Leaflet: information for the patient

Difenadex 25 mg hard capsules

dexketoprofen

Read this 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 need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, 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.

1. What isDifenadexand what it is used for

2. What you need to know before starting to takeDifenadex

3. How to takeDifenadex

4. Possible side effects

5. Storage ofDifenadex

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).

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

Do not takeDifenadex

• If you are allergic to dexketoprofen trometamol or to any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or to 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 interior due to allergy), urticaria (skin eruption), angioedema (face, eye, lip, or tongue swelling, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid (aspirin) 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 intake of ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• If you have peptic ulcers, stomach or intestinal bleeding, or if you have had stomach or intestinal bleeding in the past;
• If you have chronic digestive problems (e.g. indigestion, stomach burning); If you have had stomach or intestinal bleeding or perforation in the past 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 renal insufficiency, or severe liver insufficiency;
• If you have bleeding disorders or blood coagulation disorders;
• If you are severely dehydrated (have lost a lot 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 starting to take Difenadex:

• If you are allergic or have had allergic problems in the past;
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or fluid retention or have had any of 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. 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 smoker) consult this treatment with your doctor or pharmacist. Medicines likeDifenadexmay be associated with a small increase in the risk of heart attacks (“myocardial infarction”) or strokes (“cerebrovascular accident”). 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 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(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 (autoimmune diseases affecting connective tissue);
• If you have had or have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have had or have had gastrointestinal or intestinal disorders;
• If you have an infection, see the “Infections” heading below;
• If you are taking other medicines that increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), blood thinners like acetylsalicylic acid (aspirin) or warfarin. In these cases, consult your doctor before takingthis medicine: your doctor may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other acid-blocking medicines).
• If you have asthma, combined 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. Administration of this medicine may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

• Difenadex may mask the signs of an infection, such as fever and pain. Therefore, it is possible that this medicine 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 bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.
• Avoid using this medicine if you have chickenpox.

Children and adolescents

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

Other medicines andDifenadex

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription. There are some medicines that should not be taken together and other medicines that may require 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 associations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood clotting;
• Lithium, used to treat some mood disorders;
• Methotrexate, (cancer and immunosuppressant medicine), 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 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;
• Methotrexate, 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 autoimmune diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medicines; that is, medicines 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-type antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation.
• Beta-blockers, used for high blood pressure and heart conditions;
• Tenofovir, deferasirox, pemetrexed.

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

Administration ofDifenadexwith food and drinks and alcohol

Generally, it is recommended to take the medicine with meals to reduce the possibility of causing stomach problems (see also section 3, “Administration”).

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

Pregnancy, breastfeeding, and fertility

Do not take this medicine during the last three months of pregnancy or while breastfeeding.

Do not take this medicine if you are in the last three 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 this medicine during the first six months of pregnancy unless it is clearly necessary and as your doctor tells you. 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, this medicine 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). If you need treatment for more than a few days, your doctor may recommend additional checks.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine, as it may not be suitable for you.

Women planning to become pregnant or who are pregnant should avoid using this medicine. Treatment at any stage of pregnancy should only take place under a doctor's instructions.

The use of this medicine may affect fertility, so it is not recommended for use while trying to conceive or while studying a fertility problem.

Driving and operating machinery

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

Excipients

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially “sodium-free”.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

The necessary dose of the medication may vary, depending on the type, intensity, and duration of pain. The most effective dose should be used for the shortest period 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

In general, the recommended dose is 1 capsule (25 mg of dexketoprofen) every 8 hours, not exceeding 3 capsules per day (75 mg).

Patients with advanced age or mild renal or hepatic impairment

If you are an elderly patient or suffer from mild renal problems or mild to moderate hepatic problems, it is recommended to start treatment with a maximum of 2 capsules per 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.

You should not use dexketoprofen if you suffer from moderate or severe renal problems or severe hepatic 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 capsules 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 capsule with an empty stomach (at least 15 minutes before any food or ingestion of food) because it will be absorbed more easily (see section 2 “Taking Difenadex 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 with your doctor or pharmacist.

If you takemoreDifenadexthan you should

Consult your doctor or pharmacist immediately 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 leaflet of the medication to the healthcare professional.

If you forgot to takeDifenadex

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 Difenadex”).

If you have any doubts about the use of this medication, consult your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The possible side effects are listed below in order of frequency. Since the list is based in part on the side effects observed with oral tablet use, and since Dexketoprofeno trometamol capsules are absorbed more quickly than tablets, it is possible that the actual frequency of side effects (gastrointestinal) may be higher with Dexketoprofeno capsules. The following table indicates how many patients may experience these side effects:

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

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

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

Rotatory sensation (dizziness), 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 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 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 analysis), liver cell damage (hepatitis), acute renal insufficiency.

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

Anaphylactic reaction (hypersensitivity reaction that may 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), respiratory difficulty due to airway constriction (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis inflammation, blurred vision, 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 agents, and especially if you are an elderly patient.

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 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 Difenadex may be associated with a small increase in the risk of suffering a heart attack ("myocardial infarction") or 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, hematological reactions (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and medullary hypoplasia) may appear.

Reporting of side effects

If you experience any type of side effect, consult your doctororpharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish 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 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.

Store below 25°C.

Store the blister pack in the outer packaging to protect it 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 point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofDifenadex

• Each capsule contains 25 mg of dexketoprofen as dexketoprofen trometamol.

• The other components are:

• Capule content: Maize pregelatinized starch, microcrystalline cellulose, sodium carboxymethylcellulose (Type A) from potato, and diestearoyl glycerol.
• Composition of the capsule (body and cap): Gelatin, titanium dioxide (E171), quinoline yellow (E104), and patent blue V (E131).

Appearance of the product and contents of the packaging

Difenadex 25 mg hard capsules EFG are hard gelatin capsules of green color, containing white or almost white crystalline powder.

The capsules are presented in aluminum/PVC-ACLAR®(PCTFE) or aluminum/PVC-PE-PVDC(90) unit dose blisters, containing 10 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6.

28760 Tres Cantos,

Madrid (Spain).

Last review date of this leaflet:September 2022

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices:http://www.aemps.gob.es