Prospecto: information for the patient

Ibuprofen Stada 400 mg film-coated tablets EFG

Ibuprofeno Stada belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Ibuprofeno is indicated for the treatment of the symptoms of:

• Rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, osteoarthritis, and other acute or chronic rheumatic processes.
• Muscle and soft tissue injuries such as sprains and strains.
• Mild to moderate painful processes such as dental pain, postoperative pain, headache, and menstrual pain.
• Fever of various causes.

It is essential to use the smallest effective dose to relieve or control pain and not to take this medication for longer than necessary to manage your symptoms.

Do not take Ibuprofeno Stada:

• if you are allergic to ibuprofen or any of the other components of this medication (listed in section 6). Symptoms may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• if you have had a previous stomach or duodenal ulcer bleeding or have experienced a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• • if you currently have or have had more than one episode of stomach or duodenal ulcer or bleeding.
• if you vomit blood.
• if you have black stools or bloody diarrhea.
• if you have active Crohn's disease or ulcerative colitis.
• if you have a severe liver or kidney disease.
• if you have severe heart failure.
• if you have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• if you are in the third trimester of pregnancy.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Ibuprofeno Stada.

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and in the elderly. In these cases, your doctor may consider associating a stomach protector medication.

• If you take this medication simultaneously with medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents like aspirin, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you have kidney or liver disease. If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you should inform your doctor of your ibuprofen treatment, as it may mask fever, an important sign of infection, making its diagnosis more difficult.
• If you have an infection; see the "Infections" heading below.
• Signs of allergic reactions to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using this medication immediately and contact your doctor or emergency medical services if you observe any of these signs.

Special caution is recommended with ibuprofen:

Skin Reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (GPP), have been reported in association with ibuprofen treatment. Discontinue treatment with this medication and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

CARDIOVASCULAR PRECAUTIONS

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking Ibuprofeno Stada if:

• you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

This type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that ibuprofen 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.

Use of Ibuprofeno Stada with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Other nonsteroidal anti-inflammatory drugs (NSAIDs)
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.

• Metotrexate. Your doctor may adjust the dose of this medication.
• Mifepristone.
• Digoxin and cardiac glycosides (used to treat heart failure).
• Hidantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Corticosteroids like prednisone and prednisolone.
• Diuretics.
• Fluconazole.
• Pentoxifylline.
• Probenecid.
• Quinolones like norfloxacin.
• Sulfinpyrazone.
• Sulfonilureas like tolbutamide.
• Tacrolimus.
• Zidovudine.
• Anticoagulants (e.g., to prevent blood clotting, e.g., aspirin, warfarin, ticlopidine)
• Medications that lower high blood pressure (e.g., ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).

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

Other interactions requiring caution:

• Corticosteroids like prednisone and prednisolone, diuretics, fluconazole, pentoxifylline, probenecid, quinolones (like norfloxacin), sulfinpyrazone, sulfonilureas (like tolbutamide), tacrolimus, ciclosporin, zidovudine, as they may increase the risk of gastrointestinal ulcers or bleeding.
• Selective serotonin reuptake inhibitors (SSRIs) may also increase the risk of gastrointestinal bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take ibuprofen 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 predisposition to bleeding and delay or prolong delivery. Do not take ibuprofen 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 time possible. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels (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.

Fertility

For fertile women, it is essential to consider that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Breastfeeding

Although the levels of medication in breast milk are negligible, it is recommended to consult your doctor in cases of long-term treatment or high doses during breastfeeding.

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery.

If you only take a single dose of ibuprofen or take it for a short period, no special precautions are necessary.

Ibuprofeno Stada contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) 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.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with ibuprofen. Do not discontinue treatment beforehand, as this will not yield the expected results. Similarly, do not use ibuprofen for longer than indicated by your doctor.more time than indicated by your doctor.

Ibuprofen are tablets for oral administration. You must swallow the tablet whole with a little water.

If you have a sensitive stomach, take the medication with meals.

The effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults

The dosage should be adjusted according to the severity of the disorder and the patient's discomfort. In general, the recommended daily dose is 1,200 mg of ibuprofen (3 tablets), divided into 3 doses.

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg of ibuprofen (6 tablets).

Children and adolescents

Adolescents with a weight of over 40 kg: the recommended daily dose is 1,200 mg of ibuprofen (3 tablets); one tablet every 6-8 hours. It is recommended not to exceed the maximum daily dose of 1,600 mg of ibuprofen (4 tablets).

This medication is not recommended for use in children and adolescents weighing less than 40 kg, as the dose of ibuprofen contained is not suitable for the recommended dosage in these patients.

Senior patients

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, the dose can only be increased once your doctor has confirmed that you tolerate the medication well.

Patients with kidney and/or liver disease

If you have kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose prescribed by your doctor.

