IBUPROFEN STADA 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

IbuprofenStada600 mg film-coated tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ibuprofen Stada and what is it used for
2. What you need to know before taking Stada
3. How to take Ibuprofen Stada
4. Possible side effects
5. Storage of Ibuprofen Stada
6. Package Contents and Additional Information

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

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

This medication is indicated for the treatment of fever, treatment of mild or moderate pain, including migraine, treatment of arthritis (inflammation of the joints, including hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before taking Ibuprofen Stada

Do not take IbuprofenStada:

• if you are allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• if you have a severe liver or kidney disease.
• if you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• if you vomit blood.
• if you have black stools or bloody diarrhea.
• if you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medications 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 have severe heart failure.
• if you are in the third trimester of pregnancy.

Tell your doctor:

• if you have edema (fluid retention).
• if you have or have had heart disorders or high blood pressure.
• if you have asthma or any other respiratory disorder.
• if you are receiving treatment with ibuprofen, as it may mask fever, which is an important sign of infection, making diagnosis more difficult.
• if you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• if you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by severe abdominal pain or persistent pain and/or black stools, or even without prior warning symptoms. This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcer and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.
• if you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• if you have Crohn's disease or ulcerative colitis, as ibuprofen-like medications can worsen these conditions.
• if you are being treated with diuretics (medications to increase urine production), as your doctor should monitor your kidney function.
• if you have systemic lupus erythematosus, as it may cause aseptic meningitis.
• if you have an infection; see the "Infections" section below.
• if you experience signs of an allergic reaction to this medication, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop using this medication immediately and contact your doctor or the emergency medical service immediately if you notice 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 medical attention immediately 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 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, a family history of heart disease or stroke, or if you are a smoker.

Similarly, these types of medications can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Precautions during Pregnancy and in Women of Childbearing Age

Because the administration of ibuprofen-like medications has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to take this medication during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of ibuprofen is contraindicated.

For women of childbearing age, it should be noted that ibuprofen-like medications have been associated with a decrease in fertility.

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 may 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.

Use of IbuprofenStadawith other medications

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

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

• Other non-steroidal anti-inflammatory drugs, such as aspirin.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels), such as ticlopidine.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and other cardiac glycosides (used to treat heart disorders).
• Hydantoins, such as phenytoin (used to treat epilepsy).
• Sulfonamides, such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids, such as cortisone and prednisolone.
• Diuretics (medications used to increase urine production).
• Pentoxifylline (to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics, such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas, such as tolbutamide (for diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).
• Antihypertensives (to lower high blood pressure).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics, such as neomycin.
• Herbal extracts: Ginkgo biloba tree.
• 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 ibuprofen treatment. Therefore, you should always consult your doctor or pharmacist before using ibuprofeno with other medications.

Interference with Laboratory Tests

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood concentrations of urea nitrogen and serum creatinine and potassium (may increase)
• Liver function tests: increased transaminase values

Tell your doctor if you are going to undergo a clinical analysis and are taking or have recently taken ibuprofen.

Taking IbuprofenStadawith Food and Drinks

You can take it alone or with food. In general, it is recommended to take it before meals or with milk to reduce the possibility of stomach upset.

Pregnancy and Breastfeeding

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 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 ability to clot 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 amniotic fluid surrounding 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 monitoring.

Breastfeeding

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and Using Machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or operate hazardous machinery. If you only take one dose of ibuprofen or for a short period, you do not need to take special precautions.

IbuprofenStadacontains lactose and sodium

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

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

3. How to take Ibuprofen Stada

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

Your doctor will indicate the duration of treatment with ibuprofen. Do not stop treatment before, as the expected results will not be achieved. Similarly, do not use Ibuprofeno for longer than indicated by your doctor.

This medication is administered orally.

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

In adults and adolescents from 14 to 18 years, take one tablet (600 mg) every 6 to 8 hours, depending on the intensity of the condition and response to treatment.

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 in adults and 1,600 mg in adolescents from 14 to 18 years.

