DEXKETOPROFEN STADAPHARM 25 mg FILM-COATED TABLETS

2. What you need to know before taking Dexketoprofen Stadapharm

Do not take Dexketoprofen Stadapharm:

• If you are allergic to dexketoprofen or any of the other components of this medication (listed in section 6);
• If you are allergic to acetylsalicylic acid or another non-steroidal anti-inflammatory medication;
• 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), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or wheezing in the chest after taking acetylsalicylic acid or other non-steroidal anti-inflammatory medications;
• If 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);
• If you have a peptic ulcer, stomach or intestinal bleeding, or if you have suffered from bleeding, ulceration, or perforation of the stomach or intestine in the past;
• If you have chronic digestive problems (e.g., indigestion, heartburn);
• If you have suffered from stomach or intestinal bleeding or perforation in the past due to the use of non-steroidal anti-inflammatory medications (NSAIDs) 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 severely dehydrated (have lost a lot 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 starting to take Dexketoprofen Stadapharm:

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart disease (high blood pressure 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 strokes, 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. Medications like Dexketoprofen Stadapharm may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes. Any 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 an elderly patient, you may experience a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (see section 2, "Pregnancy, Breastfeeding, and Fertility");
• If you have a disorder in blood production and blood cells;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you have suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) in the past;
• If you have suffered from stomach or intestinal disorders in the past;
• If you have an infection; see the "Infections" heading below;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), or anticoagulant medications like warfarin. In these cases, consult your doctor before taking this medication: your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other medications that block gastric acid production);
• If you have 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 mask 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.

Avoid using this medication if you have chickenpox.

Children and Adolescents

This medication has not been studied in children or adolescents. Therefore, safety and efficacy have not been established, and it should not be used in children or adolescents.

Use of Dexketoprofen Stadapharm with Other Medications:

Inform your doctor or pharmacist if you are taking or have recently taken or may need to use any other medication, including those purchased without a prescription. There are some medications that should not be taken together, and others may require a dose change if taken together.

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

Not Recommended Combinations:

• Acetylsalicylic acid, 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 Precaution:

• ACE inhibitors, diuretics, 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 (e.g., chlorpropamide and glibenclamide), used for diabetes;
• Methotrexate, used at low doses, less than 15 mg/week;

Combinations to be Considered:

• 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;
• Beta-blockers, used for high blood pressure and heart disorders;
• Tenofovir, deferasirox, pemetrexed.

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

Taking Dexketoprofen Stadapharm with Food, Drinks, and Alcohol:

In general, it is recommended to take the medication with meals to reduce the possibility of causing stomach disorders (see also section 3, "Method of Administration").

The use of NSAIDs in combination with alcohol may worsen the adverse reactions caused by the active ingredient.

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 medication.

Do not take this medication during the last three months of pregnancy or during breastfeeding.

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 this medication during the first six 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, this medication 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 may impair fertility, so it is not recommended to use this medication while trying to conceive or while investigating a fertility problem.

Driving and Using Machines

This medication may slightly affect your ability to drive and use machines, as it may cause drowsiness, dizziness, and blurred vision as side effects. If you notice these effects, do not use machines or drive until these symptoms disappear. Ask your doctor for advice.

Dexketoprofen Stadapharm Contains Sodium

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

3. How to Take Dexketoprofen Stadapharm

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

The necessary dose of the medication may vary depending on the type, intensity, and duration of the pain.

The lowest effective dose should be used for the shortest duration necessary to relieve the symptoms. If you have an infection, consult a doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

The tablets can be divided into equal doses.

Adults Over 18 Years

Generally, the recommended dose is 1 tablet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 tablets per day (75 mg).

Elderly or Patients with Renal or Hepatic Impairment

If you are an elderly person or have mild kidney problems or mild to moderate liver problems, it is recommended to start treatment with a maximum of 2 tablets per day (50 mg of dexketoprofen).

In elderly patients, this initial dose may be increased later according to the general recommended dose (75 mg of dexketoprofen) if dexketoprofen has been well tolerated.

You should not use dexketoprofen if you have moderate or severe kidney problems or severe liver problems. Consult your doctor or pharmacist if you are unsure.

Use in Children and Adolescents

This medication should not be used in children and adolescents (under 18 years).

Method of Administration

Take the tablets with a sufficient amount of water.

The medication can be taken with or without food. Taking the medication with food helps reduce the risk of stomach disorders; however, if your pain is more intense and you need faster relief, take the tablet on an empty stomach (at least 30 minutes before any meal or food intake) because it will be absorbed more easily (see section 2, "Dexketoprofen Stadapharm with Food, Drinks, and Alcohol").

Duration of Treatment

Treatment should not exceed 4 days. If the pain persists after this period or worsens, or if other symptoms appear, you should stop treatment and consult your doctor or pharmacist.

If You Take More Dexketoprofen Stadapharm Than You Should:

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the packaging and package leaflet of the medication to the healthcare professional.

If You Forget to Take Dexketoprofen Stadapharm:

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 Stadapharm").

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Possible adverse effects are detailed below according to their frequency.

Frequent Adverse Effects(may affect up to 1 in 10 people):

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

Infrequent Adverse Effects(may affect up to 1 in 100 people):

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

Rare Adverse Effects(may affect up to 1 in 1,000 people):

Peptic ulcer, peptic ulcer perforation 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(may affect up to 1 in 10,000 people):

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 white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

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

Stop taking this medicine 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 the ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines like Dexketoprofeno Stadapharm may be associated with a small increased risk of suffering a heart attack ("myocardial infarction") or a stroke ("stroke").

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.

The most commonly observed adverse effects are of a gastrointestinal type. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, sometimes fatal, 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 occur.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Dexketoprofeno Stadapharm

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

Do not use this medicine 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 above 30°C. Store 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 medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Content of the Packaging and Additional Information

Composition of Dexketoprofeno Stadapharm:

The active ingredient is dexketoprofen (as dexketoprofen trometamol). Each tablet contains 25 mg of dexketoprofen.

The other components are:

Core of the tablet:cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (Type A) (from potato), glycerol distearate.

Coating of the tablet:hypromellose, titanium dioxide E-171, and macrogol.

Appearance of Dexketoprofeno Stadapharm and Content of the Packaging:

Film-coated tablets, white and round, scored, marked with "DT2" on one side.

The approximate dimensions of the film-coated tablets are 9.3 ± 0.5 mm x 3.9 ± 0.5 mm.

The tablets are presented in blisters (PVC/PVDC-aluminum blisters).

Available in packages containing 10 film-coated tablets.

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer:

SAG MANUFACTURING S.L.U.

Crta. N-I, Km 36, San Agustín de Guadalix

28750 Madrid

Spain

GALENICUM HEALTH S.L.

Calle De San Gabriel 50 Poligono Industrial Esplugues De Llobregat

1. Esplugues De Llobregat (Barcelona)

Spain

Date of the Last Revision of this Prospectus:January 2024

Other Sources of Information

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