DEXKETOPROFEN STADAPHARM 25 mg ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Dexketoprofen Stadapharm25 mg Oral Solution

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

Follow 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 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 your symptoms worsen or do not improve after 4 days.

Contents of the Package Leaflet:

1. What is Dexketoprofen Stadapharm and what is it used for
2. What you need to know before you start taking Dexketoprofeno Stadapharm
3. How to take Dexketoprofen Stadapharm
4. Possible side effects
5. Storage of Dexketoprofeno Stadapharm
6. Contents of the pack and further information

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

Dexketoprofen is a pain reliever belonging to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

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

2. What you need to know before you start taking Dexketoprofeno Stadapharm

Do not take Dexketoprofeno Stadapharm

• If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory medicines;
• 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 in 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 medicines;
• If you have suffered from photoallergic or phototoxic reactions (a special form of redness or sunburn) while taking ketoprofen (a non-steroidal anti-inflammatory medicine) or fibrates (medicines used to reduce blood fat levels);
• If you have a peptic ulcer, stomach or intestinal bleeding, or if you have had a history of bleeding, ulceration, or perforation of the stomach or intestine;
• If you have chronic digestive problems (e.g., indigestion, heartburn);
• If you have had a history of stomach or intestinal bleeding or perforation due to previous use of non-steroidal anti-inflammatory medicines (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 impairment, or severe hepatic impairment;
• 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;

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 (high blood pressure 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 (e.g., due to excessive urination, diarrhea, or vomiting);

- If you have heart problems, a history of stroke, or think you may be at risk of suffering from these disorders (e.g., you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should consult your doctor or pharmacist about this treatment. Medicines like dexketoprofen may be associated with a small increased risk of heart attacks ("myocardial infarction") or strokes. Any risk is more likely to occur when high doses are used and treatment is prolonged. Do not exceed the recommended dose or duration of treatment;

- 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 (see section 2, "Pregnancy, Breastfeeding, and Fertility");

- If you have a blood disorder or blood cell production disorder;

- If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);

- If you have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) in the past;

- If you have had stomach or intestinal disorders in the past;

• If you have an infection; see the "Infections" heading below;
• If you are taking other medicines 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 medicine to protect your stomach (e.g., misoprostol or other medicines 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. Administration of this medicine 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, this medicine may delay 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 medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Avoid using this medicine if you have chickenpox.

Children and AdolescentsDexketoprofenhas 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

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. There are some medicines that should not be taken together, and others that may need a dose change if taken together.

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

Not recommended combinations:

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

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

- Lithium, used to treat certain mood disorders;

- Methotrexate (a medicine for cancer and immunosuppression), used at high doses of 15 mg/week;

- Hydantoins and phenytoin, used for epilepsy;

- Sulfamethoxazole, used for bacterial infections;

Combinations that require 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, used at low doses, less than 15 mg/week.

Combinations to be considered:

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

- Cyclosporin or tacrolimus, used to treat immune system diseases and organ transplants;

- 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 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, and pemetrexed.

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

Taking Dexketoprofeno Stadapharm with Food, Drinks, and Alcohol

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

The use of NSAIDs in combination with alcohol may worsen the adverse reactions caused by the active substance.

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 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 you need treatment for more than a few days, your doctor may recommend additional checks.

Do not take dexketoprofen during breastfeeding.

The use of this medicine may impair fertility, so it is 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 side effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Ask your doctor for advice.

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 them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially "sodium-free".

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

3. How to Take Dexketoprofeno Stadapharm

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The necessary dose of the medicine may vary, depending on the type, intensity, and duration of the pain. The lowest effective dose should be used for the shortest time necessary to relieve 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 from 18 years of age

Generally, the recommended dose is 1 sachet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 sachets per day (75 mg).Elderly Patients or Patients with Renal or Hepatic Impairment

If you are an elderly patient or have mild renal or hepatic impairment, it is recommended to start therapy with a maximum of 2 sachets per day (50 mg of dexketoprofen).

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.

You should 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 should 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 pouring the contents into a glass of water. Once the sachet is opened, consume the entire contents.

The medicine can be taken with or without food. Taking the medicine with food helps reduce the risk of stomach disorders; 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 food intake) because it will be absorbed more easily (see section 2, "Taking Dexketoprofeno Stadapharm with Food, Drinks, and Alcohol").

Duration of Treatment

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

If you take more Dexketoprofeno Stadapharm than you should

Consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.If you forget to take Dexketoprofeno Stadapharm

Do not take a double dose to make up for forgotten doses. Take the next dose when it is due (according to section 3, "How to Take Dexketoprofeno Stadapharm").

If you have doubts about the use of this medicine, 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.

Possible adverse effects are detailed below according to their frequency.

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

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, peptic ulcer perforation 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 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. Decreased number of white blood cells (neutropenia), decreased 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 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 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 drugs 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, sometimes fatal, especially in elderly patients, may occur.

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, aseptic meningitis, which can occur predominantly in patients with lupus erythematosus or mixed connective tissue disease, and hematological reactions (purpura, aplastic anemia, 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, pharmacist, or nurse, even if it is a possible adverse effect that is not listed 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 Stadapharm

Keep this medicine out of the sight and reach of children.

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

Store below 30°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Dexketoprofeno Stadapharm

The active ingredient is dexketoprofen. Each sachet contains 25 mg of dexketoprofen corresponding to dexketoprofen trometamol (36.90 mg).

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

Appearance of Dexketoprofeno Stadapharm and Package Contents

Transparent yellow-orange solution with a lemon-citrus odor, packaged in sachets.

It is presented in packages containing 10 sachets.

Marketing Authorization Holder:

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

SAG MANUFACTURING S.L.U.

National Highway 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 Last Revision of this Prospectus: January 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.es/.