Ibuprofen Stadapharm 400 mg oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofen Stadapharm 400 mg oral suspension

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

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if fever worsens or does not improve after 3 days, or if pain does not improve after 5 days (3 days in adolescents).

Contents of the leaflet

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

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

Ibuprofen, the active substance in this medicine, works by reducing pain and fever.

This medicine is used in adults and adolescents aged 12 years and older weighing more than 40 kg for the symptomatic relief of mild to moderate occasional pain, such as headaches, toothaches, menstrual pain, muscle pain (cramps), or back pain (lumbago), as well as for feverish conditions.

2. What you need to know before taking Ibuprofen Stadapharm

Do not take Ibuprofen Stadapharm:

• If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6), or to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• If you have previously 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 severe heart failure.
• If you suffer from severe liver or kidney disease.
• If you have bleeding disorders or blood coagulation problems, or are taking anticoagulants (medicines used to "thin" the blood). If concomitant use of anticoagulants is necessary, your doctor will perform blood coagulation tests.
• If you are in the third trimester of pregnancy.
• If you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

Inform your doctor:

• If you have oedema (fluid retention).
• If you suffer from or have previously had heart problems or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are being treated with this medicine, as it may mask fever, 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 medicine long-term (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 experience symptoms of dehydration, e.g., severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to renal failure due to dehydration.
• 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 with high doses and prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding 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 could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
• If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis may occur.
• If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions may occur with this medicine.
• Your doctor will monitor you more closely if you are receiving ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection; see the section "Infections" below.
• Hypersensitivity reactions to ibuprofen, such as breathing problems, swelling of the face and neck area (angioedema), and 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 signs.

It is important to use the lowest effective dose that relieves/controls your pain and not to take this medicine longer than necessary to control your symptoms.

Infections

Ibuprofen Stadapharm may mask signs of infection such as fever and pain. Therefore, Ibuprofen Stadapharm may delay appropriate treatment of 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 infection symptoms persist or worsen, consult a doctor immediately.

Cardiovascular precautions

Medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially 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 this medicine 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 legs or feet due to narrowed or blocked arteries), or any type of stroke (including "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.

In addition, these medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

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 Ibuprofen Stadapharm and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Children and adolescents

There is a risk of kidney damage in dehydrated children and adolescents.

Taking Ibuprofen Stadapharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

The following medicines may interact and therefore should not be taken with ibuprofen without first consulting your doctor:

• Do not take this medicine if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, as this may increase the risk of gastrointestinal ulcer and bleeding.
• Antiplatelet agents (prevent blood clots in blood vessels), such as ticlopidine.
• Anticoagulant medicines (e.g., to treat or prevent blood clotting, e.g., acetylsalicylic acid, warfarin).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Lithium (used to treat depression). Your doctor may need to adjust the dose of this medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medicine.
• Mifepristone (used for medical abortion).
• Digoxin (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).
• Diuretics (medicines used to increase urine output).
• Corticosteroids such as cortisone and prednisolone, used in inflammatory conditions.
• Selective serotonin reuptake inhibitors (SSRIs), used for depression.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or together with penicillin for infections).
• Quinolone antibiotics such as norfloxacin.
• Ion-exchange resins such as cholestyramine (used to lower blood cholesterol levels).
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrine (used in the treatment of Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (an anti-HIV medicine).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole or fluconazole, used to treat fungal infections.
• Herbal extracts: Ginkgo biloba.

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

Interference with diagnostic tests

If you are due to have any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may affect test results.

Taking Ibuprofen Stadapharm with food, drinks and alcohol

You may take it with or without food. It is generally recommended to take it before meals to reduce the possibility of stomach discomfort.

If you drink alcohol while taking this medicine, you may be more likely to experience adverse effects.

Pregnancy, breastfeeding and fertility

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

Pregnancy

Do not take ibuprofen during the last three months of pregnancy, as it may harm the fetus or cause problems 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. You should 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 when trying to conceive, you should take the lowest effective dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Fertility

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

Breastfeeding

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

Driving and use of machines

If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, you should not drive or operate machinery. If you take only a single dose of ibuprofen or for a short period, no special precautions are necessary.

Ibuprofen Stadapharm contains sodium and maltitol liquid (E-965)

Patients on low-sodium diets should be aware that this medicine contains 57.94 mg (2.5 mmol) of sodium per sachet.

This medicine contains maltitol liquid (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Ibuprofeno Stadapharm

Follow exactly the instructions for use provided in this leaflet by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

It is important to always take the lowest dose that relieves pain, and you should not take the medicine longer than necessary to control your symptoms.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Dosage

Adults and adolescents (weighing more than 40 kg) from 12 years of age:

The recommended dose is one sachet (400 mg of ibuprofen) every 4–8 hours, depending on the intensity of symptoms and response to treatment. Do not take more than 3 sachets (1,200 mg) within 24 hours.

Elderly patients:

Dosage should be determined by the physician, as a reduction of the usual dose may be necessary. Elderly individuals are generally more prone to adverse effects.

Patients with kidney, liver, or heart disease:

Reduce the dose and consult your doctor. Ibuprofen should not be used in patients with severe renal, hepatic, or cardiac insufficiency.

