Ibuprom Max Rapid

Leaflet attached to the packaging: information for the user

IBUPROM MAX RAPID, 400 mg, coated tablets

Ibuprofen

You should carefully read the contents of the leaflet before using the 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your 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 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 MAX RAPID and what is it used for
• 2. Important information before taking IBUPROM MAX RAPID
• 3. How to take IBUPROM MAX RAPID
• 4. Possible side effects
• 5. How to store IBUPROM MAX RAPID
• 6. Contents of the pack and other information

1. What is IBUPROM MAX RAPID and what is it used for

IBUPROM MAX RAPID contains 400 mg of ibuprofen in the form of 512 mg of ibuprofen sodium dihydrate. Ibuprofen belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs) with analgesic, antipyretic, and anti-inflammatory properties.
The medicine is intended for use in the following cases:

• Acute pains of various origins of mild to moderate severity:
• headaches, including migraines with or without aura (along with additional symptoms such as nausea, sensitivity to light and sound); tension headaches;
• toothaches;
• muscle, joint, and bone pain;
• painful menstruation;
• neuralgia;
• pains accompanying the flu and cold.
• Fever of various origins (including flu, cold, or other infectious diseases).

2. Important information before taking IBUPROM MAX RAPID

When not to take IBUPROM MAX RAPID

IBUPROM MAX RAPID should not be taken by patients:

• with hypersensitivity to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• who have ever had hypersensitivity reactions (e.g., hives, runny nose, angioedema, or bronchial asthma) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
• with active or history of peptic ulcer disease of the stomach and/or duodenum (two or more distinct episodes of confirmed ulceration or bleeding);
• with gastrointestinal perforation or bleeding, past or present, associated with previous NSAID treatment;
• with severe liver failure, severe kidney failure, or severe heart failure;
• in the third trimester of pregnancy;
• with hemorrhagic diathesis;
• under the age of 12.

Warnings and precautions

Before starting treatment with IBUPROM MAX RAPID, you should discuss with your doctor if you have:

• systemic lupus erythematosus and mixed connective tissue disease;
• allergic reaction symptoms after taking acetylsalicylic acid;
• gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• hypertension and/or heart failure;
• kidney function disorders;
• liver function disorders;
• blood coagulation disorders;
• active or history of bronchial asthma or allergic reaction symptoms in the past; after taking the medicine, bronchospasm may occur;
• diseases for which the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids);
• if the patient needs to limit sodium intake in their diet.

You should avoid taking IBUPROM MAX RAPID at the same time as other NSAIDs, including selective cyclooxygenase-2 inhibitors.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning signs; they can also occur in patients who have had warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be discontinued immediately. Patients with gastrointestinal diseases, especially the elderly, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, especially during the initial treatment period.
Concomitant, long-term use of different painkillers may lead to kidney damage with a risk of kidney failure (analgetic nephropathy).
Particular caution is required (the patient should consult a doctor or pharmacist) before using the medicinal product in patients with hypertension and/or heart failure with fluid retention, hypertension, and edema associated with NSAID use in the past.
Taking anti-inflammatory and analgesic medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. You should not exceed the recommended dose and duration of treatment.
During ibuprofen treatment, allergic reactions to this medicine have occurred, including difficulty breathing, swelling in the face and neck area (angioedema), chest pain.
If any of these symptoms are noticed, the medicine should be discontinued immediately and medical help should be sought.
If, despite taking the medicine, symptoms persist and do not improve after 3 days, worsen, or new symptoms appear, you should consult a doctor.
Before taking IBUPROM MAX RAPID, you should discuss treatment with your doctor or pharmacist if:

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

Infections

IBUPROM MAX RAPID may mask the symptoms of infection, such as fever and pain. Therefore, IBUPROM MAX RAPID may delay the use of appropriate infection treatment and, as a result, 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 infection symptoms persist or worsen, they should consult their doctor immediately.
Medicines in this group (nonsteroidal anti-inflammatory drugs) may adversely affect female fertility. This effect is transient and disappears after the end of treatment. In case of difficulty in conceiving, you should consult your doctor before taking ibuprofen.

Use in elderly patients

In elderly patients, there is an increased risk of adverse reactions associated with ibuprofen use compared to younger patients. The frequency and severity of adverse reactions can be reduced by using the smallest effective dose for the shortest possible period.
You should consult your doctor, even if the above warnings refer to past situations.

