Ibuprom Max 400mg (12 Tablets)

Ibuprom Max 400mg is a drug in the form of white, oblong, biconvex tablets with a sugar coating. Each tablet contains 400mg of the active ingredient – ibuprofen (Ibuprofenum). This preparation is suitable for adults as well as for children and adolescents over 12 years of age. Ibuprofen belongs to the group of so-called non-steroidal anti-inflammatory drugs (NSAIDs). This ingredient has an analgesic effect (including headaches, toothaches, muscles, bones and joints, neuralgia, as well as painful menstruation), anti-inflammatory (importantly, inflammation can also be a source of pain) and antipyretic (e.g. in the course of colds, flu, or other infectious diseases with symptoms of fever).

Contents

The Ibuprom Max package contains:

• Ibuprom Max tablets – 12 pcs. (1 blisters of 12 pcs.),
• Patient Information Leaflet (read it before taking this medicine and keep it so you can read it again if necessary).

Symptoms

Ibuprom Max 400mg is used in people over 12 years of age:

• in acute pain of mild or moderate intensity, including pain:
  • bone,
  • menstrual
  • muscle,
  • migraines,
  • postoperative,
• to relieve mild and moderate pains of various origins, including pains:
  • head,
  • the lumbosacral region,
  • joints,
  • teeth,
  • neuralgia,
• in fever, e.g. in the course of:
  • flu
  • colds,
  • other infectious diseases.

Composition

1 tablet contains:

• active ingredient: ibuprofen (Ibuprofenum) 400 mg,
• excipients: tablet core: lactose, povidone, maize starch, talc, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica, coating: sucrose, talc, maize starch, titanium dioxide, carnauba wax, white wax.

Action of Ibuprom Max 400mg

Ibuprom Max has analgesic, anti-inflammatory and antipyretic properties.

Dosage of Ibuprom Max 400mg

Always take the medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.

• Adults and children over 12 years of age in emergency treatment: 1 tablet orally every 4 hours (but not more than 3 tablets a day).

This drug is intended for short-term use. It must not be taken for more than 3 days without consulting a doctor. If during this time, despite the use of Ibuprom Max, the symptoms persist or worsen, or if new symptoms occur, contact your doctor who will suggest further treatment.

Contraindications of Ibuprom Max 400mg

• Allergic to ibuprofen or any of the other ingredients in this medicine, or to other non-steroidal anti-inflammatory drugs (NSAIDs).
• Peptic ulcer of the stomach and / or duodenum (active or past), perforation or bleeding (including those occurring with NSAIDs).
• Severe liver failure, severe kidney failure, or severe heart failure.
• Concomitant use of other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of side effects).
• Hemorrhagic diathesis.
• Do not use the drug if allergy symptoms (such as runny nose, urticaria or bronchial asthma) have occurred in the past after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• Do not take Ibuprom Max in the third trimester of pregnancy.
• Do not give the drug to children under 12 years of age.

Storage

Keep the drug out of the sight and reach of children, at a temperature not exceeding 30°C.

Side Effects of Ibuprom Max 400mg

Ibuprom Max, like any other drug, can cause side effects, although not everyone will experience them.

• Serious skin reactions known as DRESS syndrome may occur and the symptoms include:
  • skin rash
  • fever,
  • swollen lymph nodes
  • increase in eosinophils (a type of white blood cell).
• In association with treatment with non-steroidal anti-inflammatory drugs (NSAIDs), which include ibuprofen, the following has been reported:
  • swelling,
  • hypertension,
  • heart failure.
• Taking medications like Ibuprom Max may be associated with a slightly increased risk of heart attack (heart attack) or stroke.
• Side effects are rare with acute use of this drug.
• Elderly patients are at greater risk of side effects. To reduce the frequency and severity of side effects, ibuprofen should be taken in the lowest effective dose for the shortest possible time.

Common (occurs in less than 1 in 10 but more than 1 in 100 patients):

• heartburn, abdominal pain, nausea, vomiting, gas, diarrhea, constipation,
• slight gastrointestinal bleeding (in exceptional cases may lead to anemia).

Uncommon (affects less than 1 in 100 but more than 1 in 1,000 patients):

• hypersensitivity reactions with skin rash and itching,
• attacks of breathlessness (possible with a drop in blood pressure),
• headache, dizziness,
• insomnia, agitation, irritability, fatigue,
• blurred vision,
• gastrointestinal ulceration, potentially with bleeding and perforation, ulcerative stomatitis
• exacerbation of colitis and Crohn’s disease, gastritis.

