Ibuprofen STADA 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibuprofen Stada 600 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ibuprofen Stada is and what it is used for
2. What you need to know before taking Ibuprofen Stada
3. How to take Ibuprofen Stada
4. Possible adverse effects
5. How to store Ibuprofen Stada
6. Contents of the pack and other information

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

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

This medicine is indicated for the treatment of fever, the treatment of mild to moderate pain including migraine, the treatment of arthritis (joint inflammation, usually affecting the hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder causing damage to cartilage), 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 Ibuprofeno Stada

Do not take Ibuprofeno Stada:

• if you are allergic to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other components of this medicine (listed in section 6). Signs of allergy may include skin rash with itching, swelling of the face, lips or tongue, runny nose, breathing difficulties, or asthma.
• if you have severe liver or kidney disease.
• if you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
• if you are vomiting blood.
• if you have black stools or bloody diarrhoea.
• if you have bleeding or blood clotting disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants together with ibuprofen, your doctor will perform blood clotting tests.
• if you have severe heart failure.
• if you are in the third trimester of pregnancy.

Tell your doctor:

• if you have oedema (fluid retention).
• if you have or have had heart problems or high blood pressure.
• if you have asthma or any other respiratory disorder.
• if you are being treated with ibuprofen, as it may mask fever—a key sign of infection—making diagnosis more difficult.
• if you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be performed.
• if you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.
• if you are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• if you have Crohn’s disease or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
• if you are taking diuretics (medicines to increase urine production), because your doctor needs to monitor your kidney function.
• if you have systemic lupus erythematosus, as aseptic meningitis may occur.
• if you have an infection; see the section “Infections” below.
• Serious allergic reactions to ibuprofen, such as breathing problems, swelling of the face and neck area (angioedema), or chest pain, have been reported. Stop using this medicine immediately and contact your doctor or emergency medical services without delay if you notice any of these symptoms.

Special caution is advised with ibuprofen:

Skin reactions

Serious skin reactions have been reported with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). Discontinue treatment with this medicine and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Cardiovascular precautions

Medicines such as ibuprofen (anti-inflammatory/analgesic) may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

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

• you have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary bypass surgery, peripheral arterial 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 ischaemic attack "TIA").
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

These types of medicines may also cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Precautions during pregnancy and in women of childbearing age

Because administration of medicines like ibuprofen has been associated with an increased risk of congenital abnormalities or miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration of treatment should be kept to a minimum.

Administration of ibuprofen is contraindicated during the third trimester of pregnancy.

For women of childbearing age, it should be noted that medicines like ibuprofen have been associated with reduced fertility.

Infections

Ibuprofen may mask signs of infection such as fever and pain. Therefore, ibuprofen may delay appropriate treatment of an infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and your symptoms persist or worsen, consult a doctor immediately.

Taking Ibuprofeno Stada with other medicines

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

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

• Other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin.
• Antiplatelet agents (which prevent blood clots in blood vessels), such as ticlopidine.
• Anticoagulant medicines (e.g., used to treat or prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Lithium (used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (used to induce abortion).
• Digoxin and other cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine output).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in gout patients or together 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 (an anti-HIV medicine).
• Antihypertensives (to lower high blood pressure).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan).

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

Interference with laboratory tests

Taking ibuprofen may affect the following laboratory tests:

• Bleeding time (may be prolonged for up to 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Haematocrit or haemoglobin (may decrease)
• Blood urea nitrogen levels and serum creatinine and potassium levels (may increase)
• Liver function tests: increased transaminase values

Inform your doctor if you are scheduled for a clinical test and are taking or have recently taken ibuprofen.

Taking Ibuprofeno Stada with food and drinks

You may take it alone or with food. It is generally recommended to take it before meals or with milk to reduce the possibility of stomach discomfort.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take ibuprofen during the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and may delay or prolong labour. Do not take ibuprofen during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your unborn baby if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

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

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, do not drive or operate dangerous machinery. If you take only a single dose or use ibuprofen for a short period, special precautions are generally not required.

