DEXKETOPROFEN STADA 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dexketoprofen Stada 12.5 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

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

Dexketoprofen is a pain reliever belonging to the group of medications called non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat pain of mild or moderate intensity, such as muscle or joint pain, menstrual pain (dysmenorrhea), toothache.

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 ingredients of this medication (listed in section 6);
• If you are allergic to acetylsalicylic acid 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 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 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 the use of non-steroidal anti-inflammatory medications (NSAIDs) 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.

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 strokes, 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. Medications like dexketoprofen may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") 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 blood cell 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 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. 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 are at 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 and adolescents. Therefore, safety and efficacy have not been established, and the product should not be used in children and adolescents.

Using Dexketoprofen Stada with other medications

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 Dexketoprofeno STADA, you are taking any of the following medications:

Not recommended combinations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory medications;
• Warfarin, heparin, and 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 15 mg/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 to treat bacterial infections;
• Sulfonylureas (e.g., 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;
• 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.
• Betablockers, used for high blood pressure and heart disorders.
• Tenofovir, deferasirox, pemetrexed.

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

Taking Dexketoprofeno Stada with food and drinks

Take the tablets with a sufficient amount of water. Take the tablets with food, as this helps reduce the risk of experiencing side effects in the stomach or intestine. However, in case of acute pain, take the tablets on an empty stomach; i.e., at least 30 minutes before meals, as this allows the medication to act a little faster.

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 directed 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 checks.

Do not take dexketoprofen during breastfeeding.

The use of dexketoprofen is not recommended while trying to conceive or while undergoing fertility studies.

Regarding the 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 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 for advice.

Dexketoprofeno Stada contains sodium

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

3. How to take Dexketoprofeno Stada

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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

The lowest effective dose should be used for the shortest duration 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).

Generally, the recommended dose is 1 tablet (12.5 mg of dexketoprofen) every 4-6 hours, not exceeding 6 tablets per day (75 mg).

If you are an elderly patient or have kidney or liver disease, it is recommended to start therapy with a maximum of 4 tablets 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 quick relief, take the tablets on an empty stomach (at least 30 minutes before meals) 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 of age).

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 department of your nearest hospital. Please remember to always carry the medication packaging or this package leaflet with you.

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 Dexketoprofeno 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 Dexketoprofeno Stada").

If you have any other doubts about the use of this medication, ask 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.

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, somnolence, 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 may manifest with vomiting of 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(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 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 stiffness of the neck.

The most commonly observed adverse effects are of a gastrointestinal type. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, 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, 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 occur.

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 is not listed in this prospectus.

You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: 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 the sight and reach of children.

Do not use this medicine 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 30°C. Keep the blisters in the original packaging to protect them from light.

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

6. Content of the Packaging and Additional Information

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: cornstarch, microcrystalline cellulose, sodium carboxymethyl potato starch, glycerol distearate, hypromellose, titanium dioxide, and macrogol 400.

Appearance of the Product and Content of the Packaging:

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

It is presented in packages containing 20 and 50 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960– Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

oSAG Manufacturing, S.L.U. Carretera N-I, km 36

28750 San Agustín de Guadalix (Madrid)

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/