Dexketoprofen TecniGen 25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Dexketoprofen TecniGen 25 mg film-coated tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

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

Dexketoprofen TecniGen 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 muscle or joint pain, menstrual pain (dysmenorrhea), and dental pain.

2. What you need to know before taking Dexketoprofeno TecniGen

Do not take Dexketoprofeno TecniGen

• If you are allergic to dexketoprofen trometamol or to any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid 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 chest wheezing 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 intestinal perforation, or if you 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 impairment, or severe hepatic impairment;
• 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 TecniGen:

• If you are allergic or have previously experienced 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 such conditions (e.g., high blood pressure, diabetes, high cholesterol, or if you smoke), you should discuss this treatment with your doctor or pharmacist. Medicines such as Dexketoprofeno TecniGen 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;
• If you are an elderly patient, 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 TecniGen 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, 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. In such cases, consult your doctor before taking Dexketoprofeno TecniGen; your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other drugs that block gastric acid production).

Allergic reactions to dexketoprofen, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Immediately stop treatment with Dexketoprofeno TecniGen and contact your doctor or nearest emergency service if you experience any of these symptoms.

Children and adolescents

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

Taking Dexketoprofeno TecniGen with other medicines

Inform your doctor or pharmacist if you are currently 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 TecniGen, 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 clot formation;
• 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 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 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);
• Selective Serotonin Reuptake Inhibitors (SSRIs);
• Antiplatelet agents used to reduce platelet aggregation and clot formation.

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

Taking Dexketoprofeno TecniGen with food and drinks

Take the tablets with an adequate 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, breastfeeding, and fertility

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 TecniGen during pregnancy or while breastfeeding. Consult your doctor or pharmacist before using any medicine.

• Inform your doctor if you are pregnant or planning to become pregnant, as Dexketoprofeno TecniGen may not be suitable for you.
• Do not take Dexketoprofeno TecniGen if you are breastfeeding. Seek advice from your doctor.
• From week 20 of pregnancy, dexketoprofen may cause kidney problems in your fetus if taken for more than a few days, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.
• 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 expected duration.

Driving and using machines

Dexketoprofeno TecniGen 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 resolve. Seek advice from your doctor.

3. How to take Dexketoprofeno TecniGen

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose of Dexketoprofeno TecniGen you need may vary, depending on the type, intensity, and duration of pain. Your doctor will tell you how many tablets you should take each 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 an elderly patient or suffer from 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 may subsequently be increased according to the general recommended dose (75 mg of dexketoprofen) if Dexketoprofeno TecniGen 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 TecniGen with food and drink”).

If you take more Dexketoprofeno TecniGen 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 carry the medicine pack or this leaflet with you. In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 915620420, stating the medicine and the amount ingested.

If you forget to take Dexketoprofeno TecniGen

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

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

4. Possible adverse effects

Like all medicines, Dexketoprofen TecniGen 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

Spinning sensation (vertigo), dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling feverish 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), inflammation of the liver (hepatitis), acute kidney failure.

Very rare adverse effects

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, inflammation of pancreas, 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 sensation or bleeding), if you have previously experienced any of these adverse effects due to long-term treatment with anti-inflammatory medicines, and especially if you are an elderly patient.

Stop taking Dexketoprofen TecniGen immediately if you notice the appearance of a skin rash or 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 TecniGen 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.

Adverse effects with unknown frequency: frequency cannot be estimated from available data

Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

Drug-induced fixed eruption:

An allergic skin reaction known as drug-induced fixed eruption, which may include round or oval red patches and skin swelling, blisters and itching. Skin darkening in affected areas may also occur, which may persist after healing. Drug-induced fixed eruption usually recurs in the same location or locations if the medicine is taken again.

Reporting of adverse effects

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

5. Storage of Dexketoprofen TecniGen

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

Do not use this medicine after the expiry date stated on the packaging and on the blister, after “EXP”. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexketoprofeno TecniGen

• The active substance is dexketoprofen trometamol (36.90 mg), equivalent to 25 mg of dexketoprofen.
• The other components are: microcrystalline cellulose, pregelatinized corn starch, sodium carboxymethyl potato starch, magnesium stearate, hypromellose, polydextrose, titanium dioxide (E171), and macrogol 4000.

Appearance of the medicinal product and contents of the pack

Dexketoprofeno TecniGen 25 mg is presented as film-coated tablets. The tablets are round, biconvex, scored, and white in colour.

It is available in packs containing 20, 50 tablets, and hospital pack of 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avd. de Bruselas, 13. 3º D. Polig. Arroyo de la Vega

28108 Alcobendas. Madrid

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69
08970 Sant Joan Despí (Barcelona)

Date of the most recent review of this leaflet: October 2025

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/