DEXKETOPROFEN PENSA 25 mg ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Dexketoprofen Pensa 25 mg Oral Solution 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 doubts, 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Dexketoprofen Pensa and what is it used for
2. What you need to know before taking Dexketoprofen Pensa
3. How to take Dexketoprofen Pensa
4. Possible side effects
5. Storage of Dexketoprofen Pensa

Contents of the pack and additional information

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

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

2. What you need to know before taking Dexketoprofen Pensa

Do not take Dexketoprofen Pensa

• If you are allergic to the active substance or any of the other components 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), hives (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 or have had in the past a peptic ulcer, stomach or intestinal bleeding, or have chronic digestive problems (such as indigestion, heartburn);
• If you have suffered in the past from stomach or intestinal bleeding or perforation due to the 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 pregnant or breastfeeding;
• If you are under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dexketoprofen Pensa.

Be particularly careful with Dexketoprofen Pensa:

• 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 (for example, 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 (for example, 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 Pensa may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). 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 suffer from 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 Pensa may decrease your fertility, so you should not take it if you are planning to become pregnant or if you are undergoing fertility studies);
• If you suffer from 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 suffer or have suffered in the past from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you suffer or have suffered in the past from stomach or intestinal disorders;
• If you are taking other medications that increase the risk of peptic ulcer or bleeding, for example, oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), agents that prevent clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking Dexketoprofen Pensa: it may be that your doctor prescribes an additional medication to protect your stomach (for example, misoprostol or other medications that block gastric acid production).

What you should know before taking Dexketoprofen Pensa:

With dexketoprofen, cases of allergic reactions to this medication have been reported, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop treatment with Dexketoprofen Pensa immediately and contact your doctor or the nearest emergency service if you notice any of these symptoms.

Children and adolescents

Do not take Dexketoprofen Pensa if you are under 18 years old.

Other medications and Dexketoprofen Pensa

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription. There are some medications that should not be taken together, and others may need a dose change if taken together.

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

Not recommended combinations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory medications;
• Warfarin, heparin, and other medications used to prevent clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate, used for rheumatoid arthritis and cancer;
• 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 for bacterial infections;
• Chlorpropamide and glibenclamide, used for diabetes;

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; that is, medications used to dissolve 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 clot formation.

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

Taking Dexketoprofen Pensa with food and drinks

Take the sachets with food, as this helps reduce the risk of suffering from side effects in the stomach or intestine. However, in case of acute pain, take the sachets on an empty stomach; that is, at least 30 minutes before meals, as this facilitates the medication's action.

Pregnancy and breastfeeding

Do not take Dexketoprofen Pensa 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 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. From the 20th week of pregnancy, Dexketoprofen Pensa may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Consult your doctor or pharmacist before using any medication.

• Tell your doctor if you are pregnant or planning to become pregnant, as Dexketoprofen Pensa may not be suitable for you.
• Do not take Dexketoprofen Pensa if you are breastfeeding. Ask your doctor for advice.

Driving and using machines

Dexketoprofen Pensa 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. Ask your doctor for advice.

Dexketoprofen Pensa contains methyl parahydroxybenzoate, sucrose, and sodium

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate.

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

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

3. How to take Dexketoprofen Pensa

Follow your doctor's instructions for taking this medication exactly. In case of doubts, consult your doctor or pharmacist again.

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

If you are elderly or suffer from kidney or liver disease, it is recommended to start therapy 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 Pensa has been well tolerated.

If your pain is intense and you need quick relief, take the sachets on an empty stomach (at least 30 minutes before meals) as they will be absorbed more easily (see section 2 "Taking Dexketoprofen Pensa with food and drinks").

Instructions for proper use

Before opening the sachet, press it repeatedly to ensure complete use of its contents. The oral solution can be taken directly from the sachet or, if you prefer, you can dilute the contents of the sachet in a glass of water, stir, and take it immediately. Once the sachet is opened, consume all its contents.

If you take more Dexketoprofen Pensa 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 package 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.

If you forget to take Dexketoprofen Pensa:

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 Pensa").

If you have doubts about the use of this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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).

Uncommon 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 malaise.

Rare side effects

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 the 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

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 white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Unknown: frequency cannot be determined from available data

Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Fixed drug eruption: an allergic skin reaction known as fixed drug eruption, which can include round or oval red spots and swelling of the skin, blisters, and itching. It can also cause darkening of the skin in the affected areas, which can persist after healing. The fixed drug eruption usually recurs in the same place or places if the medication is taken again.

Tell 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 suffered from any of these side effects due to prolonged treatment with anti-inflammatory medications, and especially if you are elderly.

Stop taking Dexketoprofen Pensa 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 medications, cases of fluid retention and swelling (especially in the ankles and legs), high blood pressure, and heart failure have been reported.

Medications like Dexketoprofen Pensa may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident").

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.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dexketoprofen Pensa

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

Do not use this medication after the expiration date shown on the packaging and on the sachet after EXP. The expiration date is the last day of the month indicated.

Store below 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Dexketoprofeno Pensa

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

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

Appearance of the Product and Packaging Content

Transparent yellow-orange solution with a lemon-citrus odor.

Dexketoprofeno Pensa 25 mg oral solution is presented in packages containing 20 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

SAG MANUFACTURING, S.L.U.

Ctra. N-1, Km 36

28750 San Agustín de Guadalix, Madrid

Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat,

08950, Barcelona

Spain

Date of the Last Revision of this Prospectus: August 2025

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