Ibum Supermax

Leaflet attached to the packaging: patient information

IBUM SUPERMAX

600 mg, soft capsules

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, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is IBUM SUPERMAX and what is it used for
• 2. Important information before taking IBUM SUPERMAX
• 3. How to take IBUM SUPERMAX
• 4. Possible side effects
• 5. How to store IBUM SUPERMAX
• 6. Contents of the packaging and other information

1. What is IBUM SUPERMAX and what is it used for

IBUM SUPERMAX contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory, and antipyretic properties. This medicine is indicated for short-term use in adults for acute, moderate pain of various origins:

• headaches (including migraines),
• toothaches,
• muscle and bone pain (including back pain),
• traumatic and post-operative pain, including dental surgery,
• neuralgia,
• painful menstruation.

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

2. Important information before taking IBUM SUPERMAX

When not to take IBUM SUPERMAX

• if the patient is hypersensitive to the active substance, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
• in patients who have experienced any symptoms of allergy after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) in the past, such as rhinitis, urticaria, or bronchial asthma,
• in patients who have ever had perforation (hole) or bleeding from the gastrointestinal tract associated with previous NSAID treatment,
• if there is active or recurrent peptic ulcer or gastrointestinal bleeding (previous severe bleeding, two or more independent episodes of confirmed ulceration or bleeding),
• if there is severe liver or kidney failure,
• if there is severe heart failure or coronary artery disease,
• in patients with bleeding disorders (tendency to bleed),
• in the last three months of pregnancy,
• if there is cerebral or other active bleeding,
• if the patient is significantly dehydrated (due to vomiting, diarrhea, or insufficient fluid intake),
• under the age of 18.

Warnings and precautions

IBUM SUPERMAX should be used with caution in adults with concomitant chronic diseases, after consulting a doctor. Before starting IBUM SUPERMAX, the patient should discuss it with their doctor, pharmacist, or nurse if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has 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 ischemic attack - TIA),
• the patient has high blood pressure, diabetes, high cholesterol levels, or has a family history of heart disease or stroke, or smokes,
• the patient has autoimmune diseases (systemic lupus erythematosus, connective tissue diseases), due to the increased risk of developing symptoms of aseptic meningitis,
• the patient is taking other painkillers from the NSAID group or acetylsalicylic acid in a daily dose above 75 mg,
• the patient has been diagnosed with congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria),
• the patient has gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• the patient has kidney or liver function disorders,
• the patient has fluid retention and edema associated with NSAID use,
• there is dehydration (especially in children and adolescents) due to the increased risk of kidney failure,
• the patient has a history of asthma or has experienced allergic reactions in the past (bronchial spasm may occur after taking the medicine),
• the patient has recently undergone major surgery,
• the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, or corticosteroids), or has bleeding 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 entitled "Infections".

During ibuprofen treatment, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck edema (angioedema), and chest pain. If any of these symptoms are noticed, the patient should immediately stop taking IBUM SUPERMAX and contact their doctor or emergency medical services. The patient should avoid taking ibuprofen with other nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors. Patients with a history of gastrointestinal diseases, especially the elderly, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, especially during the initial treatment period. The patient should exercise caution and consult their doctor or pharmacist before taking the medicine if they have high blood pressure and (or) heart failure with fluid retention, high blood pressure, and edema, which are associated with NSAID use in the past. Taking anti-inflammatory and analgesic medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The patient should not exceed the recommended dose and duration of treatment. Ibuprofen may cause sodium, potassium, and fluid retention in patients who have not previously had kidney disease. This can lead to edema or even heart failure or high blood pressure in patients with a predisposition to these disorders. Long-term use of ibuprofen, especially in combination with other analgesics, may cause permanent kidney damage and increase the risk of kidney failure. Patients at highest risk of such reactions are those with kidney function disorders, heart failure, liver function disorders, taking diuretics and antihypertensive drugs (ACE inhibitors), and the elderly. Patients who discontinue NSAID treatment generally return to their pre-treatment state. During long-term treatment with ibuprofen, periodic monitoring of liver and kidney function, as well as blood cell count, is necessary, especially in high-risk patients. During long-term treatment with high doses of analgesics, headaches may occur, which should not be treated with increased doses of analgesics. Skin reactions have been reported with IBUM SUPERMAX. If the patient experiences any skin rash, mucosal lesions, blisters, or other symptoms of hypersensitivity, they should stop taking IBUM SUPERMAX and seek immediate medical attention, as these may be the first symptoms of a severe skin reaction. See section 4. Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP), have occurred with ibuprofen use. If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should immediately stop taking IBUM SUPERMAX and seek medical attention. Infections IBUM SUPERMAX may mask the symptoms of infection, such as fever and pain. Therefore, IBUM SUPERMAX may delay the use of appropriate infection treatment, potentially leading to 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 infection symptoms persist or worsen, they should immediately consult their doctor. Ibuprofen may mask the signs or symptoms of infection (fever, pain, and swelling). During chickenpox, the patient should avoid taking IBUM SUPERMAX. The patient should avoid consuming alcohol during treatment, as it may increase the risk of adverse effects, especially those related to the gastrointestinal tract and nervous system. Taking the medicine in the smallest effective dose for the shortest necessary period to relieve symptoms reduces the risk of adverse effects.

