DEXKETOPROFEN TARBIS 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

Dexketoprofen Tarbis 25 mg film-coated tablets EFG

Read the 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 questions, 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 not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Dexketoprofen Tarbis and what is it used for
2. What you need to know before taking Dexketoprofen Tarbis
3. How to take Dexketoprofen Tarbis
4. Possible side effects
5. Storage of Dexketoprofen Tarbis
6. Package contents and additional information

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

Dexketoprofen Tarbis is a pain reliever belonging to the group of medications known as 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. Dexketoprofen Tarbis

Do not take Dexketoprofeno Tarbis:

• If you are allergic to dexketoprofen trometamol or any of the other components of this medication (listed in section 6);
• If you are allergic to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory medications;
• 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), 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 medications;
• If you have or have had in the past 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 Dexketoprofeno Tarbis:

• 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 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 Dexketoprofeno Tarbis 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 experience a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (Dexketoprofeno Tarbis may decrease your fertility, so you should not take it if you are planning to become pregnant or are undergoing fertility studies);
• If you suffer from a blood disorder and blood cell production;
• 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, such as oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), agents that prevent blood clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking Dexketoprofeno Tarbis: your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other medications that block gastric acid production).

Children and adolescents

Do not take Dexketoprofeno Tarbis if you are under 18 years old.

Taking Dexketoprofeno Tarbis with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. There are some medications that should not be taken together, and other medications that may need a dose change if taken together.

Always inform your doctor, dentist, or pharmacist if, in addition to Dexketoprofeno Tarbis, 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 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, 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);
• Antidepressants of the SSRI type (Selective Serotonin Reuptake Inhibitors);
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation.

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

Taking Dexketoprofeno Tarbis with food, drinks, and alcohol

Take the tablets with a sufficient amount of water. Take the tablets with food, as this helps reduce the risk of experiencing side 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 will allow the medication to act a little faster.

Pregnancy, breastfeeding, and fertility

Do not take Dexketoprofeno Tarbis during pregnancy or breastfeeding.

Consult your doctor or pharmacist before using any medication.

Do not take dexketoprofen 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. From the 20th week of pregnancy, dexketoprofen may cause kidney problems in your fetus if taken for more than a few days, 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.

• Do not take Dexketoprofeno Tarbis if you are breastfeeding. Ask your doctor for advice.

Driving and using machines

Dexketoprofeno Tarbis 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.

3. How to take Dexketoprofeno Tarbis

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

The dose of Dexketoprofeno Tarbis 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, it is recommended to take 1 tablet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 tablets 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 tablets 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 Dexketoprofeno Tarbis 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 Dexketoprofeno Tarbis with food and drinks").

If you take more Dexketoprofeno Tarbis 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 taken.

If you forget to take Dexketoprofeno Tarbis

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 Dexketoprofeno Tarbis").

If you stop treatment with Dexketoprofeno Tarbis:

If you have any other doubts about the use of this medication, ask 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 as 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).

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 experienced these side effects due to prolonged treatment with anti-inflammatory medications, and especially if you are elderly.

Stop taking Dexketoprofeno Tarbis 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), increased blood pressure, and heart failure have been reported.

Medications like Dexketoprofeno Tarbis 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 may rarely cause fever, headache, and neck stiffness.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dexketoprofeno Tarbis

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

Do not use this medication after the expiration date stated on the package after "CAD". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect 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 your pharmacy. 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 Dexketoprofeno Tarbis

• The active ingredient is dexketoprofen trometamol (36.90 mg) corresponding to dexketoprofen (DCI) 25 mg.
• The other components (excipients) are: Tablet core: cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose Type A (potato starch), colloidal anhydrous silica, magnesium stearate. Coating: titanium dioxide (E-171), hypromellose, macrogol 6000, and talc.

Appearance of the product and package contents

Dexketoprofeno Tarbis 25 mg are white or almost white, round, biconvex tablets with a break line on one face. They are available in packages containing 20 and 500 film-coated tablets (clinical packaging).

Marketing authorization holder

TARBIS FARMA, S.L.

Gran Via Carlos III, 94

08028– Barcelona-Spain

Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos (Madrid), Spain

Date of the last revision of this package leaflet: October 2022

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