Label: Information for the User

Dexketoprofen 25 mg Oral Solution EFG

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

• Keep this label, as you may need to read it again.
• ­If you have any questions, consult your doctor or pharmacist.
• ­This medication has been prescribed only for you and should not be given to others, even 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 are not listed in this label. See section 4.

Contents of the package and additional information

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

Do not take Dexketoprofeno 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 inflammation of the nasal mucosa), nasal polyps (fleshy formations in the interior of the nose 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 (for example, 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 renal insufficiency, or severe liver insufficiency;
• 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 take Dexketoprofeno Pensa.

Be especially careful with Dexketoprofeno Pensa:

• ­If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or fluid retention or have had any of these diseases in the past;
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (for example, excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of these conditions (for example, you have high blood pressure, suffer from diabetes, have increased cholesterol, or are a smoker) consult this treatment with your doctor or pharmacist. Medications like Dexketoprofeno Pensa may be associated with a small increase in the risk of suffering heart attacks ("myocardial infarctions") or strokes ("cerebrovascular accidents"). 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 Pensa may decrease your fertility, so do not take it if you are planning to become pregnant or are undergoing fertility studies);
• If you have a disorder in blood production and blood cells;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect 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, for example, oral corticosteroids, some antidepressants (SSRI type), agents that prevent clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking Dexketoprofeno Pensa: your doctor may prescribe an additional medication to protect your stomach (for example, 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 using, have used recently, or may need to use any other medication, even those purchased without a prescription. There are some medications that should not be taken together and other medications that may require a change in dose if taken together.

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

Non-recommended associations:

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

Associations that require 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 (for example, ciprofloxacin, levofloxacin), used to treat bacterial infections;
• Ciclosporin 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 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 clot formation.

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

Taking Dexketoprofeno Pensa with food and drinks

Take the sachets with food, as this helps to reduce the risk of experiencing adverse effects in the stomach or intestines. However, in the 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 a little faster.

Pregnancy and lactation

Do not take Dexketoprofeno 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 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. From week 20 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.

Consult your doctor or pharmacist before using any medication.

• ­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 advice from your doctor.

Driving and using machines

Dexketoprofeno Pensa may slightly affect your ability to drive and use machines, as it may cause drowsiness or vertigo as adverse effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Seek advice from your doctor.

Dexketoprofeno Pensa contains parahydroxybenzoate methyl ester, saccharose, and sodium

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

Dexketoprofeno Pensa contains saccharose.If your doctor has indicated 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".

Follow exactly the administration instructions for this medication 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 dexketoprofeno) every 8 hours, without exceeding 3 sachets per day (75 mg).

If you are elderly or have any 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 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 sachets 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”).

Instructions for proper use

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

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: 91 562 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 due (according to section 3 “How to take Dexketoprofeno Pensa”).

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

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

The possible side effects are listed below in order of 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, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flushes, 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, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute renal insufficiency.

Very rare

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, tinnitus (ringing in the ears), 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 reporting system included in the Spanish System of Pharmacovigilance of Medicines for Human Use:https://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 on the overwrap after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Dexketoprofeno Pensa

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

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

Appearance of the product and contents of the packaging

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

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

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:

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 review 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/.