Adoldex 25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Adoldex 25 mg film-coated tablets

dexketoprofen

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

Follow exactly the instructions for use of this medicine contained in this leaflet or those indicated 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 4 days.

Contents of the leaflet:

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

1. What Adoldex 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).

Adoldex is used in adults for the short-term symptomatic treatment of mild to moderate acute pain, such as muscle or joint pain (for example, back pain, sprains and acute injuries), menstrual pain, and dental pain.

2. What you need to know before taking Adoldex

Do not take Adoldex

• 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 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, 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 gastrointestinal 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 insufficiency, or severe hepatic insufficiency;
• 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 breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Adoldex:

• If you are allergic or have previously had allergic problems;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have previously had any of these conditions;
• 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, history of stroke, or think you may be at risk of these conditions (e.g., you have high blood pressure, diabetes, elevated cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist. Medicines like Adoldex may be associated with a small increased risk of heart attacks (“myocardial infarction”) or strokes (“cerebrovascular accident”). This risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• If you are an elderly patient, you may experience a higher incidence of 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);
• 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 have or have previously had chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
• If you 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, such as oral corticosteroids, certain antidepressants (SSRIs, selective serotonin reuptake inhibitors), or agents that prevent blood clotting such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. 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 have asthma, combined with chronic rhinitis or sinusitis, and/or nasal polyps, as you are at 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.

Infections

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

During chickenpox, it is advisable to avoid using this medicine.

Kounis Syndrome

Allergic reactions to dexketoprofen, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Discontinue treatment with Adoldex immediately and contact your doctor or the nearest emergency service immediately 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 the product should not be used in children or adolescents.

Taking Adoldex with other medicines:

Inform your doctor or pharmacist if you are currently 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 dose adjustments when used concurrently.

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

Combinations not recommended:

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

Combinations requiring caution:

• ACE inhibitors, diuretics, beta-blockers, 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 glyburide), used for diabetes;
• Methotrexate, when 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 disorders 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);
• Antidepressants of the selective serotonin reuptake inhibitor (SSRI) type;
• 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 Adoldex, consult your doctor or pharmacist.

Taking Adoldex with food and drinks:

Take the tablets with an adequate amount of water. Take the tablets with food, as this helps reduce the risk of gastrointestinal adverse effects. However, in case of acute pain, take the tablets on an empty stomach; i.e., at least 30 minutes before meals, as this allows the medicine to act slightly faster.

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 this medicine during the last three months of pregnancy or while 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 more than expected.

Do not take this medicine 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 become pregnant, you should take the lowest possible dose for the shortest possible time.

From week 20 of pregnancy, this medicine 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 is not recommended while trying to conceive or while undergoing fertility investigations. For potential effects on female fertility, 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 drowsiness or dizziness as adverse effects of treatment. If you experience these effects, do not operate machinery or drive until these symptoms have disappeared. Seek advice from your doctor.

Adoldex contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free.”

3. How to take Adoldex

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 required dose of the medicine 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 immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

The tablet can be divided into equal doses by breaking it along the score line.

Adults over 18 years of age

Generally, the recommended dose is half a tablet (12.5 mg) every 4–6 hours or 1 tablet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 tablets per day (75 mg).

Elderly patients or those with renal or hepatic impairment

If you are elderly or have kidney problems or mild to moderate liver problems, treatment should be initiated with a maximum of 2 tablets 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) if dexketoprofen has been well tolerated.

Do not use dexketoprofen if you have moderate to severe renal problems or severe hepatic problems. 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

Take the tablets with an adequate amount of water.

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 tablet on an empty stomach (at least 30 minutes before any food or drink), as it will be absorbed more easily (see section 2, "Taking Adoldex with food, drinks, and alcohol").

Duration of treatment

Treatment must 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 Adoldex than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 915620420, 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 Adoldex

Do not take a double dose to make up for forgotten doses. Take the next dose as scheduled (according to section 3, "How to take Adoldex").

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:

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):

Sensation of spinning (vertigo), dizziness, somnolence, sleep disorders, nervousness, headache, palpitations, hot flushes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish feeling 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, 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), damage to liver cells (hepatitis), acute kidney failure.

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

Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), skin ulcers, mouth, eyes and genital areas (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, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), sensitive skin, photosensitivity, itching, kidney problems. Decrease in white blood cell count (neutropenia), decrease in platelet count (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 may persist after healing. Drug-induced fixed eruption usually reappears in the same location or locations if the medicine is taken again.

Immediately inform your doctor 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 long-term treatment with anti-inflammatory medicines, and particularly if you are elderly.

Immediately stop taking this medicine if you notice the appearance of a skin rash or lesions in the mouth or genital area, 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 Adoldex 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. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, especially in elderly patients.

Following administration, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, 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 or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, website: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Adoldex

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister, following "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Adoldex

The active substance is dexketoprofen (as dexketoprofen trometamol). Each tablet contains 25 mg of dexketoprofen.

The other components are: microcrystalline cellulose, pregelatinized corn starch, sodium carboxymethyl potato starch, magnesium stearate (E 470b), hypromellose (E 464), polydextrose, titanium dioxide (E171) and macrogol 4000.

Appearance of Adoldex and contents of the pack

Film-coated, round, white tablets with a score line.

Available in packs containing 10 film-coated tablets.

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. de Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the most recent revision of this leaflet: April 2026

Detailed and up-to-date 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/