ENDOLEX 25 mg FILM-COATED TABLETS

2. What you need to know before taking Endolex

With dexketoprofen, cases of allergic reaction to this medicine have been reported, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop treatment with Endolex immediately and contact your doctor or the nearest emergency service if you notice any of these symptoms.

Do not take Endolex:

• If you are allergic to dexketoprofen or any of the other components of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or another non-steroidal anti-inflammatory medicine;
• If you have asthma or have suffered from asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose due to allergy), hives (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 suffered from photoallergic or phototoxic reactions (a special form of redness or sunburn of exposed skin) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• If you have a peptic ulcer, stomach or intestinal bleeding, or if you have had a history of bleeding, ulceration, or perforation of the stomach or intestine;
• If you have chronic digestive problems (e.g., indigestion, heartburn);
• If you have had a history of stomach or intestinal bleeding or perforation due to the previous 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 lot 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 Endolex:

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart disease (high blood pressure and/or heart failure), or fluid retention or have had any of these diseases in the past;
• If you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (e.g., due to excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of suffering from these disorders (e.g., you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker), you should consult your doctor or pharmacist about this treatment. Medicines like Endolex may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes. This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;
• If you are an elderly patient, you may suffer from a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (Endolex may decrease your fertility, so you should not take it if you are planning to become pregnant or if you are undergoing fertility studies);
• If you have a blood disorder or blood cell disorder;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you have suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) in the past;
• If you have suffered from stomach or intestinal disorders in the past;
• If you have chickenpox, as non-steroidal anti-inflammatory drugs (NSAIDs) can exceptionally worsen the infection;
• If you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), agents that prevent clot formation like acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking Endolex: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other medicines that block the production of stomach acid).
• If you have asthma combined with chronic rhinitis or sinusitis and/or nasal polyps, as you have a higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the rest of the population. The administration of this medicine may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents

This medicine 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.

Infections

This medicine may hide the signs of an infection, such as fever and pain. Consequently, this medicine may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Avoid using the medicine if you have chickenpox.

Other medicines and Endolex

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine, even those bought without a prescription. There are some medicines that should not be taken together, and others may need a dose change if taken together.

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

Not recommended combinations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate (a medicine for cancer and immunosuppression), used at high doses of 15 mg/week;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections;

Combinations that require caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure and heart disorders;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used for bacterial infections;
• Sulfonylureas (e.g., chlorpropamide and glibenclamide), used for diabetes;
• Methotrexate, used at low doses, less than 15 mg/week;

Combinations to be taken into account:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections;
• Cyclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• 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 SSRI type (Selective Serotonin Reuptake Inhibitors);
• Antiplatelet agents used to reduce platelet aggregation and clot formation;
• Betablockers, used for high blood pressure and heart disorders;
• Tenofovir, deferasirox, pemetrexed.

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

Taking Endolex with food, drinks, and alcohol:

In general, it is recommended to take it with meals to reduce the possibility of causing stomach upset (see also section 3, "Method of administration").

The use of NSAIDs in combination with alcohol may worsen the 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 and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take dexketoprofen during the first six months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, dexketoprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine, as it may not be suitable for you.

Women who are planning a pregnancy or are pregnant should avoid using this medicine. Treatment at any time during pregnancy should only be done under the guidance of a doctor.

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

Regarding the 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 drowsiness or dizziness as side effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Ask your doctor for advice.

3. How to take Endolex

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

If the pain persists for more than 4 days, you should stop treatment and consult your doctor.

The tablets can be divided into equal doses.

Adults from 18 years

Generally, the recommended dose is 1 tablet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 tablets per day (75 mg).

Elderly patients or patients with kidney or liver failure

If you are an elderly patient or suffer from kidney or liver disease, it is recommended to start therapy with a maximum of 2 tablets per day (50 mg). This initial dose may be increased later according to the general recommended dose (75 mg of dexketoprofen) if Endolex has been well tolerated.

You should not use dexketoprofen if you have moderate or severe kidney problems or severe liver problems. Consult your doctor or pharmacist if you are unsure.

