Gelodol cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Gelodol cream
Rosemary essential oil
Rosmarinus officinalis L., aetheroleum
Read this entire leaflet carefully before starting to use this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 4 weeks.
Contents of the leaflet
- What Gelodol is and what it is used for
- What you need to know before using Gelodol
- How to use Gelodol
- Possible adverse effects
- How to store Gelodol
- Contents of the pack and other information
1. What Gelodol is and what it is used for
Gelodol, which contains Rosmarinus officinalis L., aetheroleum (rosemary essential oil), is a traditional herbal medicinal product used in adults for the relief of minor muscle and joint pain and for minor peripheral circulatory disorders (with symptoms such as tired legs).
The medicine is a traditional herbal medicinal product for use in the specified indications, based exclusively on long-standing use.
2. What you need to know before using Gelodol
Do not use Gelodol:
- if you are allergic to rosemary essential oil (Rosmarinus officinalis L., aetheroleum) or to any of the other components of this medicine (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 if redness, irritation, or dry skin occurs.
If joint pain is accompanied by joint swelling, redness, or fever, you should consult your doctor.
Consult your doctor if you currently have or develop any of the following while using the medication:
- skin inflammation or hardening under the skin
- development of leg ulcers
- sudden swelling in one or both legs, especially if you notice redness or warmth, or if you have kidney or heart problems
- sudden, severe leg pain while at rest
Avoid contact with the eyes. Do not apply the cream near mucous membranes.
Wash your hands before and after applying the cream.
Consult your doctor or pharmacist if the cream is accidentally swallowed.
Children and adolescents
This product is not recommended for children and adolescents under 18 years of age due to lack of information.
Other medicines and Gelodol
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
No interactions have been reported for Gelodol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
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 use of machines
The effect of Gelodol on the ability to drive and operate machinery is negligible or none.
Gelodol contains cetostearyl alcohol and ethanol (alcohol)
Gelodol contains 60 mg of cetostearyl 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 exactly the instructions for use of the medicine provided in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Recommended dose:
Adults and elderly
Apply approximately 3–6 cm of cream 2 to 3 times daily to the affected area and massage thoroughly. The amount of cream to be used will depend on the size of the area to be treated.
Method of administration
For cutaneous use only.
Before first use, pierce the tube seal by inverting the cap and screwing it down to break the seal.
Duration of use
If symptoms worsen or persist for more than 4 weeks during use of this product, consult your doctor or nurse.
Use in children and adolescents
This product is not recommended for use in children and adolescents under 18 years of age due to lack of data.
If you use more Gelodol than you should
Cases of overdose have not been reported.
If you forget to use Gelodol
Do not apply a double dose to compensate for a missed dose.
Consult your doctor, pharmacist, or nurse if you have any further questions about the use of this medicine.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Hypersensitivity (allergic reactions) may occur, such as contact dermatitis or asthma. The frequency is unknown.
If other adverse effects not mentioned above appear, consult your doctor, nurse, or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist. This includes possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Gelodol
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 is the last day of the month indicated.
Store below 25 °C.
After opening the tube, the cream can be used for 12 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the package and other information
Composition of Gelodol
- The active substance is Rosmarinus officinalis L., aetheroleum (rosemary essential oil).
1 g of cream contains 100 mg of Rosmarinus officinalis L., aetheroleum (rosemary essential oil).
- The other ingredients are medium-chain triglycerides, octyldodecanol, ethanol (96 percent), glycerol (85 percent), cetostearyl alcohol emulsifier (Type A), glycerol monostearate 40-55, tromethamine, dimethicone, carbomers and purified water.
Appearance of the product and contents of the container
Gelodol is a shiny white cream with the characteristic odour of Rosmarinus officinalis L., aetheroleum (rosemary).
Gelodol is available in 50 g and 90 g aluminium tubes internally coated with an epoxy-phenolic resin and fitted with a high-density polyethylene (HPDE) screw cap.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Ferrer Internacional, S.A.
Gran Vía Carlos III, 94
08028 Barcelona, Spain
This medicinal product is registered in the European Economic Area countries and in the United Kingdom (Northern Ireland) under 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 most recent review of this leaflet: 05/2021
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)