Ibuprom Ultramax

Leaflet accompanying the packaging: patient information

IBUPROM ULTRAMAX, 600 mg, coated tablets

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• 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 any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

IBUPROM ULTRAMAX belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs) with analgesic, anti-inflammatory, and antipyretic effects. 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.

2. Important information before taking IBUPROM ULTRAMAX

When not to take IBUPROM ULTRAMAX:

• if the patient is hypersensitive to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever had dyspnea, asthma, hay fever, angioedema, or urticaria after taking acetylsalicylic acid or other similar painkillers (NSAIDs),
• if the patient has severe heart failure,
• if the patient has severe liver or kidney disorders,
• if the patient has unexplained blood disorders,
• if the patient has had cerebral or other active bleeding,
• if the patient has had bleeding or perforation of the stomach or intestines after taking NSAIDs,
• if the patient has, currently or in the past, recurrent stomach or duodenal ulcers or gastrointestinal bleeding (at least two confirmed cases of ulcers or bleeding),
• if the patient has severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake),
• if the patient is in the third trimester of pregnancy,
• under the age of 18.

Warnings and precautions

IBUPROM ULTRAMAX should be used in adults with concomitant chronic diseases only after consulting a doctor. Taking the medicine in the smallest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of side effects. The use of anti-inflammatory and analgesic drugs, such as ibuprofen, may be associated with a slightly increased risk of myocardial infarction or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment. During ibuprofen treatment, allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), and chest pain. If any of these symptoms are noticed, the patient should stop taking IBUPROM ULTRAMAX immediately and contact a doctor or emergency medical services immediately. Before starting IBUPROM ULTRAMAX, the patient should discuss it with their doctor or pharmacist if:

• the patient has had heart disease, including heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has peripheral arterial disease (circulatory disorders in the legs or feet 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, has high cholesterol levels, 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 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 been diagnosed with gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• the patient has been diagnosed with fluid retention and edema associated with the use of NSAIDs,
• there is dehydration (especially in children and adolescents) due to the increased risk of kidney failure,
• the patient has been diagnosed with liver or kidney disorders,
• the patient has been diagnosed with active or past asthma or a history of allergic reactions (may cause bronchospasm),
• if the patient has undergone major surgery,
• in the case of patients taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, or corticosteroids), or if the patient has bleeding disorders (ibuprofen may temporarily inhibit platelet aggregation and prolong bleeding time),
• during long-term treatment with ibuprofen, especially in the elderly (see section 3),
• if the patient has an infection - see below, section entitled "Infections".

It is recommended to avoid taking IBUPROM ULTRAMAX simultaneously with other nonsteroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (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. Particular caution and consultation with a doctor or pharmacist are recommended before taking the medicine in patients with hypertension and/or heart failure with fluid retention, hypertension, and edema, which are associated with the use of NSAIDs in the past. 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 hypertension in patients with a predisposition to these disorders. Long-term use of ibuprofen, especially in combination with other painkillers, can cause permanent kidney damage and increase the risk of kidney failure. Patients at greatest risk of such reactions are those with kidney disorders, heart failure, liver 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 ibuprofen treatment, 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 painkillers, headaches may occur, which should not be treated with increased doses of painkillers. Skin reactions Severe skin reactions have occurred with ibuprofen, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should stop taking IBUPROM ULTRAMAX immediately and seek medical attention. Infections IBUPROM ULTRAMAX may mask the symptoms of infection, such as fever and pain. Therefore, IBUPROM ULTRAMAX 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 symptoms of the infection persist or worsen, they should consult their doctor immediately. This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is transient and disappears after stopping the medicine. Do not take IBUPROM ULTRAMAX during chickenpox. It is recommended to avoid consuming alcohol during treatment with this medicine, as it may increase the risk of side effects, especially those related to the gastrointestinal tract and nervous system.