Rare (affects less than 1 in 1,000 but more than 1 in 10,000 patients):

• Tinnitus,
• renal papillary necrosis,
• increased levels of uric acid in the blood.

Very rare (affects less than 1 in 10,000 patients):

• exacerbation of infection-related inflammations (e.g. the occurrence of necrotizing fasciitis) associated with the use of non-steroidal anti-inflammatory drugs (if symptoms of infection appear or worsen while using this medicinal product, contact your doctor immediately, who will decide whether you need to use anti-infectious drugs or antibiotics) ),
• symptoms of aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever, disturbance of consciousness, mainly in patients with autoimmune disorders: systemic lupus, mixed connective tissue disease (if such symptoms occur, go to to the doctor),
• disorders of blood cell production, with the first symptoms such as fever, sore throat, superficial mouth ulcers, flu-like symptoms, fatigue, bleeding, including bruising, ecchymosis, purpura, epistaxis (if such symptoms occur, treatment should be stopped and contact your doctor immediately – do not treat them with painkillers or antipyretics),
• severe generalized hypersensitivity reactions, which may occur as face swelling, tongue swelling, internal laryngeal edema with impaired airway patency, respiratory failure, increased heart rate, drop in blood pressure – including life-threatening shock (if such symptoms occur, stop taking the drug and see a doctor immediately)
• psychotic reactions, depression,
• palpitations, heart failure, myocardial infarction
• arterial hypertension,
• oesophagitis, pancreatitis, formation of intestinal diaphragm-like strictures (if you experience severe upper abdominal pain, tarry stools or bloody vomiting, stop taking the drug and consult your doctor immediately),
• liver dysfunction (especially with long-term use), liver failure, acute hepatitis erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
• in exceptional cases, severe skin infections and complications of the soft tissue may occur during chickenpox infection,
• decrease in urination and the formation of edema, especially in patients with high blood pressure or renal failure, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure (if such symptoms occur, stop taking the drug and see a doctor immediately, as these may be the first signs of kidney damage or failure).

Not known (cannot be estimated from the available data):

• acute generalized pustular eruption – a red, scaly rash with bumps under the skin and blisters, mostly in skin folds, on the trunk and arms, with a fever that occurs at the start of treatment (if this occurs, stop taking the medicine and seek medical attention immediately ),
• the skin becomes sensitive to light.

Interactions

• Tell your doctor or pharmacist about all the drugs you are taking or have recently taken, and about all the drugs you plan to use.
• Do not take Ibuprom Max at the same time as:
  • other non-steroidal anti-inflammatory drugs (including cyclooxygenase 2 inhibitors such as celecoxib or etoricoxib)
  • other painkillers (including ibuprofen)
  • acetylsalicylic acid (at analgesic doses).
• The simultaneous use of Ibuprom Max with the above-mentioned drugs increases the risk of side effects.
• Ibuprom Max may affect the action of other drugs, and other drugs may affect the action of Ibuprom Max, including:
  • drugs with anticoagulant activity (thinning the blood / preventing blood clots, e.g. aspirin / acetylsalicylic acid, warfarin, ticlopidine),
  • medicines to lower blood pressure (ACE inhibitors such as captopril, beta blockers, e.g. medicines containing atenolol, medicines that antagonize the angiotensin II receptor e.g. losartan),
  • diuretics,
  • corticosteroids (e.g. prednisolone or dexamethasone)
  • methotrexate (an anti-cancer drug)
  • lithium (an antidepressant)
  • zidovudine (antiviral medicine).
• Also, some other drugs may affect or affect the treatment with Ibuprom Max, so before using this drug with other drugs, you should always consult your doctor or pharmacist.

Taking the drug with food and drink

• It is recommended to take the drug after a meal.

