Difenadol 400 mg comprimidos recubiertos con pelicula

Package Insert: Information for the User

Difenadol 400 mg Film-Coated Tablets

ibuprofen

Read this package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those provided by your doctor or pharmacist.

• Keep this package insert, 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 package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days if you have a fever or 4 days for pain treatment as an adult. You should consult a doctor if your condition worsens or does not improve after 3 days as a teenager.

Difenadol contains the active ingredient ibuprofen. Ibuprofen is a medication that reduces fever and relieves pain (nonsteroidal anti-inflammatory drug (NSAID).

In adults and adolescents weighing 40 kg or more (12 years or older) it is used for the short-term symptomatic treatment of mild to moderate pain and/or fever.

Do not take Difenadol

Warnings and precautions

Allergic reactions are minimized by using the lowest effective dose for the shortest period of time.

You should consult your treatment with your doctor or pharmacist before taking Difenadol:

Effects on the gastrointestinal tract

The combined use of ibuprofen with other anti-inflammatory non-steroidal drugs (NSAIDs), including those called COX-2 inhibitors (COX-2 inhibitors), should be avoided.

Bleeding of the gastrointestinal tract, ulcers, and perforation:

Cases of gastrointestinal bleeding, ulcers, and perforation (which can be fatal) have been reported during treatment with NSAIDs. At any time during treatment, with or without previous warning symptoms, and with or without previous history of severe gastrointestinal events.

The risk of experiencing gastrointestinal bleeding, ulcers, and perforation is higher with increasing doses of NSAIDs and is higher in patients with a history of ulcers, especially with complications of bleeding or perforation (see section 2 "Do not take Difenadol") and in elderly patients. These patients should start treatment with the lowest available dose.

For these patients, as well as for patients who require additional treatment with low doses of acetylsalicylic acid or other medications that may increase the risk of gastrointestinal problems, your doctor will consider the possibility of associating a stomach protector (e.g., misoprostol or proton pump inhibitors).

If you have a history of adverse reactions affecting the gastrointestinal tract - especially in elderly patients - consult your doctor in case of unusual abdominal symptoms (especially gastrointestinal bleeding), particularly at the beginning of therapy.

Caution is recommended if you are also taking other medications that may increase the risk of ulcers or bleeding, e.g., oral corticosteroids, anticoagulants (anticoagulants such as warfarin), selective serotonin reuptake inhibitors (used to treat psychiatric disorders, including depression), or platelet aggregation inhibitors such as acetylsalicylic acid (see section 2 "Other medications and Difenadol").

You should discontinue treatment and consult a doctor if you develop gastrointestinal bleeding or ulcers during treatment with Difenadol.

Effects on the cardiovascular system

NSAIDs, such as ibuprofen, may be associated with a small increase in the risk of suffering a heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

Severe cutaneous adverse reactions (SCARs)

Cases of severe cutaneous adverse reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (GAP), have been reported in association with ibuprofen treatment. Discontinue Difenadol treatment and seek medical attention immediately if you notice any of the symptoms related to these severe cutaneous adverse reactions described in section 4. If you have chickenpox, it is recommended to avoid using ibuprofen.

Infections

Difenadol may mask the signs of an infection, such as fever and pain. Consequently, Difenadol 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 medication while you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Other warnings

In rare cases, severe hypersensitivity reactions (e.g., anaphylactic shock) have been observed. If you experience the first signs of a hypersensitivity reaction after taking ibuprofen, discontinue treatment and consult your doctor. The necessary medical measures, in line with the symptoms, should be initiated by specialized personnel.

Ibuprofen may reversibly inhibit platelet aggregation and function. Therefore, patients with bleeding disorders should be carefully monitored.

During prolonged use of ibuprofen, regular monitoring of liver function, kidney function, and blood counts is required.

Prolonged use of any type of analgesic for headache may exacerbate it. If you observe or suspect this situation, consult a doctor and discontinue treatment.

Generally, the habitual use of different types of analgesics may lead to the development of severe kidney problems with a risk of renal insufficiency (analgesic nephropathy). This risk may be increased in conditions of physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.

The risk of renal insufficiency increases in dehydrated patients, elderly patients, and those taking diuretics and ACE inhibitors.

If you experience vision problems, please consult your doctor.

Cases of severe allergic reactions to this medication, including respiratory problems, swelling of the face and neck region (angioedema), and chest pain, have been reported. Discontinue ibuprofen treatment immediately and contact your doctor or emergency medical services as soon as possible if you observe any of these symptoms.

Elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation (see also the warning about bleeding at the beginning of section 2).

Adolescents

There is a risk of renal insufficiency in dehydrated adolescents.

Other medications and Difenadol

Discuss with your doctor or pharmacist that you are using or have used recently or may need to use any other medication.

Difenadol may affect or be affected by other medications. For example:

Difenadol may reduce the effect of medications used to increase urine production (diuretics) and lower blood pressure (blood pressure medications, e.g., ACE inhibitors, beta-blockers, and angiotensin II receptor antagonists). The combined administration of ibuprofen and diuretics that save potassium (medications used to increase urine production) may lead to an increase in potassium levels in the blood.

Other medications may also affect or be affected by ibuprofen treatment. Therefore, you should always consult your doctor or pharmacist before using ibuprofen with other medications.

