Ibuprom RR Max 400mg (12 Tablets)

Ibuprom RR Max is a drug for adults and children over 12 years of age with analgesic, anti-inflammatory and antipyretic properties. The drug is indicated for use in acute mild or moderate pain, such as postoperative, muscular, skeletal, migraine and menstrual pain.

Ibuprom RR Max is also used to reduce mild and moderate pain of various origins, such as: headache, toothache, low back pain, neuralgia, joint pain, and fever (in the course of a cold or flu).

Indications

• Pain of various origins of moderate and mild intensity, including: headaches, migraine, toothache, muscle and joint pain, pain in the sacral region, neuralgia, dysmenorrhea, fever in the course of colds and flu.
• Mild or moderate acute pain.

Composition

1 tablet contains:

• active ingredient: ibuprofen 400 mg,
• excipients: tablet core: microcrystalline cellulose, corn starch, pregelatinized starch, hydrogenated vegetable oil, crospovidone, talc, colloidal anhydrous silica, tablet coating: polyvinyl alcohol (E 1203), macrogol 3350 (E1521), titanium dioxide (E 171) , talc (E 553b), a mixture of aluminum, potassium silicate (E 555) and titanium dioxide (E 171), carnauba wax. The composition of the printing ink: shellac glaze approx. 45% (20% esterified) in ethanol, titanium dioxide (E 172), propylene glycol (E 1520), isopropyl alcohol, ammonium hydroxide 28% (E 527), simethicone.

Action

Analgesic, anti-inflammatory and antipyretic.

Dosage

Always use this 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 not sure.

• Adults and children over 12 years of age: in acute treatment: 1 tablet orally every 4 – 6 hours.
• Do not use more than 3 tablets a day.
• Elderly: no dosage adjustment is required.

If you have the impression that the effect of the drug is too strong or too weak, consult your doctor. The drug is intended for short-term use. If symptoms persist or worsen, or if new symptoms occur, contact your doctor. Do not take the drug for more than 3 days without consulting a doctor.

Contraindications

• Allergy to ibuprofen or any of the excipients of this medicine (listed in section 6) and to other non-steroidal anti-inflammatory drugs (NSAIDs).
• Patients who have had symptoms of allergy such as runny nose , urticaria or bronchial asthma in the past after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• Peptic ulcer of the stomach and / or duodenum, active or past, with perforation or bleeding, also with those occurring after the use of NSAIDs.
• Severe liver, kidney or heart failure.
• Taking other non-steroidal anti-inflammatory drugs at the same time, including COX-2 inhibitors (increased risk of side effects).
• III trimester of pregnancy,
• Hemorrhagic diathesis.

Storage

Store the drug below 25°C, out of the sight and reach of children.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include skin rash, fever, swollen glands, and an increase in eosinophils (a type of white blood cell).
• Edema, hypertension and cardiac failure have been reported in association with NSAID treatment. Taking medicines such as Ibuprom RR MAX may be associated with a slightly increased risk of heart attack (heart attack) or stroke.
• Side effects are rare in the event of acute drug use. Elderly patients are at an increased risk of side effects from ibuprofen than younger patients. The incidence and severity of side effects can be reduced by using the lowest therapeutic dose for the shortest possible time.

Uncommon (in 1 to 10 out of 1,000 patients taking the drug):

• headache,
• indigestion,
• stomach ache, nausea
• hives, itching.

Rare (affects 1 to 10 users in 10,000):

• diarrhea,
• flatulence,
• constipation,
• vomiting,
• gastritis,
• dizziness,
• insomnia,
• stimulation,
• irritability and fatigue,
• swelling resulting from disorders of the kidneys and urinary tract.

Very rare (less than 1 in 10,000 patients taking the drug):

• tarry stools, bloody vomiting, ulcerative stomatitis, worsening of colitis and Crohn’s disease
• gastric and / or duodenal ulcers, gastrointestinal bleeding and perforation, sometimes fatal, especially in the elderly,
• in isolated cases the following were reported: depression, psychotic reactions and tinnitus, aseptic meningitis, decreased urine output, edema, acute renal failure, renal papillary necrosis, increased serum sodium (sodium retention),
• liver dysfunction, especially during long-term use,
• abnormalities of blood counts (anemia – anemia, leukopenia – decrease in the number of leukocytes, thrombocytopenia – decrease in the number of platelets, pancytopenia – hematological disorder consisting in the deficiency of all normal blood cells: erythrocytes and thrombocytes, agranulocytosis – decrease in the number of granulocytes). The first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, fatigue, haemorrhagic diathesis (e.g. bruising, ecchymosis, purpura, nosebleed),
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
• severe hypersensitivity reactions such as: swelling of the face, tongue and larynx, dyspnoea, tachycardia – arrhythmias, hypotension – sudden drop in blood pressure, shock; asthma exacerbation and bronchospasm
• In patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms occurring in aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever and confusion have been reported during treatment with ibuprofen.