If you estimate that the action of ibuprofen is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofeno Stada than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult a doctor, pharmacist, or the Toxicological Information Service immediately, 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), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have also been reported.

If a severe overdose has occurred, the doctor will take the necessary measures.

If you forgot to take Ibuprofeno Stada

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

If you forget to take your dose, take it as soon as you remember. However, if the time for the next dose is near, skip the missed dose and take the next dose at its usual time.

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 side effects of medicines like ibuprofen are more common in people over 65 years old.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

Frequencies are established according to the following classification: very common (can affect more than 1 in 10 people); common (can affect up to 1 in 10 people); uncommon (can affect up to 1 in 100 people); rare (can affect up to 1 in 1,000 people); very rare (can affect up to 1 in 10,000 people); frequency unknown (cannot be estimated from available data).

The following side effects have been observed:

Gastrointestinal disorders

The most common side effects that occur with medicines like ibuprofen are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stools, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Very common: diarrhea and indigestion.

Common: nausea, vomiting, abdominal pain.

Uncommon: bleeding, stomach or duodenal ulcers, mouth ulcers.

Rare: gastric or intestinal perforation, flatulence, constipation, esophageal inflammation, and intestinal ulcers or inflammation.

Skin and subcutaneous tissue disorders

Common: skin rash.

Uncommon: skin redness, itching or swelling, lip, face or tongue swelling, increased nasal secretion, and breathing difficulty.

Rare: severe allergic reactions (anaphylactic shock).

Very rare: intense itching on the skin, sudden appearance of blisters on the skin, joint pain, and fever (lupus erythematosus), hair loss, skin reactions caused by light, severe skin reactions such as allergic vasculitis, Lyell syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Unknown frequency: generalized red scaly rash, with bumps under the skin and localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking ibuprofen if you experience these symptoms and seek medical attention immediately. See section 2.

A severe skin reaction known as DRESS syndrome can occur. DRESS syndrome symptoms include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Central nervous system disorders

Common: fatigue or drowsiness, headache, dizziness or feeling unsteady.

Uncommon: insomnia, anxiety, restlessness, visual disturbances, ringing or buzzing in the ears.

Rare: disorientation or confusion, agitation, irritability or depression, abnormal or blurred vision, and hearing difficulty.

Very rare: aseptic meningitis.

Blood and lymphatic system disorders

Very rare: prolonged bleeding time, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as breathing difficulty and pale skin).

Cardiovascular disorders

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

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with ibuprofen treatments. Swelling of the limbs or accumulation of fluid in the arms or legs (more likely in subjects with high blood pressure or kidney disorders). Heart failure or high blood pressure, especially in elderly patients.

Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Renal and urinary disorders

Renal alterations or insufficiency.

Hepatobiliary disorders

Medicines like ibuprofen may be associated, in rare cases, to liver damage.

Rare: hepatitis (liver inflammation) and jaundice (yellow skin discoloration).

Other

Worsening of inflammation during infectious processes.

Until now, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. Manifestations of this type of reaction may include fever, skin rash, abdominal pain, severe headache, nausea, vomiting, facial swelling, tongue, and throat swelling, breathing difficulty, asthma, palpitations, hypotension, or shock.

If any of the following side effects appear, discontinue treatment and seek immediate medical attention:

-Allergic reactions such as skin rash, facial swelling, chest tightness, or breathing difficulty.

-Vomiting blood or coffee ground-like appearance.

-Blood in stools or bloody diarrhea.

-Severe stomach pain.

-Significant blisters or peeling on the skin.

-Severe headache or persistent headache.

-Yellow skin discoloration (jaundice).

-Signs of severe hypersensitivity (see above in this same section).

-Swelling of the limbs or fluid accumulation in the arms or legs.

-Flat, red, or circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, or eye ulcers. These severe skin reactions 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. Symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, 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: https://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 store at a temperature above 30°C.

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

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 Ibuprofeno Stada

• The active ingredient is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other components are:

Core

Croscarmelosa of sodium, hypromellose, lactose, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, purified water, and magnesium stearate.

Coating

Titanium dioxide (E-171), hypromellose, talc, purified water, and propylene glycol.

Appearance of the product and content of the packaging

Ibuprofeno Stada is presented in the form of coated tablets with a film, oval, biconvex, scored on both sides, and white in color.

Each package contains 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

FARMALIDER, S.A

Aragoneses, 2

28108 Alcobendas

Madrid Spain

or

FROSST IBERICA, S.A.

Vía Complutense, 140

Alcalá de Henares

Madrid Spain

or

TOLL MANUFACTURING SERVICES S.L.

C/Aragoneses,2

28108 Alcobendas (Madrid) Spain

Last review date of this leaflet: October 2024

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