Package Leaflet: Information for the user

Endolex 25 mg film-coated tablets

Dexketoprofen

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you

Follow exactly the instructions for taking the medicine contained 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.

• Ifyou experience any side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. See section 4.

• You should consult a doctor if you get worse or do not improveafter 4 days.

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

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

Endolex is indicated for adult patients.

Do not take Endolex:

-If you are allergic to dexketoprofen or any of the other components of this medication (listed in section 6);

-If you are allergic to acetylsalicylic acid or another nonsteroidal anti-inflammatory drug;

-If you have asthma or have had asthma attacks, acute allergic rhinitis (a short period of nasal mucosa inflammation), nasal polyps (fleshy formations in the nasal cavity due to allergy), urticaria (skin eruption), angioedema (face, eye, lip, or tongue swelling, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;

-If you have had photoallergic or phototoxic reactions (a special form of skin redness or burns exposed to sunlight) during the use of ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medications used to reduce blood lipid levels);

• If you have a stomach ulcer, stomach or intestinal bleeding, or have had stomach or intestinal bleeding, ulceration, or perforation in the past;
• If you have chronic digestive problems (e.g., indigestion, stomach burning);
• If you have had stomach or intestinal bleeding or perforation due to previous use of nonsteroidal 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 insufficiency, or severe liver insufficiency;

-If you have bleeding disorders or blood clotting disorders;

-If you are severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or inadequate 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 allergic reactions in the past;

-If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or fluid retention or have had these conditions in the past;

-If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., excessive urination, diarrhea, or vomiting);

-If you have heart problems, a history of strokes, or think you may be at risk of these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking) consult this treatment with your doctor or pharmacist. Nonsteroidal anti-inflammatory drugs like Endolex may be associated with a small increase in the risk of heart attacks 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 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 (Endolex may reduce your fertility, so do not take it if you are planning to become pregnant or undergoing fertility studies);

-If you have a disorder in blood production and blood cells;

-If you have systemic lupus erythematosus or mixed connective tissue disease (immune system diseases affecting connective tissue);

-If you have had or have chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);

-If you have had or have gastrointestinal or intestinal disorders;

-If you have chickenpox, as NSAIDs may exacerbate the infection;

-If you are taking other medications that increase the risk of stomach ulcers or bleeding, such as oral corticosteroids, certain antidepressants (SSRIs), agents that prevent blood clotting like acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking Endolex: your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other medications that block stomach acid production).

-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 general population. 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 the product should not be used in children or adolescents.

Infections

This medication may mask the signs of an infection, such as fever and pain. Consequently, it may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms 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, have used recently, 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 require a dose change when taken together.

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

Non-recommended associations:

-Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;

-Warfarin, heparin, and other medications used to prevent blood clotting;

-Lithium, used to treat mood disorders;

-Metotrexate (cancer and immunosuppressant medication), used at high doses of 15 mg/week;

-Hidantoins and phenytoin, used for epilepsy;

-Sulfamethoxazole, used for bacterial infections;

Associations requiring caution:

-Inhibitors of the enzyme cyclooxygenase (COX), diuretics, and angiotensin II antagonists, used to control high blood pressure and heart conditions;

-Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;

-Zidovudine, used to treat viral infections;

-Aminoglycoside antibiotics, used to treat bacterial infections;

-Sulfonilureas (e.g., chlorpropamide and glibenclamide), used for diabetes;

-Metotrexate, used at low doses, less than 15 mg/week;

Associations to be considered:

-Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections;

-Ciclosporin or tacrolimus, used to treat immune system diseases and organ transplants;

-Streptokinase and other thrombolytic and fibrinolytic medications; that is, medications used to dissolve blood clots;

-Probenecid, used for gout;

-Digoxin, used in the treatment of chronic heart failure;

-Mifepristone, used as an abortifacient (to interrupt pregnancy);

-SSRIs (selective serotonin reuptake inhibitors);

-Antiplatelet agents used to reduce platelet aggregation and blood clotting;

• Beta-blockers, used for high blood pressure and heart conditions;
• Tenofovir, deferasirox, pemetrexed.

