Prospecto:information for the user

Adolquir 25 mg cfilm-coated tablets EFG

Dexketoprofen

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

- Keep this prospectus, as you may need to read it again.

- If you have any doubts, consult yourdoctor or pharmacist.

-This medication has been prescribedonlyto you, and you must not give it to other peoplealthoughthey may havethe same symptomsas you,as it may harm them.

- If you experience adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this prospectus. See section 4.

1.What is Adolquir and for what it is used

2.What you need to know before starting to take Adolquir

3.How to take Adolquir

4.Possible adverse effects

1. Storage of Adolquir

Contents of the package 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 in adults for the short-term symptomatic treatment of mild to moderate acute pain, such as muscle pain or joint pain, menstrual pain, and dental pain..

Do not takeAdolquir

-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 inside the nose due to allergy), urticaria (skin eruption), angioedema (swelling of the face, eyes, lips, or tongue, 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 lipid levels);

• If you have a stomach ulcer, stomach or intestinal bleeding, or have had these conditions in the past;
• If you have chronic digestive problems (e.g., indigestion, stomach burning);
• If you have had stomach or intestinal bleeding, ulceration, 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 kidney failure, or severe liver failure;

-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 takeAdolquir:

-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 (e.g., excessive urination, diarrhea, or vomiting);

-If you have heart problems, a history of strokes, or think you may be at risk of these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking), consult this treatment with your doctor or pharmacist. Medications likeAdolquirmay be associated with a small increase in the risk of heart attacks or strokes. Any 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 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 (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 (immune system diseases affecting connective tissue);

-If you have or have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);

-If you have or have had stomach or intestinal disorders;

-If you have an infection; see the "Infections" heading below;

-If you are taking other medications that increase the risk of stomach ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), blood thinners such as acetylsalicylic acid (aspirin) or warfarin. In these cases, consult your doctor before taking this medication: 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 allergic 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

Adolquir may mask the signs of an infection, such as fever and pain. Therefore, it is possible that 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 chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Avoid using this medicationif you have chickenpox.

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 Adolquir

Inform your doctor or pharmacist if you are taking or 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 if 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:

-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 and immunosuppressant medication), 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 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 for bacterial infections;

-Sulfonylureas (e.g., chlorpropamide and glibenclamide), used for diabetes;

-Metotrexate, used at low doses, less than 15 mg/week.

Associations to be taken into account:

-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 in the treatment of chronic heart failure;

-Mifepristone, used as an abortifacient (to interrupt pregnancy);

-SSRI antidepressants;

-Antiplatelet medications 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 withAdolquir, consult your doctor or pharmacist.

Adolquir with 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 takethis medicationin the last three months of pregnancy or during breastfeeding.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 Adolquir 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, Adolquir 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.

The use of this medication may harm fertility, so it is not recommended to usethis medicationwhile trying to conceive or while studying a fertility problem.

Driving and using machines

This medicationmay affect your ability to drive and use machines slightly, 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.

Adolquir contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

The effective dose should be used 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).

Tablets can be divided into equal doses.

Adults over 18 years old

Generally, the recommended dose is half a tablet (12.5 mg of dexketoprofen) every 4-6 hours or 1 tablet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 tablets per 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 of 2 tablets per day (50 mg of dexketoprofen).

In elderly patients, this initial dose can be increased later according to the general recommended dose (75 mg of dexketoprofen) if the 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 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 problems, however, if your pain is more intense and you need faster relief, take the tablet on 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 with food, drinks, and alcohol").

If you take more Adolquir than you should

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Adolquir

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

If you have doubts about the use of this medication, consult 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 flushes, 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: 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 lip and throat swelling (angioedema), difficulty breathing due to narrowing of 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 elderly.

Stop taking this medicine immediately if you notice the appearance of a skin rash or any lesion 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 Adolquir 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, they may cause hematological reactions (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and medullary hypoplasia).

Reporting of side effectsIf 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 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 usethis medicationafter the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store above 30 °C. Store the blister packs in the original packaging to protect them from light.

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

Composition ofAdolquir

- The active ingredient is dexketoprofen (as dexketoprofen trometamol). Each coated tablet contains 25 mg of dexketoprofen.

- The other components are:

Tablet core:cornstarch, microcrystalline cellulose, sodium carboxymethyl starch (Type A) (potato starch), glyceryl distearate.

Tablet coating: dry lacquer composed of: hypromellose, titanium dioxide, and macrogol 6000, and propylene glycol(E-1520).

Appearance ofAdolquirand content of the container

Coated tablets with a white film coating, round, scored on both sides, with convex sides.

It is presented in containers of 20 and 500 coated tablets. The tablets are presented in blisters (PVC-aluminum blisters).

Only some container sizes may be commercially marketed.

Marketing authorization holder

LABORATORIOS MENARINI, S.A.

Alfons XII, 587

08918 Badalona (Barcelona) Spain

Responsible for manufacturing

LABORATORIOS MENARINI, S.A.

Alfons XII, 587

08918 Badalona (Barcelona) Spain

A. MENARINI MANUFACTURING LOGISTICS AND SERVICES, s.r.l.

Via Campo di Pile s/n – L’AQUILA – Italy

Last review date of this leaflet:April 2023

Other sources of information

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