Leaflet: information for the user

Dexketoprofeno Stadapharm25 mg oral solution

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

Follow exactly the administration instructions contained in this leaflet or those 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.Seesection4.

- You should consult a doctor if you get worse or do not improve after 4 days.

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

2.WhatyouneedtoknowbeforestartingDexketoprofenoStadapharm

3.How to take Dexketoprofeno Stadapharm

4.Possible side effects

5.Storage of Dexketoprofeno Stadapharm

6.Contentsofthepackagingandadditional information

Dexketoprofenois a pain reliever belonging to the group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).

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

Do not take DexketoprofenoStadapharm

- If you are allergic to dexketoprofeno or to any of the other components of this medication (including those 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 inflammation of the nasal mucosa), nasal polyps (fleshy formations in the interior of the nose due to allergy), urticaria (skin eruption), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid (aspirin) 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 taking of ketoprofeno (a nonsteroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);

- If you have peptic ulcer, stomach or intestinal bleeding, or if you have had in the past stomach or intestinal bleeding, ulceration, or perforation;

- If you have chronic digestive problems (for example, indigestion, stomach burning);

- If you have had in the past stomach or intestinal bleeding or perforation due to the 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 insufficient fluid intake;

- If you are in the third trimester of pregnancy or in the lactation period;

Warnings and precautions

Consult your doctor or pharmacist before starting to take dexketoprofeno:

- If you are allergic or have had allergy problems in the past;

- If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or fluid retention, or have had 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 (for example, excessive urination, diarrhea, or vomiting);

- If you have heart problems, a history of strokes, or think you may be at risk of these conditions (for example, you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) consult this treatment with your doctor or pharmacist. Medications like dexketoprofeno may be associated with a small increase in the risk of suffering heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). Any 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 (see section 2, "Pregnancy, lactation, and fertility");

- If you have a disorder in blood and 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 chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);

- If you have past or present gastrointestinal 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 ulcer or bleeding, for example, oral corticosteroids, some antidepressants (of the type ISRS, Selective Serotonin Reuptake Inhibitors), agents that prevent clot formation such as acetylsalicylic acid (aspirin) or anticoagulants such as warfarin or acenocoumarol (Sintrom). In these cases, consult your doctor before taking dexketoprofeno: your doctor may prescribe an additional medication to protect your stomach (for example, misoprostol or other medications that block stomach acid production).

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, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and in 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.

Avoid using this medication if you have chickenpox.

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

Other medications andDexketoprofeno Stadapharm

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. There are some medications that should not be taken together, and other medications that may require a change in dose if taken together.

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

Non-recommended associations:

- Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory drugs;

- Warfarin or acenocoumarol (Sintrom), heparin, and other medications used to prevent clot formation;

- Lithium, used to treat some mood disorders;

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

- Hydantoins and phenytoin, used for epilepsy;

- Sulfamethoxazole, used for bacterial infections;

Associations requiring caution:

- ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used to control high blood pressure and heart conditions;

- 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;

Associations to be considered:

- 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; that is, medications used to break down clots;

- Probenecid, used for gout;

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

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

- Selective serotonin reuptake inhibitors (SSRIs);

- Antiplatelet agents used to reduce platelet aggregation and clot formation.

- Beta-blockers, used to control high blood pressure and heart conditions.

- Tenofovir, deferasirox, and pemetrexed.

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

Taking Dexketoprofeno Stadapharmwith 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, lactation, 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 lactation.

The use of this medication may affect fertility, so it is not recommended to use it while studying fertility problems.

Driving and using machines

Dexketoprofeno 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 notice these effects, do not use machines or drive until these symptoms disappear. Consult your doctor.

DexketoprofenoStadapharmcontains parahydroxybenzoate methyl ester (E-218), saccharose, sodium, and ethanol

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

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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

This medication contains 0.1% ethanol (alcohol), which corresponds to 13.8 mg per tablet.

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

The necessary dose of the medication may vary, depending on the type, intensity, and duration of the pain. The most effective dose should be used for the shortest period 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).

Adults 18 years of age and older

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

Patients with advanced age or renal or hepatic insufficiency

If you are an elderly patient or suffer from mild renal problems or mild to moderate liver problems, it is recommended to start therapy with a maximum of 2 tablets per day (50 mg of dexketoprofen).

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

Do not use dexketoprofen if you suffer from moderate or severe renal problems or severe liver 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 of age).

Administration form

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

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 sachet on an empty stomach (at least 15 minutes before any meal or ingestion of food) because it will be absorbed more easily (see section 2 “Taking Dexketoprofen Stadapharm with food, drinks, and alcohol”).

Duration of treatment

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

If you take more Dexketoprofen Stadapharm than you should

Consult your doctor or pharmacist immediately 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 Dexketoprofen Stadapharm

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

If you have any 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.

Since the list is based in part on the side effects observed with oral tablet use, and since the oral solution is absorbed more quickly than tablets, it is possible that the actual frequency of side effects (gastrointestinal) may be higher with the oral solution.

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

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

Infrequent side effects:may affect up to 1 in 100 people

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

Very rare side effects: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), difficulty breathing due to narrowing of airways (bronchospasm), lack of air, 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 an elderly patient.

Stop taking this medicine 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 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 dexketoprofenmay be associated with a small increase in the 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, meningitis may appear, which may occur predominantly in patients with lupus erythematosus or mixed connective tissue disease, and 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: https://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 overwrap after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Dexketoprofeno Stadapharm

The active ingredient is dexketoprofeno. Each blister pack contains 25 mg of dexketoprofeno corresponding to dexketoprofeno trometamol (36.90 mg).

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

Appearance of Dexketoprofeno Stadapharm and content of the container

Transparent yellow-orange solution with a lemon-citrus odor conditioned in blister packs.

Presented in containers containing 10 blister packs.

Marketing Authorization Holder:

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

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

Last review date of this leaflet: January 2023

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