DEXDOLESS 25 mg FILM-COATED TABLETS

2. What you need to know before taking Dexdoless

Do not takeDexdoless:

• 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 other non-steroidal anti-inflammatory medicines;
• 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), urticaria (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 medicines;
• if you have suffered photoallergic or phototoxic reactions (a special form of redness or sunburn) while taking ketoprofen (a non-steroidal anti-inflammatory medicine) 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 use of non-steroidal anti-inflammatory medicines (NSAIDs) 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 impairment, or severe hepatic impairment;
• 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 Dexdoless

• 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 dexketoprofen may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes. Any 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 (see section 2, "Pregnancy, breastfeeding, and fertility");
• 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 had or currently have chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• if you have had or currently have stomach or intestinal disorders;
• if you are taking other medicines that increase the risk of peptic ulcers 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 this medicine: it may be that your doctor prescribes an additional medicine to protect your stomach (e.g., misoprostol or other medicines that block gastric 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 rest of the population. The 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, 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 having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Avoid using this medicine if you have chickenpox.

Children and adolescents

This medicine has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and it should not be used in children and adolescents.

Other medicines and Dexdoless

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained 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 dexketoprofen, you are taking any of the following medicines:

Not recommended combinations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory medicines;
• Warfarin, heparin, and other medicines used to prevent clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate, a cancer medicine and immunosuppressant, 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, 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 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.
• Beta-blockers, used for high blood pressure and heart disorders;
• Tenofovir, deferasirox, pemetrexed.

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

Taking Dexdoless with food, drinks, and alcohol

Generally, it is recommended to take the medicine with meals to reduce the possibility of causing stomach disorders (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 3 months of pregnancy or during breastfeeding. It may cause kidney and heart problems in your fetus. It may affect your and your baby's ability to bleed and delay or prolong labor more than expected.

You should not take dexketoprofen during the first 6 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 lead to 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.

The use of this medicine may impair fertility, so it is not recommended to use this medicine while trying to conceive or while investigating a fertility problem.

Driving and using machines

This medicine may slightly affect your ability to drive and use machines, as it may cause drowsiness, dizziness, and blurred vision as side effects. If you notice these effects, do not use machines or drive until these symptoms disappear. Ask your doctor for advice.

3. How to take Dexdoless

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The necessary dose of the 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).

The tablets can be divided into equal doses.

Adults from 18 years

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

Elderly patients or patients with renal or hepatic impairment

If you are an elderly patient or have mild or moderate kidney or liver problems, it is recommended to start treatment with a maximum of 2 tablets per day (50 mg of dexketoprofen).

In elderly patients, this initial dose may be increased later according to the general recommended dose (75 mg of dexketoprofen) if the medicine 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).

Method of administration

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 quick relief, take the tablets on an empty stomach (at least 30 minutes before eating or ingesting food) because they will be absorbed more easily (see section 2 "Taking Dexdoless with food, drinks, and alcohol").

Duration of treatment

Treatment should not exceed 4 days. If the pain persists after this period or worsens, or if other symptoms appear, you should stop treatment and consult your doctor or pharmacist.

If you take more Dexdoless than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount taken. It is recommended to take the package and leaflet of the medicine to the healthcare professional.

If you forget to take Dexdoless

Do not take a double dose to make up for forgotten doses.

Take the next dose when it is due (according to section 3 "How to take Dexdoless").

If you have any other doubts about the use of this medicine, ask 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):

Rotatory sensation (vertigo), dizziness, somnolence, sleep disorders, nervousness, headache, palpitations, hot flashes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, 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(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).

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 elderly.

Stop taking the 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 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 dexketoprofen 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), anti-inflammatory drugs can rarely cause fever, headache, and stiffness of the neck.

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

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, hematological reactions (purpura, aplastic anemia, and hemolytic anemia, and more rarely agranulocytosis and bone marrow hypoplasia) may appear.

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 does not appear in this leaflet. You can also report them directly through the national reporting system included in www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dexdoless

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

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

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 after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines 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 you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition ofDexdoless

• The active ingredient is dexketoprofen (as dexketoprofen trometamol), each tablet contains 25 mg of dexketoprofen.
• The other components are:

Core of the tablet:cornstarch, pregelatinized cornstarch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate,

Coating of the tablet:white opadry (hypromellose, titanium dioxide, and macrogol 400).

Appearance ofDexdolessand Packaging Content

Film-coated tablets, scored, white, and round, packaged in blisters.

Packaging with 10 tablets.

Marketing Authorization Holder

Apotheke Laboratorios, S.L.

Paseo de la Castellana 40, 8th floor

28046 Madrid, Spain

Manufacturer:

Kern Pharma S.L.

C/ Venus, 72

Pol. Ind. Colón, 2

08228 Terrassa

O

LABORATORIOS MEDICAMENTOS INTERNACIONALES, S.A.

C/Solana 26, Torrejón de Ardoz, 28850

Madrid, Spain

O

Toll Manufacturing Services S.L

C/ Aragoneses, 2. 28108 Alcobendas (Madrid)

O

Farmalider S.A.

C/ Aragoneses, 2.

28108 Alcobendas, Madrid

Spain

Date of the Last Revision of this Leaflet:February 2024

"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/"