Ibuprex Max

Leaflet accompanying the packaging: information for the user

IBUPREX MAX, 400 mg, coated 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.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days of fever treatment or 4 days of pain treatment there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 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 active substance of the medicine is ibuprofen, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen reduces fever and has an analgesic effect.
The medicine is indicated for the symptomatic treatment of mild to moderate pain, including headache, migraine, painful menstruation, bone, muscle, and joint pain (also due to injuries), toothache, lower back pain, and fever, including in the course of upper respiratory tract infections, common cold, and flu or other infectious diseases.
If after 3 days of fever treatment or 4 days of pain treatment there is no improvement or the patient feels worse, they should consult a doctor.

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)
• if the patient has ever had difficulty breathing, asthma, nasal polyps, angioedema, or hives after taking acetylsalicylic acid or other similar painkillers (NSAIDs)
• if the patient has or has had recurrent stomach ulcers and/or duodenal ulcers
• if the patient has ever had stomach or duodenal ulcers, bleeding, or perforation of the gastrointestinal tract associated with NSAID treatment
• if the patient has severe liver or kidney failure, heart disease, or severe heart failure
• in children under 12 years of age
• if the patient has bleeding
• if the patient has unexplained blood disorders
• in patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake)
• in women in the last three months of pregnancy.

Warnings and precautions

Before starting treatment with the medicine, the patient should discuss it with their doctor or pharmacist:

• if they have certain skin diseases (systemic lupus erythematosus or mixed connective tissue disease). Treatment with the medicine should be stopped immediately after the first occurrence of skin rash, mucosal lesions, or any other signs of allergic reactions.
• if they have skin reactions. Serious skin reactions have been reported with the use of ibuprofen-containing medicines, 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 associated with these serious skin reactions described in section 4, they should stop taking the medicine and seek medical attention immediately.
• if they have a history of hereditary blood disorders (acute intermittent porphyria).
• if they have or have had bowel disease (ulcerative colitis or Crohn's disease).
• if they have kidney function disorders.
• if they have liver function disorders.
• after major surgical procedures and in people with reduced blood clotting or taking anticoagulant medications; ibuprofen may temporarily inhibit platelet aggregation.
• if they have or have had asthma or allergic disease, hay fever, nasal polyps, or chronic obstructive pulmonary disease, as there is an increased risk of allergic reactions. Allergic reactions can occur in the form of asthma attacks (e.g., so-called analgesic asthma), throat swelling causing difficulty swallowing and breathing, or hives.
• if they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, have had coronary artery bypass grafting, have peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or have had any stroke (including mini-stroke or transient ischemic attack - TIA).
• if they have high blood pressure, diabetes, high cholesterol levels, have a family history of heart disease or stroke, or smoke.
• if they have an infection - see below, section entitled "Infections".

While taking ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), and chest pain.
If any of these symptoms are noticed, the medicine should be stopped immediately and medical attention should be sought without delay.
Taking the medicine in the smallest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of side effects.
Elderly people are more likely to experience side effects, especially gastrointestinal bleeding and perforation.
The risk of bleeding, ulcers, and perforation of the gastrointestinal tract increases with increasing NSAID dose. In patients at increased risk of gastrointestinal ulcers and bleeding, as well as those requiring concomitant treatment with low-dose acetylsalicylic acid or other medicines that may increase the risk of adverse events in the gastrointestinal tract, concomitant treatment with protective agents (e.g., misoprostol or proton pump inhibitors) may be considered.
Caution should be exercised in patients receiving medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulant medications (e.g., warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (e.g., acetylsalicylic acid) (see "Interaction with other medicines" below).
Concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to the increased risk of adverse events (see "Interaction with other medicines" below).
Very rarely, serious skin reactions have been observed with the use of NSAIDs. The medicine should be discontinued and medical attention sought if the patient experiences skin reactions or changes in the mucous membranes.
Taking anti-inflammatory or analgesic medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. The recommended dose should not be exceeded, and treatment should not be prolonged.
Chronic use of (various) analgesic medicines may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).
After prolonged use of analgesic medicines, headaches may occur, which should not be treated with increased doses of the medicine.
When consuming alcohol, side effects, particularly those related to the gastrointestinal tract, may be exacerbated.
There is evidence that cyclooxygenase-inhibiting medicines, such as ibuprofen, may cause temporary difficulties in conceiving. The effect disappears after the end of treatment.
Ibuprofen should be avoided in cases of chickenpox.
Infections
may mask the signs of infection, such as fever and pain. This may delay the use of appropriate infection treatment and 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 symptoms of the infection persist or worsen, they should consult a doctor immediately.

Children and adolescents

There is a risk of kidney function disorders in dehydrated adolescents.

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.
The medicine may affect the action of other medicines, and other medicines may affect the action of this medicine.
For example:

• anticoagulant medicines (i.e., blood thinners that prevent blood clots, such as acetylsalicylic acid, warfarin, ticlopidine)
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan)

Also, some other medicines may be affected or may affect treatment with this medicine.
Therefore, before taking the medicine with other medicines, the patient should always consult their doctor or pharmacist.

Concomitant use of the medicine and the following medicines:

With food, drink, and alcohol
The tablet should be swallowed and washed down with a sufficient amount of water.
Ibuprofen should be avoided when consuming alcohol due to the possibility of exacerbating side effects related to the gastrointestinal tract.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The medicine should not be taken if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart disorders in the unborn child. It may also increase the risk of bleeding in the patient and their child and cause prolongation or prolongation of labor.
During the first six months of pregnancy, the medicine should not be used unless absolutely necessary and only on the advice of a doctor.
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, taking the medicine may lead to kidney function disorders in the unborn child if taken for more than a few days. This may also lead to low amniotic fluid levels around the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
The medicine passes into breast milk, but it can be used during breastfeeding if taken in the recommended doses and for the shortest possible time.
The medicine belongs to a group of NSAIDs that may have a negative effect on female fertility. This effect is temporary and disappears after the end of treatment.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines if taken for a short period and in accordance with the recommendations.

