Patient Information Leaflet

IBUPROM ULTRAMAX, 600 mg, coated tablets
Ibuprofenum
Please read this 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 IBUPROM ULTRAMAX is and what it is used for
Important information before taking IBUPROM ULTRAMAX
How to take IBUPROM ULTRAMAX
Possible side effects
How to store IBUPROM ULTRAMAX
Contents of the pack and other information

1. What IBUPROM ULTRAMAX is and what it is used for

IBUPROM ULTRAMAX belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, anti-inflammatory, and antipyretic properties.
This medicine is indicated for immediate, short-term use in adults for the treatment of acute, moderate pain of various origins:

headaches (including migraines),
toothaches,
muscular and bone pain (including back pain),
pain due to injury or following surgery, including dental procedures,
neuralgic pain,
painful menstruation.

2. Information before using IBUPROM ULTRAMAX

When not to use IBUPROM ULTRAMAX:

if the patient is allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
if the patient has ever experienced asthma, bronchial asthma, hay fever, swelling, or hives after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs),
if the patient has severe heart failure,
if the patient has severe liver or kidney function disorders,
if the patient has unexplained blood disorders,
if the patient has bleeding into the brain or any other active bleeding,
if the patient has ever experienced gastrointestinal bleeding or perforation after taking NSAIDs,
if the patient has had, currently or in the past, recurrent gastric or duodenal ulcers or gastrointestinal bleeding (at least two confirmed cases of ulcers or bleeding),
if the patient has severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake),
if the patient is in the third trimester of pregnancy,
in individuals under 18 years of age.

Warnings and precautions
IBUPROM ULTRAMAX should be used in adults with concomitant chronic diseases only after consultation with a doctor.
Using the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.
The use of anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a slightly increased risk of myocardial infarction or stroke, especially when used at high doses. The recommended dose or duration of treatment must not be exceeded.
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported.
If any of these symptoms occur, IBUPROM ULTRAMAX should be discontinued immediately and medical help should be sought without delay.
Before starting IBUPROM ULTRAMAX, consult a doctor or pharmacist if:

the patient has heart disease, including heart failure, angina (chest pain), a history of heart attack, coronary artery bypass surgery, peripheral arterial disease (circulation problems in the legs or feet 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 is a smoker,
the patient has autoimmune diseases (systemic lupus erythematosus, connective tissue disorders), due to an increased risk of aseptic meningitis,
the patient is taking other pain-relieving NSAIDs or acetylsalicylic acid at a daily dose exceeding 75 mg,
the patient has congenital porphyria metabolism disorders (e.g. acute intermittent porphyria),
the patient has gastrointestinal diseases or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
the patient has fluid retention and oedema associated with NSAID use,
the patient is dehydrated (especially in children and adolescents), due to an increased risk of kidney failure,
the patient has impaired liver or kidney function,
the patient has active or past bronchial asthma or a history of allergic reactions (bronchospasm may occur after taking the medicine),
the patient has undergone major surgery,
in patients taking other medicines (especially anticoagulants, diuretics, cardiac medicines, or corticosteroids), or if the patient has blood clotting disorders (ibuprofen may temporarily inhibit platelet aggregation and prolong bleeding time),
when using the medicine in elderly patients (see section 3),
the patient has an infection – see below, section titled "Infections".

Avoid using IBUPROM ULTRAMAX simultaneously with other non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors.
Patients with a history of gastrointestinal disorders, particularly elderly patients, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, especially during the initial treatment period.
Particular caution and consultation with a doctor or pharmacist is advised before using the medicine in patients with hypertension and/or heart failure with fluid retention, or with a history of oedema associated with NSAID use.
Ibuprofen may cause sodium, potassium, and fluid retention in patients who have not previously had kidney disease. This may lead to oedema or even heart failure or hypertension in patients predisposed to such conditions.
Long-term use of ibuprofen, especially in combination with other painkillers, may cause permanent kidney damage and risk of kidney failure.
Patients at highest risk of such reactions include those with impaired kidney function, heart failure, liver dysfunction, those taking diuretics and antihypertensive drugs (ACE inhibitors), and elderly patients. Patients who discontinue NSAID treatment generally return to their pre-treatment state.
In long-term ibuprofen therapy, periodic monitoring of liver and kidney function and blood cell counts is necessary, especially in high-risk patients.
During long-term, high-dose painkiller treatment, headaches may occur that should not be treated with increased doses of medication.

Skin reactions
Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with ibuprofen use.
If any of the symptoms associated with these severe skin reactions described in section 4 occur, IBUPROM ULTRAMAX should be discontinued immediately and medical help sought.

