Package Insert: Information for the User

Dexketoprofen Aurovitas 25 mg Film-Coated Tablets EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Dexketoprofen is a pain reliever belonging to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is used in adults to treatmoderate to mild pain, such asmuscle or joint pain, menstrual pain (dysmenorrhea), or toothache pain.

Do not take Dexketoprofeno Aurovitas:

• If you are allergic to dexketoprofen 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 interior due to allergy), urticaria (skin rash), angioedema (face, eye, lip, or tongue swelling, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid 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 ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medications used to reduce blood fat levels).
• If you have or have had peptic ulcers, stomach or intestinal bleeding, or chronic digestive problems (e.g., indigestion, stomach burning, dyspepsia).
• 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 take Dexketoprofeno Aurovitas:

• If you are allergic or have had allergy problems in the past.
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or have had any of these diseases in the past.
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., excessive urination, diarrhea, or vomiting).
• If you have heart problems, a history of strokes, or think you may be at risk for these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking), consult this treatment with your doctor or pharmacist. Nonsteroidal anti-inflammatory drugs like Dexketoprofeno Aurovitas may be associated with a small increased risk of heart attacks or strokes. 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 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 medication may reduce your fertility, so do not take it if you are planning to become pregnant or are undergoing fertility studies).
• If you have a disorder in blood production and blood cells.
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue).
• If you have chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease).
• If you have gastrointestinal or intestinal disorders.
• If you have an infection, see the "Infections" heading below.
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, certain antidepressants (SSRI type), anticoagulants like acetylsalicylic acid (aspirin), or warfarin. In these cases, consult your doctor before taking dexketoprofen: your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other medications that block stomach acid production).
• If you have asthma, combined with chronic rhinitis or 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.

During prolonged treatment with dexketoprofeno, regular monitoring of liver and kidney function, as well as blood counts, is recommended.

Children and adolescents

This medication has not been studied in children and adolescents. Therefore, the safety and efficacy of use in children and adolescents have not been established. Do not use in children and adolescents.

Other medications and Dexketoprofeno Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, 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 when taken together.

Always inform your doctor, dentist, or pharmacist if, in addition to dexketoprofeno, 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), used at high doses of 15 mg/week.
• Hidantoins 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.
• Pentoxifylline and oxpentifylline, 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.
• Ciclosporin or tacrolimus, used to treat immune system diseases and organ transplants.
• Streptokinase and other thrombolytic and fibrinolytic medications; that is, medications used to break down blood clots.
• Probenecid, used for gout.
• Digoxin, used for chronic heart failure.
• Mifepristone, used as an abortifacient (for abortion).
• SSRI-type antidepressants.

• Antiplatelet agents used to reduce platelet aggregation and blood clot formation.
• Beta-blockers, used for high blood pressure and heart conditions.

• Tenofovir, deferasirox, pemetrexed.

If you have any doubts about taking other medications 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 to reduce the risk of stomach or intestinal side 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 facilitates the medication's action a bit faster.

Pregnancy, breastfeeding, and fertility

Do not take dexketoprofeno if you are in the last three months of pregnancy or breastfeeding. 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.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication, as dexketoprofeno may not be suitable for you. Do not take this medication during the first six 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) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

It is not recommended to use dexketoprofeno while trying to conceive or while studying fertility problems. 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, blurred vision, dizziness, or vertigo as side effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Consult your doctor.

Dexketoprofeno Aurovitas 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 for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of dexketoprofeno that you may need can vary, depending on the type, intensity, and duration of pain. Your doctor will tell you how many tablets to take per day and for how long.

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

Generally, it is recommended to take half a tablet (12.5 mg) every 4 or 6 hours or 1 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 start therapy with a maximum of 2 tablets per day (50 mg).

In elderly patients, this initial dose can be increased later according to the general recommended dose (75 mg) if this medication 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 eating) as they will be absorbed more easily (see section 2 “Taking Dexketoprofeno Aurovitas with food, drinks, and alcohol”).

The tablet can be divided into equal doses.

Use in children and adolescents

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

If you take more Dexketoprofeno Aurovitas than you should

If you have taken too much medication or in case of accidental ingestion, inform your doctor or pharmacist immediately or go to the emergency service of your nearest hospital. Please remember to always carry the medication box or this leaflet with you. You can also call the Toxicological Information Service, phone 91562 04 20, indicating the medication and the amount ingested.

If you forgot to take Dexketoprofeno Aurovitas

Do not take a double dose to compensate for the missed doses. Take the next dose when due (according to section 3 “How to take Dexketoprofeno Aurovitas”).

If you have any other questions 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 order of frequency.

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

Nausea and/or vomiting, mainly upper abdominal pain, diarrhea, digestive disorders (dyspepsia).

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

Dizziness (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, stomach wall inflammation (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation and chills, general discomfort.

Rare side effects(may 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 disorders, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute renal failure.

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

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin ulcers, mouth, eye, and genital area (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), lack of air, tachycardia, low blood pressure, pancreatitis inflammation, blurred vision, ringing in the ears (tinnitus), 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 drugs, and especially if you are an elderly patient.

Stop taking dexketoprofen 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 dexketoprofen may be associated with a small increase in the risk of suffering a heart attack ("myocardial infarction") or stroke ("cerebral infarction").

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

The most commonly observed side effects are of a gastrointestinal nature. They may cause peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly patients.

After administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease have been reported. Less frequently, gastric wall inflammation (gastritis) has been observed.

Like other NSAIDs, hematological reactions (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and medullary hypoplasia) may appear.

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 prospectus.You can also report them directly through the national notification system included in theSpanish System for 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 in the blister pack. 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. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Dexketoprofeno Aurovitas Composition

• The active ingredient is dexketoprofeno trometamol (36.90 mg) corresponding to Dexketoprofeno (DCI) 25 mg.
• The other components (excipients) are: cornstarch, microcrystalline cellulose, sodium carboxymethyl starch, glyceryl distearate, hypromellose, titanium dioxide, macrogol 400.

Appearance of the product and contents of the packaging

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

Packaging sizes:20 and 50 coated tablets with a film coating.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

SAG Manufacturing SLU

Crta N-I, Km 36

28750 San Agustín de Guadalix, Madrid

Spain

O

Galenicum Health, S.L.

Avda. Cornellá 144, 7th-1st Edificio LEKLA

Esplugues de Llobregat

08950 Barcelona

Last review date of this leaflet:April2024

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