Children and adolescents

The medicine is not indicated for children under 12 years of age.
In dehydrated patients - adolescents aged 12-18 years, there is a risk of kidney function disorders.

IBUPROM MAX RAPID and other medicines

You should avoid taking IBUPROM MAX RAPID if you are taking other nonsteroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors, such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (in analgesic doses).
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, even those that are available without a prescription.
IBUPROM MAX RAPID may affect the action of other medicines or other medicines may affect the action of IBUPROM MAX RAPID. For example:

• Anticoagulant medicines (i.e., blood thinners or medicines that prevent blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• Medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

In particular, before taking ibuprofen, you should inform your doctor about taking any of the following medicines:

• Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs);
• Cardiac glycosides;
• Lithium and methotrexate;
• Cyclosporine;
• Mifepristone;
• Tacrolimus;
• Zidovudine;
• Quinolone antibiotics;
• Diuretics;
• Corticosteroids (such as prednisolone or dexamethasone).

Also, some other medicines may be affected or have an effect on treatment with IBUPROM MAX RAPID.
Therefore, before using IBUPROM MAX RAPID with other medicines, you should always consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Before taking any medicine, you should consult your doctor.
You should not take IBUPROM MAX RAPID if you are in the last 3 months of pregnancy, as it may harm your unborn baby or cause complications during delivery. IBUPROM MAX RAPID may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and child and prolong or delay labor. During the first 6 months of pregnancy, you should not take IBUPROM MAX RAPID unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, you should use the smallest possible dose for the shortest possible time. From the 20th week of pregnancy, IBUPROM MAX RAPID, if taken for more than a few days, may cause kidney function disorders in the unborn baby (which can lead to a low level of amniotic fluid surrounding the baby), 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, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts. There are no known cases of adverse reactions in breastfed infants, so there is no need to stop breastfeeding during short-term use of the medicine in small doses.
Before taking any medicine, you should consult your doctor.
Fertility
See the "Warnings and precautions" section.

Driving and using machines

There is no data on the effect of IBUPROM MAX RAPID on the ability to drive and use machines.
The ability to drive and use machines may be impaired due to side effects such as dizziness or drowsiness, which can occur after taking the medicine.

IBUPROM MAX RAPID contains

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking the medicine.
sodium
The medicine contains 44.74 mg of sodium (the main component of common salt) in each tablet.
This corresponds to 2.237% of the maximum recommended daily intake of sodium in the diet for adults.
orange yellow, lake (E 110), Allura red AC, lake (E 129)
The medicine may cause allergic reactions.

3. How to take IBUPROM MAX RAPID

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
In case of doubt, you should consult your doctor or pharmacist.
The medicine is for short-term use only.
The medicine is intended for oral use only, in adults and adolescents over 12 years of age.
Usually, the following dosing is used:
Adults and adolescents over 12 years of age:1 tablet every 4 hours. Tablets should be taken with water.
Do not take more than 3 tablets in 24 hours.
Elderly patients:in elderly patients, there is a higher risk of adverse reactions. They can be minimized by using the smallest effective dose for the shortest possible period.
You should use the smallest effective dose for the shortest period necessary to relieve symptoms. If the symptoms of infection (such as fever and pain) persist or worsen, you should consult your doctor immediately (see section 2).

Warning:

Do not exceed the recommended dose!
In case of overdose, you should consult your doctor.
If you feel that the effect of the medicine is too strong or too weak, you should contact your doctor.
If symptoms persist or worsen, or if new symptoms appear, you should contact your doctor.
You should use the smallest possible dose for the shortest possible period. This reduces the risk of adverse reactions.
Do not take the medicine for more than 3 days without consulting your doctor.
In adolescents aged 12-18 years, you should consult your doctor if it is necessary to take the medicine for more than 3 days or if symptoms worsen.

Taking a higher dose of IBUPROM MAX RAPID than recommended

If you have taken a higher dose of IBUPROM MAX RAPID than recommended or if a child has accidentally taken the medicine, you should always consult your 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, confusion, and unsteadiness. 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 have occurred; blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties. Additionally, the prothrombin time/INR may be prolonged, probably due to the disruption of circulating coagulation 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. Treatment is symptomatic and supportive, consisting of maintaining vital functions until the medicine is eliminated from the body. The doctor will monitor heart function and control vital signs if they are stable. The doctor may consider administering activated charcoal orally within 1 hour of overdose. In case of frequent or prolonged seizures, the doctor will administer diazepam or lorazepam intravenously. In case of asthma, the doctor will administer bronchodilators.

