DEXKETOPROFEN PHARMA COMBIX 25 mg FILM-COATED TABLETS

2. What you need to know before you take Dexketoprofen Pharma Combix

Do not take DexketoprofenPharma Combixtablets:

• if you are allergic to dexketoprofen trometamol 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), hives (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 or have had in the past peptic ulcer, stomach or intestinal bleeding, or have chronic digestive problems (e.g., indigestion, heartburn);
• if you have suffered in the past from stomach or intestinal bleeding or perforation due to previous use of non-steroidal 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 kidney failure, or severe liver failure;
• if you have bleeding disorders or blood coagulation disorders;
• if you are pregnant or breastfeeding;
• if you are under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dexketoprofen Pharma Combix

• if you are allergic or have had allergy problems in the past;
• if you have kidney, liver, or heart disease (hypertension and/or heart failure), or fluid retention or have suffered from 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 stroke, 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 Pharma Combix may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). This risk is more likely to occur when high doses are used and treatments are prolonged. Do not exceed the recommended dose or treatment duration;
• If you are elderly, you may suffer from a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (Dexketoprofeno Pharma Combix may decrease your fertility, so you should not take it if you are planning to become pregnant or if you are undergoing fertility studies);
• if you suffer from a blood disorder and blood cell production;
• if you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• if you suffer or have suffered in the past from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• if you suffer or have suffered in the past from stomach or intestinal disorders;
• if you are taking other medicines that increase the risk of peptic ulcer or bleeding, for example, oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), agents that prevent clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking Dexketoprofeno Pharma Combix: 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).

Children and adolescents

Do not take Dexketoprofeno Pharma Combix if you are under 18 years old.

Taking DexketoprofenoPharma Combixwith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. There are some medicines that should not be taken together and others that may need a dose change if taken together.

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

Not recommended combinations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate, used for rheumatoid arthritis and cancer;
• 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 control and heart disorders;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used for bacterial infections;
• Chlorpropamide and glibenclamide, used for diabetes;

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.

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.

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

Taking DexketoprofenoPharma Combixwith food and drinks

Take the tablets with a sufficient amount of water. Take the tablets with food, as this helps reduce the risk of suffering from adverse effects in the stomach or intestine. However, in case of acute pain, take the tablets on an empty stomach; i.e., at least 30 minutes before meals, as this facilitates the medicine acting a little 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 Dexketoprofeno Pharma Combix if you are in 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 fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take Dexketoprofeno Pharma Combix 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, Dexketoprofeno Pharma Combix may cause kidney problems in your fetus if taken for more than a few days, which can cause 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.

Consult your doctor or pharmacist before using any medicine.

• tell your doctor if you are pregnant or planning to become pregnant, as Dexketoprofeno Pharma Combix may not be suitable for you.
• do not take Dexketoprofeno Pharma Combix if you are breastfeeding. Ask your doctor for advice.

Driving and using machines

Dexketoprofeno Pharma Combix may slightly affect your ability to drive and use machines, as it can cause drowsiness or dizziness as side effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Ask your doctor for advice.

3. How to take Dexketoprofeno Pharma Combix

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Generally, it is recommended to take 1 tablet (25 mg of dexketoprofen) every 8 hours, not 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 be increased later according to the recommended general dose (75 mg of dexketoprofen) if Dexketoprofeno Pharma Combix has been well tolerated.

If your pain is intense and you need quick relief, take the tablets on an empty stomach (at least 30 minutes before meals) as they will be absorbed more easily (see section 2 "Taking Dexketoprofeno Pharma Combix with food and drinks").

If you take more DexketoprofenoPharma Combixthan you should

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

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

If you forget to take DexketoprofenoPharma Combix

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 Dexketoprofeno Pharma Combix 25 mg film-coated tablets EFG").

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects are listed below by frequency. The following table indicates how many patients may experience these side effects:

Frequent side effects

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

Uncommon side effects

Dizziness (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation, and chills, general malaise.

Rare side effects

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

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. Decreased number of white blood cells (neutropenia), decreased number of platelets (thrombocytopenia).

Tell your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g., stomach pain or heartburn or bleeding), if you have previously suffered from these side effects due to prolonged treatment with anti-inflammatory drugs, and especially if you are elderly.

Stop taking Dexketoprofeno (trometamol) Pharma Combix 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 Dexketoprofeno Pharma Combix may be associated with a small increased risk of suffering from a heart attack ("myocardial infarction") or stroke ("cerebrovascular accident").

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 neck stiffness.

If any of these side effects worsen, or you suffer from any side effect not listed in this leaflet, tell your doctor or pharmacist.

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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dexketoprofeno Pharma 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 is the last day of the month indicated.

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

6. Packaging Content and Additional Information

Composition of Dexketoprofeno Pharma Combix

• The active ingredient is dexketoprofen trometamine (36.90 mg) corresponding to 25 mg of dexketoprofen (DCI).
• 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 Packaging Content

Dexketoprofeno Pharma Combix is presented in packages containing 20, 50, and 500 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón, Madrid

Manufacturer:

Kern Pharma S.L.

C/ Venus, 72

Pol. Ind. Colón, 2

08228 Terrassa

or

Laboratorios Medicamentos Internacionales, S.A.

C/Solana 26, Torrejón de Ardoz, 28850

Madrid, Spain

or

Toll Manufacturing Services, S.L

C/ Aragoneses, 2

28108 Alcobendas – Madrid

Spain

or

Farmalider, S.A.

C/ Aragoneses, 2

Alcobendas, 28108 Madrid, Spain

This leaflet was approved in February 2023

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/”