Use in children and adolescents

This medicine should not be used in children and adolescents (under 18 years).

Instructions for proper use

Take the tablets with a sufficient amount of water.

The medicine can be taken with or without food. Taking the medicine with food helps reduce the risk of stomach disorders; however, if your pain is more intense and you need faster relief, take the tablet on an empty stomach (at least 30 minutes before any meal or food intake) because it will be absorbed more easily (see section 2, "Taking Endolex with food, drinks, and alcohol").

If you take more Endolex than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested. Please remember to always carry the medicine packaging or this leaflet with you.

If you forget to take Endolex

Do not take a double dose to make up for forgotten doses. Take the next dose when scheduled (according to section 3, "How to take Endolex").

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 all people suffer from them.

Possible adverse effects are detailed below according to their frequency.

Frequent Adverse Effects (may affect up to 1 in 10 people):

Nausea and/or vomiting, mainly pain in the upper abdominal quadrant, diarrhea, digestive disorders (dyspepsia).

Uncommon Adverse Effects (may affect up to 1 in 100 people):

Dizzy sensation (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, febrile sensation, 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 manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention, and peripheral edema (e.g., swelling of ankles), laryngeal edema, 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 can also lead to collapse), ulcers on the skin, mouth, eyes, and genital areas (Stevens-Johnson syndrome and Lyell syndrome), swelling of the face or swelling of the lips and throat (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney problems. Decrease in the number of white blood cells (neutropenia), decrease in the number of platelets (thrombocytopenia).

Adverse Effects of Unknown Frequency (frequency cannot be determined from available data):

Chest pain, which can be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Fixed Drug Eruption:

Allergic skin reaction known as fixed drug eruption that can include round or oval red spots and skin swelling, blisters, and itching. It can also cause darkening of the skin in the affected areas, which can persist after healing. The fixed drug eruption usually reappears in the same place or places if the medicine is taken again.

Inform your doctor immediately if you notice any adverse effect of a gastrointestinal type at the start of treatment (e.g., stomach pain or burning, or bleeding), if you have previously suffered from any of these adverse effects due to prolonged treatment with non-steroidal anti-inflammatory drugs, and especially if you are an elderly patient.

Stop taking this medicine immediately if you notice the appearance of a skin rash or any lesion inside the mouth or on the genitals, or any other sign of an 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 like Endolex may be associated with a small increased risk of suffering a heart attack ("myocardial infarction") or a stroke ("stroke").

In patients with immune system disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), non-steroidal anti-inflammatory drugs can rarely cause fever, headache, and neck stiffness.

The most commonly observed adverse effects are of a gastrointestinal type. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, sometimes fatal, especially in elderly patients.

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

As with other non-steroidal anti-inflammatory drugs, aseptic meningitis may occur, which can occur predominantly in patients with systemic lupus erythematosus or mixed connective tissue disease, and hematological reactions (purpura, aplastic anemia, and hemolytic anemia, and more rarely agranulocytosis and bone marrow hypoplasia).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Endolex

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

Do not use this medicine after the expiration date that appears on the packaging and on the blister pack. The expiration date is the last day of the month indicated.

PVC/PVDC-Al packaging: Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

PA/Al/PVC-Al packaging: Do not store at a temperature above 30°C.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Endolex

• The active ingredient is dexketoprofen trometamol. Each tablet contains 36.90 mg of dexketoprofen trometamol, equivalent to 25 mg of dexketoprofen.
• The other components are: cornstarch, pregelatinized cornstarch, microcrystalline cellulose, low-substitution hydroxypropylcellulose, magnesium stearate, and white Opadry (which contains hypromellose 2910, titanium dioxide, and macrogol 400).

Appearance of the Product and Packaging Contents

Coated tablet, scored, white, and round. The tablet can be divided into equal doses.

Endolex 25 mg is available in packaging that contains 12 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Laboratorios Medicamentos Internacionales, S.A. (MEDINSA)

Solana, 26

28850 Torrejón de Ardoz – Madrid

Spain

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas – Madrid

Spain

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas - Madrid

Spain

Date of the Last Revision of this Prospectus: August 2025

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