DEXKETOPROFEN PENSAVITAL 25 mg FILM-COATED TABLETS

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

Dexketoprofen is a pain reliever belonging to the group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs).

It is used to treat pain of mild or moderate intensity, such as muscle or joint pain, menstrual pain (dysmenorrhea), toothache.

2. What you need to know before taking Dexketoprofen Pensavital

Do not take dexketoprofen pensavital

• If you are allergic to dexketoprofen 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 or other non-steroidal anti-inflammatory medications;
• If you have suffered from photoallergic or phototoxic reactions (a special type of skin redness or burns when exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory medication) or fibrates (medications used to reduce blood fat levels);
• If you have a peptic ulcer, stomach or intestinal bleeding, or if you have suffered from bleeding, ulcers, or perforation of the stomach or intestine in the past;
• If you have chronic digestive problems (e.g., indigestion, heartburn);
• If you have suffered from stomach or intestinal bleeding or perforation in the past 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 severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or insufficient 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 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 (e.g., due to excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of stroke, or think you may be at risk of suffering from these disorders (e.g., 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 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 an elderly patient, you may experience a higher incidence of adverse effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (dexketoprofen 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 have a blood disorder and blood cell production disorder;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you currently have or have had in the past chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you currently have or have had in the past stomach or intestinal disorders;
• If you have an infection; see the "Infections" section below;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), agents that prevent blood clot formation like acetylsalicylic acid (aspirin) or anticoagulants like 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 medications that block gastric acid production);
• 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 rest of the population. The administration of this medication 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 medications and dexketoprofen pensavital

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

Always inform your doctor, dentist, or pharmacist if, in addition to Dexketoprofen Pensavital, 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 blood clot formation;
• 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 that require caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure control 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; i.e., medications used to dissolve blood clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for pregnancy termination);\li>
• Antidepressants of the SSRI type (Selective Serotonin Reuptake Inhibitors);
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation;
• Tenofovir, deferasirox, pemetrexed.

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

Taking dexketoprofen pensavital with food and drinks

Take the tablets with a sufficient amount of water. Take the tablets with food, as this helps reduce the risk of experiencing adverse effects in the stomach or intestine. However, in case of acute pain, take the tablets on an empty stomach; i.e., at least 30 minutes before meals, as this facilitates the medication's action.

Pregnancy, breastfeeding, and fertility

Do not take dexketoprofen 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 and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take Dexketoprofen 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 the 20th week of pregnancy, Dexketoprofen Pensavital may cause kidney problems in your fetus, which may lead to low levels of amniotic fluid 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 checks.

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

Women who are planning a pregnancy or are pregnant should avoid using dexketoprofen. Treatment at any time during pregnancy should only be done under the guidance of a doctor. The use of Dexketoprofen Pensavital is not recommended while trying to conceive or while studying a fertility problem.

Driving and using machines

Dexketoprofen 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 they disappear. Ask your doctor for advice.

Dexketoprofen pensavital contains sodium

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

3. How to take Dexketoprofen Pensavital

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

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

Generally, the recommended dose is 1 tablet (25 mg) every 8 hours, not 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 dexketoprofen 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 meals) as they will be absorbed more easily (see section 2 "Taking Dexketoprofen Pensavital with food and drinks").

Use in children and adolescents

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

If you take more dexketoprofen pensavital 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 pensavital

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 Pensavital").

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:

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

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

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

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

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, back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.

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

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), facial swelling 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, tinnitus (ringing in the ears), sensitive skin, sensitivity to light, 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), especially if you have previously suffered from these side effects due to prolonged treatment with anti-inflammatory medications, and especially if you are an elderly patient.

Stop taking Dexketoprofen 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 non-steroidal anti-inflammatory medications, cases of fluid retention and swelling (especially in the ankles and legs), increased blood pressure, and heart failure have been reported.

Medications like Dexketoprofen Pensavital may be associated with a small increased risk of suffering from a heart attack ("myocardial infarction") or stroke ("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 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: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dexketoprofen Pensavital

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

Do not store above 30°C. Keep the blister packs in the original packaging to protect them from light.

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

6. Package contents and additional information

Composition of dexketoprofen pensavital

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

Appearance of the product and packaging contents

Dexketoprofen Pensavital film-coated tablets (tablets), white, biconvex, cylindrical and scored marked with "DT2" on one side.

The tablet can be divided into equal doses.

Dexketoprofen Pensavital is available in packs containing 10 and 20 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Portugal: Dexcetoprofeno Pensavital 25mg Film-coated tablets

Italy: Dexketoprofene Pensavital 25mg, film-coated tablets

Spain: Dexketoprofeno pensavital 25mg film-coated tablets EFG

Date of the last revision of this leaflet:

February 2023.

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