ADOLDEX 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Adoldex 25 mg Film-Coated Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 4 days.

Contents of the Package Leaflet:

1. What is Adoldex and what is it 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 further information

1. What is Adoldex and what is it used for

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

Adoldex is used in adults for the short-term symptomatic treatment of acute pain of mild to moderate intensity, such as muscle or joint pain (e.g., back pain, sprains, and acute trauma), menstrual pain, and toothache.

2. What you need to know before taking Adoldex

Do not take Adoldex

• If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory medicines;
• If you have asthma or have suffered from asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose due to allergy), hives (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or wheezing in the chest after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory medicines;
• If you have or have had in the past peptic ulcer, stomach or intestinal bleeding, or chronic digestive problems (e.g., indigestion, heartburn);
• If you have suffered in the past from stomach or intestinal bleeding or perforation due to the use of non-steroidal anti-inflammatory medicines (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 impairment, or severe hepatic impairment;
• If you have bleeding disorders or blood coagulation disorders;
• If you are pregnant or breastfeeding;
• If you are under 18 years of age.

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 disease (hypertension and/or heart failure), or fluid retention or have suffered from these diseases in the past;
• If you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (e.g., due to excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of stroke, or think you may be at risk of suffering from these disorders (e.g., you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) you should consult your doctor or pharmacist about this treatment. Medicines like this one may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or stroke. This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or duration of treatment;
• If you are an elderly patient, you may suffer from a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (this medicine may decrease your fertility, so you should not take it if you are planning to become pregnant or if you are undergoing fertility studies);
• If you suffer from a blood disorder or blood cell disorder;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you suffer or have suffered in the past from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you suffer or have suffered in the past from stomach or intestinal disorders;
• If you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), agents that prevent clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. 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).

Infections

This medicine may hide the signs of an infection, such as fever and pain. Consequently, it may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Avoid using this medicine if you have chickenpox

Children and adolescents

Do not take this medicine if you are under 18 years of age.

Other medicines and Adoldex

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicine. There are some medicines that should not be taken together and others that may need a dose change if taken together.

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

Not recommended combinations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory medicines;
• Warfarin, heparin, and other medicines used to prevent clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate, used for rheumatoid arthritis and cancer;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections.

Combinations that require caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used for high blood pressure and heart disorders;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used for bacterial infections;
• Chlorpropamide and glibenclamide, used for diabetes.

Combinations to be taken into account:

• Quinolones (e.g., ciprofloxacin, levofloxacin) used for bacterial infections;
• Cyclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• 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 pregnancy termination);
• Antidepressants of the SSRI type (Selective Serotonin Reuptake Inhibitors);
• Antiplatelet agents used to reduce platelet aggregation and clot formation.

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

Taking Adoldex with food, drinks, and alcohol

Generally, it is recommended to take the medicine with meals to reduce the possibility of causing stomach disorders (see also section 3, "Method 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine during pregnancy or breastfeeding. Consult your doctor or pharmacist before using any medicine.

• Tell your doctor if you are pregnant or planning to become pregnant, as this medicine may not be suitable for you.
• Do not take this medicine if you are breastfeeding. Ask your doctor for advice.
• 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 and your baby's tendency to bleed and delay or prolong delivery more than expected. You should 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 the 20th week of pregnancy, Adoldex 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 you need treatment for more than a few days, your doctor may recommend additional monitoring.

Driving and using machines

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

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 the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

The lowest effective dose should be used for the shortest time necessary to alleviate the symptoms. If you have an infection, consult a doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

Adults over 18 years of age

Generally, the recommended dose is 1 tablet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 tablets per day (75 mg).

Elderly patients or patients with renal or hepatic impairment

If you are an elderly patient or have 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 may be increased later according to the general recommended dose (75 mg of dexketoprofen) if dexketoprofen has been well tolerated.

You should not use this medicine if you have moderate or severe renal problems or severe liver problems. Consult your doctor or pharmacist if you are not sure.

Use in children and adolescents

This medicine should not be used in children and adolescents (under 18 years of age).

Method of administration

Take the tablets with a sufficient amount of water.

The medicine can be taken with or without food. Taking the medicine with food helps to reduce the risk of stomach disorders; 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 food intake) because it will be absorbed more easily (see section 2 "Taking Adoldex with food, drinks, and alcohol").

Duration of treatment

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

If you take more Adoldex than you should

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

If you forget to take Adoldex

Do not take a double dose to make up for forgotten doses. Take the next dose when it is due (according to section 3 "How to take Adoldex").

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The possible side effects are listed below according to their frequency:

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

Nausea and/or vomiting, mainly pain in the upper abdominal quadrant, diarrhea, digestive disorders (dyspepsia).

Uncommon side effects (may affect up to 1 in 100 people):

Dizziness (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation, and chills, general malaise.

Rare side effects (may affect up to 1 in 1,000 people)

Peptic ulcer, perforation of peptic ulcer, or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention, and peripheral edema (e.g., swelling of the 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 kidney failure.

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

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin ulcers, mouth ulcers, eye ulcers, or genital ulcers (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), shortness of breath, tachycardia, low blood pressure, pancreatitis, blurred vision, tinnitus (ringing in the ears), sensitive skin, sensitivity to light, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Tell your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g., stomach pain or burning, or bleeding), especially if you have previously suffered from these side effects due to prolonged treatment with anti-inflammatory medicines, 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 non-steroidal anti-inflammatory medicines, cases of fluid retention and swelling (especially in the ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines like Adoldex may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or stroke.

In patients with immune system disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness.

The most common side effects observed are of a gastrointestinal nature. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, sometimes fatally, 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, gastritis has been observed.

As with other NSAIDs, hematological reactions (purpura, aplastic anemia, and hemolytic anemia, and more rarely agranulocytosis and bone marrow hypoplasia) may occur.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use, website: www.notificaRAM.es.

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

5. Storage of Adoldex

Keep this medicine out of the sight and reach of children.

Do not use this medicine after 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 at a temperature above 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Adoldex

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

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

Appearance of Adoldex and Package Contents

White, round, film-coated tablets with a score line.

Available in packages 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 Despi (Barcelona)

Spain

Date of the Last Revision of this Leaflet:January 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS), http://www.aemps.gob.es/