Dexketoprofen Combix 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dexketoprofeno Combix 25 mg film-coated tablets EFG

Read the 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, because it may harm them.
• 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 your condition worsens or if you do not improve after 4 days.

Contents of the leaflet

1. What Dexketoprofeno Combix is and what it is used for
2. What you need to know before taking Dexketoprofeno Combix
3. How to take Dexketoprofeno Combix
4. Possible side effects
5. How to store Dexketoprofeno Combix

Pack contents and additional information

1. What Dexketoprofeno Combix is and what it is used for

Dexketoprofeno Combix tablets is an analgesic belonging to a group of medicines known as 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 Combix

Do not take Dexketoprofeno Combix tablets:

• if you are allergic to dexketoprofen trometamol or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid (aspirin) 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 NSAIDs;
• if you currently have or have previously had peptic ulcer, gastrointestinal bleeding, or intestinal perforation, or if you suffer from chronic digestive problems (e.g., indigestion, heartburn);
• if you have previously experienced gastrointestinal bleeding or perforation due to prior use of NSAIDs taken 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 insufficiency, or severe hepatic insufficiency;
• if you have bleeding disorders or blood coagulation disorders;
• if you are pregnant or breastfeeding;
• if you are under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting Dexketoprofeno Combix

• 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 suffered from any of these conditions;
• if you are taking diuretics or are dehydrated and have reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting);
• if you have heart conditions, a history of stroke, or think you may be at risk of such conditions (e.g., you have high blood pressure, diabetes, high cholesterol, or are a smoker). You should discuss this treatment with your doctor or pharmacist. Medicines like Dexketoprofeno Combix 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 susceptible to adverse effects (see section 4). If these occur, consult your doctor immediately;
• if you are a woman with fertility problems (Dexketoprofeno Combix may reduce fertility, so you should not take it if you are planning pregnancy 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 (autoimmune diseases 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 are taking other medicines that increase the risk of peptic ulcer or gastrointestinal 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 Dexketoprofeno Combix: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other drugs that block gastric acid production).

Allergic reactions to dexketoprofen have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. Immediately stop taking dexketoprofen and contact your doctor or nearest emergency service if you experience any of these symptoms.

Children and adolescents

Do not take Dexketoprofeno Combix if you are under 18 years of age.

Taking Dexketoprofeno Combix with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines should not be taken together, while others may require dose adjustments when used concurrently.

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

Combinations not recommended:

• Acetylsalicylic acid (aspirin), corticosteroids, and other NSAIDs;
• Warfarin, heparin, and other medicines used to prevent blood clotting;
• Lithium, used to treat certain mood disorders;
• Methotrexate, used for rheumatoid arthritis and cancer;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections;

Combinations requiring caution:

• ACE inhibitors, diuretics, beta-blockers, 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;
• Chlorpropamide and glyburide, used for diabetes;

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 agents; i.e., medicines used to dissolve blood 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 blood clot formation.

If you have any questions about taking other medicines with Dexketoprofeno Combix, consult your doctor or pharmacist.

Taking Dexketoprofeno Combix 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 case of acute pain, take the tablets on an empty stomach; that is, at least 30 minutes before meals, as this allows the medicine to act slightly faster.

Pregnancy, breastfeeding, and fertility

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

Do not take Dexketoprofeno Combix during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. 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. You should not take Dexketoprofeno Combix during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest effective dose for the shortest possible time. From week 20 of pregnancy, Dexketoprofeno Combix may cause kidney problems in your fetus if taken for more than a few days, which could 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 treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Consult your doctor or pharmacist before using any medicine.

• Inform your doctor if you are pregnant or planning to become pregnant, as Dexketoprofeno Combix may not be suitable for you.
• Do not take Dexketoprofeno Combix if you are breastfeeding. Seek medical advice.

Driving and using machines

Dexketoprofeno Combix may slightly affect your ability to drive or operate machinery, 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 have resolved. Seek advice from your doctor.

3. How to take Dexketoprofeno Combix

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

If you are elderly 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 later be increased according to the general recommended dose (75 mg of dexketoprofen), provided Dexketoprofeno Combix 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 Combix with food and drink").

If you take more Dexketoprofeno Combix 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 medicine pack or this leaflet with you.

If you forget to take Dexketoprofeno Combix

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

Take the next dose at the scheduled time (according to section 3, "How to take Dexketoprofeno Combix 25 mg film-coated tablets EFG").

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

4. Possible adverse effects

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

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

Frequent adverse effects

Nausea and/or vomiting, stomach pain, diarrhoea, digestive disorders (dyspepsia).

Uncommon adverse effects

Sensation of spinning (vertigo), dizziness, somnolence, sleep disturbances, nervousness, headache, palpitations, hot flushes, stomach problems, 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, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), abnormal sensation, itchy 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

Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), skin, mouth, eye, and genital ulcers (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. Decreased number of white blood cells (neutropenia), decreased number of platelets (thrombocytopenia).

Adverse effects with unknown frequency

Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome. Fixed drug eruption: an 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 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 experience 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 anti-inflammatory medicines, and particularly if you are elderly.

Stop taking Dexketoprofen (trometamol) Combix immediately if you notice the appearance of a skin rash or any lesions in the mouth or 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 Combix 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.

If any of these adverse effects worsen, or if you experience any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the national reporting system available at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexketoprofen Combix

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

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

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

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

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

6. Contents of the pack and other information

Composition of Dexketoprofeno Combix

• The active substance is dexketoprofen trometamol (36.90 mg), equivalent to 25 mg of dexketoprofen (INN).
• The other components are: corn starch, pregelatinized corn starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, Opadry White (hypromellose, titanium dioxide, and macrogol 400).

Appearance of the product and contents of the pack

Dexketoprofeno Combix is presented in packs containing 12 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (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 Madrid

O

FARMALIDER, S.A.

C/ Aragoneses, 2

Alcobendas, 28108 Madrid, Spain

This summary of product characteristics was approved in September 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.es/”