GELODOL CREAM

Introduction

Package Leaflet: Information for the User

Gelodol Cream

Essential oil of rosemary

Rosmarinus officinalisL., aetheroleum

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

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

Contents of the Package Leaflet

1. What is Gelodol and what is it 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. Package Contents and Additional Information

1. What is Gelodol and what is it used for

Gelodol, which contains Rosmarinus officinalisL., aetheroleum (essential oil of rosemary), is a traditional herbal medicinal product used in adults for the relief of minor muscular and articular pains and minor peripheral circulatory disorders (with symptoms such as tired legs).

The medication is a traditional herbal medicinal product for use in the specified indications based solely on its long-standing use.

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

Do not use Gelodol:

• if you are allergic to essential oil of rosemary (Rosmarinus officinalisL., aetheroleum) or to 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 is accompanied by inflammation of the joint, redness, or fever, you should consult your doctor.

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

• skin inflammation or hardening of the area under the skin
• ulcer formation on the legs
• sudden swelling of one or both legs, if you notice redness or heat or have kidney or heart problems
• sharp pain in one 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

The use of this product is not recommended for children and adolescents under 18 years of age due to lack of information.

Other Medications and Gelodol

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

No interactions have been described for Gelodol.

Pregnancy and Breastfeeding

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

Pregnancy

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

Breastfeeding

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

Driving and Using Machines

Gelodol's influence on the ability to drive and use machines is zero or insignificant.

Gelodolcontains cetyl alcoholand ethanol (alcohol)

Gelodol contains 60 mg of cetyl 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.

3. How to Use Gelodol

Follow the administration instructions of the medication contained in this package leaflet or as 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 to be treated.

Method of Administration

Topical use.

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

Period of Use

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

Use in Childrenand Adolescents

The use of this product is not recommended for children and adolescents under 18 years of age due to lack of information.

If You Use More Gelodol Than You Should

No cases of overdose have been reported.

If You Forget to Use Gelodol

Do not use a double dose to make up for forgotten doses.

Consult your doctor, pharmacist, or nurse if you have any additional doubts about using the medication.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Hypersensitivity (allergic reactions) such as contact dermatitis or asthma may occur. The frequency is unknown.

If other side effects not mentioned above appear, consult your doctor, nurse, or pharmacist.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist. This includes possible side effects not mentioned in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Gelodol

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated 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.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Gelodol Composition

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

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

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

Appearance of the Product and Package Contents

Gelodol is a bright white cream with the characteristic odor of Rosmarinus officinalisL., aetheroleum (rosemary).

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

Not all presentations may be marketed.

Marketing Authorization Holderand Manufacturer

Medis GmbH

Europaring F15

2345 Brunn am Gebirge

Austria

Manufacturer

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, Spain

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

Date of the Last Revision of thisPackage Leaflet: 05/2021.

Other Sources of Information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)