Warnings and Precautions

• The drug contains ibuprofen. Talk to your doctor or pharmacist before using Ibuprom Max.
• The minimum effective dose should be used for the shortest possible time necessary to relieve symptoms.
• If symptoms such as fever and pain persist or worsen during your infection, consult your doctor immediately.
• Do not increase the recommended dose yourself. If you have the impression that the effect of the medicine is too strong or too weak, consult your doctor.
• Take special care with the drug if:
  • you suffer from lupus erythematosus and / or mixed connective tissue disease,
  • the patient has symptoms of allergic reactions after taking acetylsalicylic acid,
  • you have digestive system diseases and / or chronic inflammatory bowel diseases (e.g. ulcerative colitis, Crohn’s disease),
  • you have high blood pressure and / or heart problems,
  • you have kidney problems, liver problems, or blood clotting disorders,
  • if you have active or past bronchial asthma, or have symptoms of allergic reactions in the past (in such a situation, bronchospasm may occur after taking the drug),
  • you are taking other medications (especially anticoagulants, diuretics, cardiac medications, corticosteroids).
• There is a risk of gastrointestinal haemorrhage, ulceration or perforation, even fatal, which are sometimes, but not always, preceded by warning symptoms. If gastrointestinal haemorrhage or ulceration occurs, the drug should be discontinued immediately.
• Patients with gastrointestinal diseases (especially the elderly) should inform their physician about any unusual gastrointestinal symptoms, especially bleeding, especially at the beginning of therapy.
• Long-term use of various painkillers at the same time can damage the kidneys, with the risk of kidney failure (so-called postalgetic nephropathy).
• Caution should be exercised in dehydrated patients (and also in children and adolescents) as they are at increased risk of impaired renal function.
• Taking anti-inflammatory and pain relieving drugs such as ibuprofen may be associated with a slightly increased risk of a heart attack or stroke, especially when used in high doses.
• Before taking Ibuprom Max, the patient should discuss the treatment with a doctor or pharmacist if:
• you suffer from heart problems such as:
  • heart failure
  • angina (chest pain)
• the patient had:
  • heart attack,
  • a bypass operation,
• you have peripheral arterial disease (poor blood circulation in the legs due to narrowing or blocked arteries)
• the patient has had any stroke (including mini-stroke or transient ischemic attack (TIA))
• the patient suffers from:
  • hypertension,
  • diabetes
• you have high levels of cholesterol
• if you have a family history of heart disease or stroke
• the patient smokes tobacco,
• The use of the drug should also be discussed with a doctor if the patient has an infection. Ibuprom Max may hide symptoms of infection (such as fever and pain), so taking it may delay the diagnosis and treatment of the infection and, consequently, lead to an increased risk of complications. This has been observed, for example, in bacterial pneumonia as well as bacterial skin infections associated with chickenpox. If you are taking this medicine while you have an infection, but your symptoms persist or worsen, consult your doctor immediately.
• Do not use a higher dose or treatment duration than recommended. If symptoms persist, worsen or do not improve after 3 days (or if new symptoms occur), contact your doctor who will decide on further treatment.
• Serious skin reactions associated with the use of Ibuprom Max have been reported. In case of any skin rash, changes on the mucous membranes, blisters or other signs of allergy, stop taking Ibuprom Max and seek medical help immediately – these may be the first signs of a very severe skin reaction.
• If you have used a higher dose of Ibuprom Max than you should (or if a child under 12 has accidentally taken the medicine), contact your doctor immediately or go to the nearest hospital for an opinion on possible health risks and advice on what to do must be taken.

Use in children and adolescents

• Do not give the drug to children under 12 years of age.

Pregnancy, breast-feeding and fertility

• The Ibuprom Max drug belongs to the group of non-steroidal anti-inflammatory drugs. They can adversely affect female fertility. This is a temporary effect and will wear off after the end of therapy.
• Contact your doctor before taking ibuprofen if you have difficulties becoming pregnant.
• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• During the first 6 months of pregnancy, use of the drug is not recommended.
• Do not use the drug in women in the third trimester of pregnancy, as it may increase the risk of complications in the perinatal period, both for the mother and the child.
• Ibuprofen passes into breast milk in a very small amount. There are no known cases of side effects in breastfed infants. Therefore, it is not necessary to interrupt breast-feeding with the short-term use of low-dose ibuprofen.

Driving vehicles and operating machinery

• There are no data on the effect of the drug on the ability to drive vehicles, use of moving mechanisms and psychophysical fitness when the drug is used in the recommended doses and for the recommended period of time.

Ibuprom Max contains lactose and sucrose

• If you have an intolerance to some sugars before taking this medicine, you should contact your doctor.
• This medicine contains less than 1 mmol (23 mg) sodium per single dose (1 tablet), which means it is essentially ‘sodium-free’.

Manufacturer

US Pharmacia Sp. z o
. o . ul. Ziębicka 40
50 – 507 Wrocław

Additional information

Before use, read the leaflet, which contains indications, contraindications, data on side effects, dosage and information on the use of the medicinal product, or consult your doctor or pharmacist, as each drug used improperly is a threat to your life or health.