Leaflet: information for the user

Gelodol cream

Essential oil of rosemary

Rosmarinus officinalisL., aetheroleum

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 4 weeks.

1. What is Gelodol and what it is used for

2. What you need to know before starting to use Gelodol

3. How to use Gelodol

4. Possible side effects

5. Storage of Gelodol

6. Contents of the pack and additional information

Gelodolwhich containsRosmarinus officinalisL., essential oil (rosemary essential oil) is a traditional herbal medicine used in adults for the reliefof minor muscle and joint pains and in minor peripheral circulatory disorders (with symptoms such as tired legs).

The medicine is a traditional herbal medicine for use in the specified indications based exclusively on its long-standing use.

Do not use Gelodol:

• if you are allergic to rosemary essential oil (Rosmarinus officinalisL., aetheroleum) or any of the other components of this medication (listed in section 6),
• on irritated or damaged skin (cracked).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Gelodol.

Stop using the product in case of redness, irritation, or dry skin.

If joint pain accompanied by joint inflammation, redness, or fever appears, consult your doctor.

Consult your doctor if you currently have or have while using the medication:

• skin inflammation or thickening of the skin under the skin
• ulcers on the legs
• sudden swelling of one or both legs, if you perceive redness or heat or have kidney or heart problems
• sudden sharp pain in a leg when at rest

Avoid contact with the eyes. Do not apply the cream near mucous membranes.

Wash your hands before and after using the cream.

Consult your doctor or pharmacist if you accidentally ingest the cream.

Children and adolescents

This product is not recommended for use in children and adolescents under 18 years due to lack of information.

Other medications and Gelodol

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medication.

No interactions have been described for Gelodol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The safety of Gelodol during pregnancy has not been established. Due to lack of information, its use is not recommended during pregnancy.

Breastfeeding

The safety of Gelodol during breastfeeding has not been established. Due to lack of information, its use is not recommended during breastfeeding.

Driving and operating machines

The influence of Gelodol on the ability to drive and operate machines is negligible or insignificant.

Gelodol contains cetoestearic alcohol and ethanol (alcohol)

Gelodol contains 60 mg of cetoestearic alcohol in each 2 g dose of cream.

It may cause local skin reactions (e.g. contact dermatitis).

Gelodol contains 0.3 g of ethanol (alcohol) in each 2 g dose of cream.

It may cause a burning sensation on damaged skin.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse.In case of doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is

Adults and elderly

Apply approximately 3-6 cm of cream 2 to 3 times a day to the affected area and massage generously. The amount of cream to use will depend on the area being treated.

Method of administration

Cutaneous use.

Before using it, pierce the tube by inverting the cap and screwing it down to break the tube seal.

Period of use

If symptoms worsen or persist for more than 4 weeks while using this product, consult your doctor or nurse.

Use in childrenand adolescents

This product is not recommended for use in children and adolescents under 18 years due to lack of information.

If you use more Gelodol than you should

No cases of overdose have been reported.

If you forgot to use Gelodol

Do not use a double dose to compensate for the missed doses.

Consult with your doctor, pharmacist, or nurse in case of additional doubts about the use of the medication.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Hypersensitivity (allergic reactions) such as contact dermatitis or asthma may appear. Frequency is unknown.

If other adverse effects not mentioned previously appear, consult your doctor, nurse, or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist. This includes possible adverse effects not mentioned in this prospectus. You may also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and label after CAD. The expiration date is the last day of the month indicated.

Store below 25 °C.

Once the tube is opened, the cream can be used for 12 months.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacisthow to disposeofthecontainers and of themedicines that you no longerneed.This will help protect the environment.

Composition of Gelodol

• The active ingredient isRosmarinus officinalisL., aetheroleum (essential oil of rosemary).

1 g of cream contains 100 mg ofRosmarinus officinalisL., aetheroleum (essential oil of rosemary).

• The other ingredients are medium-chain triglycerides, octyldodecanol, ethanol (96 percent), glycerol (85 percent), cetostearyl alcohol (Type A) emulsifier, glycerol monoestearate 40-55, trometamol, dimethicone, carbomers, and purified water.

Appearance of the product and contents of the packaging

Gelodolis a bright white cream with the characteristic odor ofRosmarinus officinalisL., aetheroleum (rosemary).

Gelodolis available in aluminum tubes of 50 and 90 g, internally coated with an epoxy-phenolic resin and with an HPDE screw cap.

Not all presentations may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Medis GmbH

Europaring F15

2345 Brunn am Gebirge

Austria

Responsible for manufacturing

Medis, d.o.o.,

Brnciceva ulica 1,

1231 Ljubljana-Crnuce,

Slovenia

With manufacturing site

Brnciceva ulica 3,

1231 Ljubljana-Crnuce,

Slovenia

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona España

This medication is registered in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Bulgaria, Croatia, Latvia, Estonia, Hungary, Slovenia: Rosacta

Denmark, Czech Republic, Finland, Poland, Sweden, United Kingdom (Northern Ireland), Norway: Rowiren

Spain: Gelodol cream

Austria: Rosacta Creme

Lithuania: Rosacta kremas

Slovakia: Rowiren krém

Romania: Rosacta cremâ

Last review date of thisleaflet: 05/2021.

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)