Leaflet: information for the user

Dekendol 25 mg film-coated tablets EFG

dexketoprofen

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• For advice on any aspect of your dose, including has side effects, contact your pharmacist.
• Consult your doctor or pharmacist if you experience any side effects, even if they do not appear in this leaflet. See section 4.
• You should see a doctor if your symptoms worsen or do not improve after 3 or 4 days.

Contents of the pack and additional information

Dexketoprofen is a pain reliever belonging to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is used to treat short-term pain of mild to moderate intensity, such as muscle pain or joint pain, menstrual pain (dysmenorrhea), toothache, in adults.

Do not take Dekendol

• If you are allergic to dexketoprofen or any of the other ingredients of this medicine (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 interior 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 phototoxic or photoallergic reactions (a special form of skin redness or burns exposed to sunlight) during the intake of ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• If you have peptic ulcers, 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 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 Dekendol::

-If you are allergic or have had allergy problems in the past;

-If you have kidney, liver, or heart diseases (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., 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 smoker) consult this treatment with your doctor or pharmacist. Medicines like dexketoprofen may be associated with a small increased 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 (dexketoprofen may reduce your fertility, so do not take it if you are planning to become pregnant or are undergoing fertility studies);

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

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

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

-If you have 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 ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), anticoagulants like acetylsalicylic acid (aspirin) or warfarin. In these cases, consult your doctor before taking dexketoprofen: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other acid-blocking medicines).

• 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 medicine may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Dexketoprofen may mask the signs of an infection, such as fever and pain. Consequently, it is possible that dexketoprofeno may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to varicella. If you take this medicine while having an infection and the symptoms of the infection 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 using, have used recently, or may need to use any other medicine, even those purchased without a prescription. There are some medicines that should not be taken together, and other medicines that may require a dose change if taken together.

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

Non-recommended associations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood clotting;
• Lithium, used to treat mood disorders;
• Metotrexate (cancer and immunosuppressant medicine), used at high doses of 15 mg/week;
• Hidantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections;

Associations requiring caution:

-ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure and heart conditions;

-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;

-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 autoimmune diseases and organ transplants;

-Streptokinase and other thrombolytic and fibrinolytic medicines; that is, medicines used to break down clots;

-Probenecid, used for gout;

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

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

-SSRI-type antidepressants;

-Antiplatelet agents used to reduce platelet aggregation and clot formation;

• Beta-blockers, used for high blood pressure and heart conditions;
• 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 fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected.

If you are pregnant, think you may 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 planning to become pregnant or are pregnant should avoid using dexketoprofen. Treatment at any stage of pregnancy should only take place under the guidance of a doctor. 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 constriction 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.

Dexketoprofen is not recommended for use while trying to conceive or while studying fertility problems.

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

Driving and operating machinery

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

Dekendol contains sodium

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

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Generally, the recommended dose is½ tablet (12.5 mg) every 4-6 hours or1 tablet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 tablets a 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 indicate how many tablets you should take per day and for how long. The dose of dexketoprofen you need may vary, depending on the type, intensity, and duration of your pain.

The most effective dose should be used for the shortest period of time necessary to relieve symptoms. If you have an infection, consult a doctor as soon as possible 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 a day (50 mg).

In elderly patients, this initial dose may be increased subsequently in accordance with 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 to reduce the risk of experiencing adverse effects in the stomach or intestine. However, if your pain is intense and you need quick relief, take the tablets on an empty stomach (at least 30 minutes before food) as they will be absorbed more easily.

Use in children and adolescents

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

If you take more Dekendol than you should

If you have taken too much medication, inform your doctor or pharmacist immediately or go to the emergency service of your nearest hospital. Please remember to always carry the medication box or this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Dekendol

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

If you have any 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 in accordance with 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, prostatic disorders, abnormal liver function tests (blood analysis), 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), shortness of breath, 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 drugs, and especially 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 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 dexketoprofen may be associated with a small increased risk of suffering a heart attack ("myocardial infarction") or a stroke ("cerebral infarction").

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, they may cause hematological reactions (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and medullary hypoplasia).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://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 box and the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Dekendol

The active ingredient is dexketoprofen.

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

The other components (excipients) are microcrystalline cellulose, sodium croscarmellose, cornstarch, hypromellose, anhydrous colloidal 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 package

Film-coated tablet, white to almost white, round, biconvex, and scored on one face.

Dimensions: approximately 10 mm in diameter.

The tablet can be divided into equal doses.

This medication is available in packages containing 10, 20, 30, and 50 film-coated tablets in blister packs.

Only some package sizes may be marketed.

Marketing authorization holder

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

Responsible manufacturer

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

or

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

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

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: January 2023

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