Ibuprex max

Package leaflet: Information for the user

IBUPREX MAX, 400 mg, coated tablets
Ibuprofenum
Please read the entire leaflet carefully 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 a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment for fever or 4 days of treatment for pain, or if you feel worse, consult your 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 package and other information

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

The active substance in this medicine is ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen reduces fever and has analgesic (pain-relieving) properties.
This medicine is indicated for symptomatic treatment of mild to moderate pain, including headache, migraine, menstrual pain, bone, muscle and joint pain (including pain due to injury), toothache, lower back pain, as well as for the treatment of fever associated with upper respiratory tract infections, colds, influenza, and other infectious diseases.
If there is no improvement after 3 days of treatment for fever or 4 days of treatment for pain, or if you feel worse, consult your doctor.

2. Information before using the medicine

When not to use the medicine:

• if the patient is allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has ever experienced asthma, difficulty breathing, runny nose, swelling, or hives after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs)
• if the patient currently has or has had recurrent peptic ulcer disease of the stomach and/or duodenum
• if the patient has ever had stomach and/or duodenal ulcers, gastrointestinal bleeding, or gastrointestinal perforation related to NSAID treatment
• if the patient has severe liver failure, severe kidney failure, coronary heart disease, or severe heart failure
• in children under 12 years of age
• if the patient is experiencing bleeding
• if the patient has unexplained disorders of the blood system
• in patients with severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake)
• in women during the last three months of pregnancy.

Warnings and precautions
Before starting treatment, consult a doctor or pharmacist if:

• the patient has certain skin diseases (systemic lupus erythematosus or mixed connective tissue disease). Treatment must be stopped immediately at the first sign of skin rash, mucosal lesions, or any other symptoms of an allergic reaction.
• the patient has skin reactions. Severe skin reactions associated with medicines containing ibuprofen 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 any of the symptoms related to these severe skin reactions described in section 4 occur, the medicine must be stopped immediately and medical help should be sought without delay.
• the patient has a hereditary blood disorder (acute intermittent porphyria).
• the patient has or has ever had inflammatory bowel disease (ulcerative colitis or Crohn's disease).
• the patient has impaired kidney function.
• the patient has impaired liver function.
• immediately after major surgical procedures, or in patients with reduced blood clotting or those receiving anticoagulant therapy; ibuprofen may temporarily inhibit platelet aggregation.
• the patient has or has had asthma or allergic conditions, hay fever, nasal polyps, or chronic obstructive respiratory disorders, as there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (e.g. so-called analgesic-induced asthma), throat swelling causing difficulty in swallowing and breathing, or hives.
• the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack - TIA).
• the patient has high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.
• if the patient has an infection – see below, section titled "Infections".

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported.
If any of these symptoms occur, the medicine must be stopped immediately and the patient should contact a doctor or emergency medical services without delay.
To minimize the risk of adverse effects, the medicine should be taken at the lowest effective dose for the shortest duration necessary to relieve symptoms.
Elderly patients are more likely to experience adverse effects, particularly gastrointestinal bleeding and perforation.
The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher doses of NSAIDs. In patients who have an increased risk of gastrointestinal ulceration and bleeding, as well as in patients requiring concomitant treatment with low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal adverse events, concomitant treatment with protective agents (e.g. misoprostol or proton pump inhibitors) may be considered.
Caution is advised in patients receiving medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents such as acetylsalicylic acid (see section "Interaction with other medicines" below).
Concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to increased risk of adverse effects (see section "Interaction with other medicines" below).
Severe skin reactions associated with NSAIDs have been very rarely observed. The medicine should be discontinued and medical advice sought immediately if skin reactions or mucosal lesions occur.
Use of anti-inflammatory or 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. The recommended dose and duration of treatment should not be exceeded.
Chronic use of (various) pain-relieving medicines may lead to kidney damage with risk of kidney failure (analgesic nephropathy).
Prolonged use of pain-relieving medicines may result in headaches that should not be treated with increased doses of the medicine.
If alcohol is consumed concurrently, adverse effects, particularly those affecting the gastrointestinal tract, may be intensified.
There is some evidence that cyclooxygenase-inhibiting medicines such as ibuprofen may cause transient difficulties in becoming pregnant. This effect resolves after discontinuation of the medicine.
Use of ibuprofen is not recommended in cases of chickenpox.

Infections
The medicine may mask objective signs 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 ongoing infection and symptoms of infection persist or worsen, immediate consultation with a doctor is required.

Children and adolescents
There is a risk of impaired kidney function in dehydrated adolescents.

Interaction with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
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 clot formation, such as acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)

Also, some other medicines may be affected by or may influence treatment with this medicine.
Therefore, always consult a doctor or pharmacist before using this medicine together with other medicines.

