Dexketoprofen Pensá 25 mg oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Dexketoprofen Pensa 25 mg oral solution EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

Pack contents and additional information

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

Dexketoprofen Pensa is an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscle or joint pain, menstrual pain (dysmenorrhoea), and dental pain.

2. What you need to know before taking Dexketoprofeno Pensa

Do not take Dexketoprofeno Pensa

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or to any other non-steroidal anti-inflammatory drug (NSAID);
• If you have asthma or have previously experienced 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 (aspirin) or other non-steroidal anti-inflammatory drugs;
• If you currently have or have previously had peptic ulcer, gastrointestinal bleeding, or intestinal perforation, or have chronic digestive problems (e.g., indigestion, heartburn);
• If you have previously experienced gastrointestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain relief;
• If you have inflammatory bowel disease (Crohn’s disease or ulcerative colitis);
• If you have severe heart failure, moderate to severe renal failure, or severe hepatic failure;
• If you have bleeding disorders or blood coagulation disorders;
• If you are pregnant or breastfeeding;
• If you are under 18 years of age.

Warnings and precautions

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

Take special care with Dexketoprofeno Pensa:

• If you are allergic or have previously had allergic reactions;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), or fluid retention, or have previously suffered from any of these conditions;
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of stroke, or think you may be at risk of such conditions (e.g., high blood pressure, diabetes, high cholesterol, or if you smoke), discuss this treatment with your doctor or pharmacist. Medicines like Dexketoprofeno Pensa may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke ("cerebrovascular accident"). This risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• 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 Pensa may reduce fertility, so you should not take it if you are planning to become pregnant or undergoing fertility investigations);
• If you have a disorder affecting blood or blood cell production;
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If you currently have or have previously had chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
• If you currently have or have previously had stomach or intestinal disorders;
• If you are taking other medicines that increase the risk of peptic ulcer or gastrointestinal bleeding, such as oral corticosteroids, certain antidepressants (SSRIs, selective serotonin reuptake inhibitors), or agents that prevent clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In such cases, consult your doctor before taking Dexketoprofeno Pensa: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other drugs that block gastric acid production).

What you should know before taking Dexketoprofeno Pensa:

Allergic reactions to dexketoprofen, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Immediately stop treatment with Dexketoprofeno Pensa and contact your doctor or nearest emergency service if you experience any of these symptoms.

Children and adolescents

Do not take Dexketoprofeno Pensa if you are under 18 years of age.

Other medicines and Dexketoprofeno Pensa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Some medicines should not be taken together, while others may require dose adjustments when used concurrently.

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

Combinations not recommended:

• Acetylsalicylic acid (aspirin), corticosteroids, and other NSAIDs;
• Warfarin, heparin, and other medicines used to prevent blood clotting;
• Lithium, used to treat certain mood disorders;
• Methotrexate, used for rheumatoid arthritis and cancer;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections.

Combinations 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 glyburide, used for diabetes.

Combinations to be aware of:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections;
• Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplantation;
• Streptokinase and other thrombolytic and fibrinolytic agents—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 termination of pregnancy);
• Antidepressants of the selective serotonin reuptake inhibitor (SSRI) type;
• Antiplatelet agents used to reduce platelet aggregation and clot formation.

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

Taking Dexketoprofeno Pensa with food and drinks

Take the sachets with food, as this helps reduce the risk of gastrointestinal adverse effects. However, in cases of acute pain, take the sachets on an empty stomach—i.e., at least 30 minutes before meals—since this allows the medicine to act slightly faster.

Pregnancy and breastfeeding

Do not take Dexketoprofeno Pensa during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your unborn baby, affect your or your baby’s tendency to bleed, and delay or prolong labor. You should not take Dexketoprofeno Pensa during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or when trying to conceive, use the lowest effective dose for the shortest possible time. From week 20 of pregnancy, Dexketoprofeno Pensa may cause kidney problems in your fetus if taken for more than a few days, potentially leading to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Consult your doctor or pharmacist before using any medicine.

• Inform your doctor if you are pregnant or planning to become pregnant, as Dexketoprofeno Pensa may not be suitable for you.
• Do not take Dexketoprofeno Pensa if you are breastfeeding. Seek medical advice.

Driving and using machines

Dexketoprofeno Pensa may slightly affect your ability to drive and use machines, as it may cause drowsiness or dizziness as adverse effects of treatment. If you experience these effects, do not operate machinery or drive until they have resolved. Seek advice from your doctor.

Dexketoprofeno Pensa contains methyl parahydroxybenzoate, sucrose, and sodium

May cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate.

Dexketoprofeno Pensa contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; hence, it is essentially “sodium-free”.

3. How to take Dexketoprofeno Pensa

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

The dose of Dexketoprofeno Pensa you need may vary depending on the type, intensity, and duration of pain. Your doctor will tell you how many sachets you should take per day and for how long. Generally, it is recommended to take 1 sachet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 sachets per day (75 mg).

If you are elderly or suffer from kidney or liver disease, it is recommended to start treatment with a maximum of 2 sachets per day (50 mg).

In elderly patients, this initial dose may later be increased according to the general recommended dose (75 mg of dexketoprofen), provided Dexketoprofeno Pensa has been well tolerated.

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

Instructions for proper use

Before opening the sachet, press it several times to ensure complete use of its contents. The oral solution can be taken directly from the sachet, or if preferred, the contents may be diluted in a glass of water, stirred, and taken immediately. Once opened, consume the entire contents of the sachet.

If you take more Dexketoprofeno Pensa than you should

If you have taken too much medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Please remember to always bring the medicine pack or this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dexketoprofeno Pensa:

Do not take a double dose to make up for missed doses. Take the next dose at the scheduled time (according to section 3, "How to take Dexketoprofeno Pensa").

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Frequent adverse effects

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

Uncommon adverse effects

Sensation of spinning (vertigo), dizziness, somnolence, sleep disturbances, nervousness, headache, palpitations, hot flushes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish feeling and chills, general malaise.

Rare adverse effects

Peptic ulcer, perforation of peptic ulcer or bleeding (which may present as vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g. swelling of ankles), laryngeal oedema, 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 which may also lead to collapse), skin, mouth, eye and genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decrease in white blood cell count (neutropenia), decrease in platelet count (thrombocytopenia).

Unknown: frequency cannot be determined from available data

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

Fixed drug eruption: An allergic skin reaction known as fixed drug eruption which may include round or oval red patches and skin swelling, blisters and itching. Darkening of the skin in affected areas may also occur, which can persist after healing. Fixed drug eruption usually reappears in the same location or locations if the medicine is taken again.

Immediately inform your doctor if you notice any gastrointestinal adverse effects at the start of treatment (e.g. stomach pain or burning, or bleeding), especially if you have previously experienced such adverse effects during long-term treatment with anti-inflammatory medicines, and particularly if you are elderly.

Stop taking Dexketoprofen Pensa immediately if you notice the appearance of a skin rash or any lesions inside the mouth or on the genitals, or any other signs 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 such as Dexketoprofen Pensa may be associated with a small increased risk of having a heart attack (“myocardial infarction”) or stroke (“cerebrovascular accident”).

In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the national reporting system included in the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexketoprofen Pensa

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

Do not use this medicine after the expiry date stated on the packaging and sachet after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their packaging should be returned to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexketoprofen Pensa

The active substance is dexketoprofen trometamol (36.90 mg), equivalent to dexketoprofen (INN) 25 mg.

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

Nature of the product and pack contents

Yellowish-orange transparent solution with a lemon-citrus odor.

Dexketoprofen Pensa 25 mg oral solution is available in packs 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 most recent review of this leaflet: August 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.