Dexketoprofen Tarbis 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dexketoprofen Tarbis 25 mg film-coated tablets EFG

Read the entire 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Dexketoprofen Tarbis is and what it is used for
2. What you need to know before taking Dexketoprofen Tarbis
3. How to take Dexketoprofen Tarbis
4. Possible adverse effects
5. How to store Dexketoprofen Tarbis
6. Contents of the pack and other information

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

Dexketoprofen Tarbis is an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscular or joint pain, menstrual pain (dysmenorrhoea), and dental pain.

2. Dexketoprofeno Tarbis

Do not take Dexketoprofeno Tarbis:

• If you are allergic to dexketoprofen trometamol or to any of the other components of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid (aspirin) or to any other non-steroidal anti-inflammatory drug (NSAID);
• If you have asthma or have previously experienced 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 drugs;
• If you currently have or have previously had peptic ulcer, gastrointestinal bleeding, or have chronic digestive problems (e.g., indigestion, heartburn);
• If you have previously experienced gastrointestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain relief;
• 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 hepatic insufficiency;
• If you have bleeding disorders or blood coagulation disorders;
• If you are pregnant or breastfeeding;
• If you are under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dexketoprofeno Tarbis:

• If you are allergic or have previously had allergic reactions;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have previously suffered from any of these conditions;
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of stroke, or think you may be at risk of these conditions (e.g., high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist. Medicines such as Dexketoprofeno Tarbis may be associated with a small increased risk of heart attacks (“myocardial infarction”) or strokes (“cerebrovascular accident”). This risk is more likely when high doses are used or treatment is prolonged. Do not exceed the recommended dose or duration of treatment;
• 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 reduce fertility, so you should not take it if you are planning to become pregnant or undergoing fertility investigations);
• If you have a disorder affecting blood and blood cell production;
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If you currently have or have previously had chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
• If you currently have or have previously had stomach or intestinal disorders;
• If you are taking other medicines that increase the risk of peptic ulcer or bleeding, for example, oral corticosteroids, certain antidepressants (SSRIs, selective serotonin reuptake inhibitors), or agents that prevent 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 medicine to protect your stomach (e.g., misoprostol or other drugs that block gastric acid production).

Children and adolescents

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

Taking Dexketoprofeno Tarbis with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines should not be taken together, while others may require dose adjustments when used concomitantly.

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

Combinations not recommended:

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

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used for controlling high blood pressure and heart disorders;
• 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 for diabetes;

Combinations to be aware of:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections;
• Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplantation;
• Streptokinase and other thrombolytic and fibrinolytic drugs; i.e., medicines used to dissolve clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for termination of pregnancy);
• Selective serotonin reuptake inhibitor (SSRI) antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and clot formation.

If you have any doubts about taking other medicines 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 gastrointestinal adverse 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 allows the medicine to act slightly faster.

Pregnancy, lactation, and fertility

Do not take Dexketoprofeno Tarbis during pregnancy or while breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Do not take dexketoprofen during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labor beyond the expected duration. From week 20 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 treatment for longer than a few days is needed, 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.

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

Driving and use of 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 experience these effects, do not operate machinery or drive until these symptoms have resolved. Seek advice from your doctor.

3. How to take Dexketoprofeno Tarbis

Follow exactly the instructions for administration of this medicine as given 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 you should take per day and for how long.

In general, the recommended dose is 1 tablet (25 mg of dexketoprofen) every 8 hours, without 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 subsequently be increased according to the general recommended dose (75 mg of dexketoprofen) if Dexketoprofeno Tarbis has been well tolerated.

If your pain is severe and you need rapid relief, take the tablets on an empty stomach (at least 30 minutes before food), as they will be absorbed more easily (see section 2 “Taking Dexketoprofeno Tarbis with food and drink”).

If you take more Dexketoprofeno Tarbis than you should

If you have taken too much medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Please remember to always bring the medicine package or this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dexketoprofeno Tarbis

Do not take a double dose to make up for missed doses. Take the next dose as scheduled (according to section 3 “How to take Dexketoprofeno Tarbis”).

If you stop taking Dexketoprofeno Tarbis:

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

The possible adverse effects are detailed below according to their frequency. The following table indicates how many patients may experience these adverse effects:

Frequent adverse effects:

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

Uncommon adverse effects:

Sensation of spinning (vertigo), dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish feeling and chills, general malaise.

Rare adverse effects:

Peptic ulcer, perforation of peptic ulcer or bleeding (which may present as vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g. swelling of ankles), laryngeal oedema, 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 which may also lead to collapse), skin, mouth, eye, or genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decrease in white blood cell count (neutropenia), decrease in platelet count (thrombocytopenia).

Inform your doctor immediately if you notice any gastrointestinal adverse effects at the beginning of treatment (e.g. stomach pain or burning, or bleeding), especially if you have previously experienced such adverse effects due to prolonged treatment with anti-inflammatory drugs, and particularly if you are elderly.

Stop taking Dexketoprofen Tarbis immediately if you notice the appearance of a skin rash or any lesions in the mouth or genital area, or any other signs of allergy.

During treatment with non-steroidal anti-inflammatory drugs, cases of fluid retention and swelling (especially in ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines such as Dexketoprofen Tarbis may be associated with a small increased risk of having a heart attack (“myocardial infarction”) or stroke (“cerebrovascular accident”).

In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexketoprofen Tarbis

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexketoprofen Tarbis

• The active substance is dexketoprofen trometamol (36.90 mg), equivalent to dexketoprofen (INN) 25 mg.
• The other components (excipients) are: Core of the tablet: maize starch, microcrystalline cellulose, sodium carboxymethylstarch Type A (potato starch), colloidal anhydrous silica, magnesium stearate. Coating: titanium dioxide (E-171), hypromellose, macrogol 6000 and talc.

Appearance of the product and contents of the pack

Dexketoprofen Tarbis 25 mg are white or almost white, round, biconvex film-coated tablets with a break line on one side. They are available in packs containing 20 and 500 film-coated tablets (hospital pack).

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 most recent revision of this leaflet: October 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/