DEXKETOPROFEN TEVA 25 mg FILM-COATED TABLETS

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

Dexketoprofen Teva is a pain reliever belonging to the group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild or moderate pain, such as muscle or joint pain, menstrual pain (dysmenorrhea), toothache.

2. What you need to know before taking Dexketoprofen Teva

Do not takeDexketoprofen Tevaif:

• You are allergic to dexketoprofen trometamol or any of the other ingredients of this medication (listed in section 6);
• You are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory medications;
• 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 (urticaria), 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 medications;
• You have suffered from photoallergic or phototoxic reactions (a special form of redness or sunburn) while taking ketoprofen (a non-steroidal anti-inflammatory medication) or fibrates (medications used to reduce blood fat levels);
• You have or have had in the past peptic ulcer, stomach or intestinal bleeding, or chronic digestive problems (e.g., indigestion, heartburn);
• You have suffered from stomach or intestinal bleeding or perforation in the past due to the use of non-steroidal anti-inflammatory medications (NSAIDs) used for pain;
• You have chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• You have severe heart failure, moderate to severe kidney failure, or severe liver failure;
• You have bleeding disorders or blood coagulation disorders;
• You are pregnant or breastfeeding;
• You are under 18 years old.
• You are severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Dexketoprofen Teva if:

• You are allergic or have had allergy problems in the past;
• You have kidney, liver, or heart disease (hypertension and/or heart failure), or fluid retention or have suffered from these diseases in the past;
• 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);
• 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) and should consult your doctor or pharmacist about this treatment. Medications like Dexketoprofen Teva may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or stroke. This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;
• You are an elderly person, as you may suffer from a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• You are a woman with fertility problems (Dexketoprofen Teva may reduce your fertility, so you should not take it if you are planning to become pregnant or are undergoing fertility studies);
• You suffer from a blood disorder and blood cell production;
• You have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• You suffer or have suffered in the past from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• You suffer or have suffered in the past from stomach or intestinal disorders;
• You have an infection; see the "Infections" section below;
• You are taking other medications that increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), agents that prevent blood clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking Dexketoprofen Teva: your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other medications that block gastric acid production).
• You suffer from 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 medication may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Dexketoprofen may hide the signs of an infection, such as fever and pain. Consequently, this medication 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 medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay. During chickenpox, it is recommended to avoid using this medication.

Children and Adolescents

Do not take Dexketoprofen Teva if you are under 18 years old.

Taking Dexketoprofen Teva with Other Medications

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication.

There are some medications that should not be taken together, and other medications that may require a dose change if taken together.

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

Not recommended combinations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory medications;
• Warfarin, heparin, and other medications used to prevent blood clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate (a medication for cancer and immunosuppression), 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 (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;
• Cyclosporine or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medications; i.e., medications used to dissolve blood 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 blood clot formation.

If you have any doubts about taking other medications with Dexketoprofen Teva, consult your doctor or pharmacist.

Taking Dexketoprofen Teva 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 suffering from side 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 allows the medication to act 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 medication.

Do not take dexketoprofen 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 delivery more than expected.

Do not take dexketoprofen during the first 6 months of pregnancy unless it is clearly necessary and as directed 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 medication is not recommended while trying to conceive or while studying a fertility problem. Regarding the 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 side effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Ask your doctor for advice.

Dexketoprofen Teva Contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it is essentially "sodium-free".

3. How to Take Dexketoprofen Teva

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

The recommended dose of Dexketoprofen Teva that 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.

In general, 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 an elderly patient 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 general recommended dose (75 mg of dexketoprofen) if Dexketoprofen Teva 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 Dexketoprofen Teva with Food and Drinks").

The tablet can be divided into equal doses.

If You Take MoreDexketoprofen TevaThan You Should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91562 04 20, indicating the medication and the amount ingested.

If You Forget to TakeDexketoprofen Teva

Do not take a double dose to make up for forgotten doses. Take the next dose when scheduled (according to section 3 "How to Take Dexketoprofen Teva").

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

Common Side Effects(may affect up to 1 in 10 people)

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

Uncommon Side Effects(may affect up to 1 in 100 people)

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

Rare Side 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 the 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 Side Effects(may affect up to 1 in 10,000 people)

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin ulcers, mouth ulcers, eye ulcers, and genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling 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, tinnitus (ringing in the ears), sensitive skin, sensitivity to light, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

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

Stop taking dexketoprofen 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 medications, cases of fluid retention and swelling (especially in the ankles and legs), increased blood pressure, and heart failure have been reported.

Medications like dexketoprofen may be associated with a small increased risk of suffering from a heart attack (myocardial infarction) or stroke.

In patients with immune system disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medications can rarely cause fever, headache, and stiffness of the neck.

The most common side effects observed are of a gastrointestinal type. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, sometimes fatally, especially in elderly patients.

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 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 package leaflet. You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dexketoprofeno Teva

Keep this medication out of sight and reach of children.

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

Do not store at a temperature above 30° C.

Keep in the original packaging to protect it from light.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Dexketoprofeno Teva

• The active ingredient is dexketoprofen trometamol. Each film-coated tablet contains 25 mg of dexketoprofen, which is equivalent to 36.90 mg of dexketoprofen trometamol.
• The other components are: corn starch, microcrystalline cellulose, sodium carboxymethyl potato starch (type A), glycerol distearate, hypromellose (E464), titanium dioxide (E171), macrogol 400.

Appearance of the Product and Package Contents

Dexketoprofeno Teva 25 mg are film-coated, white, biconvex, and cylindrical tablets marked with DT2 on one side. The tablet can be divided into equal doses.

Dexketoprofeno Teva 25 mg film-coated tablets are presented in packages containing 20 and 50 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U

Anabel Segura 11, Edificio Albatros B, 1ª Planta

28108, Alcobendas, Madrid

Spain

Manufacturer

Galenicum Health, S.L.

San Gabriel, 50

Esplugues de Llobregat

08950 Barcelona (Spain)

SAG Manufacturing, S.L.U.

Ctra N-I, km. 36

28750 San Agustín del Guadalix

Madrid - Spain

Date of the Last Revision of this Prospectus: July 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77871/P_77871.html

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