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

Endolex with food, drinks, and alcohol:

Generally, it is recommended to take it with meals to reduce the possibility of causing stomach upset (see also section 3, "Form 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 while breastfeeding. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery more than expected. Do 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 week 20 of pregnancy, dexketoprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels 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 monitoring.

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

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

This medication is not recommended for use while trying to conceive or while studying a fertility problem.

Regarding potential effects on female fertility, see section 2, "Warnings and precautions".

Driving and operating machinery

This medication may slightly affect your ability to drive and operate machinery, as it may cause drowsiness or dizziness as adverse effects of treatment. If you notice these effects, do not use machinery or drive until these symptoms disappear. Consult your doctor.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

You should use the most effective dose for the shortest time necessary to alleviate symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

If pain persists for more than 4 days, you must interrupt treatment and consult your doctor.

The tablets can be divided into equal doses.

Adults 18 years and older

Generally, the recommended dose is 1 tablet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 tablets a day (75 mg).

Persons with advanced age or renal or hepatic insufficiency

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 a day (50 mg). This initial dose can 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 suffer from moderate or severe kidney problems, or severe liver problems. Consult your doctor or pharmacist if you are unsure.

Use in children and adolescents

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

Instructions for proper use

Take the tablets with an adequate amount of water.

The medication can be taken with or without food. Taking the medication with food helps to reduce the risk of stomach problems, however, if your pain is more intense and you need faster relief, take the tablet with an empty stomach (at least 30 minutes before any meal or ingestion of food) 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Please remember to always carry the medication packaging or this leaflet with you.

If you forgot to take Endolex

Do not take a double dose to compensate for the missed doses. Take the next dose when due (according to section 3 “How to take Endolex”).

If you have doubts about the use of this medication, consult your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The possible side effects are listed below, according to their frequency:

Frequent side effects (may affect up to 1 in 10 people):

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

Less frequent side effects (may affect up to 1 in 100 people):

Dizziness (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, stomach wall inflammation (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation, and chills, general discomfort.

Rare side effects (may affect up to 1 in 1,000 people):

Peptic ulcer, perforation of a peptic ulcer or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (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 renal insufficiency.

Very rare (may affect up to 1 in 10,000 people):

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin ulcers, mouth, eyes, and genital areas (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of the lips and throat (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), lack of air, tachycardia, low blood pressure, pancreatitis inflammation, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Inform your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g., stomach pain or burning, or bleeding), if you have previously experienced any of these side effects due to prolonged treatment with anti-inflammatory agents, and especially if you are an elderly patient.

Stop taking this medicine immediately if you notice the appearance of a skin rash or any lesions inside the mouth or on the genitals, or any other sign of allergy.

During treatment with nonsteroidal 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 autoimmune disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs may rarely cause fever, headache, and neck stiffness.

The most commonly observed side effects are of a gastrointestinal nature. They may cause peptic ulcers, perforation, or gastrointestinal bleeding, 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, gastric wall inflammation (gastritis) has been observed.

Like other NSAIDs, meningitis may appear, which may predominantly occur in patients with systemic lupus erythematosus or mixed connective tissue disease, and hematological reactions (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and medullary hypoplasia).

Reporting of side effects

Ifyouexperienceanytypeofsideeffect,consultwithyourdoctororpharmacist,evenifitisasideeffectthatdoesnotappearinthisleaflet.You can also report them directly through the Spanish Medicines Vigilance System for Human Use, website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and in 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.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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 hydroxypropyl cellulose, magnesium stearateand Opadry white (which containshypromellose 2910, titanium dioxideandmacrogol 400).

Appearance of the product and content of the packaging

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

Endolex 25 mg is available in packaging containing 12 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

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

Last review date of this leaflet: June 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/