Ibuprom rr max

Patient Information Leaflet

IBUPROM RR MAX
400 mg, coated tablets
Ibuprofenum
Please read the following information carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
• If there is no improvement or if your condition worsens after 3 days, consult your doctor.

Table of Contents

1. What Ibuprom RR MAX is and what it is 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 pack and other information

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

Ibuprom RR MAX is an analgesic, anti-inflammatory and antipyretic medicine. It is indicated for the treatment of mild to moderate acute pain, such as postoperative, muscular, bone, migraine and menstrual pain. The medicine is also used to relieve mild to moderate pain of various origins, including headache, toothache, lumbosacral pain, neuralgia, joint pain, as well as fever associated with cold or influenza.

2. Important information before using Ibuprom RR MAX

When not to use Ibuprom RR MAX

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), or to other non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients who have previously experienced allergic reactions such as rhinitis, urticaria, or bronchial asthma after taking acetylsalicylic acid or other NSAIDs,
• in patients with active or past history of peptic ulcer or duodenal ulcer, gastrointestinal perforation or bleeding, including events occurring after use of NSAIDs,
• in patients with severe liver failure, severe renal failure, or severe heart failure,
• in patients currently taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of adverse effects),
• during the third trimester of pregnancy,
• in patients with bleeding disorders.

Warnings and precautions
Before starting treatment with Ibuprom RR MAX, discuss this with your doctor or pharmacist.
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When to exercise particular caution when using Ibuprom RR MAX

• if the patient has systemic lupus erythematosus or mixed connective tissue disease,
• if allergic reactions occurred after taking acetylsalicylic acid,
• if the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• if the patient has hypertension and/or cardiac dysfunction,
• if the patient has renal impairment,
• if the patient has hepatic impairment,
• if the patient has blood coagulation disorders,
• if the patient has active or past history of bronchial asthma or allergic reactions; bronchospasm may occur after taking the medicine,
• if the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms or in patients who previously experienced such warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with a history of gastrointestinal disorders, particularly elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during initial treatment.

Concurrent, long-term use of various analgesic drugs may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Exercise caution in dehydrated patients (especially the elderly) due to increased risk of renal impairment.
Use of anti-inflammatory and analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

Allergic reactions to ibuprofen have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. If any of these symptoms occur, discontinue Ibuprom RR MAX immediately and contact a doctor or emergency medical services without delay.

Before using Ibuprom RR MAX, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart disease such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• the patient has hypertension, diabetes, high cholesterol levels, family history of heart disease or stroke, or if the patient smokes.

Do not use higher doses or longer treatment duration than recommended.
If symptoms persist, worsen, or do not resolve within 3 days, or if new symptoms appear, consult a doctor.
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Serious skin reactions have been reported with ibuprofen use, including 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 any of the symptoms associated with these serious skin reactions described in section 4 occur, discontinue Ibuprom RR MAX immediately and seek medical help.

Infections
Ibuprom RR MAX may mask symptoms of infection such as fever and pain. Therefore, Ibuprom RR MAX may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If this medicine is taken during an existing infection and symptoms persist or worsen, consult a doctor immediately.

This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment. In case of difficulty conceiving, consult a doctor before taking ibuprofen.

Consult a doctor even if the above warnings refer to conditions experienced in the past.

Children
This medicine is not recommended for children under 12 years of age.

Ibuprom RR MAX and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use, including those available without prescription.

Do not take Ibuprom RR MAX concurrently with other non-steroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors such as celecoxib or etoricoxib), other analgesics, or acetylsalicylic acid (at analgesic doses). Concurrent use of Ibuprom RR MAX with these medicines increases the risk of adverse 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 (i.e., 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-containing medicines, angiotensin II receptor antagonists such as losartan)
• diuretics
• corticosteroids (such as: prednisolone or dexamethasone)
• methotrexate (an anticancer medicine)
• lithium (an antidepressant medicine)
• zidovudine (an antiviral medicine)

Other medicines may also interact with or be affected by treatment with Ibuprom RR MAX. Therefore, always consult a doctor or pharmacist before using Ibuprom RR MAX with other medicines.
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Pregnancy, breastfeeding, and effects on fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take Ibuprom RR MAX during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibuprom RR MAX may cause renal and cardiac dysfunction in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong 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 required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Ibuprom RR MAX, if taken for longer than a few days, may cause renal dysfunction in the unborn child (which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios)) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart.

If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in very small amounts, and there are no known cases of adverse effects in breastfed infants. There is no need to interrupt breastfeeding during short-term use of ibuprofen at low doses.

Fertility
See section "Warnings and precautions".

Driving and operating machinery
There are no data on the effects of the medicine on the ability to drive vehicles, operate machinery, or on psycho-physical performance when used at recommended doses and for the recommended duration.

