Patient Information Leaflet

Adoldex 25 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine. It contains important information for you.

Follow exactly the instructions for taking the medicine contained in this leaflet or those given by your doctor, pharmacist or nurse.

• 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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should see a doctor if you get worse or do not improve after 4 days.

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.Storage of Adoldex

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).

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 trauma), menstrual pain, and dental pain.

Do not take Adoldex

• 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 or have had in the past peptic ulcers, stomach or intestinal bleeding, or chronic digestive problems (e.g., indigestion, stomach burning);
• If you have had in the past stomach or intestinal bleeding 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 pregnant or breastfeeding;
• If you are under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Adoldex:

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), 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 for these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking) consult this treatment with your doctor or pharmacist. Medications like this may be associated with a small increase in the risk of heart attacks ("myocardial infarction") or strokes ("cerebral vascular accident"). This 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 an elderly patient, 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 medication may decrease your fertility, so do not take it if you are planning to become pregnant or are undergoing fertility studies);
• If you have a disorder in blood production and blood cells;
• If you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases that affect connective tissue);
• If you have or have had in the past chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have or have had in the past gastrointestinal or intestinal disorders;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, some antidepressants (SSRI type), blood thinners like 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 acid-blocking medications).

Infections

This medication may mask the signs of an infection, such as fever and pain. Therefore, 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 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 medication if you have chickenpox

Children and adolescents

Do not take this medication if you are under 18 years old.

Other medications and Adoldex

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication. There are some medications that should not be taken together and other medications that may require a dose change if taken together.

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

Not recommended associations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medications used to prevent blood clotting;
• Lithium, used to treat mood disorders;
• Methotrexate, used to treat rheumatoid arthritis and cancer;
• Hydantoins and phenytoin, used to treat epilepsy;
• Sulfamethoxazole, used to treat bacterial infections.

Associations requiring caution:

• ACE inhibitors, diuretics, beta-blockers, 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;
• Chlorpropamide and glibenclamide, used to treat diabetes.

Associations to consider:

• 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 dissolve blood clots;
• Probenecid, used to treat gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• SSRI-type antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and blood clotting.

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

Adoldex 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

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 this medication during pregnancy or breastfeeding. Consult your doctor or pharmacist before using any medication.

• Inform your doctor if you are pregnant or planning to become pregnant, as this medication may not be suitable for you.
• Do not take this medication if you are breastfeeding. Seek advice from your doctor.
• Do not take Adoldex if you are in the last 3 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 Adoldex during the first 6 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, Adoldex 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.

Driving and using machines

This medication may slightly affect your ability to drive and use machines, as it may cause drowsiness or dizziness as adverse effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Seek advice from your doctor.

Adoldex contains sodium

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

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

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

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).

Adults aged 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 patient, or you have 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 dexketoprofen has been well tolerated.

Do not use this medication if you have 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

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 gastrointestinal 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 meal or ingestion of food) because it will be absorbed more easily (see section 2 "Adoldex intake with food, drinks, and alcohol").

Treatment duration

The treatment should not exceed 4 days. If the pain persists after this period of time, worsens, or other symptoms appear, you should interrupt the treatment and consult your doctor or pharmacist.

If you take more Adoldex than you should

If you have taken too much medication, immediately inform your doctor or pharmacist or go to the emergency service of your nearest hospital. Please remember to always carry the medication box or this leaflet with you. In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 915620420, indicating the medication and the amount ingested.

If you forgot to take Adoldex

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 Adoldex”).

If you have any other doubts about the use of this medication, ask 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 accordance with their 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 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 disorders, prostatic disorders, abnormal liver function tests (blood analysis), 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, eyes, and genital areas (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of the lips and throat (angioedema), respiratory difficulty due to narrowing of the airways (bronchospasm), shortness of breath, 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 beginning 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 Adoldex may be associated with a small increase in the risk of suffering a heart attack (“myocardial infarction”) or a stroke (“stroke”).

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 effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for human use, website: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 in the blister pack, after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 86°F (30°C).

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at 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 of Adoldex

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

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

Appearance of Adoldex and contents of the packaging

Coated tablets, round, with a notch and white in color.

Available in packaging containing 10 coated tablets.

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. de Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

08970 Sant Joan Despi (Barcelona)

Spain

Last review date of this leaflet:January 2023

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/