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

• a red, scaly rash with bumps under the skin and blisters, mostly in the skin folds, on the trunk and arms, with a fever at the start of treatment (acute generalized pustular eruption). If such symptoms occur, stop taking the medicine and seek medical attention immediately.

Interactions with other drugs

• Inform your doctor about all medications you have recently taken, even those sold without a prescription.
• Do not take the drug simultaneously with other drugs from the group of non-steroidal anti-inflammatory drugs (including cyclooxygenase 2 inhibitors, such as celecoxib or etoricoxib), other painkillers or acetylsalicylic acid (in analgesic doses). The simultaneous use of Ibuprom RR Max with these drugs increases the risk of side effects.
• The medicine may influence the effect of other medicines, or other medicines may influence the way this medicine works, for example:
  • Medicines with anticoagulant activity (i.e. blood thinning / preventing blood clots such as aspirin / acetylsalicylic acid, warfarin, ticlopidine)
  • Medicines to lower blood pressure (ACE inhibitors such as captopril, beta blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
  • diuretics,
  • corticosteroids (such as prednisolone or dexamethasone)
  • methotrexate (an anti-cancer drug)
  • lithium (an antidepressant)
  • zidovudine (antiviral medicine).

Warnings and Precautions

• Talk to your doctor or pharmacist before using this medicine.
• Take special care if you suffer from:
  • lupus erythematosus and mixed connective tissue disease were diagnosed,
  • there are symptoms of allergic reactions after taking acetylsalicylic acid,
  • diseases of the digestive system and chronic inflammatory bowel diseases (ulcerative colitis, Leśniowski and Crohn’s disease) were diagnosed,
  • arterial hypertension and / or cardiac dysfunction,
  • kidney and / or liver dysfunction has been diagnosed,
  • diagnosed with blood coagulation disorders,
  • you have active or past bronchial asthma or symptoms of allergic reactions in the past; bronchospasm may occur after taking the drug,
  • taking other medications (especially anticoagulants, diuretics, cardiac medications, corticosteroids).
• There is a risk of gastrointestinal haemorrhage, ulceration or perforation, which may be fatal and which may not necessarily be preceded by warning symptoms, or may occur in patients who have had these warning symptoms. Treatment should be discontinued immediately in the event of gastrointestinal haemorrhage or ulceration. Patients with a history of gastrointestinal disease, especially the elderly, should inform their physician about any unusual gastrointestinal symptoms (especially bleeding), especially at the beginning of therapy.
• Concomitant long-term use of various painkillers may lead to kidney damage with the risk of renal failure (postalgesic nephropathy).
• Caution should be exercised in dehydrated patients (children and adolescents) due to an increased risk of renal dysfunction.
• Taking anti-inflammatory / painkillers such as ibuprofen may be associated with a slightly increased risk of a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose and duration of treatment.
• Before using the drug, patients should discuss treatment with a doctor or pharmacist if:
  • you have heart problems such as heart failure, angina (chest pain), you have had a heart attack, bypass surgery, you have peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of the arteries) or if you have has had any stroke (including 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 smoke
  • you have an infection.
• Higher doses and longer duration of treatment than recommended should not be used. If symptoms persist, worsen or do not improve after 3 days, or if new symptoms occur, contact your doctor.
• If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the drug

Use in children

• The drug is not recommended for children under 12 years of age.

Pregnancy, breast-feeding and fertility

• 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.
• The use of the drug in women in the third trimester of pregnancy is contraindicated, as it could increase the risk of complications in the mother and child in the perinatal period.
• Ibuprofen passes into breast milk in very small amounts and there are no known cases of side effects in breast-fed infants. It is not necessary to stop breastfeeding in case of short-term use of ibuprofen in low doses.

Driving vehicles and operating machinery

• There are no reports 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.

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.