ENANGEL 12.5 mg/g GEL

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Enangel 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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

5 Conservation of Enangel

1. Contents of the pack and further information

1. What is Enangel and what is it used for

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

Enangel acts by preventing or reducing the formation of elements that cause pain and inflammation in joint, ligament, tendon, or muscle injuries. When the gel is applied locally, it reduces pain and inflammation in the treated area.

Enangel is used for the treatment of painful, inflammatory conditions of traumatic or degenerative origin in the joints, tendons, ligaments, and muscles.

2. What you need to know before you use Enangel

Do not useEnangel

• If you are allergic to dexketoprofen, ketoprofen, tiaprofenic acid, UV blockers, perfumes, or any of the other components of this medicine (listed in section 6).
• If you are allergic to acetylsalicylic acid (e.g., aspirin) or another non-steroidal anti-inflammatory medicine.
• In the eyes or on mucous membranes (mouth, nose, and genitals), or on open wounds or other skin lesions in the area to be treated.
• Stop using Enangel immediately if you experience any skin reaction, including skin reactions after simultaneous application of products containing octocrylene (octocrylene is one of the excipients in various cosmetic and hygiene products such as shampoo, aftershave lotion, bath and shower gel, skin creams, lip pencils, anti-aging creams, makeup removers, hair lacquers, used to delay photodegradation).
• Do not expose treated areas to the sun or to ultraviolet (UVA) lamps during treatment and for 2 weeks after stopping treatment.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Enangel.

To prevent possible allergic reactions with sun exposure during treatment with Enangel:

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

• to cover treated areas with clothing to protect them during treatment and for 2 weeks after stopping treatment to avoid any risk of photosensitization.
  • Wash your hands thoroughly after each application of Enangel.

• Once the gel has been applied, do not use tight clothing or occlusive dressings.

Children

The recommended doses and indications for children under 6 years of age have not been established, so its use is not recommended.

Other medicines and Enangel

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using any medicine.

Enangel 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 described.

Enangel contains alcohol (ethanol) and lavender 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 Enangel

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is two or three applications per day. The amount of gel will depend on the area to be treated and will be applied with a gentle massage to facilitate absorption.

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

The duration of continuous treatment with topical dexketoprofen should be limited to a maximum of 7 days.

If you use moreEnangelthan you should

As 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 gastric lavage and establish symptomatic treatment.

Dexketoprofen is dialyzable (it is eliminated by dialysis).

4. Possible side effects

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

Uncommon (between 1 and 10 in every 1,000 patients):

• Dermatitis (redness and/or inflammation of the skin) including allergic skin reactions.

Rare (more than 1 in every 1,000 but less than 1 in every 10,000 patients):

• Redness or bumps on the skin. More serious reactions (bullous or flictenular eczema, bullous eruptions) that can spread or become generalized.

Very rare (less than 1 in every 10,000 patients):

• Allergic reaction that can manifest with hives and/or difficulty breathing (bronchospasm).

Frequency not known:

• Severe skin reactions during sun exposure (photosensitivity) presenting with redness and inflammation of the skin, and in some cases, blister formation.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Enangel

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 EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition ofEnangel

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

The other ingredients are: Carbomer, ethanol 96%, lavender essence, tromethamine, and purified water.

Appearance of the product and pack contents

Enangel is a colorless, practically transparent gel, presented in flexible aluminum tubes in pack sizes of 60g.

Marketing authorization holder and manufacturer

Laboratorios Menarini, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona)

Tel: 934 628 800

Date of last revision of this leaflet:March 2020

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