Package leaflet: Information for the user

IBUPROM MAX RAPID, 400 mg, coated tablets
Ibuprofenum
Please read the entire leaflet carefully before taking 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 a
physician 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 side effects 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, consult your doctor.

Table of contents

What the medicine is and what it is used for
Important information before taking the medicine
How to take
Possible side effects
How to store
Contents of the pack and other information

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

Each tablet contains 400 mg of ibuprofen in the form of 512 mg of sodium ibuprofen dihydrate. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic and anti-inflammatory properties.
This medicine is intended for use in the following conditions:

Acute mild to moderate pain of various origins:
- Headache, migraine with or without aura (accompanied by symptoms such as nausea, sensitivity to light and sound); tension-type headache;
- Toothache;
- Muscular, joint and bone pain;
- Painful menstruation;
- Neuralgia;
- Pain associated with influenza and the common cold.
Fever of various origins (e.g. during influenza, cold or other infectious diseases).

2. Important information before taking the medicine

When not to use the medicine
Do not use the medicine in patients:

who are hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
who have previously experienced hypersensitivity reactions (e.g. urticaria, rhinitis, angioedema, or bronchial asthma) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
with active or a history of peptic ulceration of the stomach and/or duodenum (two or more confirmed episodes of ulceration or bleeding);
with gastrointestinal perforation or bleeding in the past related to previous NSAID treatment;
with severe hepatic insufficiency, severe renal insufficiency, or severe heart failure;
during the third trimester of pregnancy;
with bleeding disorders;
under 12 years of age.

Warnings and precautions
Before starting treatment, consult a doctor if the patient has previously been diagnosed with:

systemic lupus erythematosus or mixed connective tissue disease;
allergic reactions after taking acetylsalicylic acid;
gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
hypertension and/or cardiac dysfunction;
renal function disorders;
hepatic function disorders;
blood coagulation disorders;
active or previous asthma or symptoms of allergic reactions; bronchospasm may occur after taking the medicine;
conditions requiring concomitant use of other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids);
if the patient needs to restrict dietary sodium intake.

Avoid concomitant use of this medicine with NSAIDs, including selective
inhibitors of cyclooxygenase-2.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms; they may also occur in patients who have experienced warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with gastrointestinal disorders, especially elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial phase of treatment.
Long-term, concomitant use of various analgesics may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Exercise particular caution (the patient should consult a doctor or pharmacist) before using this medicinal product in patients with hypertension and/or heart failure with fluid retention, or a history of hypertension and edema associated with NSAID use.
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 difficulty breathing, facial and neck swelling (angioedema), and chest pain.
If any of these symptoms occur, discontinue the medicine immediately and contact a doctor or emergency medical services without delay.
If symptoms persist or worsen despite treatment, or if new symptoms appear after 3 days, consult a doctor.
Before using the medicine, discuss treatment with a doctor or pharmacist if:

the patient has heart conditions 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 history of stroke (including mini-stroke or transient ischemic attack - TIA).
the patient has hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or is a smoker.
the patient has an infection – see below, section titled "Infections". Serious skin reactions have been reported with ibuprofen use, 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 develops any of the symptoms associated with these serious skin reactions described in section 4, 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 is taking this medicine during an existing infection and infection symptoms persist or worsen, consult a doctor immediately.
Use in elderly patients
In elderly patients, there is an increased risk of adverse effects associated with ibuprofen use compared to younger patients. The frequency and severity of adverse effects can be reduced by using the lowest therapeutic dose for the shortest possible duration.
Consult a doctor even if the above warnings relate to conditions experienced in the past.
Children and adolescents
The medicine is not indicated for children under 12 years of age.
In dehydrated adolescents aged 12–18 years, there is a risk of impaired renal function.
Medicine and other medicines
Avoid using this medicine concomitantly with other NSAIDs (including cyclooxygenase-2 inhibitors such as celecoxib or etoricoxib), other analgesics, or acetylsalicylic acid (at analgesic doses).
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to take, including those available without a prescription.
This 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 or those preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
Medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan).

In particular, inform your doctor before taking ibuprofen if you are 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).

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.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to conceive, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Consult a doctor before using any medicine.
Do not take the medicine if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause delivery complications.
The medicine may cause kidney and heart problems 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 your 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 duration. From week 20 of pregnancy, prolonged use of the medicine (beyond a few days) may lead to impaired renal function in the unborn child (which may result in low levels of amniotic fluid surrounding the baby - oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer 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 effects in breastfed infants; therefore, it is not necessary to interrupt breastfeeding during short-term use of the medicine at low doses.
Consult a doctor before using any medicine.
Effect on fertility
Medicines in this group (nonsteroidal anti-inflammatory drugs) may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment. If you experience difficulty becoming pregnant, 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 psychomotor performance when used at the recommended doses and duration.
Contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking the medicine.
Contains sodium
The medicine contains 44.74 mg of sodium (a main component of table salt) in each tablet. This corresponds to 2.237% of the maximum recommended daily dietary sodium intake for adults.
Contains sunset yellow, lake (E 110) and Allura red AC, lake (E 129)
The medicine may cause allergic reactions.

3. How to use

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.
This medicine is intended for short-term use only.
The medicine is intended for oral use only, in adults and adolescents aged 12 years and older.
The usual dosage is as follows:
Adults and adolescents over 12 years of age: 1 tablet every four hours. Tablets should be taken with water.
Do not take more than 3 tablets per day.
Elderly patients: In elderly patients, there is an increased risk of adverse effects. This risk can be minimized by using the lowest effective dose for the shortest possible duration.
Use the lowest effective dose for the shortest period necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Warning:
Do not exceed the recommended dose!
In case of overdose, consult a doctor immediately.
If the effect of the medicine seems too strong or too weak, contact a doctor.
If symptoms persist or worsen, or if new symptoms occur, contact a doctor.
Use the lowest possible dose for the shortest possible time. This reduces the risk of adverse effects.
Do not take this medicine for longer than 3 days without medical advice.
For adolescents aged 12–18 years, consult a doctor if treatment is required for more than 3 days or if symptoms worsen.
Taking more medicine than recommended
If a patient has taken more than the recommended dose, or if a child has accidentally ingested the medicine, seek immediate medical advice from a doctor or go to the nearest hospital to assess potential health risks and receive guidance on necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Excitement, drowsiness, disorientation, or coma may also occur. Seizures have been reported occasionally. After large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. In addition, prothrombin time/INR may be prolonged, likely due to impaired circulating coagulation factors. Acute kidney 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. Treatment is symptomatic and supportive, aimed at maintaining vital functions until the drug is eliminated from the body. The doctor will monitor heart function and vital signs, as long as they remain stable. The doctor may consider administering activated charcoal orally within 1 hour of overdose. In the case of frequent or prolonged seizures, the doctor may administer intravenous diazepam or lorazepam. For patients with asthma, the doctor will administer bronchodilators.
Missed dose
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this product may 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 should be sought:

Red, flat, target-like or circular spots on the trunk, often with blisters in the center, peeling skin, mucosal 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 body temperature 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).

The adverse reactions listed below have been observed during short-term use of ibuprofen at doses available without a prescription. When ibuprofen is used for other indications or for prolonged periods, additional adverse reactions may occur.
Adverse reactions are listed according to frequency of occurrence.
Not common (may affect up to 1 in 100 people):

Dyspepsia, abdominal pain, nausea, headache, urticaria, various skin rashes and itching.

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

Diarrhea, flatulence, constipation, vomiting, inflammation of the gastric mucosa;
Psychotic disorders, depression, tinnitus;
Dizziness, insomnia, restlessness, irritability and feeling of fatigue.

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

Melena (black, tarry stools), hematemesis (vomiting blood), ulcerative stomatitis, exacerbation of colitis and Crohn's disease;
Decreased urine output, renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention);
Liver function disorders, particularly during long-term use;
Blood count abnormalities (anemia, leukopenia - reduced number of white blood cells, thrombocytopenia - reduced number of platelets, pancytopenia - hematological disorder characterized by deficiency of all normal blood cells: red, white and platelets, agranulocytosis - absence of a certain type of white blood cells called granulocytes). Initial symptoms include 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, tongue and laryngeal swelling, shortness of breath;
Tachycardia - increased heart rate, hypotension - sudden drop in blood pressure, shock;
Aseptic meningitis;
Heart failure, hypertension, edema;
Asthma exacerbation and bronchospasm.

Frequency unknown (frequency cannot be estimated from available data):

Hyperreactivity of the respiratory tract, including asthma;
Skin becomes sensitive to light;
Chest pain, which may indicate a potentially serious allergic reaction called Kounis syndrome. When using NSAIDs at high doses, cases of edema, hypertension and heart failure have been reported. Use of such drugs may be associated with a small increased risk of myocardial infarction (heart attack) or stroke. Other adverse reactions may occur in some individuals during treatment. If any of the above symptoms, or other symptoms not listed in this leaflet, are observed, the medicine should be discontinued and a doctor should be consulted.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 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 provide more information on the safety of the medicine.

5. How to store

No special storage conditions are required.
Keep the medicinal product out of the sight and reach of children.
Do not use the medicinal product after the expiry date stated on the carton and blister (EXP). The expiry date refers to the last day of the specified month.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information what it contains

The active substance is ibuprofen – 1 coated tablet contains 400 mg of ibuprofen in the form of 512 mg of ibuprofen sodium dihydrate.
Excipients: monohydrate lactose (200 M), sodium lauryl sulfate, crospovidone, povidone (K-30), colloidal hydrated silica, monohydrate lactose, talc, magnesium stearate; Coating (Opadry fx 64F580006): hypromellose 2910, monohydrate lactose, macrogol (E 1521), potassium-aluminium silicate (E 555) / titanium dioxide (E 171), talc, titanium dioxide (E 171), disodium citrate dihydrate. Printing ink 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 the medicine looks like and contents of the packaging
White or almost white, elongated-shaped coated tablets, smooth on one side and with grey printing on the other side.
PVC/PVDC/Aluminium blisters in a cardboard box.
12 pieces – 1 blister containing 12 coated tablets.
24 pieces – 2 blisters containing 12 coated tablets each.
HDPE bottle with HDPE screw cap in a cardboard box.
48 coated tablets in a bottle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
Ziębicka 40
50-507 Wrocław
For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
Poleczki 35
02-822 Warsaw
Tel.: +48 (22) 543 60 00