Prospect: information for the patient

Dexketoprofen Tevagen 25 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect..See section 4.
• You should consult a doctor if your condition worsens or does not improve after 4 days.

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

2.What you need to know before starting to take Dexketoprofen Tevagen

3.How to take Dexketoprofen Tevagen

4.Possible adverse effects

5.Storage of Dexketoprofen Tevagen

6.Contents of the package and additional information

This medicationis a pain reliever belonging to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).

Dexketoprofeno Tevagen is used in adults for the short-term symptomatic treatment of mild to moderate acute pain, such as muscle or joint pain (for example, back pain, sprains, and acute trauma), menstrual pain, and dental pain.

Do not takeDexketoprofeno Tevagen:

• If you are allergic to dexketoprofeno or any of the other components of this medication (listed in section 6);
• If you are allergic to acetylsalicylic acid or another nonsteroidal anti-inflammatory drug;
• If you have asthma or have had asthma attacks, acute allergic rhinitis (a short period of nasal mucosa inflammation), nasal polyps (fleshy formations in the nasal cavity due to allergy), urticaria (skin rash), angioedema (face, eye, lip, or tongue swelling, 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 skin redness or burns exposed to sunlight) during the use of ketoprofeno (a nonsteroidal anti-inflammatory drug) or fibrates (medications used to reduce blood lipid levels);
• If you have peptic ulcers, stomach or intestinal bleeding; or if you have had stomach or intestinal bleeding in the past;
• If you have chronic digestive problems (for example, indigestion, stomach burning);
• If you have had 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;

Warnings and precautions:

Consult your doctor or pharmacist before starting to takeDexketoprofeno Tevagen:

• If you are allergic or have had allergic reactions in the past;
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or fluid retention or have had these conditions in the past;
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (for example, excessive urination, diarrhea, or vomiting);
• If you 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 likedexketoprofenomay be associated with a small increase in the risk of suffering heart attacks (“myocardial infarction”) or strokes (“cerebrovascular accident”). 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 person, 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 (see section 2, “Pregnancy, breastfeeding, and fertility”);
• If you have a disorder in blood and blood cell production;
• If you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases that affect connective tissue);
• If you have had or have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have had or have had gastrointestinal or intestinal disorders;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), blood clotting agents like acetylsalicylic acid (aspirin) or warfarin. In these cases, consult your doctor before takingthis medication: your doctor may prescribe an additional medication to protect your stomach (for example, misoprostol or other medications that block stomach acid production).
• If you have asthma, combined with rhinitis or chronic sinusitis, and/or nasal polyps, as you have a higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the general population. Administration of this medication may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Dexketoprofeno may mask the signs of an infection, such as fever and pain. Consequently, this medication may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to varicella. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Avoid using this medication if you have varicella

Children and adolescents

This medication has not been studied in children or adolescents. Therefore, safety and efficacy have not been established and should not be used in children or adolescents.

Other medications and Dexketoprofeno Tevagen

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication, including those purchased without a prescription. There are some medications that should not be taken together and other medications that may require a dose change if taken together.

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

Not recommended associations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medications used to prevent blood clotting;
• Lithium, used to treat mood disorders;
• Metotrexate (cancer medication and immunosuppressant), usedhigh doses of 15mg/week;Hidantoínas and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections;

Associations requiring caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure and heart conditions;
• Pentoxifilina and oxpentifilina, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used for bacterial infections;
• Sulfonilureas (e.g. chlorpropamide and glibenclamide), used for diabetes;
• Metotrexate, used at low doses, less than 15 mg/week.

Associations to consider:

• Quinolones (e.g. ciprofloxacin, levofloxacin) used for bacterial infections;
• Ciclosporina or tacrolimus, used to treat autoimmune diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medications; that is, medications used to break down blood clots;
• Probenecid, used for gout;
• Digoxina, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• Antidepressants of the selective serotonin reuptake inhibitor (SSRI) type;
• Antiplatelet agents used to reduce platelet aggregation and blood clotting;
• Beta-blockers, used for high blood pressure and heart conditions
• Tenofovir, deferasirox, pemetrexed

If you have any doubts about taking other medications withDexketoprofeno Tevagen, consult your doctor or pharmacist.

