Enangel 12.5 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Enangel 12.5 mg/g gel
Dexketoprofen
Read the entire leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet as 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 give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if the effects mentioned are not listed in this leaflet. See section 4.
Leaflet contents
- What Enangel is and what it is used for
- What you need to know before using Enangel
- How to use Enangel
- Possible side effects
- How to store Enangel
- Contents of the pack and other information
1. What Enangel is and what it is used for
Enangel contains dexketoprofen, an active ingredient belonging to the group of non-steroidal anti-inflammatory drugs.
Enangel works by preventing or reducing the formation of substances that cause pain and inflammation in injuries affecting joints, ligaments, tendons, or muscles. When the gel is applied locally, pain and inflammation in the treated area are reduced.
Enangel is used for the treatment of painful and inflammatory conditions of traumatic or degenerative origin affecting joints, tendons, ligaments, and muscles.
2. What you need to know before using Enangel.
Do not use Enangel
- 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 to any other non-steroidal anti-inflammatory drug (NSAID).
- In the eyes or on mucous membranes (mouth, nose, genitals), or on open wounds or other skin lesions that compromise the integrity of the skin in the area to be treated.
- Stop using Enangel immediately if you experience any skin reaction, including skin reactions after simultaneous use 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, lipsticks, anti-aging creams, makeup removers, hair sprays, used to delay photodegradation).
- Do not expose treated areas to sunlight or ultraviolet (UVA) lamps during treatment and for 2 weeks after stopping treatment.
- If you are in the last 3 months of pregnancy.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Enangel.
To prevent possible allergic reactions with exposure to sunlight during treatment with Enangel:
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Treatment must be stopped if any skin reaction occurs after applying Enangel.
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Exposure to sunlight (even when cloudy) or to ultraviolet (UVA) lamps on areas that have been in contact with the product may cause skin reactions (photosensitization), potentially severe. Therefore, it is necessary:
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to cover treated areas with clothing to protect them during treatment and for two weeks after stopping treatment, to avoid any risk of photosensitization.
- Wash your hands thoroughly after each application of Enangel.
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After applying the gel, do not wear tight clothing or use occlusive dressings.
Children
Recommended doses and indications have not yet been established for children under 6 years of age; therefore, use is not recommended.
Other medicines and Enangel
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Interaction with other medicines is unlikely due to its direct application on the skin.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.
Administration of Enangel should be avoided during pregnancy, as its safety during this period has not been established.
There are insufficient data on the excretion of dexketoprofen in breast milk; therefore, use is not recommended during breastfeeding.
Oral forms (e.g. tablets) of dexketoprofen may cause adverse effects on the fetus. It is unknown whether the same risk applies to dexketoprofen when used on the skin.
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. Do not use dexketoprofen if you are in the last 3 months of pregnancy. Dexketoprofen should not be used during the first 6 months of pregnancy unless clearly necessary and specifically recommended by your doctor. If treatment is required during this period, the lowest dose for the shortest possible time should be used.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported.
Enangel contains alcohol (ethanol) and lavender essence
This medicine contains 0.33 g of alcohol (ethanol) in each gram of gel. Ethanol may cause a burning sensation on damaged skin.
This medicine contains lavender essence with benzyl alcohol, amyl cinnamaldehyde, 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 for this medicine provided 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 used will depend on the area to be treated, and should be gently massaged in to promote absorption.
The total daily dose should not exceed 7.5 g per day, equivalent to 14 cm of gel.
The duration of continuous treatment with topical dexketoprofen should be limited to a maximum of 7 days.
If you use more Enangel than you should
As this is a topical preparation, the risk of overdose is remote.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.
If accidental ingestion of the tube contents occurs, healthcare professionals should perform gastric lavage and initiate symptomatic treatment.
Dexketoprofen is dialyzable (removed by dialysis).
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences 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 equal to or less than 1 in every 10,000 patients):
- Skin redness or eruptions. More severe reactions (bullous or vesicular eczema, bullous rashes) that may spread or become generalized.
Very rare (less than 1 in every 10,000 patients):
- Allergic reaction that may manifest as hives and/or difficulty breathing (bronchospasm).
Frequency not known:
- Severe skin reactions during exposure to sunlight (photosensitivity), presenting as redness and inflammation of the skin, and in some cases formation of blisters.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage 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 refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Enangel
The active substance is dexketoprofen. Each gram of gel contains 12.5 mg of dexketoprofen.
The other components are: Carbomer, 96% ethanol, lavender essence, tromethamine, and purified water.
Appearance of the product and contents of the pack
Enangel is a practically colorless, transparent gel, supplied in flexible aluminum tubes with pack sizes of 60 g.
Marketing Authorization Holder and Manufacturer
Laboratorios Menarini, S.A.
Alfons XII, 587 – 08918 Badalona (Barcelona)
Tel: 934 628 800
Date of the most recent review of this leaflet: October 2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/