Leaflet: information for the user

Dexketoprofen Stadapharm 25 mg film-coated tablets

Dexketoprofen

Read this leaflet carefully before you start taking your medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 4 days.

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

2. What you need to know before starting to take Dexketoprofen Stadapharm

3. How to take Dexketoprofen Stadapharm

4. Possible side effects

5. Storage of Dexketoprofen Stadapharm

6. Contents of the pack and additional information

This medication is a pain reliever belonging to the group of medications known as nonsteroidal 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 trauma), menstrual pain, and dental pain.

Do not take Dexketoprofeno Stadapharm:

-If you are allergic to dexketoprofen or to any of the other components of this medication (listed in section 6);

-If you are allergic to acetylsalicylic acid or to another nonsteroidal 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 inside the nose due to allergy), urticaria (skin eruption), angioedema (face, eye, lip, or tongue swelling, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;

-If you have had photoallergic or phototoxic reactions (a special form of skin redness or burns exposed to sunlight) during the use of ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medications used to reduce blood lipid levels);

-If you have peptic ulcers, stomach or intestinal bleeding, or have had these conditions in the past;

-If you have chronic digestive problems (e.g. indigestion, stomach burning);

-If you have had stomach or intestinal bleeding, ulcers, or perforation due to previous use of nonsteroidal 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 renal insufficiency, or severe liver insufficiency;

-If you have bleeding disorders or blood clotting disorders;

-If you are severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or inadequate 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 Dexketoprofeno Stadapharm:

-If you are allergic or have had allergic problems 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 inadequate 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. Medications like Dexketoprofeno Stadapharm may be associated with a small increase in the risk of heart attacks ("myocardial infarction") or strokes ("cerebral infarction"). Any risk is more likely to occur when using high doses and prolonged treatments. Do not exceed the recommended dose or treatment duration;

-If you are an elderly patient, 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 in blood and blood cell production;

-If you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases that affect 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 have an infection; see the "Infections" heading below;

-If you are taking other medications that increase the risk of peptic 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 this medication: your doctor may prescribe an additional medication to protect your stomach (e.g. misoprostol or other medications that block stomach acid production);

-If you have asthma, combined with allergic rhinitis or chronic sinusitis, and/or nasal polyps, as you have a higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the general population. Administration of this medication may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Dexketoprofeno may mask the signs of an infection, such as fever and pain. Therefore, it is possible that this medication may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to varicella. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Avoid using this medication if you have varicella.

Children and adolescents

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

Use of Dexketoprofeno Stadapharm with other medications:

Inform your doctor or pharmacist if you are taking or have taken recently 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 other medications that may require a dose change when taken together.

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

Non-recommended associations:

-Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;

-Warfarin, heparin, and other medications used to prevent blood clotting;

-Lithium, used to treat mood disorders;

-Metotrexate (cancer and immunosuppressant medication), used at high doses of 15 mg/week;

-Hidantoínas and phenytoin, used for epilepsy;

-Sulfamethoxazole, used for bacterial infections;

Associations requiring caution:

-ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure and heart conditions;

-Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;

-Zidovudine, used to treat viral infections;

-Aminoglycoside antibiotics, used for bacterial infections;

-Sulfonilureas (e.g. chlorpropamide and glibenclamide), used for diabetes;

-Metotrexate, used at low doses, less than 15 mg/week;

Associations to be considered:

-Quinolones (e.g. ciprofloxacin, levofloxacin), used for bacterial infections;

-Ciclosporina or tacrolimus, used to treat autoimmune diseases and organ transplants;

-Streptokinase and other thrombolytic and fibrinolytic medications; that is, medications used to break down blood clots;

-Probenecid, used for gout;

-Digoxin, used in the treatment of chronic heart failure;

-Mifepristone, used as an abortifacient (to interrupt pregnancy);

-SSRI-type antidepressants;

-Antiplatelet medications used to reduce platelet aggregation and blood clot formation;

-Beta-blockers, used for high blood pressure and heart conditions;

-Tenofovir, deferasirox, pemetrexed.

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

Taking Dexketoprofeno Stadapharm with food, drinks, and alcohol:

Generally, it is recommended to take the medication with meals to reduce the possibility of causing stomach problems (see also section 3, "Administration form").

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 while breastfeeding.

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 more than expected.

Do 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 week 20 of pregnancy, this medication may 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 more than a few days, your doctor may recommend additional monitoring.

The use of this medication may harm fertility, so it is not recommended to use this medication while trying to conceive or while studying 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 adverse effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Consult your doctor.

Dexketoprofeno Stadapharm contains sodium

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

The most effective dose should be used for the shortest duration necessary to alleviate symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

The tablets can be divided into equal doses.

Adults aged 18 years and older

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

Older adults or those with renal or hepatic insufficiency

If you are an older adult, or have mild renal problems or mild to moderate hepatic problems, it is recommended to start treatment with a maximum of 2 tablets per day (50 mg of dexketoprofen).

In older adults, this initial dose may be increased subsequently in accordance with 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 renal problems or severe hepatic 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).

Administration form

Take the tablets with an adequate amount of water.

The medication can be taken with or without food. Taking the medication with food helps to reduce the risk of gastrointestinal disturbances, however, if your pain is more intense and you need faster relief, take the tablet with an empty stomach (at least 30 minutes before any food or ingestion of food) because it will be absorbed more easily (see section 2 "Dexketoprofen Stadapharm with food, drinks, and alcohol").

Treatment duration

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

If you take more Dexketoprofeno Stadapharm than you should:

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

If you forgot to take Dexketoprofeno Stadapharm:

Do not take a double dose to compensate for the missed doses. Take the next dose when it is due (in accordance with section 3 “How to take Dexketoprofeno Stadapharm”).

If you have doubts about the use of this medication, consult 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.

Frequent side effects(may affect up to 1 in 10 people):

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

Less frequent side effects(may affect up to 1 in 100 people):

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

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 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, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute renal insufficiency.

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

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin ulcers, mouth, eye, and genital area (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, ringing in the ears (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 agents, and especially if you are elderly.

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

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.

The most commonly observed side effects are of a gastrointestinal nature. They may cause peptic ulcers, perforation or gastrointestinal bleeding, 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, gastric wall inflammation (gastritis) has been observed.

Like other NSAIDs, they may cause hematological reactions (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and medullary hypoplasia).

Reporting of side effects

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

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

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 and in the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C). Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dexketoprofeno Stadapharm:

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

The other components are:

Tablet core:cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (Type A) (from potato), glyceryl diestearate.

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

Appearance of Dexketoprofeno Stadapharmand contents of the packaging:

Coated tablets with a film coating, white, and round, marked with “DT2” on one side.

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

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

Available in packaging containing 10 coated tablets.

Marketing Authorization Holder:

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing:

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 Industrial Estate Esplugues De Llobregat

08950. Esplugues De Llobregat (Barcelona)

Spain

Last review date of this leaflet:January 2024

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/