Dexketoprofen Qualigen 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dexketoprofeno Qualigen 25 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

1. What Dexketoprofeno Qualigen is and what it is used for
2. What you need to know before taking Dexketoprofeno Qualigen
3. How to take Dexketoprofeno Qualigen
4. Possible side effects
5. How to store Dexketoprofeno Qualigen
6. Contents of the pack and other information

1. What Dexketoprofen Qualigen is and what it is used for

Dexketoprofen Qualigen is an analgesic belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscular or joint pain, menstrual pain (dysmenorrhoea), and dental pain.

2. What you need to know before taking Dexketoprofeno Qualigen

Do not take Dexketoprofeno Qualigen

• If you are allergic to dexketoprofen trometamol or to any of the other components of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or to any other non-steroidal anti-inflammatory drug (NSAID);
• If you have asthma or have previously 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 wheezing in the chest after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs;
• If you have previously experienced photoallergic or phototoxic reactions (a special type of redness or sunburn-like skin damage 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 bleeding, ulceration, or perforation of the stomach or intestine;
• 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) used for pain relief;
• 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 coagulation disorders;
• If you are severely dehydrated (have lost a significant amount 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 taking dexketoprofen:

• If you are allergic or have previously had allergic reactions;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have previously experienced any of these conditions;
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of stroke, or think you may be at risk of such conditions (e.g., you have high blood pressure, diabetes, elevated cholesterol, or are a smoker), discuss this treatment with your doctor or pharmacist. Medicines like Dexketoprofeno Qualigen 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 (Dexketoprofeno Qualigen 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 affecting 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 “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 anticoagulants like acetylsalicylic acid (aspirin) or warfarin. In such cases, consult your doctor before taking Dexketoprofeno Qualigen; 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, especially combined 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. Taking this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Allergic reactions to dexketoprofen, including respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Immediately discontinue treatment with Dexketoprofeno Qualigen and contact your doctor or the nearest emergency service if you experience any of these symptoms.

Infections

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

It is advisable to avoid using this medicine during chickenpox.

Children and adolescents

This medicine 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.

Taking Dexketoprofeno Qualigen with other medicines

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 used concurrently.

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

Combinations not recommended:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood clotting;
• Lithium, used to treat certain mood disorders;
• Methotrexate (a cancer and immunosuppressant medicine), 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 conditions;
• 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 glibenclamide), 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 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 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 conditions;
• Tenofovir, deferasirox, pemetrexed.

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

Taking Dexketoprofeno Qualigen with food and drinks

Take the tablets with an adequate amount of water. Take the tablets with food, as this helps reduce the risk of gastrointestinal adverse effects. However, in cases of acute pain, take the tablets on an empty stomach—i.e., at least 30 minutes before meals—since this allows the medicine to act slightly faster.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take dexketoprofen during the last three months of pregnancy or while breastfeeding. It 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.

Do not take this medicine during the first six months of pregnancy unless clearly necessary and specifically advised by your doctor. If treatment is needed during this period or when trying to conceive, you should take the lowest effective dose for the shortest possible time.

From week 20 of pregnancy, this medicine may cause kidney problems in your unborn baby if taken for more than a few days, potentially leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Use of this medicine is not recommended when trying to conceive or undergoing infertility evaluation. For 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. If you experience these effects, do not operate machinery or drive until the symptoms have resolved. Seek advice from your doctor.

Dexketoprofeno Qualigen contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet and is therefore essentially “sodium-free.”

3. How to take Dexketoprofeno Qualigen

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The dose of dexketoprofen you need may vary depending on the type, intensity, and duration of pain. Your doctor will tell you how many tablets you should take per day and for how long.

The lowest effective dose should be used for the shortest time 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).

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

If you are an elderly patient or suffer from kidney or liver disease, treatment should be initiated 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), provided that dexketoprofen has been well tolerated.

If your pain is severe and you need rapid relief, take the tablets on an empty stomach (at least 30 minutes before food), as they will be absorbed more easily (see section 2 “Taking Dexketoprofeno Qualigen with food and drink”).

Use in children and adolescents

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

If you take more Dexketoprofeno Qualigen 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 bring the medication packaging or this leaflet with you. In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 915620420, indicating the medicine and the amount ingested.

If you forget to take Dexketoprofeno Qualigen

Do not take a double dose to make up for missed doses. Take the next dose as scheduled (according to section 3 “How to take Dexketoprofeno Qualigen”).

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, dexketoprofen may cause adverse effects, although not everyone experiences them.

The possible adverse effects are listed below according to their frequency. The following table indicates how many patients may experience these adverse effects:

Frequent adverse effects

Nausea and/or vomiting, mainly pain in the upper abdominal quadrant, diarrhoea, digestive disorders (dyspepsia).

Uncommon adverse effects

Sensation of spinning (vertigo), dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling feverish and chills, general malaise.

Rare adverse effects

Peptic ulcer, perforation of peptic ulcer or bleeding (which may present as vomiting blood or black stools), fainting, elevated blood pressure, slow breathing, fluid retention and peripheral swelling (e.g., swelling of 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), liver cell damage (hepatitis), acute renal failure.

Very rare adverse effects

Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), skin, mouth, eye, or genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), swelling of the face or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), skin sensitivity, light sensitivity, itching, kidney problems. Decrease in white blood cell count (neutropenia), decrease in platelet count (thrombocytopenia).

Adverse effects with unknown frequency

Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

Drug-induced fixed eruption

An allergic skin reaction known as drug-induced fixed eruption, which may include round or oval red patches and skin swelling, blisters, and itching. Darkening of the skin in affected areas may also occur, which can persist after healing. Drug-induced fixed eruption usually recurs in the same location(s) 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 prolonged treatment with anti-inflammatory medicines, and particularly if you are an elderly patient.

Stop taking Dexketoprofen Qualigen immediately if you develop 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 Qualigen may be associated with a small increased risk of 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 of gastrointestinal type. Peptic ulcers, intestinal perforation, or bleeding, sometimes fatal, may occur, particularly in elderly patients.

Following 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, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexketoprofen Qualigen

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

Do not use this medicine after the expiry date stated on the packaging and on the blister, following "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexketoprofen Qualigen

• The active substance is dexketoprofen trometamol (36.90 mg), equivalent to 25 mg of dexketoprofen.
• The other components are: microcrystalline cellulose (E 460i), pregelatinized corn starch, sodium carboxymethyl potato starch, magnesium stearate (E 470b), hypromellose (E 464), polydextrose, titanium dioxide (E171), and macrogol 4000.

Appearance of the product and contents of the pack

Dexketoprofen Qualigen 25 mg is presented as film-coated tablets. The tablets are round, white, and scored. They are available in packs containing 20 or 50 tablets, and a hospital pack containing 500 tablets.

Some pack sizes may not be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona), Spain

Date of the most recent revision of this summary: December 2025

Detailed and up-to-date 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/