3. How to use Ibuprom RR MAX

This medicine should always be taken according to the instructions in this patient leaflet or as directed by a doctor or pharmacist. If in 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 lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Do not exceed 3 tablets per day.
This medicine should not be used in children under 12 years of age.
Elderly patients: no dose adjustment is required.
Do not exceed the recommended dose.
If the effect of the medicine seems too strong or too weak, consult a doctor.
This medicine is intended for short-term use only. If symptoms persist or worsen, or if new symptoms occur, consult a doctor.
Do not take this medicine for more than 3 days without consulting a doctor.
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Taking more than the recommended dose of Ibuprom RR MAX
If a patient has taken more than the recommended dose of Ibuprom RR MAX, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital for advice on possible health risks and appropriate actions to take.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see section 4 below), diarrhoea, headache, tinnitus, confusion and nystagmus. There may also be agitation, drowsiness, disorientation or coma. Seizures may occur rarely. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold and breathing difficulties may occur. Additionally, prothrombin time/INR may be prolonged, probably due to interference with circulating clotting factors. Acute renal failure and liver damage may also occur. In asthmatic patients, asthma may be exacerbated. Additionally, low blood pressure and breathing difficulties may occur.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.
Missed dose of Ibuprom RR MAX
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

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

If any of the following symptoms occur in a patient, ibuprofen should be discontinued immediately and medical help sought:

• Red, flat, target-like or circular spots on the trunk, often with blisters in the centre, peeling skin, ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome).
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

Adverse reactions occurring not very frequently (in 1 to 10 out of 1000 patients taking the medicine):

• Headache, dyspepsia, abdominal pain, nausea, urticaria, itching.

Adverse reactions occurring rarely (in 1 to 10 out of 10,000 patients taking the medicine):

• Diarrhoea, flatulence, constipation, vomiting, gastric mucosal inflammation, dizziness,
• Insomnia, restlessness, irritability and feeling of fatigue,
• Oedema due to kidney and urinary tract disorders.

Adverse reactions occurring very rarely (less than 1 in 10,000 patients taking the medicine):

• Black, tarry stools, vomiting blood, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease,
• Gastric and (or) duodenal ulceration, gastrointestinal bleeding and perforation, sometimes fatal, particularly in elderly patients,
• In isolated cases reported: depression, psychotic reactions and tinnitus, aseptic meningitis, reduced urine output, oedema, acute renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention),
• Liver function disorders, particularly during prolonged use,
• Blood morphology abnormalities (anaemia, leukopenia - reduced white blood cell count, thrombocytopenia - reduced platelet count, pancytopenia - haematological disorder involving deficiency of all normal blood cells: erythrocytes and platelets, agranulocytosis - reduced granulocyte count). Initial symptoms include: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, haemorrhagic purpura (e.g. bruises, petechiae, purpura, nosebleeds),
• Severe hypersensitivity reactions such as: facial, tongue and laryngeal swelling, shortness of breath, tachycardia - heart rhythm disturbances, hypotension - sudden drop in blood pressure, shock; exacerbation of asthma and bronchospasm,
• In patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms typical of aseptic meningitis have been observed during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever and disorientation.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• Skin becomes sensitive to light,
• Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome.

Oedema, arterial hypertension and heart failure have been reported in connection with NSAID treatment.
The use of medicines such as Ibuprom RR MAX may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
With short-term use of the medicine, adverse reactions occur rarely.
In elderly patients, the risk of adverse reactions associated with ibuprofen use is higher than in younger patients. The frequency and severity of adverse reactions can be reduced by using the lowest therapeutic dose for the shortest possible duration.

Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ibuprom RR MAX

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

6. Contents of the pack and other information

What Ibuprom RR MAX contains
The active substance is ibuprofen, 400 mg per coated tablet.
Excipients:
Tablet core composition: microcrystalline cellulose, maize starch, pregelatinized starch,
hydrogenated vegetable oil, crospovidone, talc, colloidal anhydrous silica.
Tablet coating composition:
polyvinyl alcohol (E 1203), macrogol 3350 (E 1521), titanium dioxide (E 171), talc (E 553b),
aluminium potassium silicate (E 555) and titanium dioxide (E 171) mixture, carnauba wax.

What Ibuprom RR MAX looks like and contents of the pack
White or almost white, elongated, smooth, biconvex tablets, with the engraved mark "RR" on one side.

Available pack sizes:
10 tablets (1 blister of 10 tablets),
12 tablets (1 blister of 12 tablets),
20 tablets (2 blisters of 10 tablets each),
24 tablets (2 blisters of 12 tablets each),
48 tablets (4 blisters of 12 tablets each),
48 tablets (HDPE polyethylene bottle),
60 tablets (HDPE polyethylene bottle).

Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
Ziębicka 40 Street
50-507 Wrocław
For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
Poleczki 35 Street
02-822 Warsaw
Tel.: +48 22 543 60 00
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