiren Cream works by penetrating the skin and delivering active ingredients that reduce inflammation and pain in the affected areas.

Can I use Rowiren Cream for back pain?

Yes, Rowiren Cream can be applied to the back for pain relief caused by muscle strain or discomfort.

Is Rowiren Cream safe for all skin types?

Rowiren Cream is generally safe for most skin types, but individuals with sensitive skin should perform a patch test before full application.

How often can I apply Rowiren Cream?

You can apply Rowiren Cream up to three to four times a day on the affected area, depending on your doctor's advice.

Can I use Rowiren Cream along with other pain relievers?

Yes, but it’s best to consult your healthcare provider to ensure there are no interactions with other medications you may be using.

Is Rowiren Cream suitable for children?

Rowiren Cream is generally not recommended for children under 12. Always consult a pediatrician before use.

Are there any side effects of using Rowiren Cream?

Some users may experience mild skin irritation or allergic reactions. Discontinue use if you notice severe redness or itching.

How long should I use Rowiren Cream before seeing results?

Many patients report relief within a few days of regular use, but individual results may vary depending on the severity of the pain.

Can pregnant or breastfeeding women use Rowiren Cream?

Pregnant or breastfeeding women should consult their doctor before using Rowiren Cream to ensure it’s safe for them.

Should I wash my hands after applying Rowiren Cream?

Yes, it's recommended to wash your hands thoroughly after applying the cream unless treating your hands specifically.

Can I use Rowiren Cream on open wounds?

No, do not apply Rowiren Cream to open wounds or broken skin as this can cause further irritation.

What should I do if I forget to apply Rowiren Cream?

If you forget a dose, apply it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your schedule.

Does Rowiren Cream have a strong smell?

Rowiren Cream has a mild scent due to its active ingredients but is designed to be non-intrusive and pleasant.

Can I apply Rowiren Cream before physical activity?

Yes, applying Rowiren Cream before physical activity can help reduce discomfort during exercise; just allow it to absorb fully first.

Is it necessary to massage the cream into my skin?

Gently massaging the cream into your skin can help with absorption and increase its effectiveness in pain relief.

Where can I buy Rowiren Cream?

Rowiren Cream is available at most pharmacies and online health stores. Check with your local pharmacy for availability.

What if I experience an allergic reaction after using Rowiren Cream?

If you experience symptoms like swelling, rash, or difficulty breathing after using the cream, seek medical attention immediately.

Can I store Rowiren Cream in the fridge?

It's best to store Rowiren Cream at room temperature away from direct sunlight. Refrigeration may affect its consistency.

How do I know if I'm using too much of Rowiren Cream?

Using more than directed can lead to increased side effects like skin irritation. Always follow packaging instructions or your doctor’s advice.