Dexketoprofen Aurovitas 25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dexketoprofeno Aurovitas 25mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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. See section 4.

Leaflet Contents

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

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

Dexketoprofen is an analgesic belonging to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscular or joint pain, menstrual pain (dysmenorrhoea), and dental pain.

2. What you need to know before taking Dexketoprofeno Aurovitas

Do not take Dexketoprofeno Aurovitas:

• if you are allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid or to another non-steroidal anti-inflammatory drug (NSAID);
• if you have asthma or have 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 wheezing in the chest after taking acetylsalicylic acid or other NSAIDs;
• 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) or fibrates (medicines used to reduce blood fat levels);
• if you have peptic ulcer, gastrointestinal bleeding, or have previously experienced stomach or intestinal bleeding, ulceration, or perforation;
• if you have previously experienced stomach or intestinal bleeding or perforation due to prior use of 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 failure, or severe hepatic failure;
• if you have bleeding disorders or blood coagulation disorders;
• if you are severely dehydrated (have lost a significant amount of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;
• if you are in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Dexketoprofeno Aurovitas:

• if you are allergic or have had allergic problems in the past;
• if you have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have had any of these conditions in the past;
• if you are taking diuretics or have inadequate 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 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 Aurovitas 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 elderly, 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 (this medicine 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 or 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 have an infection, see the heading “Infections” below;
• if you are taking other medicines that increase the risk of peptic ulcer or bleeding, for example, 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 dexketoprofen: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other medicines that block gastric acid production);
• if you have asthma associated with chronic rhinitis or sinusitis, and/or nasal polyps, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

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

Infections

Dexketoprofen may mask signs of infection such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Avoid using this medicine during chickenpox.

Children and adolescents

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

Other medicines and Dexketoprofeno Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines should not be taken together, while others may require dosage adjustments when taken concurrently.

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

Combinations not recommended

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs.
• Warfarin, heparin, and other medicines used to prevent blood clotting.
• Lithium, used to treat certain mood disorders.
• Methotrexate (a cancer and immunosuppressive medicine), when used at high doses of 15 mg/week.
• Hydantoins and phenytoin, used for epilepsy.
• Sulfamethoxazole, used for bacterial infections.

Combinations requiring caution

• ACE inhibitors, diuretics, 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.
• Sulfonylureas (e.g., chlorpropamide and glyburide), used for diabetes.
• Methotrexate, when used at low doses, less than 15 mg/week.

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 clot formation.
• Beta-blockers, used for high blood pressure and heart conditions.
• Tenofovir, deferasirox, pemetrexed.

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

Taking Dexketoprofeno Aurovitas with food, drinks, and alcohol

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 cases 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, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine, as dexketoprofen may not be suitable for you. You should not take this medicine during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time.

Do not take dexketoprofen during the last three months of pregnancy or while breastfeeding. 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, leading 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.

The use of dexketoprofen is not recommended when trying to conceive or during fertility investigations. Regarding potential effects on female fertility, see also section 2: "Warnings and precautions".

Driving and using machines

Dexketoprofeno Aurovitas 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 have resolved. Seek advice from your doctor.

Dexketoprofeno Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially "sodium-free".

3. How to take Dexketoprofeno Aurovitas

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

The dose of dexketoprofen you require may vary, depending on the type, intensity, and duration of pain. Your doctor will indicate how many tablets you should take per day and for how long.

The lowest effective dose should be used for the shortest necessary duration to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

In general, the recommended dose is half a tablet (12.5 mg) every 4–6 hours or one tablet (25 mg) every 8 hours, without exceeding 3 tablets per day (75 mg).

If you are an elderly patient or suffer from kidney or liver disease, it is recommended to initiate 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), provided this medicine 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 Aurovitas with food, drinks, and alcohol").

The tablet may be divided into equal doses.

Use in children and adolescents

This medicine must not be used in children and adolescents (under 18 years of age).

If you take more Dexketoprofeno Aurovitas than you should

If you have taken too much medicine or in case of accidental ingestion, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Please remember to always bring the medicine carton or this leaflet with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Dexketoprofeno Aurovitas

Do not take a double dose to make up for forgotten doses. Take the next dose as scheduled (according to section 3, "How to take Dexketoprofeno Aurovitas").

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

4. Possible adverse effects

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

The possible adverse effects are listed below according to their frequency.

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

Nausea and/or vomiting, mainly pain in the upper abdominal quadrant, diarrhoea, digestive disorders (dyspepsia).

Uncommon adverse effects (may affect up to 1 in 100 people)

Spinning sensation (vertigo), dizziness, somnolence, sleep disorders, nervousness, headache, palpitations, hot flushes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish feeling and chills, general malaise.

Rare adverse effects (may affect up to 1 in 1,000 people)

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. swollen 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), liver cell damage (hepatitis), acute renal failure.

Very rare adverse effects (may affect up to 1 in 10,000 people)

Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), skin, mouth, eye and genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), swelling of the face or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, inflammation of the pancreas, 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).

Adverse effects of unknown frequency (frequency cannot be estimated from the available data)

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

Fixed drug eruption

Allergic skin reaction known as fixed drug eruption, which may include round or oval red patches and skin swelling, blisters and itching. Darkening of the skin in affected areas may also occur, which may persist after healing. Fixed drug eruption usually recurs in the same location or locations if the medicine is taken again.

Immediately inform your doctor if you notice any gastrointestinal adverse effects at the beginning of treatment (e.g. stomach pain or burning or bleeding), especially if you have previously experienced any of these adverse effects due to prolonged treatment with anti-inflammatory medicines, and particularly if you are an elderly patient.

Immediately stop taking dexketoprofen if you notice the appearance of a skin rash or lesions in the mouth or 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 may be associated with a small increased risk of 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.

The most commonly observed adverse effects are gastrointestinal. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients.

Following administration, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease have been reported. Less frequently, inflammation of the stomach wall (gastritis) has been observed.

As with other NSAIDs, haematological reactions may occur (purpura, aplastic and haemolytic anaemia, and more rarely agranulocytosis and medullary hypoplasia).

Reporting of adverse effects

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

5. Storage of Dexketoprofen Aurovitas

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. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexketoprofeno Aurovitas

• The active substance is dexketoprofen trometamol (36.90 mg), equivalent to dexketoprofen (INN) 25 mg.
• The other components (excipients) are: maize starch, microcrystalline cellulose, sodium carboxymethyl starch from potato, glycerol distearate, hypromellose, titanium dioxide, macrogol 400.

Appearance of the product and contents of the pack

Film-coated, white, biconvex, cylindrical tablets, scored on one side and marked with "DT2". The tablet can be divided into equal doses.

Pack sizes: 20 and 50 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

SAG Manufacturing SLU

Crta N-I, Km 36

28750 San Agustín de Guadalix, Madrid

Spain

Or

Galenicum Health, S.L.

Avda. Cornellá 144, 7th floor, 1st building LEKLA

Esplugues de Llobregat

08950 Barcelona

Date of the most recent revision of this leaflet: February 2026

Detailed 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/)