Enandol 25 mg granules for oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet Enandol 25 mg oral solution granules

Dexketoprofen

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

Always follow exactly the instructions for use of this medicine as described in this leaflet or as provided by your doctor or pharmacist.

• Keep this leaflet, as you may need to refer to it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 side 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 or to another non-steroidal anti-inflammatory drug (NSAID);

• If you have asthma or have 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 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 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 impairment, or severe hepatic impairment;

• 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 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 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 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 and 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 heading “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 blood clot-preventing agents like acetylsalicylic acid (aspirin) or anticoagulants such as warfarin or acenocoumarol (Sintrom). 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 rhinitis or chronic 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 skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

Avoid using this medicine if you have chickenpox.

Kounis syndrome

Allergic reactions to dexketoprofen, including respiratory problems, swelling of the face and neck area (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 it 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 a dose adjustment when taken 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 or acenocoumarol (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 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 glibenclamide), 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 causing stomach problems (see also section 3, “Method of administration”).

Using NSAIDs together 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 fetus. It may affect your tendency and your baby’s tendency to bleed and may delay or prolong labor more than 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 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 may impair fertility; therefore, its use is not recommended while trying to conceive or while being evaluated for infertility.

Driving and using machines

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

Enandol 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 2.418 g of sucrose per dose, which should be taken into account in patients with diabetes mellitus.

3. How to take Enandol

Follow exactly the instructions for use contained in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

In general, the recommended dose is 1 sachet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 sachets per day (75 mg of dexketoprofen).

Elderly patients or those with renal or hepatic impairment

If you are elderly or have mild renal impairment or mild to moderate hepatic impairment, treatment should be initiated with a maximum of 2 sachets per day (50 mg of dexketoprofen).

In elderly patients, this initial dose may subsequently be increased 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).

Instructions for administration

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

The medicine can be taken with or without food. Taking the medicine with food helps reduce the risk of gastrointestinal disturbances; however, if your pain is severe 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 more easily absorbed (see section 2 "Taking Enandol with food, drinks and alcohol").

Duration of treatment

Treatment should not exceed 4 days. If pain persists beyond this period, worsens, or new symptoms appear, discontinue 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 forgotten doses. Take the next dose as scheduled (according to section 3 "How to take Enandol").

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 experiences them.

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

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

Uncommon adverse effects: may affect up to 1 in 100 people
Rotational sensation (vertigo), dizziness, somnolence, 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, 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, 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 which may also lead to collapse), skin ulcers, mouth, eyes and genital areas (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, photosensitivity, itching, kidney problems. Decreased number of white blood cells (neutropenia), decreased number of platelets (thrombocytopenia).

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

Fixed drug eruption

An allergic skin reaction known as fixed drug 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 may persist after healing. Fixed drug 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, or bleeding), especially if you have previously experienced any of these adverse effects due to prolonged 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 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 Enandol 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, 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, haematological reactions may occur (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 sight and reach of children.

Do not use this medicine after the expiry date stated on the container 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. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you 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 sachet contains 25 mg of dexketoprofen.
• Other components are: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, quinoline yellow (E-104), lemon flavour, sucrose (see section 2, Enandol contains sucrose).

Appearance of Enandol and contents of the pack

Lemon-yellow granules.

The oral solution granules are supplied in single-dose heat-sealed sachets made of coated aluminium-polyethylene.

Available in packs of 10 sachets.

Marketing Authorization Holder

MENARINI CONSUMER HEALTHCARE, S.A.U.

Guifré, 724 - 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//.