Leaflet: information for the user

Dexketoprofeno Aurovitas Pharma 25 mg oral solution

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

Follow exactly the administration instructions contained in this leaflet or those given 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 4 days.

1. What isDexketoprofeno Aurovitas Pharmaand what it is used for

2. What you need to know before starting to takeDexketoprofeno Aurovitas Pharma

3. How to takeDexketoprofeno Aurovitas Pharma

4. Possible side effects

5. Storage ofDexketoprofeno Aurovitas Pharma

6. Contents of the pack and additional information

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

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

Dexketoprofeno Aurovitas Pharma is indicated for adult patients.

Do not take Dexketoprofeno Aurovitas Pharma

• 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 cavity due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, 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 ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medications used to reduce blood lipid levels);
• • If you have peptic ulcers, stomach or intestinal bleeding, or have had in the past stomach or intestinal bleeding, ulceration, or perforation;
  • If you have chronic digestive problems (e.g., indigestion, stomach burning);
  • If you have had in the past stomach or intestinal bleeding or perforation due to the use of previous 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 coagulation 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 dexketoprofen:

Children and adolescents

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

Infections

This medication may mask the signs of an infection, such as fever and pain. Consequently, it may delay the appropriate treatment of the infection, increasing 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.

Other medications and Dexketoprofeno Aurovitas Pharma

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.

Inform your doctor, dentist, or pharmacist if, in addition to this medication, you are taking any of the following medications:

Non-recommended associations:

Associations requiring caution:

Associations to be considered:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used to treat bacterial infections;
• Ciclosporin 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 to treat gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• Antidepressants of the type Selective Serotonin Reuptake Inhibitors (SSRIs);
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation.
• Beta-blockers, used to treat high blood pressure and heart conditions.
• Tenofovir, deferasirox, pemetrexed.

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

Taking Dexketoprofeno Aurovitas Pharma with food, drinks, and alcohol

Generally, it is recommended to take the medication with meals to reduce the possibility of causing gastrointestinal problems (see also section 3, "Form of administration").

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

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 medication.

Do not take dexketoprofen if you are in the last three 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 bleeding and delay or prolong delivery more than expected. Do not take dexketoprofen 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, dexketoprofen 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 monitoring.

The use of this medication may affect fertility, soit is not recommended to use it while trying to conceive or while studying a fertility problem.

Driving and using machines

This medication may slightly affect your ability to drive and use machines, as it may cause dizziness, drowsiness, 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 Aurovitas Pharma contains saccharose, parahydroxybenzoate of methyl (E-218), ethanol, and sodium

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

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

Patients with diabetes mellitus should note that this medication contains 2 g of saccharose per tablet.

This medication contains 0.1% ethanol (ethyl alcohol) per tablet, equivalent to 13.8 mg.The small amount of alcohol it contains does not produce any perceptible effect.

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 of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

You should 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).

Adults 18 years and older

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

Patients with advanced age or renal or hepatic insufficiency

If you are an elderly person or suffer from mild renal problems or mild to moderate liver problems, it is recommended to start treatment with a maximum of 2 tablets a day (50 mg of dexketoprofen).

In elderly patients, this initial dose may be increased subsequently in accordance with the general recommended dose (75 mg of dexketoprofen) if this medication has been well tolerated.

You should not use dexketoprofen if you suffer from moderate or severe renal 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).

Administration form

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

The medication can be taken with or without food. Taking the medication with food helps to reduce the risk of gastrointestinal disorders, however, if your pain is more intense and you need rapid relief, take the sachets with an empty stomach (at least 15 minutes before any meal or ingestion of food) as they will be absorbed more easily.(see section 2 “Taking Dexketoprofen Aurovitas Pharma with food, drinks, and alcohol”).

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Dexketoprofen Aurovitas Pharma

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 take Dexketoprofeno Aurovitas Pharma”).

If you interrupt treatment with Dexketoprofeno Aurovitas Pharma

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

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

The possible side effects are listed below in order of frequency.

Due to the higher plasma concentrations of dexketoprofen achieved with the oral solution formulation compared to tablets, a potential increase in the risk of adverse reactions (gastrointestinal) cannot be ruled out.

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

Nausea and/or vomiting, stomach 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 irregularities, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute renal insufficiency.

Very rare (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, liver cell damage (hepatitis), 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, bleeding), if you have previously experienced any of these side effects due to prolonged treatment with anti-inflammatory agents, and especially 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 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 a 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.

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, meningitis may occur, which may predominantly occur in patients with systemic lupus erythematosus or mixed connective tissue disease, and hematological reactions (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and medullary hypoplasia).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the 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 overwrap after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Dexketoprofen CompositionAurovitas Pharma

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

• The other components are: ammonium glycyrrhizate, neohesperidin dihydrochalcone, methyl parahydroxybenzoate (E-218), sodium saccharin, sucrose, macrogol, lemon flavor (contains ethanol), povidone, anhydrous sodium hydrogen phosphate, dihydrogen sodium phosphate dihydrate, purified water.

Product appearance and packaging contents

Transparent yellow-orange solution with a lemon-citrus odor, packaged in single-dose sachets of 10 ml.

It is presented in packaging containing 10 or 15 sachets.

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16D

28036 Madrid

Spain

Responsible 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

Last review date of this leaflet:May 2024

Other sources of information:

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