Adolquir 25 mg granules for oral solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Adolquir 25 mg oral granules for solution EFG

Dexketoprofen

Read the entire leaflet carefully before you start taking 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, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Adolquir is and what it is used for
2. What you need to know before taking Adolquir
3. How to take Adolquir
4. Possible adverse effects
5. Storage of Adolquir

Pack contents and additional information

1. What Adolquir is and what it is used for

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

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

2. What you need to know before taking Adolquir

Do not take Adolquir

• 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 any other 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 non-steroidal anti-inflammatory drugs;
• If you have had photosensitivity reactions 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, gastrointestinal bleeding, or have previously experienced gastrointestinal bleeding, ulceration, or perforation;
• 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) 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 large amount 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

Talk to your doctor or pharmacist before taking Adolquir:

• 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., from excessive urination, diarrhea, or vomiting);
• If you have heart conditions, 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 Adolquir 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 (see section 2, "Pregnancy, breastfeeding, and fertility");
• If you have a disorder affecting blood and 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 titled «Infections» below;
• If you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, certain antidepressants (SSRIs, selective serotonin reuptake inhibitors), or anticoagulant agents like acetylsalicylic acid (aspirin) or anticoagulants such as warfarin or acenocumarol (Sintrom). In these cases, consult your doctor before taking this medicine: 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, especially when associated 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. Taking this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Adolquir may mask signs of infection such as fever and pain. Therefore, this medicine may delay appropriate treatment of 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 your infection symptoms persist or worsen, consult a doctor immediately.

Avoid using this medicine if you have chickenpox.

Kounis Syndrome

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

Children and Adolescents

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

Other Medicines and Adolquir

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 a dose adjustment when used concomitantly.

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

Associations not recommended:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin or acenocoumarol (Sintrom), heparin, or other medicines used to prevent blood clot formation;
• Lithium, used to treat certain mood disorders;
• Methotrexate (a cancer medication and immunosuppressant), when used at high doses of 15 mg/week;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections;

Associations requiring caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists, used for controlling high blood pressure and heart disorders;
• 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 glibenclamide), used for diabetes;
• Methotrexate, used at low doses (less than 15 mg/week).

Associations 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 agents—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 disorders;
  • Tenofovir, deferasirox, pemetrexed.

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

Taking Adolquir with food, drinks, and alcohol

In general, it is recommended to take the medicine with food to reduce the possibility of gastrointestinal disturbances (see also section 3, "Directions for use").

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

Pregnancy, breastfeeding, and fertility

Do not take this medicine during the last three months of pregnancy or during breastfeeding. It may cause kidney and heart problems in your fetus. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labor beyond expected duration.

You should not take Adolquir 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 become pregnant, the lowest effective dose should be used 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 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 for longer than a few days is needed, your doctor may recommend additional monitoring.

Use of this medicine may impair fertility; therefore, its use is not recommended when trying to conceive or when undergoing infertility evaluation.

Driving and use of machines

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

Adolquir contains sucrose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine. It contains 2.418 g of sucrose per dose, which should be taken into account in patients with diabetes mellitus.

3. How to take Adolquir

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

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

The lowest effective dose should be used for the shortest time 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

In general, the 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 an elderly patient or have mild renal impairment or mild to moderate hepatic impairment, it is recommended to start treatment 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 the medicine has been well tolerated.

Dexketoprofen must not be used 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

Dissolve the entire contents of one sachet in a glass of water; shake/stir to help dissolve. The resulting solution should be taken immediately after reconstitution.

The medicine may be taken with or without food. Taking the medicine with food helps reduce the risk of stomach disturbances; however, if your pain is more intense and you need faster relief, take the sachet on an empty stomach (at least 15 minutes before any meal or food intake), as it will be absorbed more rapidly (see section 2, "Taking Enandol with food, drinks and alcohol").

If you take more Adolquir than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Adolquir:

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

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. Since this list is partly based on adverse effects observed with the oral use of tablets, and granules for oral solution are absorbed more rapidly than tablets, the actual frequency of (gastrointestinal) adverse effects may be higher with the granules for oral solution.

Frequent adverse effects: may affect up to 1 in 10 people

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

Uncommon adverse effects: may affect up to 1 in 100 people

Rotational 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, feeling of fever 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, elevated blood pressure, slow breathing, fluid retention and peripheral swelling (e.g., swelling of 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: may affect up to 1 in 10,000 people

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

Not known: frequency cannot be estimated from available data

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

Drug-induced fixed eruption

Allergic skin reaction known as drug-induced fixed 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 can persist after healing. Drug-induced fixed eruption usually reappears 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 such adverse effects due to prolonged treatment with anti-inflammatory medicines, and particularly if you are elderly.

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 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 Adolquir 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.

After administration, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, 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, haematological reactions (purpura, aplastic and haemolytic anaemia, and more rarely agranulocytosis and bone marrow hypoplasia) may occur.

Reporting of adverse effects

If you experience any type of adverse effect, consult 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 Adolquir

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging and sachet after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Adolquir

• The active substance is dexketoprofen (as dexketoprofen trometamine). Each sachet contains 25 mg of dexketoprofen.

• The other components are: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, quinoline yellow (E-104), lemon flavor, and sucrose (see section 2, Adolquir contains sucrose).

Appearance of Adolquir and contents of the pack

Yellow lemon-colored granules.

The oral solution granules are supplied in single-dose sachets made of coated aluminum-polyethylene, heat-sealed.

Available in packs of 20 and 500 sachets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS MENARINI, S.A.
Alfons XII, 587
08918 Badalona (Barcelona), Spain

Date of the most recent review of this leaflet: September 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.es/.