Leaflet: information for theuser

Dexketoprofeno Tarbis 25 mg film-coated tablets

Read this 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 doubts, consult your doctororpharmacist.
• This medicine has been prescribed for you only, and you must not give it to otherseven if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor orpharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Dexketoprofeno Tarbis

3.How to take Dexketoprofeno Tarbis

4.Possible side effects

5.Storage of Dexketoprofeno Tarbis

6.Contents of the pack and additional information

DexketoprofenoTarbis 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), and toothache pain.

Do not take Dexketoprofeno Tarbis:

• If you are allergic to dexketoprofen trometamol or to any of the other components of this medication (listed in section 6);
• If you are allergic to acetylsalicylic acid (aspirin) or to 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 interior due to allergy), urticaria (skin eruption), angioedema (face, eye, lip, or tongue swelling, 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 (e.g., 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 Tarbis:

• If you are allergic or have had allergic problems in the past;
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or have had 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., 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 smoker) consult this treatment with your doctor or pharmacist. Medications like Dexketoprofeno Tarbis may be associated with a small increased risk of suffering heart attacks ("myocardial infarction") or strokes ("cerebral vascular 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 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 Tarbis 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 (immune system diseases affecting 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), blood clotting agents like acetylsalicylic acid (aspirin) or 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 stomach acid production).

Children and adolescents

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

Taking Dexketoprofeno Tarbis with other medications

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

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

Not recommended associations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medications 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, 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 (e.g., 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 blood 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 blood clotting.

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 an adequate amount of water. Take the tablets with food, as this helps reduce the risk of experiencing adverse effects in the stomach or intestines. 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 bit more quickly.

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 renal and cardiac problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected. From week 20 of pregnancy, dexketoprofen may cause renal problems in your fetus if taken for more than a few days, 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 medication.

• Do not take Dexketoprofeno Tarbis if you are breastfeeding. Seek advice from your doctor.

Driving and using machines

Dexketoprofeno Tarbis may slightly affect your ability to drive and use machines, as it may cause drowsiness or dizziness 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.

Follow exactly the administration instructions for this medication 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 pain. Your doctor will tell you how many tablets to take per day and for how long.

Generally, it is recommended to take 1 tablet (25 mg of dexketoprofeno) every 8 hours, without exceeding 3 tablets 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 tablets per day (50 mg).

In elderly patients, this initial dose can be increased later in accordance with the recommended general dose (75 mg of dexketoprofeno) 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 eating) 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 service of your nearest hospital. Please remember to always carry the medication packaging 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 forget to take Dexketoprofeno Tarbis

Do not take a double dose to make up for the missed doses. Take the next dose when due (in accordance with section 3 “How to take Dexketoprofeno Tarbis”).

If you interrupt treatment with Dexketoprofeno Tarbis:

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

Infrequent 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 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 (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 inflammation, blurred vision, ringing in the ears (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 agents, and especially if you are elderly.

Stop taking Dexketoprofeno Tarbis 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 Tarbis 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 Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute toproviding 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 after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30º C.

Storeintheoriginalpackagingtoprotectitfromlight.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGREpoint of the pharmacy. Please ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

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, carboxymethylstarch sodium Type A (potato starch),anhydrous colloidal silica, magnesium stearate.Covering:titanium dioxide (E-171), hypromellose, macrogol 6000, and talc.

Appearance of the product and content of the packaging

DexketoprofenoTarbis 25 mg are white or almost white, round, biconvex, and with a breaking bar on one face. They are presented in packaging that contains 20 and 500 coated tablets (clinical packaging).

Holder of the marketing authorization

TARBIS FARMA, S.L.

Gran Via Carlos III, 94

08028– Barcelona-Spain

Responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos (Madrid), Spain

Last review date of this leaflet: October 2022

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