Medicine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it 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.
The smallest effective dose should be used for the shortest duration necessary 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 for more than 3 days for fever treatment and 4 days for pain treatment without consulting a doctor. If it is necessary to give the medicine to adolescents for more than 3 days or if the symptoms worsen, the patient should consult a doctor.

Treatment of fever and pain, including headache, migraine, toothache, bone, muscle, and joint pain, back pain

Adults, elderly, adolescents (over 12 years of age):
400 mg (1 tablet) up to 3 times a day at 4-6 hour intervals. The dose should not exceed 1200 mg (3 tablets) per day.
Painful menstruation:
400 mg (1 tablet) as needed, 1-3 times a day, with an interval of 4-6 hours between doses. The dose should not exceed 1200 mg (3 tablets) per day.
The medicine is not intended for use in children (under 12 years of age).
The tablets should be swallowed with a glass of water.

Overdose

If the patient has taken more than the recommended dose of the medicine or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to their health 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 convulsions. It may also cause agitation, drowsiness, disorientation, or coma. Seizures have occasionally occurred in patients. After taking large 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 difficulty breathing have occurred. Additionally, the prothrombin time/INR may be prolonged, probably due to the disruption of circulating clotting factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. Additionally, low blood pressure and difficulty breathing, as well as cyanosis, may occur.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.

Missed dose

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Taking the medicine in the smallest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of side effects.
The likelihood of side effects increases in elderly patients.

The patient should contact their doctor immediately if they experience:

• rash, severe swelling of the face, lips, tongue, or throat, which may cause difficulty breathing, speaking, or swallowing, low blood pressure, slow or fast heart rate, pale skin, anxiety, increased sweating, dizziness, or bronchospasm
• gastrointestinal bleeding (vomiting blood or black stools or blood in the stool)
• red, non-raised, target-like, or circular patches on the skin, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These serious 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 nodules under the skin and blisters, usually located in skin folds, on the trunk, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking the medicine and seek medical attention immediately. See also section 2.

Side effects are listed according to frequency of occurrence.

Uncommon (may affect up to 1 in 100 people):

• stomach pain, nausea, indigestion
• headache
• hives, itching.

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

• diarrhea, bloating, constipation, and vomiting, stomach inflammation
• dizziness, insomnia, fatigue, ringing in the ears
• irritability, depression, psychotic reactions
• edema.

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

• stomach and duodenal ulcers
• gastrointestinal bleeding (due to perforation of the stomach or intestinal wall) sometimes with a fatal outcome, especially in elderly people
• ulcerative stomatitis
• worsening of ulcerative colitis and Crohn's disease symptoms
• high blood pressure, heart failure
• kidney failure, renal papillary necrosis
• reduced urine output
• increased sodium levels in the blood (causing edema)
• liver function disorders, especially during long-term use of the medicine
• significant decrease in the number of all blood cells (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial oral mucosal ulceration, flu-like symptoms, significant fatigue, nosebleeds, or subcutaneous bleeding
• erythema multiforme (blue-red spots on the skin, sometimes with blisters)
• toxic epidermal necrolysis, occurrence of blisters on the skin and (or) mucous membranes, which after rupture form painful ulcers, often accompanied by fever, muscle and joint pain (this is called Stevens-Johnson syndrome)
• exfoliation of large areas of skin and its necrosis
• systemic lupus erythematosus (a chronic disease caused by immune system disorders, affecting many organs)
• mixed connective tissue disease
• stiffness of the neck, headaches, nausea, vomiting, fever, disorientation (these are symptoms of aseptic meningitis)
• severe hypersensitivity reactions: facial swelling, tongue and throat swelling, which may cause difficulty breathing, speaking, or swallowing, shortness of breath, rapid heart rate, low blood pressure, or shock, worsening of asthma symptoms.

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

• serious skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell).
• red, scaly rash with nodules under the skin and blisters, usually located in skin folds, on the trunk, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking the medicine and seek medical attention immediately. See also section 2.
• the skin becomes sensitive to light.
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Taking such medicines as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. 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, Al. Jerozolimskie 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store the medicine

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
The medicine should not be taken after the expiry date stated on the packaging and blister after the EXP symbol. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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

What the medicine contains

• The active substance of the medicine is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other ingredients (excipients) are: tablet core (microcrystalline cellulose, hypromellose 5 cP, sodium croscarmellose, colloidal anhydrous silica, purified water, macrogol 6000, sodium stearyl fumarate), coating Opadry 200 White (polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, methacrylic acid, and ethyl acrylate copolymer (1:1), sodium carbonate).

What the medicine looks like and contents of the pack

12 coated tablets, oblong, biconvex, white or almost white in color.
In a cardboard box, 2 PVC/Aluminum blisters, 6 tablets in each blister.

Marketing authorization holder

OLIMP LABORATORIES Sp. z o.o.
Pustynia 84F
39-200 Dębica
+48 14 680 32 00

Manufacturer

OLIMP LABORATORIES Sp. z o.o.
Pustynia 84F
39-200 Dębica
OLIMP LABORATORIES Sp. z o.o.
Nagawczyna 109 c
39-200 Dębica
{Logo Olimp Laboratories}

Date of last revision of the leaflet: