Dexketoprofen Aurovitas Pharma 25 mg oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dexketoprofen Aurovitas Pharma 25 mg oral solution

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

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

Contents of this leaflet

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

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

This medicine is an analgesic belonging to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as acute muscle or joint pain, menstrual pain (dysmenorrhoea), or dental pain.

Dexketoprofeno Aurovitas Pharma is indicated for use in adult patients.

2. What you need to know before taking Dexketoprofeno Aurovitas Pharma

Do not take Dexketoprofeno Aurovitas Pharma

• If you are allergic to dexketoprofen or to any of the other components 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 (aspirin) or other non-steroidal anti-inflammatory drugs;
• 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 drug) or fibrates (medicines used to reduce blood fat levels);
• • If you have peptic ulcer, stomach or intestinal bleeding, or have previously experienced bleeding, ulceration, or perforation of the stomach or intestine;
  • If you have chronic digestive problems (e.g., indigestion, heartburn);
  • If you have previously experienced stomach or intestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) 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 impairment, or severe hepatic impairment;
  • If you have bleeding disorders or blood coagulation disorders;
  • If you are severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;
  • If you are in the third trimester of pregnancy or during breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take dexketoprofen:

• 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), or 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., from excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of stroke, or think you may be at risk of these conditions (e.g., you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist. Medicines like dexketoprofen may be associated with a small increased risk of heart attacks (“myocardial infarction”) or strokes (“cerebrovascular accident”). Any risk is more likely when high doses are used or treatment is prolonged. 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) (see section 2, “Pregnancy, breastfeeding, and fertility”);
• 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 section “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 or acenocoumarol. In such cases, consult your doctor before taking this medicine: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other drugs that block gastric acid production);
• If you suffer from asthma, combined 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.

Children and adolescents

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

Infections

This medicine may mask signs of infection, such as fever and pain. Therefore, it may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin bacterial infections related to 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 if you have chickenpox.

Other medicines and Dexketoprofeno Aurovitas Pharma

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine, including those obtained without a prescription. Some medicines should not be taken together, and others may require dose adjustments when taken concurrently.

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

Combinations not recommended:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin or acenocoumarol, heparin, or other medicines used to prevent blood clotting;
• Lithium, used to treat certain mood disorders;
• Methotrexate, used for rheumatoid arthritis, cancer, and as an immunosuppressant, 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 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;
• Sulfonylureas (e.g., chlorpropamide and glyburide), used for diabetes;
• Methotrexate, 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 diseases 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;
• Beta-blockers, used for high blood pressure and heart conditions;
• Tenofovir, deferasirox, pemetrexed.

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

Taking Dexketoprofeno Aurovitas Pharma with food, drinks, and alcohol

In general, it is recommended to take the medicine with food to reduce the likelihood of gastrointestinal disturbances (see also section 3, “How to take”).

You should not drink alcohol while using this medicine. Some side effects, such as those affecting the gastrointestinal tract or the central nervous system, are more likely when alcohol is consumed at the same time as dexketoprofen.

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 dexketoprofen during the last three months of pregnancy or while breastfeeding, as it may harm the fetus or cause delivery complications. 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 the expected duration.

You should not take dexketoprofen during the first six 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 effective dose for the shortest possible time.

From week 20 of pregnancy, dexketoprofen may cause kidney problems in your fetus if taken for more than a few days, which may lead 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 is needed for longer than a few days, your doctor may recommend additional monitoring.

The use of this medicine may impair fertility; therefore, its use is not recommended while trying to conceive or during fertility investigations (see also section 2, “Warnings and precautions”).

Driving and using machines

This medicine may slightly affect your ability to drive and use machines, as it may cause dizziness, drowsiness, and blurred vision as adverse effects. If you experience these effects, do not operate machinery or drive until these symptoms resolve. Seek advice from your doctor.

Dexketoprofeno Aurovitas Pharma contains sucrose, methyl parahydroxybenzoate (E-218), ethanol, and sodium

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate.

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 2 g of sucrose per sachet.

This medicine contains 13.8 mg of alcohol (ethanol) in each sachet. The amount in 10 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.

