Ibuprom Max

Leaflet attached to the packaging: patient information

IBUPROM MAX

400 mg, effervescent 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, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

The medicine is a pain-relieving medicine. It is used to treat inflammatory conditions, which are one of the causes of pain. The medicine lowers fever.
Indications for use of the medicine are acute pains of mild or moderate severity: post-operative, muscular, bone, migraine, and menstrual. The medicine is also used to reduce mild and moderate pains of various origins: headaches, toothaches, lower back pain, joint pains, neuralgia, as well as fever (in the course of a cold, flu, or other infectious diseases).

2. Important information before taking the medicine

When not to take the medicine:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) and to other non-steroidal anti-inflammatory drugs (NSAIDs),
• if after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, there have been any allergic symptoms in the past, such as runny nose, hives, or 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,

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• in case of bleeding disorders.

Warnings and precautions

Before starting to take the medicine, the patient should discuss it with their doctor or pharmacist.

Special caution should be exercised when taking the medicine:

• if the patient has been diagnosed with systemic lupus erythematosus and mixed connective tissue disease,
• if there are symptoms of allergic reactions after taking acetylsalicylic acid,
• if the patient has been diagnosed with gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• if the patient has been diagnosed with hypertension and/or heart failure,
• if the patient has been diagnosed with kidney function disorders,
• if the patient has been diagnosed with liver function disorders,
• if the patient has been diagnosed with blood coagulation disorders,
• if the patient has been diagnosed with active or recurrent asthma or has had allergic reactions in the past; 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. In case of gastrointestinal bleeding or ulceration, 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.
Taking different painkillers at the same time 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/pain-relieving medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. The recommended dose should not be exceeded, and the treatment duration should not be prolonged.
During treatment with ibuprofen, symptoms of an allergic reaction to this medicine have been reported, including difficulty breathing, facial and neck swelling (angioedema), chest pain. If any of these symptoms are noticed, the medicine should be discontinued immediately and medical help should be sought.
Before taking the medicine, 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 narrowed or blocked 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 tobacco.
• the patient has an infection - see below, section "Infections".

Do not take higher doses or longer treatment than recommended.
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If symptoms persist, worsen, or do not improve after 3 days, or if new symptoms occur, the patient should consult their doctor.
With the use of ibuprofen, severe skin reactions have been reported, 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 of the symptoms related to these severe skin reactions described in section 4, they should discontinue the medicine and seek medical attention immediately.
Infections
may mask the symptoms of an infection, such as fever and pain. This may delay the use of appropriate infection treatment and, as a consequence, lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medicine during an infection and the infection symptoms persist or worsen, they should consult their doctor immediately.
The medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and disappears after the end of treatment. In case of difficulty in conceiving, the patient should consult their doctor before taking ibuprofen.

Children

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

Medicine 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.
Do not take the medicine at the same time as other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors, such as celecoxib or etoricoxib), other pain-relieving medicines, or acetylsalicylic acid (in pain-relieving doses). Taking the medicine with these medicines increases the risk of side effects.
The medicine may affect the action of other medicines or other medicines may affect the action of the medicine, for example:

• anticoagulant medicines (e.g., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-adrenergic 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 have an effect on the treatment with the medicine.
Therefore, before taking the medicine with other medicines, the patient should always consult their doctor or pharmacist.
With food and drink
It is recommended to take the medicine after a meal.
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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 baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Do not take the medicine if the patient is in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. The medicine may cause kidney and heart disorders in the unborn baby. It may also increase the risk of bleeding in the patient and the baby and cause delayed or prolonged labor.
In the first 6 months of pregnancy, the medicine should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, the medicine, if taken for more than a few days, may cause kidney disorders in the unborn baby (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 a longer period than a few days, the doctor may recommend additional monitoring.

Breastfeeding

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

Fertility

In case of difficulty in conceiving, the patient should consult their doctor before taking ibuprofen.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive vehicles, operate machinery, and psychophysical fitness during treatment with the recommended doses and for the recommended period.

The medicine contains lactose, sucrose, and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per single dose (1 tablet), which means 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. In case of doubt, the patient should consult their doctor or pharmacist.
Adults and adolescents over 12 years of age:for acute treatment, 1 tablet orally every 4 hours (do not take more than 3 tablets per day).
Use the smallest effective dose for the shortest possible time to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).

