IBUPROFEN STADA 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ibuprofen Stada 400 mg Film-Coated Tablets EFG

Contents of the Package Leaflet

• What is Ibuprofen Stada and what is it used for
• What you need to know before you take Ibuprofen Stada

1. How to take Ibuprofen Stada
2. Possible side effects
3. Storage of Ibuprofen Stada
4. Package Contents and Additional Information

1. What is Ibuprofen Stada and what is it used for

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

Ibuprofen is indicated for the treatment of symptoms of:

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

2. What you need to know before you take Ibuprofen Stada

It is important to use the smallest dose that relieves/pain and you should not take this medicine for longer than necessary to control your symptoms.

Do not take Ibuprofen Stada:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6). May appear: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• if you have previously had a stomach or duodenal bleeding or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• • if you currently have or have had more than one occasion an ulcer or stomach or duodenal bleeding.
• if you vomit blood.
• if you have black stools or bloody diarrhea.
• if you have active ulcerative colitis or Crohn's disease.
• if you have severe liver or kidney disease.
• if you have severe heart failure.
• if you have bleeding disorders or blood coagulation, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• if you are in the third trimester of pregnancy.

Warnings and Precautions

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

• If you have had or develop an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medication.

• If you take simultaneously medications that alter blood coagulation such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also comment on the use of other medications that could increase the risk of such bleeding as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis because medications of the ibuprofen type can worsen these pathologies.
• If you have had kidney or liver disease. If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you go to the doctor's office, you should inform them of your treatment with ibuprofen, as it can mask fever, which is an important sign of infection, making diagnosis difficult.
• If you have an infection; see the "Infections" heading later.
• With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using this medication immediately and contact your doctor or emergency medical services immediately 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with this medication and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Cardiovascular Precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

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

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

Similarly, this type of medication can 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. Consequently, ibuprofen may delay the appropriate treatment of the infection, which can increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Using Ibuprofeno Stada with Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

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

• Methotrexate. Your doctor may adjust the dose of this medication.
• Mifepristone.
• Digoxin and cardiac glycosides (used in the treatment of heart failure).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics.
• Fluconazole.
• Pentoxifylline.
• Probenecid.
• Antibiotics of the quinolone group such as norfloxacin.
• Sulfinpyrazone.
• Sulfonylureas such as tolbutamide.
• Tacrolimus.
• Zidovudine.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).

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

Other interactions that require caution:

• Corticosteroids such as cortisone and prednisolone, diuretics, fluconazole, pentoxifylline, probenecid, quinolones (such as norfloxacin), sulfinpyrazone, sulfonylureas (such as tolbutamide), tacrolimus, cyclosporine, zidovudine, as they may increase the risk of gastrointestinal ulcer or bleeding.
• Selective serotonin reuptake inhibitor antidepressants (SSRIs) may also increase the risk of gastrointestinal bleeding.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 can cause kidney and heart problems in your fetus. It can affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take ibuprofen during 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 the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of the fluid that surrounds 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 checks.

Fertility

For female patients of childbearing age, it should be noted that medications of the ibuprofen type have been associated with a decrease in fertility.

Breastfeeding

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

Driving and Using Machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medication, you should not drive or use hazardous machinery.

If you only take one dose of ibuprofen or take it for a short period, you do not need to take special precautions.

Ibuprofen Stada Contains Lactose and Sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to some sugars, 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".

3. How to Take Ibuprofen Stada

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 stop treatment before, as the expected results will not be obtained. Similarly, do not use ibuprofen for longer than indicated by your doctor.

Ibuprofen is a tablet for oral administration. You should swallow the tablet whole with a little water.

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

The effective lowest dose should be used for the shortest time necessary to relieve 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

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 processes, 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 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).

The use of this medication is not recommended in children and adolescents with less than 40 kg of weight, as the dose of ibuprofen it contains is not suitable for the recommended dosage in these patients.

Elderly Patients

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

Patients with Kidney and/or Liver Disease

If you have kidney and/or liver disease, it is possible that your doctor will prescribe a lower dose than usual. If so, take the exact dose that your doctor has prescribed.

If you think the action of ibuprofen is too strong or too weak, tell your doctor or pharmacist.

If You Take More Ibuprofen 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 Toxicology Information Service (telephone: 91 562 04 20), indicating the medication and the amount ingested, or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported.

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

If You Forget to Take Ibuprofen Stada

Do not take a double dose to make up for forgotten doses.

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Adverse effects of medicines like ibuprofen are more common in people over 65 years of age.

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

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

The following adverse effects have been observed:

Gastrointestinal Disorders

The most frequent adverse effects that occur with medicines like ibuprofen are gastrointestinal: peptic ulcers, digestive hemorrhages, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stool, oral ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Very frequent: diarrhea and indigestion.

Frequent: nausea, vomiting, abdominal pain.

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

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

Disorders of the Skin and Subcutaneous Tissue

Frequent: skin rash.

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

Rare: severe allergic reactions (anaphylactic shock).

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

Frequency not known: Generalized red scaly rash, with bumps under the skin and blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking ibuprofen if you experience these symptoms and seek medical attention immediately. See also section 2.

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

Disorders of the Central Nervous System

Frequent: fatigue or somnolence, headache, and dizziness or feeling of instability.

Uncommon: insomnia, anxiety, restlessness, vision changes, 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.

Disorders of the Blood and Lymphatic System

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 difficulty breathing 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), arterial hypertension, and heart failure have also been observed in association with treatments with medicines of the ibuprofen type. Swelling of the limbs or fluid accumulation in the arms or legs (more likely in subjects with high blood pressure or kidney disorders). Heart failure or high blood pressure (hypertension), 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, with liver damage.

Rare: hepatitis (liver inflammation) and jaundice (yellowing of the skin).

Others

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, intense and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension, or shock.

If any of the following adverse effects appear, interrupt treatment and go to your doctor immediately:

• Allergic reactions such as skin rashes, swelling of the face, wheezing, or difficulty breathing.
• Vomiting blood or coffee grounds-like material.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Blisters or significant skin peeling.
• Intense or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Red, target-like, or circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Ibuprofeno Stada

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30°C.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibuprofeno Stada

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

Nucleus

Croscarmellose sodium, hypromellose, lactose, microcrystalline cellulose, pregelatinized corn starch, 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 Package Contents

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

Each package contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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

Date of the Last Revision of this Leaflet:October 2024

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/