Use in Children and Adolescents

The use of this medication is not recommended in children and adolescents under 14 years, as the dose of ibuprofen it contains is not suitable for the recommended dosage in this group of patients.

Elderly Patients

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

Patient with Kidney or Liver Disease

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

If you think the effect of this medication is too strong or too weak, tell your doctor or pharmacist.

If you take more IbuprofenStadathan 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 such as 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 overdose has occurred, the doctor will take the necessary measures.

If you forget to take IbuprofenStada

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 for the next dose is near, skip the forgotten dose and take the next dose at the usual time.

4. Possible Adverse Effects

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

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

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, gastrointestinal bleeding, perforations (in some cases fatal), especially in the elderly. 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.

Other adverse effects are:

Uncommon: inflammation of the oral mucosa with ulcer formation.

Rare: esophageal inflammation, esophageal narrowing (esophageal stenosis), exacerbation of intestinal diverticulitis, hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

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 ibuprofen-like medicines. Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Disorders of the Skin and Subcutaneous Tissue

Medicines like ibuprofen may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes and purpuric lesions, preferably on the trunk) and toxic epidermal necrolysis (mucosal erosions and painful lesions with necrosis and shedding of the epidermis).

Other adverse effects are:

Frequent: skin rash.

Uncommon: skin redness, itching, or swelling of the skin, purpura (purple spots on the skin).

Very rare: hair loss, erythema multiforme (skin lesion), skin reactions due to light influence, inflammation of the skin blood vessels.

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.

Severe skin infections and soft tissue complications may exceptionally occur during chickenpox.

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

Disorders of the Immune System

Uncommon: transient edema in areas of the skin, mucous membranes, or sometimes in viscera (angioedema), nasal mucosa inflammation, bronchospasm (bronchial spasm that prevents air from passing into the lungs).

Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, facial swelling, tongue, and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.

Very rare: joint pain and fever (lupus erythematosus).

Disorders of the Central Nervous System

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

Rare: paresthesia (sensation of numbness, tingling, prickling, etc., more frequent in hands, feet, arms, or legs).

Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric Disorders

Uncommon: insomnia, anxiety, restlessness.

Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Disorders of the Ear and Labyrinth

Frequent: vertigo.

Uncommon: ringing or buzzing in the ears.

Rare: hearing difficulty.

Ocular Disorders

Uncommon: vision disturbances.

Rare: abnormal or blurred vision.

Disorders of the Blood and Lymphatic System

Rare: decreased platelets, 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 skin pallor), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red, white blood cells, and platelets in the blood), agranulocytosis (very significant decrease in granulocytes), aplastic anemia (bone marrow failure to produce different types of cells), or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding.

Very rare: prolonged bleeding time.

Renal and Urinary Disorders

Based on experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and body swelling), and renal failure (sudden loss of kidney function) cannot be excluded.

Hepatobiliary Disorders

Medicines like ibuprofen 600 mg may be associated, in rare cases, with liver damage.

Other rare adverse effects are: hepatitis (liver inflammation), abnormal liver function, and jaundice (yellowing of the skin and eyes).

Frequency not known: liver failure (severe liver deterioration).

General Disorders and Administration Site Conditions

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with ibuprofen 600 mg, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, facial swelling, tongue, and throat swelling, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects occur, discontinue treatment and seek medical attention immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee-ground-like material.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blistering.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (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, throat, nose, genital, and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized 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. Storage of Ibuprofeno Stada

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

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. 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 600 mg of ibuprofen.
• The other ingredients are:

Core

Croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate, purified water.

Coating

Hypromellose, titanium dioxide (E-171), 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, and white in color.

Ibuprofeno Stada is available in blister packs containing 20, 40, or 500 (clinical package) tablets.

It is possible that only some package sizes are marketed.

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

o

FROSST IBÉRICA, S.A.

Vía Complutense, 140

28805 Alcalá de Henares, Spain

Madrid

o

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/