Enantyum 25 mg oral solution in sachet

Patient Information Leaflet

Introduction

Patient Information Leaflet

Enantyum 25 mg oral solution in sachet

dexketoprofen

Read this entire leaflet carefully before you start taking this medicine, as 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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. How to store Enantyum
6. Contents of the pack and other information

1. What Enantyum is and what it is used for

This medicine 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 muscular or joint pain, menstrual pain (dysmenorrhoea), and dental pain.

This medicine is indicated for use in adult patients.

2. What you need to know before taking Enantyum

Do not take Enantyum

• If you are allergic (hypersensitive) 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 chest wheezing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;

• 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, gastrointestinal bleeding, or have previously experienced gastrointestinal 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 kidney failure, or severe liver 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 during 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), or fluid retention, or have previously had any of these conditions;
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting);
• If you have heart conditions, 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 stroke ("cerebrovascular accident"). Any 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 (this medicine 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 currently have or have previously had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you currently 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, for example, oral corticosteroids, certain antidepressants (SSRIs, selective serotonin reuptake inhibitors), or agents that prevent blood clotting such as aspirin or anticoagulants like warfarin. In these cases, consult your doctor before taking this medicine: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other medicines that block gastric acid production).
• If you have asthma, combined with rhinitis or chronic sinusitis, and/or nasal polyps, as you have a higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Dexketoprofen may mask signs of infection, such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor without delay.

Kounis syndrome

With dexketoprofen, cases of allergic reaction to this medicine have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. Immediately stop treatment with Enantyum and contact your doctor or the nearest emergency service immediately if you experience any of these symptoms.

Children and adolescents

Dexketoprofen 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.

Use of Enantyum with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, 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 this medicine, you are taking any of the following medicines:

Combinations not recommended:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood clotting;
• Lithium, used to treat certain mood disorders;
• Methotrexate (a cancer and immunosuppressive medicine), 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 for high blood pressure control and cardiac disorders;
• 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;
  • Methotrexate, used at low doses, less than 15 mg/week.

Combinations to be aware of:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections;
• Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplantation;
• Streptokinase and other thrombolytic and fibrinolytic medicines; i.e., medicines used to dissolve clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for pregnancy termination);
• Antidepressants of the selective serotonin reuptake inhibitor (SSRI) type;
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation.
  • Beta-blockers, used for high blood pressure and cardiac disorders.
  • Tenofovir, deferasirox, pemetrexed.

If you have any doubts about taking other medicines with Enantyum, consult your doctor or pharmacist.

Taking Enantyum with food, drinks, and alcohol

It is recommended to take the medicine with food to reduce the likelihood of gastrointestinal disturbances (see also section 3, “Method of administration”).

You should not drink alcohol while using this medicine. Some side effects, such as those affecting the gastrointestinal tract or the central nervous system, are more likely when alcohol is consumed at the same time as Enantyum.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine during the last three months of pregnancy or during breastfeeding. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labor more than expected.

Do not take this medicine during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time.

From week 20 of pregnancy, this medicine may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

The use of this medicine is not recommended when trying to conceive or while undergoing fertility investigations.

Regarding potential effects on female fertility, see also section 2, “Warnings and precautions”.

Driving and using machines

This medicine may slightly affect your ability to drive and use machines, as it may cause dizziness, drowsiness, or visual disturbances as adverse effects of treatment. If you experience these effects, do not operate machinery or drive until the symptoms resolve. Seek advice from your doctor.

Enantyum contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per sachet; hence, it is essentially “sodium-free”.

Enantyum contains methyl parahydroxybenzoate (E 218)

It may cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate.

Enantyum contains sucrose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 2 g of sucrose per dose.

3. How to take Enantyum

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.

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

The lowest effective dose should be used for the shortest possible time needed 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 from 18 years of age

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

If you are an elderly patient or suffer from renal or hepatic impairment, it is recommended to start treatment with a maximum of 2 sachets per day (50 mg of dexketoprofen).

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

Use in children and adolescents

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

Method of administration

The oral solution can be taken directly from the sachet or after mixing the contents in a glass of water. Once the sachet has been opened, consume all of its contents.

Take the sachets with food, as this helps reduce the risk of gastrointestinal or intestinal side effects (see also section 2). If the pain is severe and you need faster relief, take the sachets on an empty stomach, i.e., at least 15 minutes before meals, as this helps the medicine to start acting slightly faster.

If you take more Enantyum than you should

If you have taken too much medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department, or call the Toxicology Information Service at: 91.562.04.20, indicating the medicine and the amount taken. Please remember to always bring the medicine pack or this leaflet with you.

If you forget to take Enantyum

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

If you have any doubts about the use of this medicine, consult 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 likelihood of occurrence.

Because peak plasma concentrations of dexketoprofen achieved with the oral solution dosage form are higher than those obtained with tablets, a potential increase in the risk of adverse reactions (particularly gastrointestinal) cannot be ruled out.

Common adverse effects (may affect up to 1 in 10 people):

Nausea and/or vomiting, mainly upper abdominal pain, diarrhoea, digestive disorders (dyspepsia).

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

Spinning sensation (vertigo), dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling feverish 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 oedema, loss of appetite (anorexia), abnormal sensation, pruritic 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 adverse effects (may affect up to 1 in 10,000 people):

Anaphylactic reaction (hypersensitivity reaction that may also lead to collapse), skin, mouth, eye, or genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of the 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 white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Not known: frequency cannot be estimated from the available data

Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

Drug-induced fixed eruption

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 recurs in the same location(s) if the medicine is taken again.

Immediately inform your doctor if you experience any gastrointestinal adverse effects at the beginning of treatment (e.g., stomach pain or burning sensation or bleeding), especially if you have previously experienced such adverse effects during long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), and particularly if you are an elderly patient.

Immediately stop taking this medicine if you develop a skin rash, lesions in the mouth or genitals, or any other signs of allergy.

During treatment with non-steroidal 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 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 in nature. Peptic ulcers, gastrointestinal perforation, or gastrointestinal bleeding, sometimes fatal, may occur, particularly in elderly patients.

Following administration, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, and exacerbation of colitis and Crohn's disease have been reported. Less frequently, inflammation of the stomach lining (gastritis) has been observed.

As with other NSAIDs, aseptic meningitis may occur, predominantly in patients with systemic lupus erythematosus or mixed connective tissue disease, and haematological reactions (purpura, aplastic and haemolytic anaemia, and more rarely agranulocytosis and bone marrow hypoplasia) may also occur.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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 after EXP. 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 or household waste. Return unused medicines and any waste packaging to the SIGRE collection 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 oral solution sachet contains 25 mg of dexketoprofen as dexketoprofen trometamol.
• The other components are: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, methyl p-hydroxybenzoate (E-218), sodium saccharin, sucrose, macrogol 400, lemon flavor, povidone K-90, anhydrous disodium phosphate, sodium dihydrogen phosphate dihydrate, purified water (see section 2, Enantyum contains sucrose).

Appearance of Enantyum and contents of the pack

Clear-colored solution with a lemon odor and sweet lemon-citrus taste.

It is available in packs containing 2, 4, 10, 20 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 European Economic Area member states under the following names:

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

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

Other sources of information

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