Ibuprofeno Stada contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Ibuprofen Stada

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

This medicine is administered orally.

The lowest effective dose for the shortest necessary duration should be used 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

In adults and adolescents aged 14 to 18 years, one tablet (600 mg) should be taken every 6 to 8 hours, depending on the severity of symptoms and response to treatment.

In some conditions, 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 aged 14 to 18 years.

Use in children and adolescents

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

Elderly patients

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

Patients with kidney and/or liver disease

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

If you think that the effect of this medicine is too strong or too weak, inform 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 medicine, consult immediately with a doctor, pharmacist, or the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to find out about the risk and obtain advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties 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 missed doses.

If you forget to take your dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed 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 everyone experiences them.

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

The incidence of adverse effects is lower with short-term treatments and when the daily dose is below the recommended maximum dose.

Frequencies are defined according to the following classification: very common (may affect more than 1 in 10 people); common (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 common adverse effects occurring 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 stools, oral ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed.

Less frequently, gastritis has been observed.

Other adverse effects are:

Uncommon: inflammation of the oral mucosa with ulcer formation.

Rare: inflammation of the esophagus, narrowing of the esophagus (esophageal stricture), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular disorders

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

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments using ibuprofen-type medicines. Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome, may also occur.

Skin and subcutaneous tissue disorders

Medicines such as ibuprofen may, in very rare cases, be associated with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purple-colored lesions, predominantly on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis).

Other adverse effects are:

Common: skin rash.

Uncommon: redness of the skin, 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 exposure, inflammation of blood vessels in the skin.

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

Rarely, severe skin infections and soft tissue complications may occur during chickenpox.

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

Immune system disorders

Uncommon: transient swelling in areas of the skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of the nasal mucosa, bronchospasm (spasm of the bronchi preventing airflow to the lungs).

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

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

Central nervous system disorders

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

Rare: paresthesia (numbness, tingling, "pins and needles" sensation, more commonly in hands, feet, arms, or legs).

Very rare: aseptic meningitis. In most reported cases of aseptic meningitis with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which represented a risk factor. Symptoms observed included neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric disorders

Uncommon: insomnia, anxiety, restlessness.

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

Ear and labyrinth disorders

Common: dizziness.

Uncommon: tinnitus (ringing or buzzing in the ears).

Rare: hearing difficulty.

Eye disorders

Uncommon: visual disturbances.

Rare: abnormal or blurred vision.

Blood and lymphatic system disorders

Rare: decreased platelets, decreased white blood cells (may present as frequent infections with fever, chills, or sore throat), decreased red blood cells (may present as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe decrease in granulocytes), aplastic anemia (failure of the bone marrow to produce various types of blood cells), or hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, 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 urine and body swelling), and renal failure (sudden loss of kidney function) cannot be excluded.

Hepatobiliary disorders

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

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

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

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. Manifestations of such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulty, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulty.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blisters or extensive skin peeling.
• 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.
• Flat, non-elevated, red, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno Stada

• The active substance is ibuprofen. Each tablet contains 600 mg of ibuprofen.
• The other components are:

Core

Sodium croscarmellose, hypromellose, monohydrate lactose, 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 contents of the pack

Ibuprofeno Stada is presented as film-coated tablets, oval, biconvex and white in colour.

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

Some pack sizes may be the only ones marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturing Responsible Party:

FARMALIDER, S.A.

Aragoneses, 2

28108 Alcobendas

Madrid, Spain

or

FROSST IBÉRICA, S.A.

Vía Complutense, 140

28805 Alcalá de Henares

Madrid, Spain

or

TOLL MANUFACTURING SERVICES S.L.

C/Aragoneses, 2

28108 Alcobendas (Madrid), Spain

Date of the most recent review of this leaflet: October 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/