Infections
IBUPROM ULTRAMAX may mask symptoms of infection such as fever and pain. Therefore, IBUPROM ULTRAMAX may delay appropriate treatment of infection, thereby increasing 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 persist or worsen, immediate consultation with a doctor is required.
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of the medicine.
Do not use IBUPROM ULTRAMAX during chickenpox.
Alcohol consumption should be avoided during treatment, as it may increase adverse effects, particularly those related to the gastrointestinal tract and nervous system.

IBUPROM ULTRAMAX and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
IBUPROM ULTRAMAX may affect other medicines, and other medicines may affect the action of this medicine. For example:
 Anticoagulants (i.e. blood thinners or clot-preventing medicines, e.g. acetylsalicylic acid, warfarin, ticlopidine).
 Medicines lowering blood pressure (ACE inhibitors, e.g. captopril, beta-blockers, e.g. atenolol, or angiotensin II receptor antagonists, e.g. losartan).
Always consult a doctor or pharmacist before using IBUPROM ULTRAMAX with other medicines.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
diuretics and potassium-sparing agents,
antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal adverse effects,
methotrexate (used in cancer or rheumatic disease treatment), as its effects may be enhanced,
lithium (used in depression treatment), as its effects may be enhanced,
cardiac glycosides (e.g. digoxin), as ibuprofen may increase its plasma concentration,
phenytoin (an anticonvulsant), as ibuprofen may increase its plasma concentration,
corticosteroids (such as prednisolone or dexamethasone), as they may increase the risk of gastrointestinal ulceration or bleeding,
tacrolimus (an immunosuppressant), as there is an increased risk of nephrotoxicity,
cyclosporine (an immunosuppressant), as limited data suggest an increased risk of nephrotoxicity,
zidovudine (used in AIDS treatment), as using IBUPROM ULTRAMAX may increase the risk of joint bleeding or bleeding leading to swelling (in haemophilia patients with a positive HIV antibody test),
ritonavir (used in HIV therapy): ritonavir may increase plasma concentrations of NSAIDs,
antibiotics (quinolones or aminoglycosides),
sulfonylurea derivatives (antidiabetic agents): clinical interactions between these drugs and NSAIDs may occur; blood glucose monitoring is recommended,
probenecid and sulfinpyrazone (used in gout treatment): may delay ibuprofen excretion,
cholestyramine: may delay and reduce absorption of NSAIDs,
voriconazole and fluconazole (antifungal agents): may increase exposure to NSAIDs,
baclofen (a muscle relaxant): toxic effects of baclofen may occur after starting ibuprofen,
aminoglycosides (a class of antibiotics): NSAIDs may reduce aminoglycoside excretion,
mifepristone: NSAIDs should not be used within 8–12 days after mifepristone administration, as they may weaken its effect,
calcium channel blockers: reduced antihypertensive efficacy and increased risk of gastrointestinal bleeding,
desipramine: increased desipramine toxicity typical of tricyclic antidepressants,
levofloxacin and ofloxacin: increased risk of serious central nervous system effects,
thienopyridine derivatives: increased bleeding risk due to additive antiplatelet and anticoagulant effects,
bisphosphonates: increased risk of gastrointestinal adverse effects,
anticoagulant medicines (i.e. blood thinners or clot-preventing agents, such as aspirin – acetylsalicylic acid, warfarin, ticlopidine),
blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as atenolol-containing medicines, angiotensin II receptor antagonists, such as losartan).

Concurrent use of ibuprofen with herbal preparations such as Japanese pagoda tree (Ginkgo biloba) and meadowsweet (Filipendula ulmaria) may increase bleeding risk due to antiplatelet effects.
Simultaneous use of ibuprofen and products containing Chinese ephedra (Ephedra sinica) may increase the risk of gastrointestinal mucosal damage.
Other medicines may also influence or be influenced by IBUPROM ULTRAMAX. Therefore, always consult a doctor or pharmacist before using IBUPROM ULTRAMAX with other medicines.

Taking IBUPROM ULTRAMAX with food, drink, and alcohol
Food reduces gastrointestinal absorption of ibuprofen.
During high-dose ibuprofen use and concomitant alcohol consumption, symptoms such as fatigue and headache may occur.

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

Pregnancy
If pregnancy occurs during treatment with IBUPROM ULTRAMAX, the doctor should be informed.
During the last 3 months of pregnancy, DO NOT take this medicine, as ibuprofen may have very serious, even fatal, effects on the baby's heart and kidneys, even after a single dose.
IBUPROM ULTRAMAX should not be used during the last 3 months of pregnancy, as it may harm the unborn child or cause delivery complications. IBUPROM ULTRAMAX 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 labour.
During the first 6 months of pregnancy, IBUPROM ULTRAMAX should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used.
From week 20 of pregnancy, IBUPROM ULTRAMAX may cause kidney function disturbances in the unborn child if used for longer than a few days. This may lead to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts. Short-term use of ibuprofen at doses used for pain relief is unlikely to harm the infant. However, if prolonged ibuprofen use is required, earlier weaning from breastfeeding should be considered.