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

Do not exceed the recommended dose.
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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 or worsen or if new symptoms occur, the patient should consult their doctor.
Do not take the medicine for more than 3 days without consulting a doctor.

Taking a higher dose of the medicine than recommended

If the patient has taken a higher dose of the medicine than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do in such a case.
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, confusion, and nystagmus. It may also cause agitation, drowsiness, disorientation, or coma. Rarely, patients may experience seizures. After taking high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties have been reported. Additionally, the prothrombin time/INR may be prolonged, probably due to the disruption of the action of circulating clotting factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. Additionally, low blood pressure and breathing difficulties may occur.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.

Missing a dose of the medicine

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking ibuprofen and seek medical attention immediately if any of the following symptoms occur:

• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the 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, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Common side effects(affecting 1 to 10 in 100 patients taking the medicine):

• heartburn, stomach pain, nausea, vomiting, bloating with gas, diarrhea, constipation, and minor gastrointestinal bleeding, which may lead to anemia in exceptional cases.

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

• allergic reactions with skin rash and itching, as well as shortness of breath (may occur in combination with a drop in blood pressure),
• headaches, dizziness, insomnia, agitation, irritability, and fatigue,
• vision disorders,
• gastrointestinal ulcers, potentially with bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis.

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

• tinnitus,
• renal papillary necrosis, increased blood uric acid levels.

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

• worsening of inflammatory conditions associated with infection (e.g., occurrence of necrotizing fasciitis) related to the use of non-steroidal anti-inflammatory drugs.

If the patient experiences any symptoms of infection or if they worsen during treatment with the medicine, they should immediately consult their doctor to determine if it is necessary to use anti-infective/antibiotic medicines.

• symptoms of aseptic meningitis, such as stiffness of the neck, headache, nausea, vomiting, fever, or changes in consciousness, mainly in patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease). If such symptoms occur, the patient should immediately consult their doctor.
• blood disorders: the first symptoms are fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g., bruising, petechiae, purpura, nosebleeds). In such a case, the patient should discontinue the treatment and immediately consult their doctor. Do not treat these symptoms with pain-relieving or antipyretic medicines.
• severe generalized allergic reactions. They may occur as facial swelling, tongue swelling, internal swelling of the larynx with impaired airway patency, respiratory failure, increased heart rate, decreased blood pressure, up to life-threatening shock. If the above symptoms occur, the patient should discontinue the medicine and immediately consult their doctor.
• psychotic reactions, depression,
• palpitations, heart failure, myocardial infarction,
• hypertension,
• esophagitis, pancreatitis, formation of esophageal-like strictures of the intestine.

In case of severe abdominal pain, black stools, or bloody vomiting, the patient should discontinue the medicine and immediately consult their doctor.

• liver function disorders, especially during long-term use, liver failure, acute hepatitis,
• in rare cases, during chickenpox infection, severe skin infections and soft tissue complications may occur,
• decreased urine output and edema formation, especially in patients with hypertension or kidney failure, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute kidney failure. In such a case, the patient should discontinue the medicine and immediately consult their doctor, as these may be the first symptoms of kidney damage or failure.

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

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

With the use of NSAIDs, reports of edema, hypertension, and heart failure have been made.
Taking such medicines as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
In case of acute use of the medicine, side effects are rare.
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In elderly patients, there is an increased risk of side effects associated with the use of 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 time.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C

• 02 - 222 Warszawa tel.: +48 22 492 13 01 faks: +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 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 blister pack (month/year). The applied labeling for the blister is: EXP - expiry date, Lot - batch number.

6. Contents of the pack and other information

What the medicine contains

• The active substance of the medicine is ibuprofen 400mg.
• The excipients are: core: lactose, povidone, corn starch, talc, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica; coating: sucrose, talc, corn starch, titanium dioxide, carnauba wax, white wax.

What the pack contains

A white, elongated, biconvex tablet with a sugar coating.

Available packs:

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 bottle with a screw cap;
48 tablets in a bottle with a screw cap;
60 tablets in a bottle with a screw cap.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
ul. Ziębicka 40

• 50 - 507 Wrocław

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To obtain more detailed information about this medicine, the patient should contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35

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

Date of last revision of the leaflet:
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