DEXKETOPROFEN STADA 25 mg ORAL SOLUTION POWDER

2. What you need to know before taking Dexketoprofen Stada

Do not take Dexketoprofen Stada

• If you are allergic (hypersensitive) to dexketoprofen trometamol or any of the other components of Dexketoprofen STADA (see section 6);
• If you are allergic to acetylsalicylic acid (aspirin) 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 (aspirin) 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 or have had in the past a peptic ulcer, stomach or intestinal bleeding, or if you have suffered in the past from bleeding, ulceration, or perforation of the stomach or intestine;
• If you have chronic digestive problems (e.g., indigestion, heartburn);
• If you have suffered in the past from stomach or intestinal bleeding or perforation due to the previous use of non-steroidal anti-inflammatory medications (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 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;
• If you are under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take dexketoprofen:

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), or fluid retention or have suffered from any of 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 may be associated with a small increased risk of suffering from heart attacks ("myocardial infarctions") or strokes. 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 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 (dexketoprofen may reduce your fertility, so you should not take it if you are planning to become pregnant or if you are undergoing fertility studies);
• If you have a blood disorder or a disorder of blood cell production;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you have or have had in the past chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have or have had in the past stomach or intestinal disorders;
• If you have an infection; see the "Infections" section 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 or acenocoumarol (Sintrom). In these cases, consult your doctor before taking dexketoprofen: 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, dexketoprofen 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.

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

Children and adolescents

Dexketoprofen 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.

Taking Dexketoprofen Stada with other medications

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

Always inform your doctor, dentist, or pharmacist if, in addition to dexketoprofen, you are using or are being administered any of the following medications:

Not recommended combinations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory medications;
• Warfarin or acenocoumarol (Sintrom), heparin, or 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 15mg/week;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections.

Combinations that require 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 for bacterial infections
• Sulfonylureas (e.g., chlorpropamide and glibenclamide), used for diabetes;

• Methotrexate, used at low doses, less than 15mg/week.

Combinations to be taken into account:

• 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.

Dexketoprofen Stada with food and beverages

In case of acute pain, take the sachets on an empty stomach; i.e., at least 15 minutes before meals, as this facilitates the medication's action a little more quickly.

Pregnancy, breastfeeding, and fertility

Do not take dexketoprofen 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 and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take dexketoprofen 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 the 20th week of pregnancy, dexketoprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause 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 monitoring.

Do not take dexketoprofen during breastfeeding.

The use of dexketoprofen is not recommended while studying a fertility problem.

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

Driving and using machines

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

Dexketoprofen Stada contains sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Dexketoprofen Stada

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist again.

The lowest effective dose should be used for the shortest time necessary to alleviate 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).

Adults over 18 years old

The dose of dexketoprofen you need may vary, depending on the type, intensity, and duration of the pain. Your doctor will indicate how many sachets you should take per day and for how long. The recommended dose is 1 sachet (25 mg) every 8 hours, not exceeding 3 sachets per day (75 mg).

If you are an elderly person or suffer from kidney or liver disease, it is recommended to start treatment with a maximum of 2 sachets per day (50 mg). 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.

If your pain is intense and you need rapid relief, take the sachets on an empty stomach (at least 15 minutes before meals) as they will be absorbed more easily (see section 2 "Taking Dexketoprofen Stada with food and beverages").

Use in children and adolescents

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

Instructions for proper use

Dissolve the entire contents of a sachet in a glass of water; stir to help dissolve. The resulting solution should be taken immediately after reconstitution.

If you take more Dexketoprofen Stada than you should

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

If you forget to take Dexketoprofen Stada

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 Stada").

If you have any other 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. The possible adverse effects are detailed below according to their frequency. Since the list is based in part on the adverse effects observed with the use of dexketoprofen tablets, and dexketoprofen powder is absorbed more quickly than tablets, it is possible that the real frequency of adverse effects (gastrointestinal) may be higher with dexketoprofen powder.

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).

Uncommon Adverse Effects: may affect up to 1 in 100 people

Rotatory sensation (vertigo), dizziness, drowsiness, 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, perforation of peptic ulcer or bleeding (which can 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 kidney failure.

Very Rare Adverse Effects: 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. Decrease in the number of white blood cells (neutropenia), decrease in the number of platelets (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 anti-inflammatory drugs, and especially if you are elderly.

Stop taking dexketoprofen 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 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 immune system disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medications 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 fatally, 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 and hemolytic anemia, and more rarely agranulocytosis and bone marrow hypoplasia) may appear.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Dexketoprofeno Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and on the envelope after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need at the SIGRE Point. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Dexketoprofeno Stada 25 mg Powder for Oral Solution EFG

Each envelope contains 25 mg of dexketoprofen (as dexketoprofen trometamol).

The other components are: sucrose and lemon flavor (sucrose and lemon flavor).

Appearance of the Product and Package Contents

Envelopes containing white powder.

It is presented in packages of 20 envelopes.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

Spain

[email protected]

Manufacturer:

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10-Políg Areta

31620 Huarte-Pamplona. Navarra.

Spain

or

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat,

08950, Barcelona, Spain

Date of the Last Revision of this Prospectus:June 2023

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