Dexketoprofen Stadapharm 25 mg oral solution EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Dexketoprofen Stadapharm 25 mg oral solution

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or as indicated 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 doctor or pharmacist.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

• You should consult a doctor if you worsen or do not improve after 4 days.

Contents of the leaflet:

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

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

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

It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as acute musculoskeletal or joint pain, menstrual pain (dysmenorrhea), and dental pain. Dexketoprofeno is used in adult patients.

2. What you need to know before taking Dexketoprofeno Stadapharm

Allergic reactions to dexketoprofen have been reported, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain. Immediately stop 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 (aspirin) or to any other non-steroidal anti-inflammatory drug (NSAID);
• If you have asthma or have previously 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 wheezing in the chest after taking acetylsalicylic acid (aspirin) or other NSAIDs;
• If you have previously experienced photoallergic or phototoxic reactions (a special type of redness or sunburn-like skin reaction in sun-exposed areas) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines 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 digestive problems (e.g., indigestion, heartburn);
• If you have previously experienced stomach or intestinal bleeding or perforation due to prior use of NSAIDs for pain relief;
• 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 significant amount 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:

• 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 previously had any of these conditions;
• If you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of stroke, or think you may be at risk of these 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 dexketoprofen 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 “Infections” section 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 or acenocumarol (Sintrom). In these cases, consult your doctor before taking dexketoprofen: 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, especially combined with chronic rhinitis or sinusitis, and/or nasal polyps, as you are at higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the general population. Taking 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 associated with chickenpox. If you take this medicine while having an infection and the symptoms persist or worsen, consult a doctor without delay.

Avoid using this medicine if you have chickenpox.

Children and adolescents
Dexketoprofen has not been studied in children or adolescents. Therefore, safety and efficacy have not been established, and the medicine should not be used in children or adolescents.

Other medicines and Dexketoprofeno Stadapharm

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines. Some medicines should not be taken together, and others may require dose adjustments when used concurrently.

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

Combinations not recommended:

• Acetylsalicylic acid (aspirin), corticosteroids, and other NSAIDs;
• Warfarin or acenocumarol (Sintrom), heparin, and other medicines used to prevent blood clot formation;
• Lithium, used to treat certain mood disorders;
• Methotrexate (a cancer and immunosuppressive medicine), 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, 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 to treat bacterial infections;

• Chlorpropamide and glibenclamide, used for diabetes;

• Methotrexate, when 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 for immune system disorders and organ transplantation;
• Streptokinase and other thrombolytic and fibrinolytic medicines (i.e., medicines used to dissolve blood 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, and pemetrexed.

If you have any questions 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 possibility of stomach-related side effects (see also section 3, “How to take”).

Using NSAIDs together with alcohol may worsen adverse reactions caused by the active substance.

Pregnancy, breastfeeding, and fertility

Do not take dexketoprofen during 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 unborn baby. It may affect your and your baby’s tendency to bleed and may delay or prolong labor more than expected. You should not take dexketoprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest effective dose for the shortest possible time. From week 20 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 treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Do not take dexketoprofen while breastfeeding.

This medicine may impair fertility and is therefore not recommended while investigating fertility problems.

Driving and using machines

Dexketoprofen may slightly affect your ability to drive and use machines, as it may cause dizziness, drowsiness, and visual disturbances as adverse effects of treatment. If you experience these effects, do not operate machinery or drive until the symptoms have resolved. Seek advice from your doctor.

Dexketoprofeno Stadapharm contains methyl parahydroxybenzoate (E-218), sucrose, sodium, and ethanol

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218).

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

This medicine contains 0.1% ethanol (alcohol), which corresponds to a small amount of 13.8 mg per sachet.

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 a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults aged 18 years and older

The usual recommended dose is 1 sachet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 sachets per day (75 mg of dexketoprofen).

Elderly patients or patients with renal or hepatic impairment

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

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

Do not use dexketoprofen 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

The oral solution can be taken directly from the sachet or after dissolving the contents in a glass of water. Once the sachet is opened, consume all of its contents.

The medicine may be taken with or without food. Taking the medicine with food helps reduce the risk of gastrointestinal disturbances. However, if your pain is severe and you require faster relief, take the sachet on an empty stomach (at least 15 minutes before any food or drink), as it will be absorbed more quickly (see section 2 "Taking Dexketoprofeno Stadapharm with food, drinks, and alcohol").

Duration of treatment

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

If you take more Dexketoprofeno Stadapharm than you should

Contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 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 missed doses. Take the next dose at the scheduled time (according to section 3 "How to take Dexketoprofeno Stadapharm").

If you have any doubts about how to use 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.

Since this list is partly based on adverse effects observed with oral tablet use, and since the oral solution is absorbed faster than tablets, the actual frequency of gastrointestinal adverse effects may be higher with the oral solution.

Frequent adverse effects: may affect up to 1 in 10 people
Nausea and/or vomiting, mainly upper abdominal pain, diarrhoea, digestive disorders (dyspepsia).

Uncommon adverse effects: may affect up to 1 in 100 people
Spinning sensation (vertigo), dizziness, somnolence, sleep disturbances, nervousness, headache, palpitations, hot flushes, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling of fever and chills, general malaise.

Rare adverse effects: may affect up to 1 in 1,000 people
Peptic ulcer, perforation of peptic ulcer 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 kidney failure.

Very rare adverse effects: 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, light sensitivity, itching, kidney problems. Decrease in white blood cell count (neutropenia), decrease in platelet count (thrombocytopenia).

Unknown frequency: cannot be estimated from the available data
Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

Fixed drug eruption: An 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 start of treatment (e.g. stomach pain or burning sensation or bleeding), especially if you have previously experienced any of these adverse effects due to prolonged treatment with anti-inflammatory medicines, and particularly if you are an elderly patient.

Stop taking this medicine immediately if you notice the appearance of a skin rash or any lesions inside the mouth or on the genitals, or any other signs 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 may be associated with a small increased risk of having a 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. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, especially in elderly patients.

Following administration, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported. Less frequently, inflammation of the stomach lining (gastritis) has been observed.

As with other NSAIDs, aseptic meningitis may occur, predominantly in patients with systemic lupus erythematosus or mixed connective tissue disease, and haematological reactions (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: https://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 packaging and on the sachet after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexketoprofeno Stadapharm

The active substance is dexketoprofen. Each sachet contains 25 mg of dexketoprofen, equivalent to 36.90 mg of dexketoprofen trometamol.

The other components are: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, methyl parahydroxybenzoate (E-218), sodium saccharin, sucrose, macrogol 400, lemon flavour (contains ethanol), povidone K-90, disodium phosphate, sodium dihydrogen phosphate dihydrate, purified water.

Appearance of Dexketoprofeno Stadapharm and contents of the pack

Yellow-orange transparent solution with a lemon-citrus odour, packed in sachets.

Available in packs containing 10 sachets.

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

SAG MANUFACTURING S.L.U.

Carretera Nacional I, Km. 36

28750 San Agustin de Guadalix

Spain

or

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50

08950 Esplugues de Llobregat (Barcelona)

Spain

Date of the most recent review of this package leaflet: October 2025

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