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

• anticoagulants (e.g., acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, or angiotensin II receptor antagonists, such as losartan),
• other NSAIDs (including COX-2 inhibitors, such as celecoxib or etoricoxib),
• diuretics and potassium-sparing diuretics,
• antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal side effects,
• methotrexate (a medicine used to treat cancer or rheumatic diseases), as its effect may be increased,
• lithium (a medicine used to treat depression), as its effect may be increased,
• cardiac glycosides (e.g., 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 and bleeding,
• tacrolimus (an immunosuppressive medicine), as the risk of toxic effects on the kidneys is increased,
• cyclosporin (an immunosuppressive medicine), as there is limited data on increased risk of toxic effects on the kidneys,
• zidovudine (a medicine used to treat AIDS), as taking IBUPROM ULTRAMAX may increase the risk of bleeding into the joints or bleeding that leads to swelling (in patients with hemophilia with a positive HIV antibody test),
• ritonavir (a medicine used to treat HIV infection): ritonavir may increase the concentration of NSAIDs in the blood,
• antibiotics (quinolones or aminoglycosides),
• sulfonylurea derivatives (oral hypoglycemic agents): there may be clinical interactions 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,
• 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 gastrointestinal side effects,
• anticoagulant medicines (e.g., aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, or angiotensin II receptor antagonists, such as losartan).

Taking ibuprofen with herbal preparations such as Ginkgo biloba and 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 mucosal damage. Other medicines may also be affected or have an effect on the action of IBUPROM ULTRAMAX. Therefore, before taking IBUPROM ULTRAMAX with other medicines, the patient should always consult their doctor or pharmacist.

Taking IBUPROM ULTRAMAX 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 If the patient becomes pregnant while taking IBUPROM ULTRAMAX, they should inform their doctor. Do not take this medicine during the last 3 months of pregnancy, as ibuprofen may have a very serious, even fatal, effect on the fetus's heart and kidneys, even after a single dose. Do not take IBUPROM ULTRAMAX if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. IBUPROM ULTRAMAX may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the mother and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, IBUPROM ULTRAMAX should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time. From the 20th week of pregnancy, IBUPROM ULTRAMAX may cause kidney function disorders in the unborn child if taken for more than a few days. This may lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the fetus's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring. Breastfeeding Ibuprofen passes into breast milk in small amounts. During short-term use of ibuprofen in pain-relieving doses, harmful effects on breastfed infants seem unlikely. However, if long-term use of ibuprofen is recommended, breastfeeding should be discontinued. 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 IBUPROM ULTRAMAX in accordance with the recommended dosage has no effect or a negligible effect on the ability to drive and use machines. If symptoms such as blurred vision, fatigue, dizziness, or other nervous system side effects occur, driving and operating machinery are not recommended.

IBUPROM ULTRAMAX contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

IBUPROM ULTRAMAX contains propylene glycol

The medicine contains 0.97 mg of propylene glycol in each coated tablet.

IBUPROM ULTRAMAX contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take IBUPROM ULTRAMAX

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The recommended dose is: 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) can be repeated, with an interval of 6-8 hours. The maximum daily dose, without consulting a doctor, should not exceed 1200 mg (2 tablets). IBUPROM ULTRAMAX 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 administration of the 400 mg dose. The patient should use the smallest effective dose for the shortest period necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2). Side effects can be minimized by using the smallest effective doses for the shortest possible time necessary to control symptoms. If it is necessary to use the medicine for more than 3 days or if the symptoms worsen, the patient should consult their doctor. Special patient groups Elderly: The medicine should be used only after consulting a doctor. Nonsteroidal anti-inflammatory drugs (NSAIDs) should be used with caution, especially in elderly patients, who are more prone to side effects and at risk of potentially fatal gastrointestinal bleeding, ulcers, and perforations. Renal or hepatic impairment: The medicine should be used only after consulting a doctor. There is no need to modify the dose in patients with mild to moderate renal or hepatic impairment. However, in these patients, it is recommended to use the smallest effective dose for the shortest possible time necessary to control symptoms.

