Patient Information Leaflet

IBUM SUPERMAX
600 mg, soft capsules
Ibuprofen
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as directed by your doctor,
pharmacist, or nurse.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 days, or if you feel worse, you should consult your doctor.

Leaflet Contents

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

1. What I S is and what it is used for

I S contains ibuprofen, a substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which has analgesic, anti-inflammatory, and antipyretic properties.
This medicine is indicated for short-term, immediate relief of acute, moderate pain of various origins in adults:

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

I S is also indicated for symptomatic relief of pain in joint diseases (e.g. rheumatoid arthritis), degenerative joint diseases (e.g. osteoarthritis) in adults. This medicine is intended for use as continuation of treatment in diagnosed patients.

2. Important information before using the medicine I S

When not to use the medicine I S

if the patient is allergic to the active substance, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
in patients who in the past experienced allergic reactions such as rhinitis, urticaria, or bronchial asthma during treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
in patients who have previously experienced gastrointestinal perforation (a hole) or bleeding associated with prior treatment with NSAIDs,
if there is active or recurrent peptic ulcer disease of the stomach and/or duodenum, or gastrointestinal bleeding (previous serious bleeding, two or more independent episodes of confirmed ulceration or bleeding),
if there is severe hepatic insufficiency or severe renal insufficiency,
if there is severe heart failure or coronary artery disease,
in patients with bleeding disorders (tendency to bleed),
during the last three months of pregnancy,
if cerebral haemorrhage or any other active bleeding is present,
if the patient is significantly dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake),
in individuals under 18 years of age.

Warnings and precautions
Medicine I S should be used in adults with concomitant chronic diseases only after consultation with a doctor.
Before starting treatment with I S, discuss this with your doctor, pharmacist, or nurse if:

the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or has experienced any stroke (including mini-stroke or transient ischaemic attack - TIA),
the patient has hypertension, 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 increased risk of aseptic meningitis symptoms,
the patient is taking other analgesic NSAIDs or acetylsallylic acid at daily doses exceeding 75 mg,
the patient has congenital porphyria metabolism disorders (e.g. acute intermittent porphyria),
the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
the patient has impaired kidney or liver function,
the patient has fluid retention and oedema related to NSAID use,
dehydration occurs (especially in children and adolescents) due to increased risk of renal failure,
the patient has active or past bronchial asthma or allergic reactions (bronchospasm may occur after drug administration),
the patient has recently undergone major surgery,
the patient is taking other medications (especially anticoagulants, diuretics, cardiac glycosides, or corticosteroids), or has coagulation disorders (ibuprofen may temporarily inhibit platelet aggregation and prolong bleeding time),
the patient is elderly (see section 3),
the patient has an infection – see below, section titled "Infections".

Allergic-type reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported.
If any of these symptoms occur, discontinue I S immediately and contact a doctor or emergency medical services without delay.
Avoid concomitant use of ibuprofen with other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors.
Patients with a history of gastrointestinal disorders, particularly elderly patients, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, particularly during the initial treatment period.
Exercise special caution and consult a doctor or pharmacist before using the medicine in patients with hypertension and/or heart failure with fluid retention, hypertension, and oedema previously associated with NSAID use.
Taking anti-inflammatory and analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Ibuprofen may cause sodium, potassium, and fluid retention in patients who previously did not have kidney disease. This may lead to oedema or even heart failure or hypertension in patients predisposed to such disorders.
Long-term use of ibuprofen, especially in combination with other analgesics, may cause permanent kidney damage and risk of renal failure.
Patients at highest risk of such reactions include those with impaired kidney function, heart failure, impaired liver function, those taking diuretics and antihypertensives (ACE inhibitors), and elderly patients. Patients who discontinue NSAID therapy generally return to their pre-treatment condition.
During long-term ibuprofen treatment, periodic monitoring of liver and kidney function and blood cell counts is necessary, especially in high-risk patients.
During prolonged treatment with high doses of analgesics, headaches may occur, which should not be treated with increased drug doses.

Skin reactions
Severe skin reactions associated with the use of medicine I S have been reported. If any skin rash, mucosal changes, blisters, or other allergic symptoms appear, stop taking I S immediately and seek medical help promptly, as these may be early signs of a very serious skin reaction. See section 4.
Serious skin reactions 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) have been reported with ibuprofen use. If any of the symptoms related to these severe skin reactions described in section 4 occur, discontinue I S immediately and seek medical help.

Infections
I S may mask signs of infection such as fever and pain. Therefore, I S may delay appropriate treatment of 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 takes this medicine during an ongoing infection and infection symptoms persist or worsen, immediate consultation with a doctor is required.
Ibuprofen may mask signs or symptoms of infection (fever, pain, and swelling).
Avoid using medicine I S 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.
Using the medicine at the lowest effective dose for the shortest necessary duration to relieve symptoms reduces the risk of adverse effects.

