Enantyum 25 mg, granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enantyum 25 mg granules for oral solution

dexketoprofen

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should 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 these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Enantyum is and what it is used for

2. What you need to know before taking Enantyum

3. How to take Enantyum

4. Possible side effects

5. Storage of Enantyum

6. Contents of the pack and other information

1. What Enantyum is and what it is used for

Enantyum is an analgesic belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as acute muscle or joint pain, menstrual pain (dysmenorrhea), and dental pain.

2. What you need to know before taking Enantyum

Do not take Enantyum

• If you are allergic to dexketoprofen or to any of the other components of this medicine (listed in section 6);

• If you are allergic to acetylsalicylic acid or to another non-steroidal anti-inflammatory drug (NSAID);

• If you have asthma or have previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue, or difficulty breathing), or wheezing in the chest after taking acetylsalicylic acid or other NSAIDs;

• If you have previously experienced photoallergic or phototoxic reactions (a special type of redness or sunburn-like skin damage on sun-exposed skin) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);

  • If you have peptic ulcer, stomach or intestinal bleeding, or have previously had stomach or intestinal bleeding, ulceration, or perforation;
  • If you have chronic digestive problems (e.g., indigestion, heartburn);
  • If you have previously experienced stomach or intestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain;

• If you have chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis);

• If you have severe heart failure, moderate to severe renal failure, or severe hepatic failure;

• If you have bleeding disorders or blood coagulation disorders;

• If you are severely dehydrated (have lost a large amount of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;

• If you are in the third trimester of pregnancy or breastfeeding;

Warnings and precautions

Consult your doctor or pharmacist before starting to take Enantyum:

• If you are allergic or have previously had allergic problems;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have previously had any of these conditions;
• If you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of stroke, or think you may be at risk of these conditions (e.g., you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist. Medicines like Enantyum may be associated with a small increased risk of heart attacks (“myocardial infarction”) or strokes (“cerebrovascular accident”). This risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• If you are elderly, you may be more likely to experience adverse effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (Enantyum may reduce fertility, so you should not take it if you are planning to become pregnant or undergoing fertility investigations);
• If you have a disorder affecting blood or blood cell production;
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If you have or have previously had chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
• If you have or have previously had stomach or intestinal disorders;
• If you have an infection; see the section “Infections” below;
• If you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, certain antidepressants (SSRIs, Selective Serotonin Reuptake Inhibitors), or agents that prevent blood clotting such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin or acenocumarol (Sintrom). In such cases, consult your doctor before taking Enantyum: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other drugs that block gastric acid production).
• If you have asthma, combined with chronic rhinitis or sinusitis, and/or nasal polyps, as you are at higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the general population. Taking this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Enantyum may mask signs of infection such as fever and pain. Therefore, Enantyum may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

Use of this medicine is not recommended during chickenpox.

Kounis Syndrome

Cases of allergic reaction to dexketoprofen, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Immediately discontinue treatment with Enantyum and contact your doctor or the nearest emergency service if you experience any of these symptoms.

Children and adolescents

Enantyum has not been studied in children or adolescents. Therefore, safety and efficacy have not been established, and the product should not be used in children or adolescents.

Taking Enantyum with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine, including those obtained without a prescription. Some medicines should not be taken together, and others may require dose adjustments when taken concurrently.

Always inform your doctor, dentist, or pharmacist if, in addition to Enantyum, you are using or are being given any of the following medicines:

Combinations not recommended:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin or acenocumarol (Sintrom), heparin, or other medicines used to prevent blood clotting;
• Lithium, used to treat certain mood disorders;
• Methotrexate (a cancer and immunosuppressive medicine), when used at high doses of 15 mg/week;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections;

Combinations requiring caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists, used to control high blood pressure and heart conditions;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used to treat bacterial infections;
• Sulfonylureas (e.g., chlorpropamide and glyburide), used for diabetes;
• Methotrex游戏副本

3. How to take Enantyum

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults over 18 years

The dose of Enantyum you need may vary, depending on the type, intensity, and duration of pain. Your doctor will tell you how many sachets you should take per day and for how long.

The recommended dose is 1 sachet (25 mg) every 8 hours, without exceeding 3 sachets per day (75 mg).