TakingDexketoprofeno Tevagenwith food, drinks, and alcohol

In general, it is recommended to take the medication with meals to reduce the possibility of causing stomach problems (see also section 3, “Administration form”).

The use of NSAIDs in combination with alcohol may worsen the adverse reactions caused by the active ingredient.

Pregnancy, breastfeeding, and fertility

Do not take this medication 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 bleed and delay or prolong delivery more than expected. Do not take dexketoprofeno during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, dexketoprofeno 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). If you need treatment for more than a few days, your doctor may recommend additional controls.

Driving and using machines

This medicationmay slightly affect your ability to drive and use machines, as it may cause drowsiness, dizziness, and blurred vision as adverse effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Consult your doctor.

Dexketoprofeno Tevagen contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; that is, it is essentially “sodium-free.”

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.the instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.the instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The necessary dose of the medication may vary, depending on the type, intensity, and duration of the pain.

Use the most effective dose for the shortest time necessary to alleviate symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

The tablets can be divided into equal doses.

Adults over 18 years old

Generally, the recommended dose is 1 tablet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 tablets a day (75 mg).

Patients of advanced age or with renal or hepatic insufficiency

If you are an elderly patient, or you suffer from mild renal problems or mild to moderate liver problems, it is recommended to start treatment with a maximum of2 tablets a day (50 mg of dexketoprofen).

In elderly patients, this initial dose can be increased later in accordance with the general recommended dose (75 mg of dexketoprofen) ifthe treatmenthas been well tolerated.

You should not use dexketoprofen if you suffer from moderate or severe kidney problems, or severe liver problems. Consult your doctor or pharmacist if you are unsure.

Use in children and adolescents

This medication should not be used in children and adolescents (under 18 years old).

Administration form

Take the tablets with an adequate amount of water.

The medication can be taken with or without food. Taking the medication with food helps to reduce the risk of stomach disorders, however, if your pain is more intense and you need faster relief, take the tablet with an empty stomach (at least 30 minutes before any food or ingestion of food) because it will be absorbed more easily (see section 2 "Taking Dexketoprofen Tevagen with food, drinks, and alcohol").

Treatment duration

The treatment should not exceed 4 days. If the pain persists after this period of time, worsens, or other symptoms appear, you should interrupt the treatment and consult your doctor or pharmacist.

If you take moreDexketoprofen Tevagenthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91562 04 20, indicating the medication and the amount ingested.It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

If you forgot to takeDexketoprofen Tevagen

Do not take a double dose to compensate for the missed doses. Take the next dose when due (in accordance with section 3 “How to takeDexketoprofeno Tevagen”).

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

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

The possible side effects are listed below in accordance with their frequency.

Frequent side effects (may affect up to 1 in 10 people)

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

Less common side effects (may affect up to 1 in 100 people)

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 discomfort.

Rare side effects (pmay affect up to 1 in 1,000 people)

Peptic ulcer, perforation of a peptic ulcer or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g., swelling of ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, lower back pain, frequent urination, menstrual irregularities, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute renal insufficiency.

Very rare side effects (pmay affect up to 1 in 10,000 people)

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin ulcers, 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 inflammation, blurred vision, tinnitus (ringing in the ears), 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, or 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 this medicine 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 Tevagen 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.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 and on the blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30° C.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dexketoprofeno Tevagen:

• The active ingredient is dexketoprofen trometamol. Each film-coated tablet contains 25 mg of dexketoprofen, which is equivalent to 36.90 mg of dexketoprofen trometamol.

• The other components are:

Tablet core: maize starch, microcrystalline cellulose, sodium carboxymethyl starch (type A) from potato, diestearoyl glycerol; Coating: hypromellose (E464), titanium dioxide (E171), macrogol 400.

Appearance of Dexketoprofeno Tevagen and contents of the packaging:

Scored, white, biconvex, cylindrical tablets marked with DT2 on one side. The tablet can be divided into equal doses.

It is presented in packaging containing 10 film-coated tablets.

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas.

Madrid, Spain

Responsible for manufacture

Galenicum Health, S.L.

San Gabriel, 50Esplugues de Llobregat

08950 Barcelona(Spain)

SAG Manufacturing, S.L.U.

Ctra N-I, km. 36

28750 San Agustín del Guadalix

Madrid - Spain

Last review date of this leaflet:August 2022

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