Taking Difenadol with alcohol

The risk of adverse reactions to ibuprofen may be increased with the consumption of alcohol, especially those affecting the central nervous system and the gastrointestinal tract. Do not drink alcohol while taking ibuprofen.

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.

Pregnancy

Do not take this medication 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 this medication in the first 6 months of pregnancy unless it is clearly necessary and as directed 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, if you take this medication for more than a few days, it may cause kidney problems in your fetus, 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 a period longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Small amounts of ibuprofen pass into breast milk. However, as no adverse effects have been reported so far, it is usually not necessary to discontinue breastfeeding during a short period of ibuprofen use at the recommended dose for fever and pain.

Fertility

This product belongs to the group of NSAIDs that may affect fertility in women. This effect is reversible when the medication is discontinued. You should consult your doctor if you plan to become pregnant or if you have difficulty becoming pregnant.

Driving and operating machinery

Ibuprofen generally has no or insignificant influence on the ability to drive and operate machinery. However, at higher doses, adverse effects such as fatigue and dizziness may appear, affecting reaction time when driving and operating machinery. This is especially important when combined with alcohol.

Difenadol contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The effective dose should be the lowest dose 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).

The usual dose is:

Adults and adolescents over 40 kg (12 years or older)

One tablet (400 mg) as a single dose.

The dosing interval should be chosen according to the observed symptoms and the recommended maximum daily dose. The interval between doses should not be less than 6 hours. Do not take more than 3 tablets (1,200 mg) of ibuprofen in a 24-hour period.

This medication is not recommended for use in adolescents weighing less than 40 kg or children under 12 years of age.

Adverse reactions can be minimized by using the lowest effective dose for the shortest possible time to control symptoms.

If you have severe liver or kidney disease or are an elderly patient, your doctor will indicate the correct dose for you, which will be the lowest possible dose.

Administration form

Oral route.

Take the tablet with a glass of water.

Ibuprofen tablets should be swallowed whole, without chewing, crushing, or sucking to avoid mouth discomfort or throat irritation.

Patients with sensitive stomachs are recommended to take ibuprofen with food. Difenadol is intended for short-term use only.

For adults

If you need this medication for more than 3 days to treat fever or more than 4 days to treat pain, or if symptoms worsen, you must consult a doctor.

For adolescents

If adolescents need this medication for more than 3 days, or if symptoms worsen, you must consult a doctor.

If you take more Difenadol than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus),gastrointestinal bleeding (see also section 4 below),diarrhea, headache, ringing in the ears, confusion, and involuntary eye movements.

It may also cause blurred vision and worsening of asthma in asthmatics.

Additionally, nervousness, drowsiness, disorientation, or coma may occur. Occasionally, patients develop seizures.

At high doses, symptoms of somnolence, excitement, disorientation, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, low blood pressure, increased prothrombin time/INR, probably due to interference with the action of circulating clotting factors, acute renal failure, hepatic damage, respiratory depression, cyanosis, decreased body temperature, respiratory problems with decreased breathing, and chills have been reported.

If you forgot to take Difenadol

Do not take a double dose to compensate for the missed doses.

If you have any other questions 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 most common side effects observed affect the digestive tract. They may occur ulcers in the stomach/duodenum (peptic ulcers), perforation or bleeding, sometimes fatal, especially in elderly patients (see section 2: "Warnings and precautions"). Nausea, vomiting, diarrhea, flatulence, constipation, digestive problems, abdominal pain, blood in stool, vomiting with blood, ulcers (wounds) in the mouth and throat region (stomatitis ulcerosa). Exacerbation of colitis and Crohn's disease (see section 2: "Warnings and precautions") have been reported after use. Less frequently, gastritis has been observed. In particular, the risk of developing gastrointestinal bleeding depends on the dose level and duration of treatment.

There have been observed inflammation (edema), high blood pressure (hypertension) and heart failure in association with NSAID treatments.

More serious side effects

• Stop taking ibuprofen and seek medical attention immediately if you notice the following symptoms:

• Flat, red spots, in the shape of a target or circular on the trunk, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin eruptions may be preceded by fever and symptoms similar to the flu [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature and swollen lymph nodes (DRESS syndrome).
• Generalized, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

• Stop taking the medication and seek immediate medical attention if you develop severe allergic reactions (hypersensitivity), a very rare side effect (may affect up to 1 in 10,000 people):

These may manifest as:

If you experience any of these side effects or if they worsen, stop taking the medication and seek immediate medical attention.

Other side effects

Frequent (may affect more than 1 in 10 people)

Rare (may affect up to 1 in 100 people)

Stop taking ibuprofen and inform your doctor immediately.

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

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

Frequency unknown (cannot be estimated from available data)

Medications like ibuprofen may be associated with a small increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 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 medication.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications 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. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Difenadol

The active ingredient is ibuprofen. Each tablet contains 400 mg of ibuprofen.

The other components are:

Tablet core:microcrystalline cellulose, calcium phosphate, croscarmellose sodium,hypromellose,polyvinylpyrrolidone, stearic acid, talc.

Coating:hypromellose, titanium dioxide (E-171), macrogol, and talc.

Appearance of the product and content of the packaging

White or almost white film-coated tablets, oblong and biconvex, engraved with “I400” on one face and smooth on the other, with a diameter of 14.4 mm x 7.2 mm ± 10%.

Each package contains 12 or 20 film-coated tablets in an aluminum-PVC blister.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (Spain)

Date of the last review of this leaflet:January 2025

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