If you are elderly or suffer from kidney or liver disease, it is recommended to start treatment with a maximum of 2 sachets per day (50 mg).

In elderly patients, this initial dose may subsequently be increased according to the general recommended dose (75 mg of dexketoprofen), if Enantyum has been well tolerated.

If your pain is severe and you need rapid relief, take the sachets on an empty stomach (at least 15 minutes before meals), as they will be absorbed more easily (see section 2 “Enantyum with food and drink”).

Use in children and adolescents

This medicine must not be used in children and adolescents (under 18 years of age).

Instructions for proper use

Dissolve the entire contents of one sachet in a glass of water; stir/mix to help dissolve. The resulting solution should be taken immediately after reconstitution.

If you take more Enantyum than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91.562.04.20, indicating the medicine and the amount taken. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Enantyum

Do not take a double dose to make up for forgotten doses. Take the next dose at the scheduled time (according to section 3 “How to take Enantyum”).

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The possible adverse effects are listed below according to their frequency. Since this list is partly based on adverse effects observed with the use of Enantyum tablets, and Enantyum granules are absorbed faster than tablets, the actual frequency of adverse effects (particularly gastrointestinal) may be higher with Enantyum granules.

Frequent adverse effects: may affect up to 1 in 10 people
Nausea and/or vomiting, mainly upper abdominal pain, diarrhea, digestive disorders (dyspepsia).

Uncommon adverse effects: may affect up to 1 in 100 people
Spinning sensation (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flushes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling of fever and chills, general malaise.

Rare adverse effects: may affect up to 1 in 1,000 people
Peptic ulcer, peptic ulcer perforation or bleeding (which may present as vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g., swollen ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.

Very rare: may affect up to 1 in 10,000 people
Anaphylactic reaction (hypersensitivity reaction that may also lead to collapse), skin, mouth, eye, and genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decreased number of white blood cells (neutropenia), decreased number of platelets (thrombocytopenia).

Frequency not known: frequency cannot be estimated from available data
Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Drug-induced fixed eruption

An allergic skin reaction known as drug-induced fixed eruption, which may include round or oval red patches and skin swelling, blisters, and itching. Darkening of the skin in affected areas may also occur, which can persist after healing. Drug-induced fixed eruption usually reappears in the same location or locations if the medicine is taken again.

Immediately inform your doctor if you notice any gastrointestinal adverse effects at the beginning of treatment (e.g., stomach pain or burning sensation or bleeding), especially if you have previously experienced any of these adverse effects due to long-term treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), and particularly if you are elderly.

Stop taking Enantyum immediately if you notice the appearance of a skin rash or any lesions inside the mouth or in the genital area, or any other sign of allergy.

During treatment with nonsteroidal anti-inflammatory drugs, cases of fluid retention and swelling (especially in ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines such as Enantyum may be associated with a small increased risk of having a heart attack ("myocardial infarction") or stroke ("cerebrovascular accident").

In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness.

The most commonly observed adverse effects are gastrointestinal. Peptic ulcers, gastrointestinal perforation, or bleeding—sometimes fatal—may occur, particularly in elderly patients.

After administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported. Less frequently, inflammation of the stomach wall (gastritis) has been observed.

As with other NSAIDs, hematological reactions may occur (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and bone marrow hypoplasia).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Enantyum

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

Do not use this medicine after the expiry date stated on the packaging and sachet. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater drains or household waste. Instead, return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are unsure, 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 Enantyum

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each sachet contains 25 mg of dexketoprofen.

• The other components are: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, quinoline yellow (E-104), lemon flavor, and sucrose (see section 2, Enantyum contains sucrose).

Appearance of the product and contents of the pack

Sachets containing a lemon-yellow granule.

Enantyum 25 mg is available in packs of 2, 4, 10, 20, 30, 40, 50, 100, and 500 sachets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS MENARINI, S.A.
Alfons XII, 587 - Badalona (Barcelona) Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Hungary, Italy, Spain: Enantyum
Estonia, Latvia, Lithuania: Ketesse
Greece: Viaxal
Poland: Ketesse SL

Date of the most recent revision of this leaflet: September 2025

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