Ibuprom Rr Max

Leaflet attached to the packaging: patient information

IBUPROM RR MAX

400 mg, coated tablets

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects not listed in this leaflet, they should tell their doctor or pharmacist.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Ibuprom RR MAX and what is it used for
• 2. Important information before taking Ibuprom RR MAX
• 3. How to take Ibuprom RR MAX
• 4. Possible side effects
• 5. How to store Ibuprom RR MAX
• 6. Contents of the packaging and other information

1. What is Ibuprom RR MAX and what is it used for

Ibuprom RR MAX is a pain-relieving, anti-inflammatory, and antipyretic medicine. It is used to treat mild to moderate acute pain: post-operative, muscular, bone, migraine, and menstrual. The medicine is also used to reduce mild to moderate pain of various origins: headache, toothache, lower back pain, neuralgia, joint pain, and fever (in the course of a cold or flu).

2. Important information before taking Ibuprom RR MAX

When not to take the medicine

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6) and to other non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients who have ever had symptoms of allergy after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (e.g., nasal congestion, urticaria, or bronchial asthma),
• in patients with active or recurrent stomach and/or duodenal ulcers, perforation, or bleeding, also those that occurred after taking NSAIDs,
• in patients with severe liver, kidney, or heart failure,
• in patients taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of side effects),
• in the third trimester of pregnancy,
• in case of bleeding disorders.

Warnings and precautions

Before starting treatment with Ibuprom RR MAX, the patient should discuss it with their doctor or pharmacist.
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When to exercise special caution when taking Ibuprom RR MAX

• if the patient has systemic lupus erythematosus and mixed connective tissue disease,
• if there are symptoms of allergic reactions after taking acetylsalicylic acid,
• if the patient has gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• if the patient has hypertension and/or heart failure,
• if the patient has kidney function disorders,
• if the patient has liver function disorders,
• if the patient has blood coagulation disorders,
• if the patient has a history of asthma or allergic reactions; after taking the medicine, bronchospasm may occur,
• if the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be discontinued immediately. Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.
Concomitant, long-term use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).
Care should be taken in dehydrated patients (youth) due to the increased risk of kidney function disorders.
Taking anti-inflammatory and pain-relieving medicines, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose and duration of treatment.
During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), chest pain.
If any of these symptoms are noticed, the medicine Ibuprom RR MAX should be discontinued immediately and medical help should be sought.
Before taking Ibuprom RR MAX, the patient should discuss the treatment with their doctor or pharmacist if:

• the patient has heart diseases, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has peripheral artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• the patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes.
• the patient has an infection - see below, section "Infections".

Do not take higher doses or longer treatment than recommended.
If symptoms persist, worsen, or do not improve after 3 days, or if new symptoms occur, consult a doctor.
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In connection with the use of ibuprofen, severe skin reactions have occurred, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms related to these severe skin reactions described in section 4, they should discontinue Ibuprom RR MAX and seek medical help.
Infections
Ibuprom RR MAX may mask the symptoms of an infection, such as fever and pain. Therefore, Ibuprom RR MAX may delay the use of appropriate infection treatment, which may lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection, and the symptoms of the infection persist or worsen, they should immediately consult a doctor.
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and reverses after treatment is stopped.
If the patient is having trouble getting pregnant, they should consult their doctor before taking ibuprofen.
The patient should consult their doctor, even if the above warnings refer to past situations.

Children

The medicine is not indicated for children under 12 years of age.

Ibuprom RR MAX and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, even those that are available without a prescription.
Do not take Ibuprom RR MAX at the same time as other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors, such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (in analgesic doses). Concomitant use of Ibuprom RR MAX with these medicines increases the risk of side effects.
Ibuprom RR MAX may affect the action of other medicines or other medicines may affect the action of Ibuprom RR MAX, for example:

• anticoagulant medicines (e.g., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan)
• diuretics
• corticosteroids (e.g., prednisolone or dexamethasone)
• methotrexate (anticancer medicine)
• lithium (antidepressant)
• zydovudine (antiviral medicine)

Also, some other medicines may be affected or may affect treatment with Ibuprom RR MAX. Therefore, before taking Ibuprom RR MAX with other medicines, the patient should always consult their doctor or pharmacist.
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Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Do not take Ibuprom RR MAX if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery.
Ibuprom RR MAX may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the mother and child and cause prolonged or delayed labor. During the first 6 months of pregnancy, Ibuprom RR MAX should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest effective dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibuprom RR MAX, if taken for more than a few days, may cause kidney problems in the unborn child (which may lead to low amniotic fluid levels around the baby) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen passes into breast milk in very small amounts, and no cases of side effects have been reported in breastfed infants. There is no need to stop breastfeeding when taking ibuprofen for a short period and in small doses.

Fertility

See the "Warnings and precautions" section.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive vehicles, operate machinery, and mental performance during treatment with the recommended doses and duration.

