Prospect: information for theuser

Dexketoprofen pensa 25 mg film-coated tablets

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other peopleeven 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 do not appear in this prospect. See section 4.

1.What isDexketoprofen pensaand for what it is used

2.What you need to know before starting to take Dexketoprofen pensa

3.How totake Dexketoprofen pensa

4.Possible adverse effects

5.Storage of Dexketoprofen pensa

6.Contents of the package and additional information

Dexketoprofeno pensais 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), dental pain.

Do not takeDexketoprofeno pensa

• If you are allergic to the active ingredient 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 cavity 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 or have had in the past peptic ulcers, stomach or intestinal bleeding, or chronic digestive problems (e.g., indigestion, stomach burning);
• If you have had in the past 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 kidney failure, or severe liver failure;
• If you have bleeding disorders or blood clotting disorders;
• If you are pregnant or breastfeeding;
• If you are under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeDexketoprofeno pensa:

• 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 fluid retention, 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 for these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking), consult this treatment with your doctor or pharmacist. Medications likeDexketoprofeno pensamay be associated with a small increased risk of heart attacks 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 elderly, 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 (Dexketoprofeno pensamay decrease 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 cell formation;
• If you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases affecting 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 gastrointestinal or intestinal disorders;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, certain antidepressants (SSRI type), blood thinners like acetylsalicylic acid (aspirin) or warfarin. In these cases, consult your doctor before takingDexketoprofeno pensa: your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other medications that block stomach acid production).

Children and adolescents

Do not take Dexketoprofeno pensa if you are under 18 years old.

Other medications and Dexketoprofeno pensa

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication. There are some medications that should not be taken together and other medications that may require a dose change when taken together.

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

Not recommended associations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medications used to prevent blood clotting;
• Lithium, used to treat mood disorders;
• Methotrexate, used to treat rheumatoid arthritis and cancer;
• Hydantoins and phenytoin, used to treat epilepsy;
• Sulfamethoxazole, used to treat 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 to treat diabetes;

Associations to consider:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used to treat bacterial infections;
• Ciclosporin or tacrolimus, used to treat autoimmune diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medications; that is, medications used to dissolve blood clots;
• Probenecid, used to treat gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• SSRI-type antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation.

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

Taking Dexketoprofeno pensa with food and drinks

Take the tablets with an adequate amount of water. Take the tablets with food, as this helps reduce the risk of stomach or intestinal adverse 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 pensa during pregnancy or breastfeeding.

Do not take Dexketoprofeno pensa 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 pensa 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. After 20 weeks of pregnancy, Dexketoprofeno pensa 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). If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and using machines

Dexketoprofeno pensamay slightly affect your ability to drive and use machines, as it may cause drowsiness or dizziness as adverse effects. If you notice these effects, do not use machines or drive until these symptoms disappear. Consult your doctor.

Dexketoprofeno pensa contains sodium

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

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

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

Generally, it is recommended to take 1 tablet (25 mg of dexketoprofeno) every 8 hours, without exceeding 3 tablets per day (75 mg).

If you are an elderly patient or suffer from any 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 dexketoprofeno) if Dexketoprofeno pensa 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 pensa with food and drinks”).

The tablet can be divided into equal doses.

If you take more Dexketoprofeno pensa 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 91562 04 20, indicating the medication and the amount ingested.

If you forgot to take Dexketoprofeno pensa

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The possible side effects are listed below according to their frequency. The following table indicates how many patients may experience these side effects:

Frequent side effects:

Nausea and/or vomiting, stomach pain, diarrhea, digestive disorders (dyspepsia).

Infrequent side effects:

Dizziness (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation and chills, general discomfort.

Rare side effects:

Peptic ulcer, perforation of a peptic ulcer or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (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.

Muy rare side effects:

Anaphylactic reaction (hypersensitivity reaction that may also lead to collapse), skin ulcers, mouth, eye, and genital area ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or lip and throat swelling (angioedema), respiratory difficulty due to narrowing of airways (bronchospasm), shortness of breath, 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 elderly.

Stop taking Dexketoprofeno pensa 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 Dexketoprofeno pensa may be associated with a small increased risk of suffering a heart attack ("myocardial infarction") or stroke ("cerebrovascular accident").

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.

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 leaflet.

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 in the blister pack after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Dispose of 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 pensa

The active ingredient is dexketoprofeno trometamol (36.90 mg) corresponding to Dexketoprofeno (DCI) 25 mg.

The other components (excipients) are: cornstarch, microcrystalline cellulose, sodium carboxymethyl starch, glyceryl distearate, hypromellose, titanium dioxide, macrogol 400.

Appearance of the product and content of the packaging

Dexketoprofeno pensa 25 mg: scored, white, biconvex, cylindrical tablets marked with DT2 on one side. The tablet can be divided into equal doses.

Dexketoprofeno pensa 25 mg film-coated tablets are presented in packs containing 20 and 50 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

or

SAG MANUFACTURING, S.L.U.

Ctra. N-1, Km 36

28750 San Agustín de Guadalix, Madrid

Spain

Last review date of this leaflet: December 2022

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