Fertility
Ibuprofen may impair fertility. If the patient plans to become pregnant or has difficulty conceiving, she should inform her doctor.

Driving and using machines
Short-term use of IBUPROM ULTRAMAX according to the recommended dosage has no effect or negligible effect on the ability to drive or operate machinery.
If visual disturbances, fatigue, dizziness, or other nervous system-related adverse effects occur, driving and operating machinery are not recommended.

IBUPROM ULTRAMAX contains lactose
If the patient has previously been diagnosed with sugar intolerance, they should consult a doctor before using this medicine.

IBUPROM ULTRAMAX contains propylene glycol
The medicine contains 0.97 mg of propylene glycol per tablet.

IBUPROM ULTRAMAX contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use IBUPROM ULTRAMAX

This medicine should always be taken exactly as described in the patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose:
Adults:
The recommended dose is 600 mg of ibuprofen (1 tablet) as a single dose.
If necessary, the single dose of 600 mg (1 tablet) may be repeated, maintaining an interval of 6–8 hours. The maximum daily dose without prior consultation with a doctor should not exceed 1200 mg (2 tablets).
IBUPROM ULTRAMAX should only be used if the patient does not experience improvement after taking ibuprofen at a dose of 400 mg (maximum 1200 mg ibuprofen/day). In such a case, a dose of 600 mg ibuprofen may be taken, provided that an interval of 6–8 hours is maintained from the previous 400 mg dose.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If symptoms of infection (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
Adverse effects can be minimized by using the lowest effective dose for the shortest duration needed to control symptoms.
If it is necessary to use the medicine for longer than 3 days, or if symptoms worsen, medical advice should be sought.

Special patient groups
Elderly patients:
This medicine should only be used after consultation with a doctor. Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with caution, especially in elderly patients who are more prone to adverse effects and at increased risk of potentially fatal gastrointestinal bleeding, ulcers, and perforation.

Renal or hepatic impairment:
This medicine should only be used after consultation with a doctor. Dose adjustment is not required in patients with mild to moderate renal or hepatic dysfunction. However, in these patients, the lowest effective dose for the shortest duration necessary to control symptoms should be used.

Children and adolescents
The use of IBUPROM ULTRAMAX is contraindicated in children and adolescents under 18 years of age.

Method of administration
IBUPROM ULTRAMAX is intended for oral use. Tablets should be swallowed whole with a glass of water.
Patients with a sensitive stomach are advised to take IBUPROM ULTRAMAX with food.

Accidental overdose of IBUPROM ULTRAMAX
If a patient has taken more than the recommended dose of IBUPROM ULTRAMAX, or if a child has accidentally ingested the medicine, medical advice should always be sought immediately from a doctor or the nearest hospital to assess potential health risks and receive guidance on appropriate 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. Stimulation, drowsiness, disorientation, or coma may also occur. Seizures may occur sporadically. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, haematuria, hypokalaemia, feeling cold, and breathing difficulties may occur. Prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In asthmatic patients, asthma may worsen. Additionally, hypotension, breathing difficulties, or cyanosis may occur.
In children, myoclonic jerks (repetitive muscle jerks) may occur.
In children, a single dose exceeding 400 mg/kg body weight may cause symptoms of overdose. In adults, the dose causing such symptoms has not been precisely established.

Treatment
There is no specific antidote available. Treatment is symptomatic and supportive. Oral activated charcoal may be considered within 1 hour of overdose.
If symptoms of overdose occur, the medicine should be discontinued immediately and medical advice should be sought from a doctor or emergency department.

Missed dose of IBUPROM ULTRAMAX
Do not take a double dose to make up for a missed dose.
If you have any further doubts 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.
You should stop taking ibuprofen and seek immediate medical help if any of the following symptoms occur:
 red, flat, non-raised, target-like or circular spots on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. 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 fever, 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 list below includes all adverse reactions observed during ibuprofen treatment, including those occurring after long-term, high-dose therapy used in patients with rheumatic disease.
With regard to the adverse reactions listed below, it should be remembered that they are predominantly dose-dependent and their occurrence varies individually.
Patients taking IBUPROM ULTRAMAX should discontinue the medicine and immediately consult a doctor if signs or symptoms of ulceration, mucosal damage or gastrointestinal bleeding (tarry stools, bloody vomiting), acute upper abdominal pain, blurred vision or other eye-related symptoms, skin rash or other hypersensitivity reactions, weight gain or oedema occur.