Missing a dose of IBUPROM MAX RAPID

Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, IBUPROM MAX RAPID can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, you should stop taking ibuprofen and seek medical attention:

• Red, non-raised, target-like, or round 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).

During short-term use of ibuprofen in doses available without a prescription, the following side effects have been observed. When using ibuprofen for other indications and long-term, other side effects may occur.
Side effects are listed by frequency of occurrence.
Uncommon(may occur in up to 1 in 100 people):

• Indigestion, stomach pain, nausea, headaches, hives, various skin rashes, and itching.

Rare(may occur in up to 1 in 1,000 people):

• Diarrhea, bloating, constipation, vomiting, gastritis;
• Psychotic disorders, depression, tinnitus;
• Dizziness, insomnia, agitation, irritability, and fatigue.

Very rare(may occur in up to 1 in 10,000 people):

• Tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease;
• Decreased urine output, kidney failure, renal papillary necrosis, increased sodium levels in the blood (sodium retention);
• Liver function disorders, especially during long-term use;
• Blood count disorders (anemia, leukopenia - decreased white blood cell count, thrombocytopenia - decreased platelet count, pancytopenia - a blood disorder characterized by a deficiency of all normal blood cells: red, white, and platelets, agranulocytosis - absence of a certain type of white blood cell - granulocytes). The first symptoms are fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g., bruising, petechiae, purpura, nosebleeds);
• Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis;
• Facial edema, tongue and throat edema, dyspnea;
• Tachycardia - accelerated heart rate, hypotension - sudden decrease in blood pressure, shock;
• Aseptic meningitis;
• Heart failure, hypertension, edema;
• Exacerbation of asthma and bronchospasm.

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

• Hyperreactivity of the airways, including asthma;
• Skin becomes sensitive to light;
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome. In connection with the use of NSAIDs in high doses, reports of edema, hypertension, and heart failure have been received. Taking such medicines as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. In some people, during the use of the medicine, other side effects may occur. If you notice any of the above symptoms, as well as any other symptoms not listed in this leaflet, you should discontinue the medicine and consult your doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: +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, you can help provide more information on the safety of the medicine.

5. How to store IBUPROM MAX RAPID

There are no special recommendations for storage conditions.
The medicine should be stored out of sight and reach of children.
Do not use IBUPROM MAX RAPID after the expiry date stated on the carton and blister (EXP). The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information about IBUPROM MAX RAPID

• The active substance of the medicine is ibuprofen - 1 coated tablet contains 400 mg of ibuprofen in the form of 512 mg of ibuprofen sodium dihydrate.
• The excipients are: lactose monohydrate (200 M), sodium lauryl sulfate, crospovidone, povidone (K-30), silica, colloidal anhydrous, lactose monohydrate, talc, magnesium stearate; Coating (Opadry fx 64F580006): hypromellose 2910, lactose monohydrate, macrogol (E 1521), potassium aluminum silicate (E 555) / titanium dioxide (E 171), talc, titanium dioxide (E 171), sodium citrate. Tusz Opacode Monogramming Ink S-1-175005 Grey: shellac, isopropyl alcohol, titanium dioxide (E 171), indigo carmine, lake (E 132), orange yellow, lake (E 110), Allura red AC, lake (E 129), propylene glycol (E 1520), n-butyl alcohol, ammonium hydroxide.

What IBUPROM MAX RAPID looks like and contents of the pack

White or almost white coated tablets of elongated shape, smooth on one side and with gray imprint IBUPROM on the other side.
PVC/PVDC/Aluminum blisters in a carton box.
12 tablets - 1 blister of 12 coated tablets.
24 tablets - 2 blisters of 12 coated tablets.
HDPE bottle with HDPE cap in a carton box.
48 coated tablets in a bottle.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
Ziębicka Street 40
50-507 Wrocław
To obtain more detailed information about this medicine, you should contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
Poleczki Street 35
02-822 Warsaw
phone: +48 (22) 543 60 00

Date of last revision of the leaflet: