PATIENT INFORMATION LEAFLET

Enangel 12.5 mg / g gel

Dexketoprofen

Read this leaflet carefully before you start taking this medicine because it contains important information for you.Keep this leaflet, you may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Enangel and what it is used for

2.What you need to know before using Enangel

3.How to use Enangel

4.Possible side effects.

5Storage of Enangel

6.Contents of the pack and additional information

Enangelcontains dexketoprofen, an active ingredient that belongs to the group of nonsteroidal anti-inflammatory drugs.

Enangelacts by preventing or reducing the formation of the 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.

Enangelis used for the treatment ofpainful, inflammatory conditions, of traumatic or degenerative origin, affecting joints, tendons, ligaments, and muscles.

No useEnangel

• If you are allergic to dexketoprofen, ketoprofen, tiaprofenic acid, UV blockers, perfumes, or some of the other components of this medication (listed in section 6).
• If you are allergic to acetylsalicylic acid (e.g. aspirin) or another nonsteroidal anti-inflammatory drug.
• In the eyes or mucous membranes (mouth, nose, and genitals), or in open wounds or other skin lesions that compromise the integrity of the skin in the treated area.
• 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 of various cosmetic and hygiene products such as shampoo, aftershave lotion, bath and shower gel, skin creams, lipsticks, anti-aging creams, makeup removers, hair lacquers, which is used to delay photodegradation).
• Do not expose treated areas to the sun or 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 exposure to sunlight, during Enangel treatment:

• Treatment should be interrupted if any skin reaction appears after applying Enangel.
• Exposure to the sun (even on cloudy days) or ultraviolet (UVA) lamps on areas that have been in contact with the product may cause skin reactions (phototoxicity) potentially severe. Therefore, it is necessary:

- Cover treated areas with clothing to protect them during treatment and for two weeks after stopping treatment to avoid any risk of phototoxicity.

• Wash your hands thoroughly after each application of Enangel.

- Once the gel is applied, do not use tight clothing or occlusive bandages.

Children

No recommended doses or indications have been established for children under 6 years, so its use is not recommended.

Other medications and Enangel

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

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using any medication.

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

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

Driving and operating machinery

No effects have been described on the ability to drive and use machinery.

Enangel contains alcohol (ethanol) and lavender essence

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is two or three applicationsdaily.The amount of gel will depend on the area to be treated, and it will be applied by giving a gentle massage to favor absorption.

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

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

If you use moreEnangelthan you should

Given that it is a topical preparation, the possibility of overdosing is remote.

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

If accidental ingestion of the tube contents occurs, the medical staff will proceed to perform gastric lavage and initiate symptomatic treatment.

Dexketoprofen is dialyzable (it is eliminated through dialysis).

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Infrequent (between 1 and 10 per 1,000 patients):

• Dermatitis (redness and/or inflammation of the skin) that includes allergic reactions on the skin.

Rare (more than one per 1,000 but equal to or less than one per 10,000 patients):

• Redness or prominence on the skin. More severe reactions (eczema bullosa or flictenular, bullous eruptions)that may spread or generalize.

Very rare (in fewer than one per 10,000 patients):

- Allergic reaction that may manifest with urticaria and/or difficulty breathing (bronchospasm).

Frequency not known:

-Severe skin reactions during sun exposure (photosensitivity) presenting redness and inflammation of the skin, and in some cases, vesicle formation

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication 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 medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofEnangel

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

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

Appearance of the product and contents of the packaging

Enangelis a colorless and practically transparent gel, which is presented in flexible aluminum tubes in packaging sizes of 60 g.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Menarini, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona)

Tel: 934 628 800

Date of the last review of this leaflet:March 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/