The most commonly observed adverse reactions involve the gastrointestinal tract. Gastrointestinal ulcers, perforation, or bleeding may occur, sometimes with fatal outcome (particularly in elderly patients). These may occur without warning symptoms or may occur in patients who have previously experienced such warning signs.

The risk of gastrointestinal bleeding is particularly dependent on the dose range and duration of ibuprofen use.

Taking ibuprofen, especially long-term at high doses (2400 mg per day), may be associated with a small increased risk of arterial thrombosis (e.g. myocardial infarction or stroke).

Common (occur in no more than 1 in 10 people):

heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, dyspepsia, constipation, and minor gastrointestinal bleeding, which may exceptionally lead to anaemia.

Uncommon (occur in no more than 1 in 100 people):

hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly occurring together with a drop in blood pressure); in such cases, the medicine should be discontinued and immediate medical advice sought,
headache, drowsiness, dizziness, insomnia, restlessness, irritability, or fatigue,
visual disturbances,
gastrointestinal ulcers, potentially with bleeding and perforation, oral mucosal ulcers, exacerbation of ulcerative colitis, Crohn's disease, gastric mucosal inflammation, tarry stools, bloody vomiting.

Rare (occur in no more than 1 in 1000 people):

tinnitus,
kidney tissue damage (papillary necrosis) and increased blood uric acid levels.

Very rare (occur in no more than 1 in 10,000 people):

severe, generalized hypersensitivity reactions. These may present, for example, as facial swelling, tongue swelling, internal laryngeal swelling with impaired airway patency, respiratory failure, rapid heartbeat, low blood pressure, up to life-threatening shock. If any of the above symptoms occur, which may happen even after the first dose of the medicine, immediate medical assistance is required.
blood system disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms may include fever, sore throat, oral ulcers, flu-like symptoms, marked weakness, nosebleeds, and subcutaneous haemorrhages. Blood morphology parameters should be monitored regularly during long-term treatment.
development of oedema, particularly with hypertension or renal failure, nephrotic syndrome, interstitial nephritis associated with acute renal failure. For this reason, kidney function should be monitored regularly during prolonged treatment.
liver function disorders, liver damage (especially with long-term use), liver failure, acute hepatitis. For this reason, liver function should be monitored regularly during prolonged treatment.
palpitations, heart failure, myocardial infarction,
hypertension,
oesophagitis, pancreatitis, development of diaphragm-like intestinal strictures,
psychotic reactions, depression,
infections associated with conditions that are the reason for using non-steroidal anti-inflammatory drugs (e.g. necrotizing fasciitis). If signs of infection appear or worsen during ibuprofen use, the patient should immediately consult a doctor. The doctor will assess whether antimicrobial treatment (antibiotic therapy) is indicated. Aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or disturbances in consciousness has been observed during ibuprofen use. Patients with autoimmune diseases (SLE, mixed connective tissue disease) appear to be particularly susceptible.
in exceptional cases, severe skin infections and soft tissue complications may occur during varicella virus infection.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any 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 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the representative of the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store IBUPROM ULTRAMAX

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging after
"Expiry date". The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What IBUPROM ULTRAMAX contains
The active substance is ibuprofen. Each coated tablet contains 600 mg of ibuprofen.
The other ingredients are:
Tablet core: hypromellose 2910 (6 mPa·s), sodium croscarmellose, monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, colloidal anhydrous silica, and magnesium stearate;
Tablet coating: hypromellose 2910 (6 mPa·s), titanium dioxide (E 171), talc, and propylene glycol.

What IBUPROM ULTRAMAX looks like and contents of the pack
Coated tablet. White, elongated, biconvex coated tablets.
IBUPROM ULTRAMAX is available in blisters (Aluminium/PVC/PVDC) containing 10 coated tablets, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer/Importer

Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław, Poland

Manufacturers/Importers
ROVI PHARMA INDUSTRIAL SERVICES, S.A.
Vía Complutense, 140, Alcalá de Henares,
28805 Madrid, Spain
Farmalider, S.A.
C/Aragoneses, 2, Alcobendas
28108 Madrid, Spain
TOLL MANUFACTURING SERVICES, S.L
C/Aragoneses, 2
28108 Alcobendas, Madrid, Spain

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
{logo of the Marketing Authorisation Holder}
USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warsaw
tel.: +48 (22) 543 60 00

This medicine is authorised in the Member States of the European Economic Area under the following names:
Poland: IBUPROM ULTRAMAX

Ibuprofen ultramax