Product Information for the User

Dexketoprofeno Stada 25 mg Film-Coated Tablets EFG

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

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

2.What you need to know before starting to take Dexketoprofeno Stada

3.How to take Dexketoprofeno Stada

4.Possible adverse effects

5.Storage of Dexketoprofeno Stada

6.Contents of the package and additional information

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

Do not takeDexketoprofeno Stada:

• If you are allergic (hypersensitive) to dexketoprofeno trometamol 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 in the nasal interior 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 phototoxic or photoallergic reactions (a special form of skin redness or burns exposed to sunlight) during the use of ketoprofeno (a nonsteroidal anti-inflammatory drug) or fibrates (medications used to reduce blood fat levels);
• If you have peptic ulcers, stomach or intestinal bleeding, or have had stomach or intestinal bleeding in the past;
• If you have chronic digestive problems (e.g. indigestion, stomach burning);
• If you have had stomach or intestinal bleeding 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 coagulation 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 takedexketoprofeno:

• If you are allergic or have had allergic reactions 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 smoker) consult this treatment with your doctor or pharmacist. Medications likedexketoprofenomay be associated with a small increased risk of suffering heart attacks (“myocardial infarction”) or strokes (“cerebral vascular accident”). This 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 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 (dexketoprofenomay reduce your fertility, so do not take it if you are planning to become pregnant or undergoing fertility studies);
• If you have a disorder in blood production and blood cells;
• If you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases affecting connective tissue);
• If you have had or have chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have had or have stomach or intestinal disorders;
• If you have an infection; see the heading “Infections” below;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), anticoagulants like acetylsalicylic acid (aspirin) or warfarin. In these cases, consult your doctor before takingdexketoprofeno: 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 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 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. Consequently, dexketoprofeno may delay the appropriate treatment of the infection, which may increase 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.

During varicella, it is recommended to avoid using this medication.

Children and adolescents

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

Use of Dexketoprofeno Stada with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicationincluding those acquired without a prescription.

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 toDexketoprofeno STADA, you are taking any of the following medications:

Not recommended associations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medications used to prevent blood clotting;
• Lithium, used to treat some mood disorders;
• Metotrexato(cancer medication and immunosuppressant), used at high doses of 15 mg/week;
• Hidantoínas and phenytoin, used for epilepsy;
• Sulfametoxazol, used for bacterial infections;

Associations requiring caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists, used to control high blood pressure and heart conditions;
• Pentoxifilina and oxpentifilina, used to treat chronic venous ulcers;
• Zidovudina, used to treat viral infections;
• Aminoglycoside antibiotics, used for bacterial infections
• Sulfonilureas (e.g. clorpropamida and glibenclamida), used for diabetes;
• Metotrexato, used at low doses, less than 15 mg/week;

Associations to be taken into account:

• Quinolonas (e.g. ciprofloxacino, levofloxacino) used for bacterial infections;
• Ciclosporina or tacrolimus, used to treat autoimmune diseases and organ transplants;
• Estreptoquinasa and other thrombolytic and fibrinolytic medications; that is, medications used to break down blood clots;
• Probenecid, used for gout;
• Digoxina, used in the treatment of chronic heart failure;
• Mifepristona, used as an abortifacient (to interrupt pregnancy);
• Antidepressants of the selective serotonin reuptake inhibitor (SSRI) type;
• Antiplatelet agents 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 withdexketoprofeno, consult your doctor or pharmacist.

TakingDexketoprofeno Stadawith food and drinks

Take the tablets with an adequate amount of water. Take the tablets with food, as this helps to reduce the risk of experiencing stomach or intestinal side effects. However, in case of acute pain, take the tablets on an empty stomach; that is, at least 30 minutes before meals, as this facilitates the medication's action a bit more quickly.

Pregnancy, breastfeeding, and fertility

Do not take dexketoprofeno 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 predisposition and that of your baby to bleed and delay or prolong delivery more than expected. Do not take dexketoprofeno during the first 6 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, dexketoprofeno 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 checks.

Do not take dexketoprofeno during breastfeeding.

It is not recommended to use dexketoprofeno while studying a fertility problem.

Regarding potential effects on female fertility, see also section 2, “Warnings and precautions”.

Driving and operating machines

Dexketoprofenomay slightly affect your ability to drive and operate 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. Consult your doctor.

Dexketoprofeno Stada contains sodium

This medication containsless than 1 mmol of sodium (23 mg) per tablet; that is, it is essentially “sodium-free”.

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

The dose of dexketoprofen that you need may vary, depending on the type, intensity, and duration of pain. Your doctor will tell you how many tablets to take per day and for how long.

The tablet can be divided into equal doses.

You should use the lowest effective dose for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor as soon as possible if symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended dose is generally 1 tablet (25 mg of dexketoprofen) every 8 hours, without 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 can be increased later according to the general recommended dose (75 mg of dexketoprofen) if dexketoprofen 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 eating) as they will be absorbed more easily (see section 2 “Taking Dexketoprofeno Stada with food and drinks”).

Use in children and adolescents

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

If you take more Dexketoprofeno Stada than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Dexketoprofeno Stada

Do not take a double dose to compensate for the missed doses. Take the next dose when due (according to section 3 “How to take Dexketoprofeno Stada”).

If you have any other questions about the use of this medication, ask 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):

Dizziness (vertigo), 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 edema (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.

Muy 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 airway constriction (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis inflammation, blurred vision, 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 dexketoprofen 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 dexketoprofen may be associated with a small increased risk of suffering a heart attack (“myocardial infarction”) or a stroke (“stroke”).

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, hematological reactions (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and medullary 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 that does not appear in this prospectus.

You can also report them directly through the national notification system included in the Spanish System of 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 on the blister after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Deposit 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 Stada 25 mg film-coated tablets EFG:The active ingredient is dexketoprofen. Each tablet contains 25 mg of dexketoprofen corresponding to dexketoprofen trometamol (36.90 mg).

The other components are: maize starch, microcrystalline cellulose, sodium carboxymethyl starch, glyceryl distearate, hypromellose, titanium dioxide, and macrogol 400.

Appearance of the product and content of the packaging:

Film-coated, scored on one side, white, biconvex, and cylindrical tablets marked with DT2 on one side, packaged in blisters.

It is presented in packaging that contains 20 and 50 film-coated tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization:

STADA Laboratory, S.L.

Frederic Mompou, 5

08960– Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

or
SAGManufacturing,S.L.U.
CarreteraN-I,km36

28750SanAgustíndeGuadalix(Madrid)

Last review date of this leaflet::June 2023

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