Ibufen 400 mg oral powder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibufén 400 mg oral powder

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience 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 you worsen or do not improve after 3 days.

Contents of the leaflet

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

1. What Ibufén is and what it is used for

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

This medicine is indicated in adolescents and adults:

• for the symptomatic relief of mild to moderate occasional pain;
• for the treatment of fever.

You should consult a doctor if symptoms worsen or do not improve after 3 days.

2. What you need to know before taking Ibufén

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

Do not take Ibufén

• If you are allergic to ibuprofen or to any of the other components of this medicine (listed in section 6).
• If you have experienced, after taking acetylsalicylic acid or other NSAIDs, itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• If you have had stomach or duodenal bleeding or suffered a gastrointestinal perforation while taking an anti-inflammatory medicine.
• If you currently have or have had on more than one occasion: a stomach or duodenal ulcer or bleeding.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.
• If you have 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 you have an exacerbation of ulcerative colitis or Crohn's disease.
• If you have severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake).

Warnings and precautions

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

• 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 and treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor may consider prescribing a stomach-protecting medicine.
• If you have had kidney or liver disease.
• If you have oedema (fluid retention).
• If you suffer from asthma or any other respiratory disorder.
• If you are taking this medicine, as ibuprofen may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have or have had any heart disorder or have high blood pressure.
• 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 the frequency of these checks.
• If you show symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this specific case could lead to renal failure as a consequence of dehydration.
• If you are taking medications that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medicines of this type may worsen these conditions.
• If you are being treated with diuretics (medicines to increase urine output), because your doctor must 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 (inflammation of the meninges—the membranes protecting the brain and spinal cord—without bacterial cause) may be more likely.
• 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.
• If you have an infection; see the section «Infections» below.
• 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.
• Signs of allergic reaction to ibuprofen, such as breathing problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibufén immediately and contact your doctor or medical emergency services immediately if you notice any of these signs.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen 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 Ibufén 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 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.

Special caution is recommended with Ibufén

Skin reactions

Serious skin reactions have been reported with Ibufén, 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 Ibufén and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Stop taking Ibufén and see your doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.

Ibufén may mask signs of infection such as fever and pain. Therefore, Ibufén 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 without delay.

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

Children and adolescents

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

Interference with laboratory tests:

Taking ibuprofen may alter 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 levels of urea nitrogen and serum levels of creatinine and potassium (may increase).

Liver function tests: increased transaminase values.

Inform your doctor if you are undergoing clinical testing and are taking or have recently taken ibuprofen.

Consult your doctor or pharmacist before starting to take Ibufén.

Use of Ibufén with other medicines

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

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

• Other non-steroidal anti-inflammatory drugs (NSAIDs): as this may increase the risk of adverse effects.
• Anticoagulant medicines (e.g. to treat or prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine). Lithium (a medicine used to treat depression): as this may increase blood levels of lithium and the risk of adverse effects. If you need to take both lithium and ibuprofen, your doctor may need to adjust your lithium dose.
• Methotrexate: taking methotrexate and ibuprofen simultaneously (within a 24-hour interval) may increase methotrexate blood levels and the risk of toxicity. Your doctor may advise against taking ibuprofen if you are receiving high-dose methotrexate therapy.
• Hydantoins such as phenytoin (for treatment of epilepsy).
• Sulphonamides: as they may increase their toxic effects.
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).
• Corticosteroids such as cortisone and prednisolone, as they may increase the risk of gastrointestinal ulcer or bleeding.
• Diuretics (medicines used to increase urine output), as they may increase the risk of kidney toxicity.

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

• Fluconazole and voriconazole (used to treat fungal infections), pentoxifylline, probenecid and sulfinpyrazone (for gout), quinolones (such as norfloxacin), mifepristone, sulfonylureas (such as tolbutamide), tacrolimus and cyclosporine (used to prevent transplant rejection), zidovudine (risk of kidney damage), cholestyramine (a medicine used to treat high cholesterol).
• Selective serotonin reuptake inhibitor (SSRI) antidepressants may also increase the risk of gastrointestinal bleeding.

Taking Ibufén with food, drinks and alcohol

For patients with gastric discomfort, it is recommended to take the medicine during meals.

Consumption of alcohol may increase the risk of adverse reactions.

Pregnancy, breastfeeding and fertility

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.

Precautions during pregnancy and in women of childbearing age

Do not take Ibufén 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 unborn baby. It may affect your tendency and your baby's tendency to bleed and delay or prolong labour more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is needed during this period or while 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 is needed for longer than a few days, your doctor may recommend additional monitoring.

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

Breastfeeding

Although drug levels in breast milk are negligible, it is recommended to consult your doctor for long-term treatment or high-dose therapy during breastfeeding.

Driving and using machines

If you experience dizziness, vertigo, vision 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 use it for a short period, no special precautions are necessary.