If symptoms worsen, if fever persists for more than 3 days, or if pain lasts longer than 5 days (3 days in adolescents), you must consult a doctor.

Administration of this medicine should be based on the presence of pain or fever. As these symptoms subside, treatment should be discontinued.

Use in children and adolescents:

This medicine is not recommended for use in children or adolescents weighing less than 40 kg.

Method of administration

This medicine is a suspension and is administered orally.

The suspension must be homogenized before use, as shown in the following figure:

1 – Press repeatedly with fingers on the top and bottom parts of the sachet

2 – Press alternately from top to bottom and vice versa for at least 30 seconds

The suspension can be taken directly from the sachet or diluted in water.

If gastrointestinal discomfort occurs, it is recommended to take the medicine with food.

If you take more Ibuprofeno Stadapharm than you should

If you have taken more oral suspension than you should, or have accidentally ingested the contents of the container, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 5620420, indicating the medicine and the amount ingested. It is recommended to bring the container and the package leaflet to the healthcare professional.

If you have taken more Ibuprofeno Stadapharm than you should, or if a child has accidentally ingested the medicine, consult a doctor or go to the nearest hospital to assess the risk and receive 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, dizziness, blood in urine, low blood potassium levels, chills, and breathing difficulties have been reported.

More severe symptoms such as gastrointestinal bleeding, low blood pressure, decreased body temperature, metabolic acidosis, seizures, impaired kidney function, coma, adult respiratory distress syndrome, and transient respiratory arrest in children (after ingestion of large quantities) are rare.

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

If you forget to take Ibuprofeno Stadapharm

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

If you forget to take your scheduled 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 one at the usual time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

The frequencies shown below refer to short-term use of maximum daily oral doses of up to 1,200 mg of ibuprofen:

• Common adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, dyspepsia (disorder of secretion or gastrointestinal motility), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, dizziness or feeling unsteady, fatigue.

• Uncommon adverse effects (may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple spots on the skin), skin reactions due to light exposure, hypersensitivity, paraesthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms or legs), headache and drowsiness, insomnia, anxiety, hearing disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth ulcers), gastrointestinal perforations, hepatitis (liver inflammation), abnormalities in liver function and jaundice (yellowing of the skin and eyes), asthma, bronchospasm (difficulty breathing).

• Rare adverse effects (may affect up to 1 in 1,000 people):

Disorientation or confusion, dizziness, tinnitus (ringing or noise in the ears), reversible toxic amblyopia, liver injury, oedema (swelling due to fluid accumulation in tissues), optic neuritis.

• Very rare adverse effects (may affect up to 1 in 10,000 people): pancreatitis, very severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, mainly on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion). In case of severe generalized hypersensitivity reaction, signs may include swelling of the face, tongue and larynx, dyspnoea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock), aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which represented a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever or disorientation. Other very rare adverse effects include decreased platelets, decreased white blood cells (may present as frequent infections with fever, chills or sore throat), decreased red blood cells (may present as difficulty breathing and pale skin), neutropenia (reduction in neutrophils) and agranulocytosis (severe reduction in neutrophils), aplastic anaemia (bone marrow failure to produce various types of blood cells), haemolytic anaemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, unexplained bleeding and bruising. Liver failure (severe liver impairment), heart failure, myocardial infarction, hypertension. Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling) and renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea.

Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to seek medical advice promptly.

• Frequency not known (cannot be estimated from available data):

Colitis and Crohn's disease (chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea).

Generalized red scaly rash, with bumps under the skin and blisters mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno Stadapharm if you experience these symptoms and seek immediate medical attention. See also section 2.

Skin becomes sensitive to light.

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

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).

If any of the following adverse effects occur, stop treatment immediately and consult your doctor:

• Allergic reactions such as skin rashes, facial swelling, wheezing or difficulty breathing.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or diarrhoea with blood.
• Severe stomach pain.
• Blisters or extensive peeling of the skin.
• 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 arms or legs.
• Flat, non-elevated red circular or target-shaped rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized rash, high 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 exanthematous pustulosis).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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: www.notificaRAM.es.

5. Storage of Ibuprofen Stadapharm

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

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Ibuprofen Stadapharm

• The active substance is ibuprofen. Each 10 ml sachet of suspension contains 400 mg of ibuprofen.
• The other components (excipients) are: Sodium benzoate (E-211), glycerol 99.5% (E-422), maltitol liquid (E-965), xanthan gum, sodium saccharin (E-954), anhydrous citric acid, sodium citrate (E-331), sodium chloride, hypromellose 15 cPs, strawberry flavor, and purified water.

Presentation of the product and contents of the container

Ibuprofen Stadapharm is a white, strawberry-flavored oral suspension contained in single-dose 10 ml sachets made from a polyester, aluminum, polyester, and polyethylene laminate.

It is available in packs of 12 or 20 units.

Only certain pack sizes may be 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

ZINEREO PHARMA, S.L.U.

A Relva, s/n, O Porriño,

36410 Pontevedra

Spain

or

FARMALIDER, S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

or

EDEFARM S.L.

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante (Valencia)

Spain

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

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