Dekendol 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dekendol 25 mg film-coated tablets EFG

dexketoprofen

Read the entire leaflet carefully before you start taking this medicine, as 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 effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 or 4 days.

Contents of the leaflet:

1. What Dekendol is and what it is used for

2. What you need to know before taking Dekendol

3. How to take Dekendol

4. Possible adverse effects

5. How to store Dekendol

6. Contents of the pack and other information

1. What Dekendol is and what it is used for

Dexketoprofen is an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat short-term mild to moderate pain, such as muscle or joint pain, menstrual pain (dysmenorrhoea), and dental pain, in adults.

2. What you need to know before taking Dekendol

Do not take Dekendol

• If you are allergic to dexketoprofen or to any of the other ingredients 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 chest wheezing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• If you have previously experienced photoallergic or phototoxic reactions (a special type of skin redness or sunburn-like 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, gastrointestinal bleeding, or have previously experienced gastrointestinal bleeding, ulceration, or perforation;
• If you have chronic digestive problems (e.g., indigestion, heartburn);
• If you have previously experienced gastrointestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) taken 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, diarrhea, or insufficient fluid intake;
• If you are in the third trimester of pregnancy or are breastfeeding.

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 dexketoprofen and contact your doctor or nearest emergency service if you experience any of these symptoms.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dekendol:

• If you are allergic or have had allergic 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 conditions in the past;

• 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, history of stroke, or think you may be at risk of these conditions (e.g., high blood pressure, diabetes, high cholesterol, or if you smoke), you should discuss this treatment with your doctor or pharmacist. Medicines like dexketoprofen may be associated with a small increased risk of heart attacks (“myocardial infarction”) or strokes (“cerebrovascular accident”). This risk is more likely with high doses and prolonged treatment. 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 (dexketoprofen may reduce fertility, so you should not take it if you are planning to become pregnant or undergoing fertility investigations);

• If you have a disorder in 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 titled “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 agents that prevent blood clotting such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In such cases, consult your doctor before taking dexketoprofen: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other drugs that block gastric acid production).

  • If you have asthma associated 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. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

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

Children and adolescents

Dexketoprofen 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.

Other medicines and Dekendol

Inform your doctor or pharmacist if you are currently 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 taken concurrently.

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

Combinations not recommended:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood clot formation;
• Lithium, used to treat certain mood disorders;
• Methotrexate (a cancer and immunosuppressant drug), 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 drugs; 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 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 Dekendol, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

Do not take Dekendol during the last three months of pregnancy or while breastfeeding. Dexketoprofen 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 labor more than expected.

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

Women who are planning pregnancy or are pregnant should avoid using dexketoprofen. Treatment at any stage of pregnancy should only occur under a doctor’s guidance. From week 20 of pregnancy, dexketoprofen 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 constriction of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

The use of dexketoprofen is not recommended when trying to conceive or while undergoing fertility evaluation.

Regarding potential effects on female fertility, see also section 2, “Warnings and precautions.”

Driving and using machines

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

Dekendol contains sodium

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

3. How to take Dekendol

Follow exactly the administration instructions for this medicine provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

In general, the recommended dose is ½ tablet (12.5 mg) every 4–6 hours or 1 tablet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 tablets per day (75 mg).

If you do not feel better or feel worse after 3 or 4 days, you must contact your doctor. Your doctor will advise you on how many tablets to take per day and for how long. The dexketoprofen dose you require may vary depending on the type, intensity, and duration of your 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).

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).

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.

Method of administration

Take the tablets with an adequate amount of water. Take the tablets with food, as this helps reduce the risk of adverse effects on the stomach or intestines. However, if your pain is severe and you need rapid relief, take the tablets on an empty stomach (at least 30 minutes before a meal), as they will be absorbed more easily.

Use in children and adolescents

This medicine must not be used in children and adolescents (under 18 years of age).

If you take more Dekendol than you should

If you have taken too much medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Please remember to always carry the medicine carton or this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dekendol

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 Dekendol”).

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.

Common 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, feverish feeling 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 (for example, 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), damage to liver cells (hepatitis), acute kidney failure.

Very rare (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 the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, photosensitivity, itching, kidney problems. Decrease in the number of white blood cells (neutropenia), decrease in the 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

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 the affected areas may also occur, which can persist after healing. Fixed drug eruption usually recurs in the same location or locations if the medicine is taken again.

Inform your doctor immediately if you notice any gastrointestinal adverse effects at the beginning of treatment (e.g. stomach pain or burning sensation or bleeding), especially if you have previously experienced any of these adverse effects due to long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), and particularly if you are an elderly patient.

Stop taking dexketoprofen immediately if you notice the appearance of a skin rash or any lesions inside the mouth or in the 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 dexketoprofen 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 in nature. 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 (purpura, aplastic and haemolytic anaemia, and more rarely agranulocytosis and bone marrow hypoplasia) may occur.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dekendol

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

Do not use this medicine after the expiry date stated on the carton and blister after CAD/EXP. The expiry date is the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and any waste materials to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dekendol

The active substance is dexketoprofen.

Each film-coated tablet contains 25 mg of dexketoprofen (as dexketoprofen trometamol).

The other components (excipients) are microcrystalline cellulose, sodium croscarmellose, corn starch, hypromellose, colloidal anhydrous silica, and magnesium stearate in the tablet core, and hypromellose, macrogol 6000, propylene glycol, and titanium dioxide (E171) in the coating. See section 2, “Dekendol contains sodium”.

Appearance of the product and contents of the container

Film-coated tablet, white to almost white, round, biconvex, with a score line on one side.

Dimensions: diameter of approximately 10 mm.

The tablet can be divided into equal doses.

This medicine is available in packs containing 10, 20, 30, and 50 tablets in unit dose blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Manufacturer responsible

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

or

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information on this medicine, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: November 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es//.