Label: information for the user

Dexketoprofen pensavital 25 mg film-coated tablets

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

Follow exactly the administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, 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 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 do not appear in this label. See section 4.

Dexketoprofeno is 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 take dexketoprofen pensavital

• If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or 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 rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
• If you have had phototoxic or photoallergic reactions (a special form of skin redness or burns exposed to sunlight) during the use of ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• If you have peptic ulcers, stomach or intestinal bleeding, or have had these conditions in the past;
• If you have chronic digestive problems (e.g. indigestion, stomach burning);
• If you have had 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 severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or inadequate 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 allergic reactions in the past;
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), 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 of these conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking) consult this treatment with your doctor or pharmacist. Medicines like dexketoprofen may be associated with a small increased risk of heart attacks or strokes. This risk is more likely to occur when using high doses and prolonged treatments. Do not exceed the recommended dose or treatment duration;
• If you are an elderly patient, 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 (dexketoprofen may reduce your fertility, so do not take it if you are planning to become pregnant or undergoing fertility studies);
• If you have blood disorders or blood cell production disorders;
• If you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases affecting connective tissue);
• If you have had or have chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have had or have stomach or intestinal disorders;
• If you have an infection; see the "Infections" heading below;
• If you are taking other medicines that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, some antidepressants (SSRI type), blood thinners like acetylsalicylic acid (aspirin) or 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 acid-blocking medications);
• If you have asthma, combined with chronic rhinitis or sinusitis, and/or nasal polyps, as you have a higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the general population. Administration of this medicine may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents

Dexketoprofen pensavital has not been studied in children or adolescents. Therefore, safety and efficacy have not been established, and the product should not be used in children or adolescents.

Other medicines and dexketoprofen pensavital

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription. There are some medicines that should not be taken together, and other medicines that may require a dose change if taken together.

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

Not recommended associations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood clotting;
• 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 requiring caution:

• ACE inhibitors, diuretics, 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 terminate pregnancy);
• SSRI-type antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and blood clotting;
• Tenofovir, deferasirox, pemetrexed.

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

Taking dexketoprofeno pensavital with food and drinks

Take the tablets with an adequate amount of water. Take the tablets with food, as this helps to reduce the risk of stomach or intestinal side effects. However, in the 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 little faster.

Pregnancy, breastfeeding, and fertility

Do not take dexketoprofeno during the last three 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 pensavital during the first six 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 pensavital may cause kidney problems in your fetus, which may cause low amniotic fluid levels 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 monitoring.

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

Women planning to become pregnant or are pregnant should avoid using dexketoprofeno. Treatment at any stage of pregnancy should only take place under a doctor's instructions. It is not recommended to use Dexketoprofeno pensavital while trying to conceive or while studying a fertility problem.

Driving and operating machinery

Dexketoprofeno may slightly affect your ability to drive and operate machinery, as it may cause drowsiness or dizziness as side effects of treatment. If you notice these effects, do not use machinery or drive until these symptoms disappear. Consult your doctor.

Dexketoprofeno pensavital contains sodium

This medicine 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 or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

The recommended dose is generally 1 tablet (25 mg) every 8 hours, without exceeding 3 tablets per day (75 mg).

If you are an elderly patient or suffer from 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 may be increased later according to the general recommended dose (75 mg) if dexketoprofeno 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 pensavital with food and drinks”).

Use in children and adolescents

This medication should not be used in children and adolescents (under 18 years old).

If you take more dexketoprofeno pensavital 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 pensavital

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 pensavital”).

If you have any doubts about the use of this medication, consult 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 in accordance with their frequency:

Frequent side effects(may affect up to 1 in 10 people):

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

Infrequent side effects(may affect up to 1 in 100 people):

Rotatory sensation (dizziness), 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(may affect up to 1 in 1,000 people):

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 edema (e.g., swelling of ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, back pain, frequent urination, menstrual irregularities, prostatic disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute renal insufficiency.

Very rare(may affect up to 1 in 10,000 people):

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin ulcers, mouth, eyes, and genital areas (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, 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 drugs, and especially if you are an elderly patient.

Stop taking Dexketoprofeno pensavital 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 edema (especially in ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines like Dexketoprofeno pensavital may be associated with a small increased risk of suffering a heart attack ("myocardial infarction") or a 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 prospectus.

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

Do not store at a temperature above 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 dexketoprofene pensavital

• The active ingredient is dexketoprofene trometamol (36.90 mg) corresponding to 25 mg of dexketoprofene.
• The other components (excipients) are: cornstarch, microcrystalline cellulose, carboxymethylcellulose sodium, glyceryl distearate, hypromellose, titanium dioxide, and macrogol 400.

Appearance of the product and content of the container

Dexketoprofene pensavital coated tablets (tablets), white, biconvex, cylindrical, and scored marked with “DT2” on one side.

The tablet can be divided into equal doses.

Dexketoprofene pensavital is available in containers containing 10 and 20 coated tablets.

Only some container sizes may be commercially marketed.

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

Crta. N-I, Km 36,

San Agustín de Guadalix,

Madrid, 28750 - Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

Barcelona, 08950 – Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Portugal: Dexcetoprofene Pensavital 25mg Coated Tablets

Italy: Dexketoprofene Pensavital 25mg, coated tablets

Spain: Dexketoprofene pensavital 25mg coated tablets EFG

Date of the last review of this prospectus:

February 2023.

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