Enandol 25 mg oral solution in sachets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enandol 25 mg oral solution in sachets

Dexketoprofen

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• 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.
• You should consult a doctor if your condition worsens or does not improve after 4 days.

Leaflet contents

1. What Enandol is and what it is used for
2. What you need to know before taking Enandol
3. How to take Enandol
4. Possible adverse effects
5. How to store Enandol
6. Contents of the pack and other information

1. What Enandol is and what it is used for

This medicine is an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

Enandol is used in adults for the short-term symptomatic treatment of mild to moderate acute pain, such as muscle or joint pain (for example, back pain, sprains and acute injuries), menstrual pain, and dental pain.

2. What you need to know before taking Enandol

Do not take Enandol

• 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 (aspirin) 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 breathing difficulties), or wheezing in the chest after taking acetylsalicylic acid (aspirin) 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 reaction 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 experienced 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, diarrhoea, 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 Enandol:

• 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 experienced any of these conditions;
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., due to excessive urination, diarrhoea, or vomiting);
• If you have heart problems, a history of stroke, or think you may be at risk of such 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 Enandol may be associated with a small increased risk of heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). Any risk is more likely when high doses are used or treatment is prolonged. 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 (see section 2, "Pregnancy, breastfeeding and fertility");
• 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 acetylsalicylic acid (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, especially combined with chronic rhinitis or sinusitis, and/or nasal polyps, as you are at higher risk of being allergic 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

Enandol 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 a doctor without delay.

Avoid using this medicine if you have chickenpox.

Kounis syndrome

Allergic reactions to dexketoprofen, including respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Immediately discontinue treatment with Enandol and contact your doctor or the nearest emergency service if you experience any of these symptoms.

Children and adolescents

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

Taking Enandol with other medicines

Inform 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, while others may require dose adjustments when used concurrently.

Always inform your doctor, dentist, or pharmacist if, in addition to this medicine, you are taking any of the following:

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 immunosuppressant 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 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, when 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 termination of pregnancy);
• 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 heart disorders;
  • Tenofovir, deferasirox, pemetrexed.

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

Taking Enandol with food, drinks, and alcohol

In general, it is recommended to take the medicine with food to reduce the possibility of stomach-related problems (see also section 3, "How to take Enandol").

Using NSAIDs in combination with alcohol may worsen adverse reactions caused by the active ingredient.

Pregnancy, breastfeeding, and fertility

Do not take this medicine during the last three months of pregnancy or during breastfeeding.

It may cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labour beyond what is expected.

You should not take Enandol 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, Enandol may cause kidney problems in your unborn baby 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.

Use of this medicine may impair fertility; therefore, its use is not recommended when trying to conceive or while being investigated for infertility.

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. If you experience these effects, do not operate machinery or drive until the symptoms have resolved. Seek advice from your doctor.

Enandol contains methylparahydroxybenzoate (E-218), sucrose, sodium, benzyl alcohol, and ethanol

It may cause allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate.

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

It contains 2 g of sucrose per dose, which should be considered in patients with diabetes mellitus.

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

This medicine contains 4.8 mg of benzyl alcohol per unit dose.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

This medicine contains less than 0.002% ethanol (alcohol), a small amount corresponding to less than 0.2 mg/dose.

3. How to take Enandol

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

The required dose of the medicine may vary depending on the type, intensity, and duration of pain.

The lowest effective dose should be used for the shortest duration 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 of age

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

Elderly patients or those with renal or hepatic impairment

If you are an elderly patient or have mild renal impairment or mild to moderate 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 of dexketoprofen) if dexketoprofen has been well tolerated.

Dexketoprofen must not be used if you have moderate or severe renal impairment or severe hepatic impairment. Consult your doctor or pharmacist if you are unsure.

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 dissolving the contents in a glass of water. Once the sachet has been opened, consume all of its contents.

The medicine can be taken with or without food. Taking the medicine with food helps reduce the risk of stomach disturbances; however, if your pain is more intense and you need faster relief, take the sachet on an empty stomach (at least 15 minutes before any meal or food intake), as it will be absorbed more easily (see section 2 "Taking Enandol with food, drinks and alcohol").

Duration of treatment

Treatment must not exceed 4 days. If pain persists beyond this period, worsens, or new symptoms appear, you must stop treatment and consult your doctor or pharmacist.

If you take more Enandol than you should

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

If you forget to take Enandol

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

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 frequency.

Since this list is partly based on adverse effects observed with the oral tablet formulation, and the oral solution in sachets is absorbed more rapidly than tablets, the actual frequency of (gastrointestinal) adverse effects may be higher with the oral solution in sachets.

Frequent 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 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, perforation of peptic ulcer 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, itchy rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), damage to liver cells (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), swelling of the face or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decrease in white blood cell count (neutropenia), decrease in platelet count (thrombocytopenia).

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

Drug-related fixed eruption

An allergic skin reaction known as drug-related 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-related 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 start of treatment (e.g., stomach pain or burning sensation or bleeding), especially if you have previously experienced such adverse effects due to long-term treatment with anti-inflammatory medicines, and particularly if you are elderly.

Stop taking this medicine immediately if you develop a skin rash or lesions in the mouth or genital area, or any other sign of allergy.

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

Medicines such as Enandol 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, especially in elderly patients.

After administration, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, 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, 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).

Reporting of adverse effects

If you experience any adverse effect, consult 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 Enandol

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 drains or in household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enandol

• 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 4-hydroxybenzoate (E-218), sodium saccharin, sucrose, macrogol 400, lemon flavour (contains benzyl alcohol and ethanol), povidone K-90, anhydrous disodium phosphate, sodium dihydrogen phosphate dihydrate, purified water (see section 2).

Appearance of Enandol and contents of the pack

Sachets containing a clear-coloured solution with a lemon odour and a sweet lemon-citrus taste.

Available in packs of 10 and 16 sachets.

Marketing Authorization Holder

Menarini Consumer Healthcare, S.A.U.

Guifré, 08918 Badalona

(Barcelona) Spain

Manufacturer

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona) Spain

Date of the most recent revision 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.