DEXKETOPROFEN TECNIGEN 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Dexketoprofen TecniGen 25 mg Film-Coated Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet:

1. What is Dexketoprofen TecniGen and what is it used for
2. What you need to know before taking Dexketoprofen TecniGen
3. How to take Dexketoprofen TecniGen
4. Possible side effects
5. Storage of Dexketoprofen TecniGen
6. Package Contents and Additional Information

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

Dexketoprofen TecniGen is a pain reliever belonging to the group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild or moderate pain, such as muscle or joint pain, menstrual pain (dysmenorrhea), or toothache.

2. What you need to know before taking Dexketoprofen TecniGen

Do not take Dexketoprofen TecniGen

• If you are allergic to dexketoprofen trometamol or any other component of this medication (listed in section 6);
• If you are allergic to acetylsalicylic acid or another non-steroidal anti-inflammatory medication;
• If you have asthma or have suffered from asthma attacks, acute allergic rhinitis (a short period of nasal mucosa inflammation), nasal polyps (fleshy growths inside the nose due to allergies), hives (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 medications;
• If you have or have had a peptic ulcer, stomach or intestinal bleeding, or chronic digestive problems (such as indigestion, heartburn);
• If you have suffered from stomach or intestinal bleeding or perforation in the past due to the use of non-steroidal anti-inflammatory medications (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 kidney failure, or severe liver failure;
• If you have bleeding disorders or blood coagulation 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 Dexketoprofen TecniGen:

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), or fluid retention or have suffered from 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., due to excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of stroke, or think you may be at risk of suffering from these disorders (e.g., you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker), you should consult your doctor or pharmacist about this treatment. Medications like Dexketoprofeno TecniGen may be associated with a small increased risk of heart attacks ("myocardial infarction") or stroke. 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 an elderly patient, you may experience a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (Dexketoprofeno TecniGen may decrease your fertility, so you should not take it if you are planning to become pregnant or are undergoing fertility studies);
• If you have a blood disorder or blood cell production disorder;
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system diseases that affect connective tissue);
• If you have or have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have or have had stomach or intestinal disorders;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, some antidepressants (e.g., selective serotonin reuptake inhibitors), or anticoagulants like warfarin. In these cases, consult your doctor before taking Dexketoprofeno TecniGen; your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other medications that block gastric acid production).

Children and Adolescents

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

Taking Dexketoprofeno TecniGen with Other Medications

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

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

Not Recommended Combinations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory medications;
• Warfarin, heparin, and other medications used to prevent clot formation;
• Lithium, used to treat mood disorders;
• Methotrexate, used for rheumatoid arthritis and cancer;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections.

Combinations that Require Caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used for 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 Consider:

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

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

Taking Dexketoprofeno TecniGen with Food and Drinks

Take the tablets with a sufficient amount of water. Take the tablets with food, as this helps reduce the risk of gastrointestinal side effects. However, in case of acute pain, take the tablets on an empty stomach; i.e., at least 30 minutes before meals, as this facilitates faster absorption (see section 2 "Taking Dexketoprofeno TecniGen with Food and Drinks").

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take Dexketoprofeno TecniGen during pregnancy or breastfeeding. Consult your doctor or pharmacist before using any medication.

• Tell 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. Ask your doctor for advice.
• From the 20th week 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 you need treatment for more than a few days, 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 delay or prolong labor more than expected.

Driving and Using Machines

Dexketoprofeno TecniGen may slightly affect your ability to drive and use machines, as it can cause drowsiness or dizziness as side effects of treatment. If you notice these effects, do not use machines or drive until they disappear. Ask your doctor for advice.

3. How to Take Dexketoprofeno TecniGen

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The dose of Dexketoprofeno TecniGen you need may vary, depending on the type, intensity, and duration of the 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 dexketoprofen) every 8 hours, not exceeding 3 tablets per day (75 mg).

If you are an elderly patient or have 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 be increased later according to the general recommended dose (75 mg of dexketoprofen) if Dexketoprofeno TecniGen 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 meals), as they will be absorbed more easily (see section 2 "Taking Dexketoprofeno TecniGen with Food and Drinks").

If You Take More Dexketoprofeno TecniGen Than You Should

If you have taken too much medication, inform your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to always carry the medication package or this package leaflet with you. In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 915620420, indicating the medication 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 when scheduled (according to section 3 "How to Take Dexketoprofeno TecniGen").

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Dexketoprofeno TecniGen can cause side effects, although not everyone will experience them.

Possible side effects are listed below according to their frequency. The following table indicates how many patients may experience these side effects:

Common Side Effects

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

Uncommon 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 malaise.

Rare Side Effects

Peptic ulcer, perforation of peptic ulcer or bleeding (which may manifest as vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention, and peripheral edema (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 inflammation (hepatitis), acute kidney failure.

Very Rare Side Effects

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), ulcers on the skin, mouth, eyes, and genital areas (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, blurred vision, tinnitus (ringing in the ears), sensitive skin, sensitivity to light, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Tell your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g., stomach pain or burning, or bleeding), especially if you have previously experienced these side effects due to prolonged treatment with anti-inflammatory medications, and especially if you are an elderly patient.

Stop taking Dexketoprofeno TecniGen immediately if you notice the appearance of a skin rash or any lesion inside the mouth or on the genitals, or any other sign of allergy.

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

Medications like Dexketoprofeno TecniGen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use, website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dexketoprofeno TecniGen

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and blister pack, after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE Collection Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dexketoprofeno TecniGen

• The active ingredient is dexketoprofen trometamol (36.90 mg) corresponding 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 Product and Package Contents

Dexketoprofeno TecniGen 25 mg is presented in the form of film-coated tablets. The tablets are round, scored, and white.

It is available in packages containing 20, 50 tablets, and a clinical package of 500 tablets.

Only some package 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, 6908970 Sant Joan Despí (Barcelona)

Date of Last Revision of this Package Leaflet:February 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS), http://www.aemps.gob.es/