Ibuprom max

Package leaflet: Information for the patient

IBUPROM MAX
400 mg, coated tablets
Ibuprofenum
Please read carefully the entire leaflet before use, 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 doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, you should consult a doctor.

Table of contents

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

1. What the medicine is and what it is used for

The medicine is an analgesic. It is used in the treatment of inflammation, which is one of the causes of pain. The medicine reduces fever.
The medicine is indicated for the treatment of mild to moderate acute pain: postoperative, muscular, bone, migraine, and menstrual pain. It is also used to relieve mild to moderate pain of various origins: headache, toothache, lumbosacral pain, joint pain, neuralgia, as well as fever (associated with colds, influenza or other infectious diseases).

2. Information before using the medicine

When not to use the medicine:

• 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),
• if symptoms of allergy such as rhinitis, urticaria or bronchial asthma occurred after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• in patients with active or past history of peptic ulcer or duodenal ulcer, gastrointestinal perforation or bleeding, including cases occurring after use of NSAIDs,
• in patients with severe liver failure, severe renal failure or severe heart failure,
• in patients taking other non-steroidal anti-inflammatory drugs simultaneously, 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, discuss this with your doctor or pharmacist.
Exercise special caution when using the medicine:

• 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, Leśniowski-Crohn disease),
• if the patient has hypertension and/or heart function disorders,
• if the patient has kidney function disorders,
• if the patient has liver function disorders,
• if the patient has blood clotting 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 medications, 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, especially elderly patients, should inform their doctor about any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial period of treatment.

Concurrent, long-term use of various painkillers may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Exercise caution in dehydrated patients (especially elderly) due to increased risk of kidney function disorders.
Taking anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack 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), chest pain. If any of these symptoms occur, discontinue the medicine immediately and contact a doctor or emergency medical services without delay.

The patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischemic attack - TIA),
• the patient has hypertension, diabetes, elevated cholesterol levels, family history of heart disease or stroke, or if the patient smokes.
• the patient has an infection – see below, section titled "Infections".

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

Infections
The medicine may mask symptoms of infection such as fever and pain. This may delay appropriate treatment of the infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an existing infection and infection symptoms persist or worsen, immediate consultation with a doctor is required.

This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) which 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.

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

Medicine and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.

Do not take this medicine simultaneously with other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (at analgesic doses). Concurrent use of this medicine with these drugs increases the risk of adverse effects.

The medicine may affect the action of other medicines, or other medicines may affect the action of this medicine, 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 medicines containing atenolol, angiotensin II receptor antagonists such as losartan),
• diuretics,
• corticosteroids (e.g. prednisolone or dexamethasone),
• methotrexate (anticancer medicine),
• lithium (antidepressant medicine),
• zidovudine (antiviral medicine).

Some other medicines may also be affected by or may affect treatment with this medicine. Therefore, always consult a doctor or pharmacist before using this medicine with other medicines.

With food and drink
It is recommended to take the medicine after a meal.
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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 baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Do not take the medicine during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medicine may cause kidney and heart function disorders in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labor.

Do not use the medicine during the first 6 months of pregnancy 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 week 20 of pregnancy, prolonged use of the medicine (longer than a few days) may lead to kidney function disorders in the unborn child (which may result in low levels of amniotic fluid surrounding the baby - oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is required, 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
In case of difficulty conceiving, consult a doctor before taking ibuprofen.

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

The medicine contains lactose, sucrose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, he/she should consult a doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per single dose (1 tablet), meaning the medicine is considered "sodium-free".

3. How to take the medicine

This medicine should always be taken exactly as described 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 hours
(do not exceed a dose of 3 tablets per day).
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, its symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
This medicine should not be used in children under 12 years of age.
Do not exceed the recommended dose.
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If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
This medicine is intended for short-term use only. If symptoms persist or worsen, or if new symptoms occur, contact your doctor.
Do not take this medicine for more than 3 days without consulting a doctor.
Taking more medicine than recommended
If a patient has taken more than the recommended dose, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital to assess possible health risks and receive advice on the necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see section 4 below), diarrhoea, headache, ringing in the ears, confusion and nystagmus. Agitation, drowsiness, disorientation or coma may also occur. 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 impaired function of circulating coagulation factors. Acute kidney failure and liver damage may also occur. In asthmatics, asthma may be exacerbated. Furthermore, low blood pressure and breathing difficulties may occur.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.
If you miss a dose
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.
You should stop taking ibuprofen and seek immediate medical help if any of the following symptoms occur:

• Red, flat, target-like or circular spots on the trunk, often with blisters in the center, peeling skin, and 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 generalized exanthematous pustulosis).