IBUM SUPERMAX 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. IBUM SUPERMAX may affect the action of other medicines or other medicines may affect the action of IBUM SUPERMAX. For example:

• other nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, such as celecoxib or etoricoxib,
• diuretics and potassium-sparing drugs,
• antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of adverse effects in the gastrointestinal tract,
• methotrexate (a medicine used to treat cancer or rheumatic diseases), as its effect may increase,
• lithium (a medicine used to treat depression), as its effect may increase,
• cardiac glycosides (such as digoxin), as ibuprofen may increase their serum concentration,
• phenytoin (an antiepileptic medicine), as ibuprofen may increase its serum concentration,
• corticosteroids (such as prednisolone or dexamethasone), as they may increase the risk of gastrointestinal ulcers or bleeding,
• tacrolimus (an immunosuppressive medicine), as the risk of toxic effects on the kidneys may increase,
• cyclosporin (an immunosuppressive medicine), as there is limited data on the increased risk of toxic effects on the kidneys,
• zydovudine (a medicine used to treat AIDS), as IBUM SUPERMAX may increase the risk of bleeding into the joints or bleeding that leads to swelling (in patients with hemophilia and a positive HIV antibody test),
• ritonavir (a medicine used to treat HIV infection): ritonavir may increase the serum concentration of NSAIDs,
• antibiotics (quinolones or aminoglycosides),
• sulfonylurea derivatives (oral hypoglycemic agents): clinical interactions may occur between these medicines and NSAIDs; blood glucose monitoring is recommended,
• probenecid and sulfinpyrazone (medicines used to treat gout): they may delay the excretion of ibuprofen,
• cholestyramine: it may delay and reduce the absorption of NSAIDs,
• voriconazole and fluconazole (antifungal medicines): they may increase the exposure to NSAIDs,
• baclofen (a muscle relaxant): toxic effects of baclofen may occur after starting ibuprofen treatment,
• aminoglycosides (a type of antibiotic): NSAIDs may decrease the excretion of aminoglycosides,
• mifepristone: NSAIDs should not be used within 8-12 days after mifepristone administration, as they may reduce its effect,
• calcium channel blockers: reduced antihypertensive effect and increased risk of gastrointestinal bleeding,

and increased risk of gastrointestinal bleeding,

• desipramine: increased toxicity of desipramine, typical of tricyclic antidepressants,
• levofloxacin and ofloxacin: increased risk of serious central nervous system effects,
• thienopyridine derivatives: increased risk of bleeding due to additive anti-aggregatory and anticoagulant effects,
• bisphosphonates: increased risk of adverse effects on the gastrointestinal tract,
• anticoagulant medicines (e.g., acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Taking ibuprofen with herbal products containing Ginkgo biloba or Filipendula ulmaria may increase the risk of bleeding due to anti-aggregatory effects. Concurrent use of ibuprofen and products containing Ephedra sinica may increase the risk of gastrointestinal mucosa damage. Other medicines may also be affected by or have an effect on IBUM SUPERMAX. Therefore, before taking IBUM SUPERMAX with other medicines, the patient should always consult their doctor or pharmacist.

Taking IBUM SUPERMAX with food, drink, and alcohol

Food reduces the absorption of ibuprofen from the gastrointestinal tract. When taking ibuprofen in high doses and consuming alcohol at the same time, symptoms such as fatigue and headaches may occur.