3. How to take Ibuprom RR MAX

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Adults and adolescents over 12 years of age:for short-term treatment: 1 tablet orally every 4-6 hours.
Use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Do not take more than 3 tablets per day.

The medicine should not be taken by children under 12 years of age.

Elderly patients: no dose adjustment is required.
Do not increase the recommended dose.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.
The medicine is intended for short-term use. If symptoms persist, worsen, or new symptoms occur, consult a doctor.
Do not take the medicine for more than 3 days without consulting a doctor.
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Taking a higher dose of Ibuprom RR MAX than recommended

If the patient has taken a higher dose of Ibuprom RR MAX than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see section 4 below), diarrhea, headache, ringing in the ears, and confusion. It may also cause agitation, drowsiness, disorientation, or coma. Rarely, patients may experience seizures. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred. Additionally, there may be an extension of prothrombin time/INR, probably due to the disruption of circulating clotting factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. Additionally, there may be low blood pressure and difficulty breathing.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.

Missing a dose of Ibuprom RR MAX

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

4. Possible side effects

Like all medicines, Ibuprom RR MAX can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they should stop taking ibuprofen and seek medical help:

• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• red, peeling rash with nodules under the skin and blisters, with fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Uncommon side effects(affecting 1 to 10 in 1000 patients taking the medicine):

• headache, indigestion, stomach pain, nausea, urticaria, itching.

Rare side effects(affecting 1 to 10 in 10,000 patients taking the medicine):

• diarrhea, bloating, constipation, vomiting, gastritis, dizziness,
• insomnia, agitation, irritability, and fatigue,
• edema resulting from kidney and urinary tract disorders.

Very rare side effects(affecting less than 1 in 10,000 patients taking the medicine):

• tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease,
• gastric and/or duodenal ulcer, gastrointestinal bleeding, and perforation, sometimes with a fatal outcome, especially in the elderly,
• in individual cases, the following have been reported: depression, psychotic reactions, and tinnitus, aseptic meningitis, decreased urine output, edema, acute kidney failure, renal papillary necrosis, increased sodium levels in the serum (sodium retention),

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• liver function disorders, especially during long-term use,
• blood morphology disorders (anemia, leukopenia, thrombocytopenia, pancytopenia). The first symptoms are: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding disorders (e.g., bruising, petechiae, purpura, nosebleeds),
• severe hypersensitivity reactions such as: facial, tongue, and laryngeal edema, dyspnea, tachycardia, hypotension, shock; exacerbation of asthma and bronchospasm,
• in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) during ibuprofen treatment, individual cases of symptoms occurring in aseptic meningitis have been reported, such as neck stiffness, headache, nausea, vomiting, fever, disorientation.

Side effects with unknown frequency(frequency cannot be estimated from available data):

• skin becomes sensitive to light,
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

In connection with the use of NSAIDs, reports of edema, hypertension, and heart failure have been made.
Taking medicines like Ibuprom RR MAX may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.
In the case of short-term use of the medicine, side effects are rare.
In elderly patients, there is an increased risk of side effects associated with ibuprofen compared to younger patients. The frequency and severity of side effects can be reduced by using the smallest therapeutic dose for the shortest possible period.

Reporting side effects

If side effects occur, including any possible side effects not listed in this leaflet, the patient should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C

• 02 - 222 Warsaw tel.: +48 22 492 13 01 fax: +48 22 492 13 09 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ibuprom RR MAX

Store the medicine at a temperature below 25°C.
Keep out of sight and reach of children.
Do not use after the expiry date stated on the carton and blister packaging - blister (month/year).
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Labeling on the blister: EXP - expiry date, Lot - batch number.

6. Contents of the packaging and other information

What Ibuprom RR MAX contains

The active substance of the medicine is ibuprofen in a dose of 400 mg per coated tablet.
The excipients are:
Core tablet:microcrystalline cellulose, maize starch, pregelatinized starch, hydrogenated vegetable oil, crospovidone, talc, colloidal anhydrous silica.
Coating:
polyvinyl alcohol (E 1203), macrogol 3350 (E 1521), titanium dioxide (E 171), talc (E 553b),
aluminum potassium silicate (E 555) and titanium dioxide (E 171) mixture, carnauba wax.

What Ibuprom RR MAX looks like and what the pack contains

White or almost white, oblong, smooth, biconvex tablets with "RR" embossed on one side.

Pack sizes:

10 tablets (1 blister of 10),
12 tablets (1 blister of 12),
20 tablets (2 blisters of 10),
24 tablets (2 blisters of 12),
48 tablets (4 blisters of 12),
48 tablets (HDPE bottle),
60 tablets (HDPE bottle).

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
Ziębicka 40

• 50 - 507 Wrocław

To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
Poleczki 35

• 02 - 822 Warsaw tel.: +48 22 543 60 00

Date of last revision of the leaflet:
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