GELODOL CREAM
Ask a doctor about a prescription for GELODOL CREAM
How to use 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
- What is Gelodol and what is it used for
- What you need to know before starting to use Gelodol
- How to use Gelodol
- Possible side effects
- Storage of Gelodol
- 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/)
- Country of registration
- Prescription requiredNo
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to GELODOL CREAMDosage form: TOPICAL SOLUTION, 10 gActive substance: variousManufacturer: Laboratorio Reig Jofre, S.A.Prescription not requiredDosage form: GEL, 20 mg/g + 2 mg/g + 3 mg/gActive substance: variousManufacturer: Laboratorio Stada S.L.Prescription requiredDosage form: CREAM, 20 mg / 100 mg / 10 mg / 50 mg / 20 mgActive substance: variousManufacturer: Laboratorios Vinas S.A.Prescription not required
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