Label: information for the user

Difenadex 25 mg oral solution

Dexketoprofen

Read this label carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to 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 not listed in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 4 days.

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, and dental pain.

Do not take Difenadex

Warnings and precautions

Consult your doctor or pharmacist before starting to take Difenadex:

Infections

Difenadex may mask the signs of an infection, such as fever and pain. Consequently, this medication 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 varicella. 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 varicella.

Children and adolescents

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

Other medications and Difenadex

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription. 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:

Associations requiring caution:

Associations to consider:

• 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 medications; that is, medications used to break down blood clots.
• Probenecid, used for gout.
• Digoxin, used in chronic heart failure treatment.
• 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 medications with Difenadex, consult your doctor or pharmacist.

Taking Difenadex with food, drinks, and alcohol

Generally, 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

Do not take this medication during the last three months of pregnancy or while breastfeeding. Difenadex may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected. Do not take Difenadex during the first six 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, Difenadex 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 constriction 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.

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

Driving and using machines

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

Difenadex contains saccharose, parahydroxybenzoate, ethanol, and sodium

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate.

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 13.8 mg of alcohol (ethanol) in each sachet equivalent to 1.4 mg/ml (0.14% v/v). The amount in 10 ml of this medication is equivalent to less than 1 ml of beer or wine.

The small amount of alcohol in this medication does not produce any perceptible effect.

This medication contains less than 23 mg of sodium (1 mmol) per sachet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication 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 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 18 years and older

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

Patients with advanced age or renal or hepatic insufficiency

If you are an elderly patient, or you suffer from mild renal problems or mild to moderate hepatic 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 this medication 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

The oral solution can be taken directly from the sachet or after removing the contents of this in a glass of water. Once the sachet is opened, consume all its contents.

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 sachet on 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

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

If you take more Difenadex than 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 take Difenadex

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 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 according to their frequency.

Since the list is based in part on the side effects observed with oral tablet use, and since the oral solution in a sachet is absorbed more quickly than tablets, it is possible that the actual frequency of side effects (gastrointestinal) may be higher in the oral solution in a sachet.

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)

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, prostate disorders, abnormal liver function tests (blood tests), 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, eye, and genital area (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or lip and throat swelling (angioedema), difficulty breathing due to narrowing of 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 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 drugs, 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 (“cerebral infarction”).

In patients with immune system 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 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, meningitis aséptica may appear, which may predominantly occur in patients with systemic lupus erythematosus or mixed connective tissue disease, and hematological reactions (purpura, aplastic and hemolytic anemia, and, less rarely, agranulocytosis and medullary hypoplasia).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the 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 on the overwrap after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Difenadex

The active ingredient is dexketoprofen trometamol. Each sachet of oral solution contains 36.9 mg of dexketoprofen trometamol equivalent to 25 mg of dexketoprofen.

The other components are: ammonium glycyrrhizate, neohesperidin dihydrochalcone, methyl parahydroxybenzoate (E-218), sodium saccharin, sucrose, macrogol, lemon flavor (contains ethanol), povidone, anhydrous sodium hydrogen phosphate, dihydrogen sodium phosphate dihydrate, purified water.

Appearance of the product and contents of the packaging

Transparent yellow-orange solution with a lemon-citrus odor, packaged in single-dose sachets of 10 ml.

It is presented in packaging containing 10 sachets.

Marketing Authorization Holder:

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

Tres Cantos, 28760, Madrid

Responsible for manufacturing

SAG MANUFACTURING S.L.U.

Crta N-I, Km 36, San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health., S.L.

Calle de San Gabriel 50

Pol Ind Esplugues de Llobregat

Esplugues de Llobregat,

08950 Barcelona

Spain

Last review date of this leaflet:March 2024

Other sources of information:

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.