Common adverse reactions (occurring in 1 to 10 out of 100 patients using the medicine):

• Heartburn, abdominal pain, nausea, vomiting, bloating with gas release, diarrhea, constipation, and minor gastrointestinal bleeding, which may exceptionally lead to anemia.

Uncommon adverse reactions (occurring in 1 to 10 out of 1,000 patients using the medicine):

• Hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly occurring together with a drop in blood pressure),
• Headache, dizziness, insomnia, restlessness, irritability, and fatigue,
• Visual disturbances,
• Gastrointestinal ulcers, potentially with bleeding and perforation, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease, gastritis.

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Rare adverse reactions (occurring in 1 to 10 out of 10,000 patients using the medicine):

• Tinnitus,
• Renal papillary necrosis, increased blood uric acid levels.

Very rare adverse reactions (occurring in fewer than 1 out of 10,000 patients using the medicine):

• Worsening of inflammatory conditions related to infection (e.g., necrotizing fasciitis) associated with the use of nonsteroidal anti-inflammatory drugs. If symptoms of infection occur or worsen during treatment with this medicinal product, you should immediately consult a doctor to determine whether antimicrobial/antibiotic therapy is necessary.
• Symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever, or altered consciousness, mainly in patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease). If such symptoms occur, you should contact a doctor immediately.
• Blood cell production disorders: initial symptoms include fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, and bleeding (e.g., bruises, petechiae, purpura, nosebleeds). In such cases, treatment should be discontinued and medical advice sought immediately. These symptoms must not be treated with painkillers or antipyretics.
• Severe generalized hypersensitivity reactions. These may present as facial swelling, tongue swelling, internal laryngeal swelling with impaired airway patency, respiratory failure, rapid heartbeat, low blood pressure, up to life-threatening shock. If any of the above symptoms occur, stop taking the medicine and contact a doctor immediately.
• Psychotic reactions, depression,
• Palpitations, heart failure, myocardial infarction,
• Hypertension,
• Esophagitis, pancreatitis, development of diaphragm-like intestinal strictures. If acute upper abdominal pain, tarry stools, or bloody vomit occur, stop taking the medicine and contact a doctor immediately.
• Liver function disorders, particularly during prolonged use, liver failure, acute hepatitis,
• In exceptional cases, during varicella virus infection, severe skin infections and soft tissue complications may occur,
• Reduced urine output and development of edema, particularly in patients with hypertension or kidney failure, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute kidney failure. In such cases, medicine intake should be stopped and medical advice sought without delay, as these may be the first signs of kidney damage or kidney failure.

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

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

Edema, hypertension, and heart failure have been reported during treatment with NSAIDs.
The use of such medicines may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke.
When the medicine is used occasionally, adverse reactions are rare.
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In elderly patients, the risk of adverse reactions associated with ibuprofen use is increased compared to younger patients. The frequency and severity of adverse reactions can be reduced by using the lowest effective 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 Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine

Keep the medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use after the expiry date stated on the carton and on the immediate packaging (month/year). The labelling on the blister reads: EXP – expiry date, Lot – batch number.

6. Contents of the pack and other information

What the medicine contains

• The active substance is ibuprofen 400 mg.
• The other ingredients are: core composition: lactose, povidone, maize starch, talc, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica; coating composition: sucrose, talc, maize starch, titanium dioxide, Carnauba wax, white wax. What the tablet looks like and contents of the pack A white, elongated, biconvex tablet with a sugar coating.

Pack sizes available:
6 tablets – 1 blister of 6 tablets;
12 tablets – 1 blister of 12 tablets;
24 tablets – 2 blisters of 12 tablets;
24 tablets in a screw-top bottle;
48 tablets in a screw-top bottle;
60 tablets in a screw-top bottle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
Ziębicka 40 Street
50 - 507 Wrocław
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For further information about this medicine, contact:
USP Zdrowie Sp. z o.o.
Poleczki 35 Street
02 - 822 Warsaw
tel.: +48 22 543 60 00
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