I S and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Medicine I S may affect the action of other medicines, or other medicines may affect the action of I S. For example:

other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
diuretics and potassium-sparing agents,
antiplatelet drugs (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 ibuprofen may increase methotrexate effects,
lithium (used in depression treatment), as ibuprofen may increase lithium effects,
cardiac glycosides (e.g. digoxin), as ibuprofen may increase serum levels of this drug,
phenytoin (an antiepileptic), as ibuprofen may increase serum levels of this drug,
corticosteroids (such as prednisolone or dexamethasone), as they may increase the risk of gastrointestinal ulceration or bleeding,
tacrolimus (an immunosuppressant), as there is increased risk of nephrotoxicity,
cyclosporine (an immunosuppressant), as limited data suggest increased risk of nephrotoxicity,
zidovudine (used in AIDS treatment), as use of I S may increase the risk of joint bleeding or bleeding leading to swelling (in haemophilia patients with positive HIV antibody test),
ritonavir (used in HIV therapy): ritonavir may increase NSAID plasma concentrations,
antibiotics (quinolones or aminoglycosides),
sulfonylurea derivatives (antidiabetic drugs): clinical interactions between these drugs and NSAIDs may occur; blood glucose monitoring is recommended,
probenecid and sulfinpyrazone (used in gout treatment): may delay ibuprofen elimination,
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 mifepristone's effect,
calcium channel antagonists: 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 anti-aggregatory and anticoagulant effects,
bisphosphonates: increased risk of gastrointestinal adverse effects,
anticoagulant drugs (i.e. blood thinners or those preventing clot formation, such as acetylsalicylic acid, warfarin, ticlopidine),
antihypertensive drugs (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing drugs, angiotensin II receptor antagonists such as losartan).

Concomitant use of ibuprofen with herbal products containing Ginkgo biloba or Filipendula ulmaria may increase bleeding risk due to anti-aggregatory effects.
Simultaneous use of ibuprofen and products containing Ephedra sinica may increase the risk of gastrointestinal mucosal damage.
Other medicines may also influence or be influenced by I S.
Therefore, always consult a doctor or pharmacist before using I S with other medicines.

Using I S with food, drink, and alcohol
Food reduces gastrointestinal absorption of ibuprofen.
During use of high-dose ibuprofen with concomitant alcohol consumption, symptoms such as fatigue and headaches may occur.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take I S during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. It may cause kidney and heart problems in the unborn child. It may increase bleeding tendency in both mother and child and may delay or prolong labour. Do not use the medicine during the first six months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, I S may cause kidney dysfunction in the unborn child if taken for longer than a few days (this may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios)), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is necessary, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts. After short-term use of ibuprofen at analgesic doses, harmful effects on infants seem unlikely. However, if longer-term use is required, consider stopping breastfeeding earlier.

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

Driving and operating machinery
Short-term use of I S according to recommended dosing 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.

I S contains sorbitol and potassium
The medicine contains 150 mg of liquid, partially dehydrated sorbitol per capsule. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, the patient should consult a doctor before taking the medicine.
The medicine contains 54 mg of potassium per dose, which should be considered in patients with reduced kidney function and in patients controlling potassium intake in their diet.

3. How to use Ibum Supermax

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is taken orally. The capsule should be swallowed whole with a glass of water.

Adults
The recommended dose is 600 mg of ibuprofen (1 capsule) as a single dose.
If necessary, the single dose of 600 mg (1 capsule) may be repeated, leaving an interval of 6–8 hours.
The maximum daily dose without prior consultation with a doctor should not exceed 1200 mg (2 capsules).

Ibum Supermax should only be used if the patient does not experience improvement after using ibuprofen at a dose of 400 mg (maximum 1200 mg ibuprofen per day). In such a case, a dose of 600 mg ibuprofen may be taken, provided that at least 6–8 hours have passed since the previous 400 mg dose.

The lowest effective dose for the shortest necessary duration should be used to relieve symptoms. This helps reduce the risk of adverse effects. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

If it is necessary to use the medicine for longer than 3 days, or if symptoms worsen, consult a doctor.

Elderly patients
Do not use without consulting a doctor. Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with caution, especially in elderly patients, who are more susceptible to adverse effects and at risk of potentially fatal gastrointestinal bleeding, ulcers, and perforation.

Renal or hepatic impairment
Do not use without consulting a doctor. There is no requirement to adjust the dose in patients with mild to moderate renal or hepatic impairment. However, in these patients, the lowest effective dose for the shortest possible duration necessary to control symptoms should be used.

Use of a higher than recommended dose of Ibum Supermax
If a patient has taken more than the recommended dose of Ibum Supermax, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital to assess potential health risks and receive advice on necessary actions. Cases of overdose are rare.

Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties may occur.

In children, a single dose exceeding 400 mg/kg body weight may cause symptoms of overdose. In adults, the dose that may cause such symptoms has not been precisely established.

In children, myoclonic seizures (repetitive muscle jerks) may occur. In severe poisoning, metabolic acidosis (disturbance of acid-base balance) may develop, and prothrombin time (a parameter related to the blood coagulation system) may be prolonged. Acute renal failure, liver damage, hypotension, respiratory depression, or cyanosis may occur.

In patients with asthma, worsening of asthma symptoms may occur.

Treatment
There is no specific antidote (antidote). Symptomatic and supportive treatment should be given. Oral activated charcoal may be considered within 1 hour of overdose.

If symptoms of overdose occur, stop taking the medicine immediately and contact a doctor or go to the nearest emergency department.

Missed dose of Ibum Supermax
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, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The list below includes all adverse reactions observed during treatment with ibuprofen, including those occurring after long-term therapy with high doses used in patients with rheumatic disease.
With regard to the adverse reactions listed below, it should be remembered that the majority of them are dose-dependent and their occurrence varies individually.
Patients taking Ibum Supermax should discontinue the medicine and immediately consult a doctor if symptoms or signs 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 swelling occur.
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, skin peeling, mouth, throat, nose, genital or eye ulcers. 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 fever, 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 generalized exanthematous pustulosis).

The most commonly observed adverse reactions involve the gastrointestinal tract. Ulceration, perforation, or gastrointestinal bleeding may occur, sometimes with fatal outcomes (particularly in elderly patients). These may not necessarily be preceded by warning symptoms or may occur in patients who 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).
Other possible adverse reactions include:
Common (occur in 1 to 10 out of 100 patients):

Heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, indigestion, constipation, and minor gastrointestinal bleeding, which may exceptionally lead to anemia.

Uncommon (occur in 1 to 10 out of 1,000 patients):

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 medical advice sought immediately,
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 mucositis, tarry stools, bloody vomiting.

Rare (occur in 1 to 10 out of 10,000 patients):

Tinnitus,
Kidney tissue damage (papillary necrosis) and increased blood uric acid levels.

Very rare (occur in less than 1 out of 10,000 patients):

Severe, generalized hypersensitivity reactions. These may manifest as, for example, facial swelling, tongue swelling, internal laryngeal swelling with impaired airway patency, respiratory failure, rapid heartbeat, drop in blood pressure, up to life-threatening shock. If any of these symptoms occur, which may happen even after the first dose, immediate medical assistance is required,
Bullous reactions, including erythema multiforme, Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction), toxic epidermal necrolysis, and exfoliative dermatitis. The highest risk of these severe reactions occurs at the beginning of therapy, in most cases within the first month of treatment,
Blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms may include fever, sore throat, oral ulcers, flu-like symptoms, marked weakness, nosebleeds, and subcutaneous hemorrhages. During long-term treatment, regular monitoring of blood morphology parameters is recommended,
Development of edema, particularly with hypertension or renal failure, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure. For this reason, kidney function should be regularly monitored during long-term treatment,
Liver function disorders, liver damage (especially with long-term use), liver failure, acute hepatitis. Therefore, liver function should be regularly monitored during prolonged treatment,
Palpitations, heart failure, myocardial infarction,
Hypertension,
Esophagitis, pancreatitis, formation 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. During ibuprofen use, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or disturbances in consciousness have been observed. Patients with autoimmune diseases (SLE, mixed connective tissue disease) appear to be particularly susceptible,
In exceptional cases, during varicella virus infection, severe skin infections and soft tissue complications may occur.

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

Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.
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, predominantly located in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, Ibum Supermax should be discontinued immediately and medical help sought without delay. See also section 2.
Skin becomes photosensitive.

Reporting of adverse reactions
If any adverse symptoms 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store the medicine I S

Store below 25°C.
Keep in the original packaging to protect from moisture.
Keep the medicine out of sight and reach of children.
Do not use the medicine I S after the expiry date stated on the packaging.
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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What I S contains

The active substance is ibuprofen. Each soft capsule contains 600 mg of ibuprofen.
The other ingredients (excipients) are: macrogol 400, potassium hydroxide 50%, capsule shell: gelatin, partially dehydrated liquid sorbitol, quinoline yellow (E 104), patent blue (E 131).

What I S looks like and contents of the pack
I S is in the form of elongated, green, transparent soft capsules with a smooth, glossy surface, containing liquid ibuprofen.
1, 10 or 20 soft capsules in PVC/PVDC/Aluminium blisters, in a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Product information
tel.: (22) 742 00 22
e-mail: [email protected]

Ibum supermax