The small amount of alcohol contained in this medicine does not produce any noticeable effect.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; therefore, it is essentially “sodium-free”.

3. How to take Dexketoprofen Aurovitas Pharma

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The dose you require may vary depending on the type, intensity, and duration of pain.

The lowest effective dose should be used for the shortest duration necessary 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).

Adults over 18 years of age

The usual recommended dose is 1 sachet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 sachets per day (75 mg).

Elderly patients or patients with renal or hepatic impairment

If you are elderly or have mild renal impairment or mild to moderate hepatic impairment, treatment should be initiated with a maximum of 2 sachets per day (50 mg of dexketoprofen).

In elderly patients, this initial dose may subsequently be increased according to the general recommended dose (75 mg of dexketoprofen), provided this medicine has been well tolerated.

Do not use dexketoprofen if you have moderate or severe renal impairment or severe hepatic impairment. Consult your doctor or pharmacist if you are unsure.

Use in children and adolescents

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

Method of administration

The oral solution can be taken directly from the sachet or after dissolving the contents in a glass of water. Once the sachet has been opened, consume all of its contents.

This medicine may be taken with or without food. Taking the medicine with food helps reduce the risk of stomach or intestinal disturbances. However, if your pain is more intense and you need faster relief, take the sachets on an empty stomach (at least 15 minutes before any food or intake of food), as they will be absorbed more easily (see section 2, "Taking Dexketoprofen Aurovitas Pharma with food, drinks, and alcohol").

Duration of treatment

Treatment should not exceed 4 days. If pain persists beyond this period, worsens, or new symptoms appear, discontinue treatment and consult your doctor or pharmacist.

If you take more Dexketoprofen Aurovitas Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Please remember to always carry the medicine packaging or this leaflet with you.

If you forget to take Dexketoprofen Aurovitas Pharma

Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time (according to section 3, "How to take Dexketoprofen Aurovitas Pharma").

If you stop treatment with Dexketoprofen Aurovitas Pharma

If you have any further questions about the use of this medicine, consult 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.

Since peak plasma concentrations of dexketoprofen achieved with the oral solution formulation are higher than those obtained with tablets, a potential increase in the risk of adverse reactions (gastrointestinal) cannot be ruled out.

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

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

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

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

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

Peptic ulcer, peptic ulcer perforation 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 kidney failure.

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

Anaphylactic reaction (hypersensitivity reaction that may also lead to collapse), skin ulcers, mouth, eyes or genital areas (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, photosensitivity, itching, kidney problems. Decreased number of white blood cells (neutropenia), decreased number of platelets (thrombocytopenia).

Adverse effects with unknown frequency (frequency cannot be determined 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 can persist after healing. Drug-induced fixed eruption usually recurs in the same location or locations if the medicine is taken again.

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), especially if you have previously experienced any of these adverse effects due to prolonged treatment with anti-inflammatory drugs, and particularly if you are an elderly patient.

Stop taking this medicine immediately if you notice the appearance of a skin rash or any lesions inside the mouth or in the genital area, or any other signs of allergy.

During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), 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 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.

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

Following administration, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, and 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, aseptic meningitis may occur, predominantly in patients with systemic lupus erythematosus or mixed connective tissue disease, and haematological reactions (purpura, aplastic and haemolytic anaemia, and more rarely agranulocytosis and bone marrow hypoplasia).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Pharma

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

Store below 30°C.

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. If in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Dexketoprofeno Aurovitas Pharma

• The active substance is 25 mg of dexketoprofen, in the form of dexketoprofen trometamol.

• The other components are: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, methyl 4-hydroxybenzoate (E-218), sodium saccharin, sucrose, macrogol, lemon flavour (containing ethanol), povidone, anhydrous sodium hydrogen phosphate, sodium dihydrogen phosphate dihydrate, and purified water.

Appearance of the product and contents of the pack

Yellow-orange transparent solution with a lemon-citrus odour, packed in single-dose 10 ml sachets.

It is available in packs containing 10 or 15 sachets.

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16D

28036 Madrid

Spain

Manufacturer:

SAG MANUFACTURING S.L.U.

Crta N-I, Km 36, San Agustin de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50,

Esplugues de Llobregat,

08950 Barcelona

Spain

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

Other sources of information

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