Ibuprofen may slow your reaction time, which should be taken into account before engaging in activities requiring high alertness, such as driving and operating machinery.

Ibufén contains isomalt (E-953)

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

3. How to take Ibufén

Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Dosage

Adults and adolescents (over 12 years of age and >40 kg)

The recommended dose is 1 sachet (400 mg of ibuprofen) three times daily, every 6–8 hours.

The dosing interval should be chosen according to symptom severity. Do not exceed 1,200 mg of ibuprofen (3 sachets) within 24 hours.

Use the lowest effective dose 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).

This medicine is intended for short-term treatment.

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

This medicine should only be administered when pain or fever occurs. As these symptoms subside, treatment should be discontinued.

Paediatric population

Do not administer to children or adolescents weighing less than 40 kg, as the dose cannot be adjusted to their required dosage.

Elderly population (over 65 years of age)

Dosage should be determined by the doctor, as a reduction from the usual dose may be necessary.

Patients with kidney, liver, or heart disease

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

Administration method

For oral use.

Empty the contents of the sachet directly into the mouth. In patients experiencing gastric discomfort, it is recommended to take the medicine during meals.

If you take more Ibufén than you should

If you have taken more Ibufén than you should, or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately, or contact the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you have taken more Ibufén than recommended, 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 necessary measures.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding (see section 4), diarrhoea, headache, tinnitus, confusion, and involuntary eye movements. Agitation, disorientation, or coma may also occur. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

Additionally, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors.

Acute renal failure and liver damage may occur.

Asthma may worsen in asthmatic patients. In addition, low blood pressure and reduced breathing may occur.

If you forget to take Ibufén

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 the time for your next dose is approaching, skip the missed dose and take the next dose 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 experiences them.

The frequencies are defined as follows:

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 the available data.

The following adverse effects have been observed:

Gastrointestinal disorders

The most common adverse effects occurring with medicines containing this active substance are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, constipation, heartburn, abdominal pain, blood in stools, mouth ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Common: nausea, vomiting, abdominal pain, heartburn, flatulence, and constipation.

Uncommon: gastrointestinal bleeding, stomach or duodenal ulcers.

Rare: gastric or intestinal perforation, inflammation of the oesophagus, and ulceration or inflammation of the intestine.

Skin and subcutaneous tissue disorders

Common: skin rash.

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

Rare: severe allergic reactions (anaphylactic shock).

Very rare: sudden onset of intense itching or blisters on the skin, joint pain, and fever (systemic lupus erythematosus), hair loss, and skin reactions triggered by light exposure. Medicines containing this active substance may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and allergic vasculitis.

Severe allergic reaction that may present with nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulties, asthma, palpitations, hypotension, or shock.

Frequency not known: widespread 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). The skin becomes sensitive to light. Stop taking Ibufén if you experience these symptoms and seek immediate medical attention. See also section 2.

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).

Nervous system disorders

Common: headache.

Uncommon: fatigue or drowsiness.

Very rare: aseptic meningitis (inflammation of the membranes covering the brain and spinal cord), mostly occurring in patients with an underlying autoimmune disease such as systemic lupus erythematosus.

Psychiatric disorders

Common: feeling unsteady and nervousness.

Uncommon: anxiety.

Rare: disorientation or confusion, depression.

Ear and labyrinth disorders

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

Rare: hearing impairment.

Eye disorders

Uncommon: vision disturbances.

Rare: abnormal or blurred vision.

Blood and lymphatic system disorders

Very rare: prolonged bleeding time, blood cell abnormalities (early symptoms may include: fever, sore throat, mouth ulcers, flu-like symptoms, excessive tiredness, nosebleeds, and skin bleeding).

Cardiovascular disorders

These medicines may be associated with a moderately increased risk of heart attack ("myocardial infarction") or stroke. Oedema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatment using this type of medicine.

Frequency not known: chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Renal and urinary disorders

Kidney disease.

Hepatobiliary disorders

Rare: hepatitis (liver inflammation) and jaundice (yellowing of the skin). These medicines may, in rare cases, be associated with liver injury.

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

• Flat, red, target-shaped or circular spots 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].
• 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 Ibufén

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition

• The active substance is Ibuprofen. Each sachet contains 400 mg of ibuprofen.
• The other components (excipients) are: Isomalt (E-953), anhydrous citric acid, potassium acesulfame (E-950), glycerol distearate (type I), and lemon flavour (natural flavourings, maltodextrin, alpha tocopherol (E-307)).

Appearance of the product and contents of the pack

Ibufén is presented as a white or almost white oral powder with a pronounced lemon odour, in single-dose sachets made of coated paper/polyextruded polyethylene/aluminium/polyextruded polyethylene.

Two pack sizes are available: packs containing 12 units and packs containing 24 units.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer responsible for manufacturing

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

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: November 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/"