Package Insert: Information for the Patient

Dexketoprofen TARBIS 25 mg Powder for Oral Solution EFG

Dexketoprofen trometamol

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 are not listed in this package insert.

Dexketoprofeno TARBIS is a pain reliever belonging to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as acute muscle pain or joint pain, menstrual pain (dysmenorrhea), dental pain.

Do not take Dexketoprofeno TARBIS

• If you are allergic to dexketoprofen trometamol or any of the other components of this medication (see section 6);
• If you are allergic to acetylsalicylic acid (aspirin) or another nonsteroidal anti-inflammatory drug;
• If you have asthma or have had asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy formations in the interior of the nose due to allergy), urticaria (skin eruption), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs;
• If you have had photoallergic or phototoxic reactions (a special form of redness or burns of the skin 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 or have had in the past peptic ulcers, stomach or intestinal bleeding, or chronic digestive problems (for example, 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 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;
• 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;
• Have kidney, liver, or heart diseases (hypertension and/or heart failure), or have had any of these diseases in the past;
• Are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (for example, excessive urination, diarrhea, or vomiting);
• Have heart problems, a history of strokes, or think you may be at risk of these conditions (for example, you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) consult this treatment with your doctor or pharmacist. Medications like Dexketoprofeno TARBIS may be associated with a small increase in the risk of suffering heart attacks ("myocardial infarctions") or strokes ("cerebral vascular accidents"). This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;
• Are elderly, you may be more likely to experience adverse effects (see section 4). If these occur, consult your doctor immediately;
• Are a woman with fertility problems (Dexketoprofeno TARBIS may reduce your fertility, so do not take it if you are planning to become pregnant or are undergoing fertility studies);
• Have a disorder in blood and blood cell production;
• Have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• Have had or have had in the past chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• Have had or have had in the past gastrointestinal or intestinal disorders;
• Have chickenpox, as NSAIDs may occasionally worsen the infection;
• Are taking other medications that increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), blood thinners such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin or acenocoumarol (Sintrom). In these cases, consult your doctor before taking Dexketoprofeno TARBIS: your doctor may prescribe an additional medication to protect your stomach (for example, 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 change in dose if taken together.

Inform your doctor, dentist, or pharmacist 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 or acenocoumarol (Sintrom), 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 that require 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 (for example, 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

In case of acute pain, take the capsules on an empty stomach; that is, at least 15 minutes before meals, as this will facilitate the medication's action more quickly.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication, as Dexketoprofeno TARBIS may not be suitable for you.

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 predisposition and that of your baby to bleeding and delay or prolong delivery. From week 20 of pregnancy, dexketoprofen may cause kidney 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 checks.

• Do not take Dexketoprofeno TARBIS during the third trimester of pregnancy or while breastfeeding.
• Do not take Dexketoprofeno TARBIS if you are breastfeeding. Consult 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 side effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Consult your doctor.

Dexketoprofeno TARBIS contains saccharose and yellow orange S (E-110)

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication may cause allergic reactions because it contains yellow orange S (E-110) dye. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions for this medication as indicated by your doctor.

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 packets to take per day and for how long.

Generally, it is recommended to take 1 packet (25 mg of dexketoprofeno) every 8 hours, without exceeding 3 packets per day (75 mg).

If you are elderly or have kidney or liver disease, it is recommended to start therapy with a maximum of 2 packets per day (50 mg).

In elderly patients, this initial dose may be increased later according to the general recommended dose (75 mg of dexketoprofeno) if Dexketoprofeno TARBIS has been well tolerated.

If your pain is intense and you need quick relief, take the packets on an empty stomach (at least 15 minutes before eating) as they will be absorbed more easily (see section 2 “Taking Dexketoprofeno TARBIS with food and drinks”).

Instructions for proper use

Dissolve the entire contents of a packet in a glass of water; shake to help dissolve. The resulting solution should be taken immediately after reconstitution.

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 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 TARBIS:

Do not take a double dose to make up for the missed doses. Take the next dose when due (according to section 3).

If you have doubts about the use of this medication, consult your doctor or pharmacist.

Like all medicines, Dexketoprofeno TARBIS may cause side effects, although not everyone will experience them.

The possible side effects are listed below according to their frequency. Since the list is based in part on the side effects observed with the use of dexketoprofeno tablets, and since dexketoprofeno granules are absorbed more quickly than tablets, it is possible that the actual frequency of side effects (gastrointestinal) may be higher with dexketoprofeno granules. 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).

Rare side effects:

Rotatory sensation (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.

Very 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, peripheral edema (e.g., swelling of ankles), loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostatic disorders, abnormal liver function tests (blood analysis), acute renal failure.

Very rare:

Anaphylactic reaction (hypersensitivity reaction that may also lead to collapse), skin ulcers, mouth, eye, and genital area ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or lip and throat swelling (angioedema), respiratory difficulty due to airway constriction (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, liver cell damage (hepatitis), 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, 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 increase in the 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.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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.

Store at a temperature below 30 °C.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Dexketoprofeno TARBIS

• The active ingredient is dexketoprofeno. Each sachet contains 36.90 mg of dexketoprofeno trometamol equivalent to 25 mg of dexketoprofeno.
• The other components are: Colloidal silica, orange essence, xanthan gum, yellow-orange dye (E-110), and compression sugar.

Appearance of the product and content of the packaging

Dexketoprofeno TARBIS 25 mg is presented in the form of an oral granulated solution, yellow-orange in color. Each package contains 20 sachets.

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)

This leaflet was approved in February 2023

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