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. Pregnancy Do not take IBUM SUPERMAX 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 increase the risk of bleeding in the patient and their child and cause delayed or prolonged labor. During the first six months of pregnancy, the medicine should not be used unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose should be used for the shortest possible time. From the 20th week of pregnancy, IBUM SUPERMAX may cause kidney function disorders in the unborn child if taken for more than a few days (which may lead to reduced amniotic fluid around the baby or narrowing of the arterial duct in the baby's heart). If treatment is necessary for a longer period, the doctor may recommend additional monitoring. Breastfeeding Ibuprofen passes into breast milk in small amounts. With short-term use of ibuprofen in pain treatment doses, harmful effects on breastfed infants seem unlikely. However, if long-term use of ibuprofen is recommended, the patient should consider stopping breastfeeding. Fertility Ibuprofen may make it more difficult to become pregnant. If the patient plans to become pregnant or is having trouble becoming pregnant, they should inform their doctor.

Driving and using machines

Short-term use of IBUM SUPERMAX, as recommended, has no significant effect on the ability to drive or operate machinery. If the patient experiences dizziness, fatigue, drowsiness, or other adverse effects on the nervous system, they should not drive or operate machinery.

IBUM SUPERMAX contains sorbitol and potassium

The medicine contains 150 mg of liquid sorbitol, partially dehydrated, in each capsule. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine. The medicine contains 54 mg of potassium per dose, which should be taken into account in patients with reduced kidney function and those controlling their potassium intake.

3. How to take IBUM SUPERMAX

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 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) can be repeated, with an interval of 6-8 hours. The maximum daily dose, without consulting a doctor, should not exceed 1200 mg (2 capsules). IBUM SUPERMAX should only be used if the patient does not feel improvement after taking ibuprofen in a dose of 400 mg (maximum 1200 mg of ibuprofen per day). In such cases, a dose of 600 mg of ibuprofen can be used, taking into account the 6-8 hour interval from the 400 mg dose. The patient should use the smallest effective dose for the shortest period necessary to relieve symptoms. This reduces the risk of adverse effects. If the infection symptoms (such as fever and pain) persist or worsen, the patient should immediately consult their doctor (see section 2). If it is necessary to use the medicine for more than 3 days or if the symptoms worsen, the patient should consult their doctor. Elderly patients The medicine should not be used without consulting a doctor. Nonsteroidal anti-inflammatory drugs (NSAIDs) should be used with caution, especially in elderly patients, who are more prone to adverse effects and at risk of potentially life-threatening gastrointestinal bleeding, ulcers, and perforation. Kidney or liver function disorders The medicine should not be used without consulting a doctor. There is no need to modify the dose in patients with mild to moderate kidney or liver function disorders. However, in these patients, the smallest effective dose should be used for the shortest possible time necessary to control symptoms.

Overdose of IBUM SUPERMAX

If the patient has taken more than the recommended dose of IBUM SUPERMAX or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to assess potential health risks and seek advice on what to do. Overdose cases are rare. Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headaches, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and breathing difficulties may occur. In children, a single dose above 400 mg/kg body weight may cause overdose symptoms. In adults, the dose that can cause such symptoms has not been precisely determined. In children, myoclonic seizures (repeated muscle contractions) may occur. During severe poisonings, metabolic acidosis (a disorder of acid-base balance) may occur, and the prothrombin time (a measure related to blood clotting) may be increased. Acute kidney failure, liver damage, hypotension, respiratory failure, or cyanosis may occur. In patients with asthma, worsening of asthma symptoms may occur. Treatment There is no specific antidote. Symptomatic and supportive treatment is used. Activated charcoal may be considered for oral administration within 1 hour of overdose. If overdose symptoms occur, the patient should immediately stop taking the medicine and contact their doctor or emergency medical services.

Missed dose of IBUM SUPERMAX

The patient should not take a double dose to make up for a missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, IBUM SUPERMAX can cause side effects, although not everybody gets them. The following list of side effects includes all side effects observed during ibuprofen treatment, including those occurring during long-term treatment with high doses used in rheumatic diseases. Regarding the following adverse reactions to the medicine, it should be remembered that they are largely dose-dependent and their occurrence is individually variable.

Patient taking IBUM SUPERMAX should stop taking the medicine and immediately consult their doctor if they experience signs or symptoms of ulcers, gastrointestinal damage, or bleeding (black stools, bloody vomiting), severe abdominal pain, blurred vision, or other eye symptoms, skin rash, or other hypersensitivity reactions, weight gain, or edema.

If the patient experiences any of the following symptoms, they should immediately stop taking ibuprofen and seek medical attention:

red, scaly rash with bumps under the skin and blisters, often with fever, or other symptoms of hypersensitivity, such as severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), or acute generalized exanthematous pustulosis (AGEP).

Very common side effects (occurring in 1 to 10 patients in 100):

• heartburn, stomach pain, nausea, vomiting, bloating with gas, diarrhea, indigestion, constipation, and minor gastrointestinal bleeding, which may lead to anemia in exceptional cases.

Less common side effects (occurring in 1 to 10 patients in 1000):

• allergic reactions with skin rash and itching, as well as asthma attacks (which may occur in combination with a drop in blood pressure); in such cases, the patient should stop taking the medicine and immediately consult their doctor,
• headache, drowsiness, dizziness, insomnia, agitation, irritability, or fatigue,
• vision disorders,
• gastrointestinal ulcers, potentially with bleeding and perforation, oral mucosa ulcers, exacerbation of ulcerative colitis, Crohn's disease, gastritis, black stools, bloody vomiting.

Rare side effects (occurring in 1 to 10 patients in 10,000):

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

Very rare side effects (occurring in less than 1 patient in 10,000):

• severe, generalized hypersensitivity reactions, which may occur as, for example, facial edema, tongue edema, internal edema of the larynx with impaired airway patency, respiratory failure, tachycardia, blood pressure drop, up to life-threatening shock. If any of these symptoms occur, immediate medical attention is necessary,
• blistering reactions, including erythema multiforme, Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction), and toxic epidermal necrolysis, as well as exfoliative dermatitis. The greatest risk of these severe reactions occurs at the beginning of treatment, in most cases within the first month of taking the medicine.
• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms may be fever, sore throat, oral ulcers, flu-like symptoms, significant weakness, nosebleeds, and subcutaneous bleeding. During long-term treatment, regular monitoring of blood morphology is necessary,
• fluid retention, especially with high blood pressure and kidney failure, nephrotic syndrome, interstitial nephritis, which may be associated with acute kidney failure. Therefore, regular monitoring of kidney function is necessary during long-term treatment,
• liver function disorders, liver damage (especially with long-term use), liver failure, acute hepatitis. Therefore, regular monitoring of liver function is necessary during long-term treatment,
• palpitations, heart failure, myocardial infarction,
• high blood pressure,
• esophageal inflammation, pancreatitis, formation of diaphragm-like intestinal strictures,
• psychotic reactions, depression,
• infections associated with conditions that are the reason for using nonsteroidal anti-inflammatory drugs (e.g., necrotizing fasciitis). If infection symptoms worsen or persist during ibuprofen treatment, the patient should immediately consult their doctor. The doctor will assess whether there are indications for using anti-infective treatment (antibiotic therapy). In exceptional cases, during chickenpox, severe skin and soft tissue infections may occur.

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

• Chest pain, which may be a symptom of a potentially severe allergic reaction known as Kounis syndrome.
• Severe skin reactions known as DRESS syndrome. Symptoms of DRESS syndrome include skin rash, fever, lymph node enlargement, and increased eosinophil count (a type of white blood cell).
• Red, scaly rash with bumps under the skin and blisters, usually on the skin folds, 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 IBUM SUPERMAX and seek immediate medical attention. See also section 2.
• The skin becomes sensitive to light.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store IBUM SUPERMAX

Store in a temperature below 25°C. Store in the original packaging to protect from moisture. The medicine should be stored out of sight and reach of children. Do not use IBUM SUPERMAX after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines, as this will help protect the environment.

6. Contents of the packaging and other information

What IBUM SUPERMAX contains

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

What IBUM SUPERMAX looks like and contents of the pack

IBUM SUPERMAX is a green, transparent, soft capsule, with a smooth, shiny surface, containing liquid ibuprofen. 1, 10, or 20 soft capsules in PVC/PVDC/Aluminum blisters, in a cardboard box.

Marketing authorization holder and manufacturer

PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK S.A. 51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

tel.: (22) 742 00 22 e-mail: [email protected]

Date of last revision of the leaflet: