ENDOLEX 25 mg ORAL SOLUTION

Introduction

Leaflet: Information for the user

Endolex 25 mg oral solution

Dexketoprofen

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

Follow the administration instructions for the medication contained in this leaflet or as indicated 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 doctor or pharmacist.
• If you experience side 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 symptoms worsen or do not improve after 4 days.

Contents of the leaflet:

1. What is Endolex and what is it used for
2. What you need to know before taking Endolex
3. How to take Endolex
4. Possible side effects
5. Storage of Endolex
6. Package contents and additional information

1. What is Endolex and what is it used for

This medication is a pain reliever belonging to the group of medications called non-steroidal anti-inflammatory drugs (NSAIDs).

It is used for the short-term symptomatic treatment of acute pain of mild or moderate intensity, such as muscle or joint pain, menstrual pain (dysmenorrhea) or toothache.

Endolex is indicated for adult patients.

2. What you need to know before taking Endolex

With dexketoprofen, cases of allergic reactions to this medication 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 (hypersensitive) to dexketoprofen trometamol or any of the other components of this medication (listed in section 6);
• If you are allergic to acetylsalicylic acid or another non-steroidal anti-inflammatory medication;
• 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 (aspirin) or other non-steroidal anti-inflammatory medications;
• If you have suffered from photoallergic or phototoxic reactions (a special type of redness or sunburn) while taking ketoprofen (a non-steroidal anti-inflammatory medication) or fibrates (medications 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 medications (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 (hypertension 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. Medications 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 experience a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (this medication may reduce 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 production disorder;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you have had a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have had stomach or intestinal disorders in the past;
• If you have an infection; see the "Infections" section below;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), or anticoagulant medications like warfarin. In these cases, consult your doctor before taking this medication: your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other medications 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 rest of the population. The administration of this medication may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents

This medication 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.

Infections

This medication may hide the signs of an infection, such as fever and pain. Consequently, this medication 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 medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Avoid using the medication if you have chickenpox.

Other medications and Endolex

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication, including those purchased without a prescription. There are some medications that should not be taken together, and other medications that may need a dose change if taken together.

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

Not recommended combinations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory medications;
• Warfarin or acenocoumarol (Sintrom), heparin, and other medications used to prevent blood clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate, used for rheumatoid arthritis and cancer, 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, beta-blockers, 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 to treat bacterial infections
• 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;
• Cyclosporine or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medications; i.e., medications used to dissolve blood 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 blood clot formation.
• Beta-blockers, used for high blood pressure and heart disorders;
• Tenofovir, deferasirox, pemetrexed.

If you have any doubts about taking other medications 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 medication 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 predisposition to bleeding 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 medication, as it may not be suitable for you.

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

The use of this medication 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 medication 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.

Endolex contains methyl parahydroxybenzoate (E-218), sucrose, aspartame (E-951), and sodium

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

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may harm your teeth.

This medication contains 0.095 mg of aspartame in each sachet. Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medication contains less than 1 mmol of sodium (23 mg) per sachet; i.e., it is essentially "sodium-free".

3. How to take Endolex

Follow the administration instructions for this medication contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

The lowest effective dose should be used for the shortest necessary time to relieve 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.

Adults from 18 years old

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

If you are an elderly person or have 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 be increased later according to the general recommended dose (75 mg of dexketoprofen) if the medication has been well tolerated.

Use in children and adolescents

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

Instructions for proper use

The oral solution can be taken directly from the sachet or after pouring the contents into a glass of water. Once the sachet is opened, consume its entire contents.

Take the medication with food, as this helps reduce the risk of experiencing adverse effects on the stomach or intestine. However, if your pain is intense and you need quick relief, take the sachets on an empty stomach (at least 15 minutes before meals) as they will be absorbed more easily.

If you take more Endolex than you should

If you have taken too much medication, inform your doctor or pharmacist immediately or go to the emergency department of your nearest hospital or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medication and the amount taken. Please remember to always carry the medication 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 doubts about the use of this medication, 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.

Due to the fact that the plasma concentration levels of dexketoprofen achieved with the oral solution pharmaceutical form are higher than those obtained with tablets, a potential increase in the risk of adverse reactions (gastrointestinal) cannot be ruled out.

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

Nausea and/or vomiting, stomach pain, 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, stomach problems, 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, peptic ulcer perforation, 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(may affect up to 1 in 10,000 people):

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin, mouth, eye, and genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or lip and throat swelling (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, liver cell damage (hepatitis), 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 may be a symptom of a potentially severe allergic reaction called Kounis syndrome. Fixed drug eruption: an allergic skin reaction known as a fixed drug eruption that may include round or oval red patches and skin swelling, blisters, and itching. There may also be darkening of the skin in the affected areas, which can persist after healing. The fixed drug eruption usually recurs 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 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 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 stroke ("cerebrovascular accident").

In patients with immune system disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), 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, inflammation of the stomach wall (gastritis) has been observed.

As with other NSAIDs, aseptic meningitis may occur, which may predominantly affect 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 a possible adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system included in the Spanish Medicines Surveillance System for Human Use: 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 stated on the packaging and carton. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Endolex

The active ingredient is dexketoprofen. Each sachet contains 25 mg of dexketoprofen corresponding to dexketoprofen trometamol 36.90 mg.

The other ingredients are: macrogol 400, methyl parahydroxybenzoate (E-218), sucralose, povidone, disodium phosphate, sodium dihydrogen phosphate dihydrate, purified water, flavoring (sucrose and aspartame (E-951)), and cola flavor.

Appearance ofEndolexand Package Contents

Transparent yellow-orange solution with a cola flavor in single-dose sachets of 10 ml.

It is presented in packages containing 10 sachets.

Marketing Authorization Holder and Manufacturer:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

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.es/.