Package Insert: Information for the Patient

DexketoprofenPharma Combix25 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Dexketoprofeno Pharma Combix tablets are a pain reliever belonging to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscle pain or joint pain, menstrual pain (dysmenorrhea), dental pain.

Do not take DexketoprofenoPharma Combixtablets:

• 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 or to another non-steroidal 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 cavity due to allergy), urticaria (skin eruption), angioedema (face, eye, lip, or tongue swelling, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs;
• if you have or have had a stomach ulcer, stomach or intestinal bleeding, or chronic digestive problems (e.g., indigestion, stomach burning);
• if you have had 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 clotting 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 Dexketoprofeno Pharma Combix

• if you are allergic or have had allergic reactions in the past;
• if you have kidney, liver, or heart diseases (hypertension and/or heart failure), or have had these conditions 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 smoking) consult this treatment with your doctor or pharmacist. Medicines likeDexketoprofeno Pharma Combixmay 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 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 Pharma Combix may reduce your fertility, so do not take it if you are planning to become pregnant or undergoing fertility studies);
• if you have blood or bone marrow disorders;
• if you have systemic lupus erythematosus or mixed connective tissue disease (immune system diseases affecting connective tissue);
• if you have or have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• if you have or have had stomach or intestinal disorders;
• if you are taking other medicines that increase the risk of stomach ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), blood thinners like acetylsalicylic acid (aspirin) or warfarin. In these cases, consult your doctor before taking Dexketoprofeno Pharma Combix: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other acid-blocking medicines).

Children and adolescents

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

Taking Dexketoprofeno Pharma Combix with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Some medicines should not be taken together, and other medicines may require a dose change when taken together.

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

Not recommended associations:

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

Associations 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 glibenclamide, used to treat diabetes;

Associations to consider:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used to treat bacterial infections;
• Ciclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medicines; that is, medicines used to break down blood clots;
• Probenecid, used to treat gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• SSRI-type antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and blood clotting.

Associations to consider:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used to treat bacterial infections;
• Ciclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medicines; that is, medicines used to break down blood clots;
• Probenecid, used to treat gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• SSRI-type antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and blood clotting.

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

Taking Dexketoprofeno Pharma Combix with food and drinks

Take the tablets with a sufficient amount of water. Take the tablets with food, as this helps to reduce the risk of stomach or intestinal side 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 a little faster.

Pregnancy, breastfeeding, and fertility

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

Do not takeDexketoprofeno Pharma Combixin 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 predisposition and that of your baby to bleed and delay or prolong delivery. Do not take DexketoprofenoPharma Combixin 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 time possible. From week 20 of pregnancy, DexketoprofenoPharma Combixmay 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 narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period 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, asDexketoprofeno Pharma Combixmay not be suitable for you.
• do not takeDexketoprofeno Pharma Combixif you are breastfeeding. Seek advice from your doctor.

Driving and operating machines

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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 pain. Your doctor will tell you how many tablets to take per day and for how long.

Generally, it is recommended to take 1 tablet (25 mg of dexketoprofeno) every 8 hours, without exceeding 3 tablets per day (75 mg).

If you are elderly or have any 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 dexketoprofeno) 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 eating) as they will be absorbed more easily (see section 2 “Taking Dexketoprofeno Pharma Combix with food and drinks”).

If you take more Dexketoprofeno Pharma Combix 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 your medication box or this leaflet with you.

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

If you forgot to take Dexketoprofeno Pharma Combix

Do not take a double dose to make up for the missed 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 questions about the use of this medication, ask 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 order of 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, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flushes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation and chills, general discomfort.

Rare side effects

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

Anaphylactic reaction (hypersensitivity reaction that may also lead to collapse), skin ulcers, mouth, eye, and genital area ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or lip and throat swelling (angioedema), respiratory difficulty due to narrowing of airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis inflammation, blurred vision, 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 elderly.

Stop taking Dexketoprofeno (trometamol) Pharma Combix 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 Dexketoprofeno Pharma Combix may be associated with a small increase in the risk of suffering a heart attack (“myocardial infarction”) or stroke (“cerebrovascular accident”).

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.

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

Reporting 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 prospectus. You can also report them directly through the Spanish Medicines Adverse Reactions Monitoring System: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

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

Dexketoprofeno CompositionPharma Combix

• The active ingredient is dexketoprofeno trometamol (36.90 mg) corresponding to 25 mg of dexketoprofeno (DCI).
• The other components are: cornstarch, pregelatinized cornstarch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, opadry white (hypromellose, titanium dioxide, and macrogol 400).

Appearance of the product and content of the packaging

Dexketoprofeno Pharma Combix is presented in packaging that contains 20, 50, and 500 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Combix Laboratories, S.L.U.

C/ Badajoz 2, Building 2

28223 Pozuelo de Alarcón, Madrid

Responsible for manufacturing:

Kern Pharma S.L.

C/ Venus, 72

Pol. Ind.Colón, 2

08228 Terrassa

or

International Medicines Laboratories, 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 prospectus was approved in February 2023

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