ENANDOL 12.5 mg/g GEL

Introduction

Package Leaflet: Information for the User

Enandol 12.5 mg/g gel

dexketoprofen

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What is Enandol and what is it used for
2. What you need to know before you start using Enandol
3. How to use Enandol
4. Possible side effects

5 Conservation of Enandol

1. Contents of the packaging and additional information

1. What is Enandol and what is it used for

This medicine contains dexketoprofen, an active ingredient that belongs to the group of non-steroidal anti-inflammatory drugs.

It is used in adults for the local relief of pain and mild and occasional inflammation, of traumatic origin, affecting joints, tendons, ligaments, and muscles, such as bruises and blows, tendinitis, sprains, contractures, back pain (lumbalgia), dislocations, and sprains.

2. What you need to know before you start using Enandol

Do not useEnandol

• If you are allergic to dexketoprofen or any of the other components of this medicine (listed in section 6).
• In case you have suffered allergic reactions to dexketoprofen, ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid (e.g., aspirin), or another non-steroidal anti-inflammatory medicine (symptoms are difficulty breathing, inflammation of the mucous membranes of the nasal passages, or hives).
• If you have a history of skin reactions in areas that have been in contact with a product when exposed to the sun (even when cloudy) or to ultraviolet lamps (UVA) (photosensitivity reactions).
• If you have a history of skin allergy to dexketoprofen, ketoprofen, tiaprofenic acid, fenofibrate, or UV blockers or perfumes.
• Do not use it in the eyes or mucous membranes (mouth, nose, and genitals), or on infected skin or open wounds, or other lesions that alter the integrity of the skin in the area to be treated.
• Stop using this medicine immediately if you experience any skin reaction, including skin reactions after the simultaneous application of products containing octocrylene (octocrylene is one of the excipients of various cosmetic and hygiene products such as shampoo, aftershave lotion, bath and shower gel, skin creams, lip pencils, anti-aging creams, make-up removers, hair lacquers, which is used to delay photodegradation).
• Do not expose the treated areas to the sun or ultraviolet lamps (UVA) during treatment and for 2 weeks after discontinuation.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Enandol.

To prevent possible allergic reactions with exposure to sunlight during treatment with this medicine:

• Treatment should be discontinued if any skin reaction occurs after applying Enandol.
• Exposure to the sun (even when cloudy) or ultraviolet lamps (UVA) of areas that have been in contact with the product may cause skin reactions (photosensitization) that can be potentially serious. Therefore, it is necessary:

• to cover the treated areas with clothing to protect them during treatment and for two weeks after discontinuation to avoid any risk of photosensitization.
  • Wash your hands thoroughly after each application of the medicine.

• Once the gel has been applied, do not use tight clothing or occlusive dressings.
• There may be cross-reactions with some sunscreens, fenofibrate, and other products that include benzophenone in their chemical structure.

Children and adolescents

Safety and efficacy have not been established in children and adolescents.

Other medicines and Enandol

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

It is unlikely to interact with other medicines due to its direct application to the skin.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

This medicine should be avoided during pregnancy, as its safety during this period has not been established.

There is not enough data on the elimination of dexketoprofen in breast milk, so its use is not recommended during breastfeeding.

Driving and using machines

No effects on the ability to drive and use machines have been reported.

Enandol contains alcohol (ethanol) andlavender essence

This medicine contains 0.33g of alcohol (ethanol) per gram of gel. Ethanol may cause a burning sensation on damaged skin.

This medicine contains lavender essence with benzyl alcohol, amylcinnamaldehyde, citral, eugenol, hydroxycitronellal, coumarin, geraniol, farnesol, linalool, benzyl benzoate, citronellol, and d-limonene, which may cause allergic reactions.

3. How to use Enandol

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

The usual dose is two or three applications per day, one application every 12 or 8 hours. The amount of gel will depend on the area to be treated and will be applied with a gentle massage to facilitate absorption.

Use the minimum amount necessary for the shortest time required.

The total daily dose should not exceed 7.5g per day, which is equivalent to 14cm of gel.

The duration of continuous treatment with this medicine should be limited to a maximum of 7 days. If the pain or swelling worsen or persist after 7 days of treatment, consult your doctor.

If you use moreEnandolthan you should

Since it is a topical preparation, the possibility of overdose is remote.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20.

If accidental ingestion of the tube contents occurs, the healthcare personnel will perform a gastric lavage and establish symptomatic treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people):

• Dermatitis (redness, itching, inflammation of the skin, burning sensation) including allergic skin reactions.

Rare (may affect up to 1 in 1,000 patients):

• Severe reactions such as blister-like lesions similar to burns (bullous or flictenular eczema) that can spread or generalize.

Very rare (may affect up to 1 in 10,000 patients):

• Allergic reaction that can manifest with the appearance of white or reddish patches on the skin with itching (urticaria) and/or difficulty breathing (bronchospasm).

Frequency not known (cannot be estimated from the available data):

• Skin reactions when exposing the application site to the sun (photosensitivity) presenting redness and inflammation of the skin, and in some cases, mild vesicle formation.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Enandol

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

No special storage conditions are required. However, it is recommended not to expose the product to heat for prolonged periods, as it may deteriorate.

Do not use this medicine after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the packaging and additional information

Composition ofEnandol

The active ingredient is dexketoprofen. Each gram of gel contains 12.5mg of dexketoprofen.

The other components are: carbomer, ethanol 96%, lavender essence, tromethamine, and purified water.

Appearance of Enandol and contents of the packaging

Colorless, practically transparent gel, presented in flexible aluminum tubes in packaging sizes of 60g.

Marketing authorization holder

MENARINI CONSUMER HEALTHCARE, S.A.U.

Guifré, 724 - 08918 Badalona (Barcelona)

Spain

Manufacturer

LABORATORIOS MENARINI, S.A.

Alfons XII, 587. Badalona (Barcelona) Spain

Date of the last revision of this leaflet:October 2024.

Other sources of information

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