Concomitant use of this medicine and the following medicines:

With food, drink and alcohol
The tablet should be swallowed and taken with an adequate amount of water.
Concomitant use of ibuprofen with alcohol should be avoided due to the possibility of exacerbating gastrointestinal adverse effects.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

This 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 problems in the unborn child. It may also increase the tendency to bleeding in both the patient and her child, and may delay or prolong labour.

During the first six months of pregnancy, this medicine should not be used unless absolutely necessary and only on the advice of a doctor. If treatment is required during this period or when trying to become pregnant, the lowest possible dose should be used for the shortest possible duration.

From the 20th week of pregnancy, use of this medicine may lead to impaired kidney function in the unborn child if taken for longer than a few days. It may also lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.

The medicine passes into breast milk, but may be used during breastfeeding if administered at recommended doses and for the shortest possible duration.

This medicine belongs to the group of NSAIDs (non-steroidal anti-inflammatory drugs) that may have an adverse effect on female fertility. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery when used short-term and according to recommendations.

The medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, 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. If in doubt, consult a doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If symptoms of an infection (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
Do not use this medicine for more than 3 days for fever or more than 4 days for pain without consulting a doctor. If treatment with this medicine is required for more than 3 days in adolescents, or if symptoms worsen, consult a doctor.
Treatment of fever and pain, including headache, migraine, toothache, bone, muscle and joint pain, back pain:
Adults, elderly and adolescents (over 12 years of age):
400 mg (1 tablet) up to 3 times daily, at intervals of 4–6 hours. Do not exceed 1200 mg (3 tablets) per day.
Painful menstruation:
400 mg (1 tablet) as needed, 1–3 times daily, with at least 4–6 hours between doses. Do not exceed 1200 mg (3 tablets) per day.
This medicine is not intended for use in children (under 12 years of age).
Tablets should be taken with a glass of water.
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 medical advice from a doctor or go to the nearest hospital immediately 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 vertigo. Agitation, drowsiness, disorientation or coma may also occur. Seizures have been reported occasionally. 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. In addition, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may be exacerbated. Hypotension, breathing difficulties and cyanosis may also occur.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.
If a dose is missed
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 all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Taking the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse reactions.
The likelihood of adverse reactions increases in elderly patients.
You should contact your doctor immediately if any of the following occur:

• rash, severe swelling of the face, lips or throat causing difficulty breathing, speaking or swallowing, low blood pressure, slow or rapid heartbeat, pale skin, restlessness, excessive sweating, dizziness, bronchospasm
• gastrointestinal bleeding (bloody vomit or black stools or blood in stool)
• red, flat, target-like or circular spots on the body, often with blisters in the centre, skin peeling, 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 enlarged lymph nodes (DRESS syndrome)
• red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

Adverse reactions are listed according to frequency of occurrence.
Uncommon (may occur in less than 1 in 100 patients treated):

• abdominal pain, nausea, indigestion
• headache
• urticaria, itching.

Rare (may occur in less than 1 in 1,000 patients treated):

• diarrhoea, bloating, constipation and vomiting, gastritis
• dizziness, insomnia, fatigue, tinnitus
• restlessness, irritability, depression, psychotic reactions
• oedema.

Very rare (may occur in less than 1 in 10,000 patients treated):

• gastric and/or duodenal ulcer disease
• gastrointestinal bleeding (caused by perforation of the stomach or intestinal wall), sometimes fatal, particularly in elderly patients
• erosive stomatitis
• worsening of symptoms of ulcerative colitis and Crohn's disease
• hypertension, heart failure
• renal failure, renal papillary necrosis
• decreased urine output
• increased blood sodium concentration (causing oedema)
• liver function disorders, particularly during prolonged use of the medicine
• marked decrease in the number of all blood cells (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include: fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, marked exhaustion, nosebleeds or subcutaneous haemorrhages
• erythema multiforme (blue-red skin lesions, sometimes with blisters)
• toxic epidermal necrolysis, occurrence of blisters on the skin and/or mucous membranes which, when ruptured, form painful wounds; fever, muscle and joint pain often occur simultaneously (this is known as Stevens-Johnson syndrome)
• extensive peeling of the skin and skin necrosis
• systemic lupus erythematosus (a chronic disease caused by immune system disorders affecting multiple organs)
• mixed connective tissue disease
• neck stiffness, headache, nausea, vomiting, fever, disorientation (symptoms of aseptic meningitis)
• severe hypersensitivity reactions: facial, tongue and laryngeal oedema causing difficulty breathing, speaking or swallowing, dyspnoea, tachycardia, hypotension or shock, worsening of asthma symptoms.

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

• severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell).
• red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, the medicine should be discontinued and medical help sought immediately. See also section 2.
• skin becomes sensitive to light.
• chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

Taking medicines such as this may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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; tel: +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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine

Keep the medicine in a place out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after the
EXP symbol. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What the medicine contains

• The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other components (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 film-coated tablets, elongated, biconvex, white or almost white.
In a cardboard box: 2 PVC/Aluminium blisters with 6 tablets in each blister.
Marketing Authorisation 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}