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. The tablets should be swallowed whole with a glass of water. It is recommended that patients with sensitive stomachs take IBUPROM ULTRAMAX with food.

Overdose of IBUPROM ULTRAMAX

If the patient has taken more than the recommended dose of IBUPROM ULTRAMAX or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to assess the potential risk to their health and for advice on what to do. Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see section 4 below), diarrhea, headache, ringing in the ears, confusion, and eye movement disorders. It may also cause agitation, drowsiness, disorientation, or coma. Rarely, patients may experience seizures. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties may occur. Additionally, the prothrombin time/INR may be prolonged, probably due to the disruption of circulating clotting factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. Additionally, low blood pressure and breathing difficulties or cyanosis may occur. In children, myoclonic seizures (repeated muscle contractions) may occur. In children, a single dose of over 400 mg/kg body weight may cause overdose symptoms. In adults, the dose that can cause such symptoms has not been precisely determined. Treatment There is no specific antidote. Symptomatic and supportive treatment is used. Oral administration of activated charcoal within 1 hour of overdose may be considered. If overdose symptoms occur, the patient should stop taking the medicine immediately and contact their doctor or emergency medical services immediately.

Missed dose of IBUPROM ULTRAMAX

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 or pharmacist.

4. Possible side effects

Like all medicines, IBUPROM ULTRAMAX can cause side effects, although not everybody gets them. The patient should stop taking ibuprofen and seek medical attention immediately if they experience any of the following symptoms: red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, 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 swollen lymph nodes (DRESS syndrome). red, peeling rash with bumps under the skin and blisters, accompanied by fever (acute generalized exanthematous pustulosis). The following list of side effects includes all side effects observed during ibuprofen treatment, including those that occur during long-term treatment with high doses, used in patients with 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. Patients taking IBUPROM ULTRAMAX should stop the medicine and consult their doctor immediately if they experience signs or symptoms of ulcers, mucosal damage, or gastrointestinal bleeding (black stools, bloody vomiting), severe abdominal pain, blurred vision, or other eye symptoms, skin rash, or other allergic reactions, weight gain, or edema. The most common adverse reactions observed are related to the gastrointestinal tract. Ulcers, perforation, or gastrointestinal bleeding may occur, sometimes with a fatal outcome (especially in the elderly). These do not necessarily have to be preceded by warning symptoms or may occur in patients who have had such warning symptoms. The risk of gastrointestinal bleeding is particularly dependent on the dose range and duration of ibuprofen use. Taking ibuprofen, especially long-term and in high doses (2400 mg per day), may be associated with a slight increase in the risk of arterial thrombosis (e.g., myocardial infarction or stroke). Frequent (occurring in no more than 1 in 10 people):

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

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

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

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. 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 representative of the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store IBUPROM ULTRAMAX

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton after "Expiry date". The expiry date refers to the last day of the month. Store at a temperature below 30°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What IBUPROM ULTRAMAX contains

The active substance of the medicine is ibuprofen. Each coated tablet contains 600 mg of ibuprofen. The other ingredients are: tablet core: hypromellose 2910 (6mPas), sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, maize starch, colloidal anhydrous silica, and magnesium stearate; tablet coating: hypromellose 2910 (6mPas), titanium dioxide (E 171), talc, and propylene glycol.

What IBUPROM ULTRAMAX looks like and contents of the pack

Coated tablet. White, oblong, biconvex coated tablets. IBUPROM ULTRAMAX is available in blisters (Aluminum/PVC/PVDC) of 10 coated tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

US Pharmacia Sp. z o.o., ul. Ziębicka 40, 50-507 Wrocław

Manufacturer

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 more detailed information on this medicine, the patient should contact their local representative of the marketing authorization holder: USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw, tel.: +48 (22) 543 60 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland IBUPROM ULTRAMAX

Date of last revision of the leaflet: