Dexketoprofen Stadapharm 25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dexketoprofeno Stadapharm 25 mg film-coated tablets

Dexketoprofen

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Always follow exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• 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 must consult a doctor if your condition worsens or does not improve after 4 days.

Contents of the package leaflet

1. What Dexketoprofeno Stadapharm is and what it is used for
2. What you need to know before taking Dexketoprofeno Stadapharm
3. How to take Dexketoprofeno Stadapharm
4. Possible adverse effects
5. How to store Dexketoprofeno Stadapharm
6. Contents of the pack and other information

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

This medicine is an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

Dexketoprofeno Stadapharm is used in adults for the short-term symptomatic treatment of mild to moderate acute pain, such as muscle or joint pain (for example, back pain, sprains and acute injuries), menstrual pain, and dental pain.

2. What you need to know before taking Dexketoprofeno Stadapharm

Allergic reactions to dexketoprofen, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Immediately discontinue treatment with Dexketoprofeno Stadapharm and contact your doctor or nearest emergency service if you experience any of these symptoms.

Do not take Dexketoprofeno Stadapharm:

• If you are allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or to any other non-steroidal anti-inflammatory drug (NSAID);
• If you have asthma or have 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 chest wheezing after taking acetylsalicylic acid or other NSAIDs;
• If you have previously experienced photoallergic or phototoxic reactions (a special form of redness or sunburn-like skin lesions on sun-exposed skin) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medications used to reduce blood fat levels);
• If you have peptic ulcer, gastrointestinal bleeding, or have previously experienced stomach or intestinal bleeding, ulceration, or perforation;
• If you have chronic gastrointestinal problems (e.g., indigestion, heartburn);
• If you have previously experienced stomach or intestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (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 renal impairment, or severe hepatic impairment;
• If you have bleeding disorders or blood coagulation disorders;
• If you are severely dehydrated (have lost a significant amount of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;
• If you are in the third trimester of pregnancy or during breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dexketoprofeno Stadapharm:

• If you are allergic or have had allergic problems in the past;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have had any of 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 stroke, or think you may be at risk of such conditions (e.g., high blood pressure, diabetes, high cholesterol, or if you smoke), you should discuss this treatment with your doctor or pharmacist. Medicines like Dexketoprofeno Stadapharm may be associated with a small increased risk of heart attacks (“myocardial infarction”) or strokes (“cerebrovascular accident”). Any risk is more likely when high doses or prolonged treatment are used. Do not exceed the recommended dose or duration of treatment;
• 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 (see section 2, “Pregnancy, breastfeeding, and fertility”);
• If you have a disorder affecting blood or blood cell production;
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders 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 have an infection; see the heading “Infections” below;
• If you are taking other medicines that increase the risk of peptic ulcer or 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 this medicine: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other drugs that block gastric acid production);
• If you have asthma, combined with chronic rhinitis or sinusitis, and/or nasal polyps, as you are at higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Dexketoprofen may mask signs of infection such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Avoid using this medicine if you have chickenpox.

Children and adolescents

This medicine 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.

Taking Dexketoprofeno Stadapharm with other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Some medicines should not be taken together, and others may require dose adjustments when used concomitantly.

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

Combinations not recommended:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood clotting;
• Lithium, used to treat certain mood disorders;
• Methotrexate (cancer and immunosuppressive drug), when used at high doses of 15 mg/week;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections;

Combinations requiring caution:

• 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 to treat bacterial infections;
• Sulfonylureas (e.g., chlorpropamide and glibenclamide), used for diabetes;
• Methotrexate, used at low doses, less than 15 mg/week;

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 drugs; 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 termination of pregnancy);
• Antidepressants of the selective serotonin reuptake inhibitor (SSRI) type;
• Antiplatelet agents used to reduce platelet aggregation and clot formation;
• Beta-blockers, used for high blood pressure and heart disorders;
• Tenofovir, deferasirox, pemetrexed.

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

Taking Dexketoprofeno Stadapharm with food, drinks, and alcohol:

In general, it is recommended to take the medicine with food to reduce the likelihood of gastrointestinal disturbances (see also section 3, “How to take”).

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

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 this medicine during the last three months of pregnancy or during breastfeeding.

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.

Do not take this medicine during the first six 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 possible dose for the shortest possible time.

From week 20 of pregnancy, this medicine may cause kidney problems in your unborn baby 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 treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

The use of this medicine may impair fertility; therefore, its use is not recommended while trying to conceive or while being evaluated for infertility.

Driving and using machines

This medicine may slightly affect your ability to drive and use machines, as it may cause drowsiness, dizziness, and blurred vision as adverse effects of treatment. If you experience these effects, do not operate machinery or drive until they resolve. Seek advice from your doctor.

Dexketoprofeno Stadapharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take Dexketoprofeno Stadapharm

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The required dose of the medicine may vary depending on the type, intensity, and duration of pain.

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

The tablets can be divided into equal doses.

Adults over 18 years of age

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

Elderly patients or those with renal or hepatic impairment

If you are elderly or have mild renal impairment or mild to moderate hepatic impairment, treatment should be initiated with a maximum of 2 tablets per day (50 mg of dexketoprofen).

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

Dexketoprofen must not be used if you have moderate or severe renal impairment or severe hepatic impairment. Consult your doctor or pharmacist if you are unsure.

Use in children and adolescents

This medicine must not be used in children and adolescents (under 18 years of age).

Method of administration

Take the tablets with an adequate amount of water.

The medicine can be taken with or without food. Taking the medicine with food helps reduce the risk of gastrointestinal disturbances. 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), as it will be absorbed more easily (see section 2 "Dexketoprofeno Stadapharm with food, drinks and alcohol").

Duration of treatment

Treatment must not exceed 4 days. If pain persists beyond this period, worsens, or new symptoms appear, treatment must be discontinued and you should consult your doctor or pharmacist.

If you take more Dexketoprofeno Stadapharm than you should:

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at phone number 91.562.04.20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Dexketoprofeno Stadapharm:

Do not take a double dose to make up for the missed dose. Take the next dose as scheduled (according to section 3 "How to take Dexketoprofeno Stadapharm").

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The possible adverse effects are listed 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, diarrhoea, digestive disorders (dyspepsia).

Uncommon adverse effects (may affect up to 1 in 100 people):

Spinning sensation (vertigo), dizziness, somnolence, sleep disorders, nervousness, headache, palpitations, hot flushes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling feverish 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 present as vomiting blood or black stools), fainting, elevated blood pressure, slow breathing, fluid retention and peripheral swelling (e.g. swollen ankles), laryngeal oedema, 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 renal failure.

Very rare (may affect up to 1 in 10,000 people):

Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), skin, mouth, eye or 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, decrease in white blood cell count (neutropenia), decrease in platelet count (thrombocytopenia).

Unknown frequency (frequency cannot be determined from available data):

Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

Fixed drug eruption: A drug-related 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.

Immediately inform your doctor if you notice any gastrointestinal adverse effects at the beginning of treatment (e.g. stomach pain or burning, 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.

Immediately stop taking this medicine if you notice the appearance of a skin rash or lesions in the mouth or genital area, or any other sign of allergy.

During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), cases of fluid retention and swelling (especially in ankles and legs), increased blood pressure and heart failure have been reported.

Medicines such as Dexketoprofen Stadapharm 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.

The most commonly observed adverse effects are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients.

Following administration, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, and 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, haematological reactions may occur (purpura, aplastic and haemolytic anaemia, and more rarely agranulocytosis and bone marrow hypoplasia).

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexketoprofen Stadapharm

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

Do not use this medicine after the expiry date which is stated on the outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Keep in the original packaging to protect from light.

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

6. Contents of the pack and other information

Composition of Dexketoprofen Stadapharm:

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

The other components are:

Tablet core: maize starch, microcrystalline cellulose, sodium carboxymethyl starch (Type A) (from potato), glyceryl distearate.

Tablet coating: hypromellose, titanium dioxide E-171 and macrogol.

Appearance of Dexketoprofen Stadapharm and contents of the pack:

Film-coated, white, round, scored tablets marked “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 packs 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 most recent revision of this leaflet: October 2025

Other sources of information

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