Dexketoprofen Tarbis 25 mg granules for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dexketoprofeno TARBIS 25 mg granulate for oral solution EFG

Dexketoprofen trometamol

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Contents of the leaflet:

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

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

Dexketoprofeno TARBIS is an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as acute musculoskeletal or joint pain, menstrual pain (dysmenorrhea), and dental pain.

2. What you need to know before taking Dexketoprofeno Tarbis

Do not take Dexketoprofeno TARBIS

• If you are allergic to dexketoprofen trometamol or to any of the other ingredients of this medicine (see 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 had 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 have previously experienced photoallergic or phototoxic reactions (a special type of redness or sunburn-like skin damage on sun-exposed skin) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• 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) taken 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 impairment, or severe liver failure;
• If you have bleeding disorders or blood coagulation disorders;
• If you are severely dehydrated (have lost a large amount of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;
• If you are in the third trimester of pregnancy or breastfeeding;
• If you are under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dexketoprofeno TARBIS if you:

• Are allergic or have had allergic problems in the past;
• Have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have had any of these conditions in the past;
• Are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting);
• Have heart problems, a history of stroke, or think you may be at risk of such conditions (e.g., high blood pressure, diabetes, high cholesterol, or are a smoker). You should discuss this treatment with your doctor or pharmacist. Medicines like Dexketoprofeno TARBIS may be associated with a small increased risk of heart attacks (“myocardial infarction”) or strokes (“cerebrovascular accident”). This risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• Are elderly, as you may be more susceptible to adverse effects (see section 4). If these occur, consult your doctor immediately;
• 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);
• Have a disorder affecting blood or blood cell production;
• Have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• Have or have previously had chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
• Have or have previously had stomach or intestinal disorders;
• Have chickenpox, as NSAIDs may exceptionally worsen the infection;
• Are taking other medicines that increase the risk of peptic ulcer or gastrointestinal bleeding, such as oral corticosteroids, certain antidepressants (SSRIs, Selective Serotonin Reuptake Inhibitors), or agents that prevent blood clotting such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin or acenocoumarol (Sintrom). In such 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

Tell 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 concurrently.

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 or acenocoumarol (Sintrom), 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 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 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 medicines; 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);
• Antidepressants of the Selective Serotonin Reuptake Inhibitor (SSRI) type;
• Antiplatelet agents used to reduce platelet aggregation and blood 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

For acute pain, take the sachets on an empty stomach; that is, at least 15 minutes before meals, as this helps the medicine act 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 medicine, 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 and your baby’s tendency to bleed and may delay or prolong labor more than expected. From week 20 of pregnancy, dexketoprofen may cause kidney problems in your fetus if taken for more than a few days, which could 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.

• Do not take Dexketoprofeno TARBIS during the third trimester of pregnancy or while breastfeeding.
• Do not take Dexketoprofeno TARBIS while breastfeeding. Seek medical 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 adverse effects of treatment. If you experience these effects, do not operate machinery or drive until the symptoms have resolved. Seek advice from your doctor.

Dexketoprofeno TARBIS contains sucrose and sunset yellow FCF (E-110)

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

This medicine may cause allergic reactions as it contains the yellow dye sunset yellow FCF (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Dexketoprofen Tarbis

Follow exactly the instructions for administration of this medicine as given by your doctor.

If in doubt, consult your doctor or pharmacist again.

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

In general, the recommended dose is 1 sachet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 sachets 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 sachets 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 Dexketoprofen TARBIS has been well tolerated.

If your pain is severe and you need rapid relief, take the sachets on an empty stomach (at least 15 minutes before a meal), as they will be absorbed more easily (see section 2, "Taking Dexketoprofen TARBIS with food and drinks").

Instructions for proper use

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

If you take more Dexketoprofen 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 pack 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: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dexketoprofen TARBIS:

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

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Dexketoprofeno TARBIS can cause adverse effects, although not everyone experiences them.

The possible adverse effects are listed below according to their frequency. Since this list is partly based on adverse effects observed with the use of dexketoprofen tablets, and because dexketoprofen granules are absorbed faster than tablets, the actual frequency of adverse effects (gastrointestinal) may be higher with dexketoprofen granules. 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, feeling of fever and chills, general malaise.

Rare adverse effects:

Peptic ulcer, perforation of peptic ulcer or bleeding (which may present as vomiting of blood or black stools), fainting, elevated blood pressure, slow breathing, fluid retention and peripheral swelling (e.g., swelling of ankles), 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), interruption of kidney function (acute renal failure).

Very rare:

Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), skin, mouth, eye, or genital ulcers (Stevens-Johnson syndrome and Lyell's syndrome), swelling of the face or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, inflammation of the pancreas, liver cell damage (hepatitis), blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decrease in the number of white blood cells (neutropenia), decrease in the number of platelets (thrombocytopenia).

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

Stop taking Dexketoprofen TARBIS immediately if you notice the appearance of a skin rash or any lesions inside the mouth or in the genital area, or any other sign 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.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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.

Store below 30 °C.

Medicines should not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly 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 Dexketoprofeno TARBIS

• The active substance is dexketoprofen. Each sachet contains 36.90 mg of dexketoprofen trometamol, equivalent to 25 mg of dexketoprofen.
• The other components are: Colloidal silica, orange flavour, xanthan gum, orange-yellow colourant (E-110), and compressible sucrose.

Appearance of the product and contents of the pack

Dexketoprofeno TARBIS 25 mg is presented as a yellow-orange granulate for oral solution. Each pack contains 20 sachets.

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)

This leaflet was approved in February 2023

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/