Ibumax Forte 600 mg

Leaflet accompanying the packaging: patient information

Ibumax Forte 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.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. 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 Ibumax Forte 600 mg and what is it used for
• 2. Important information before taking Ibumax Forte 600 mg
• 3. How to take Ibumax Forte 600 mg
• 4. Possible side effects
• 5. How to store Ibumax Forte 600 mg
• 6. Contents of the packaging and other information

1. What is Ibumax Forte 600 mg and what is it used for

Ibumax Forte 600 mg contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic, antipyretic, and anti-inflammatory effects. The indications for use are:

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

2. Important information before taking Ibumax Forte 600 mg

When not to take Ibumax Forte 600 mg:

• if the patient is allergic 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 had any symptoms of allergy after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) in the past, such as runny nose, hives, or bronchial asthma,
• in patients who have had gastrointestinal perforation or bleeding, related to previous NSAID treatment,
• if there is active or recurrent peptic ulcer disease 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

Ibumax Forte 600 mg should be used in adults with concomitant chronic diseases only after consulting a doctor. Before starting Ibumax Forte 600 mg, the patient should discuss it with their doctor or pharmacist:

• 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 narrowing or blockage of arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA),
• if the patient has high blood pressure, diabetes, high cholesterol levels, or a family history of heart disease or stroke, or if the patient smokes.
• if the patient has systemic lupus erythematosus and mixed connective tissue disease,
• if the patient has had symptoms of allergic reactions after taking acetylsalicylic acid,
• if the patient has been diagnosed with congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria),
• if the patient has gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• if the patient has high blood pressure and/or heart function disorders,
• if the patient has kidney function disorders,
• if the patient has liver function disorders,
• if the patient has fluid retention and edema associated with taking NSAIDs,
• if the patient is taking other painkillers from the NSAID group or acetylsalicylic acid in a daily dose above 75 mg,
• if the patient has had active or past asthma or symptoms of allergic reactions; bronchospasm may occur after taking the medicine,
• if the patient has taken other medicines (especially anticoagulants, diuretics, cardiac glycosides, or corticosteroids),
• if there is dehydration - due to increased risk of kidney failure,
• immediately after major surgical procedures,
• in 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 the use of the medicine in the elderly (see section 3).

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and is not necessarily preceded by warning signs or may occur in patients who have had such warning signs. In case of gastrointestinal bleeding or ulceration, ibuprofen should be discontinued immediately. Patients with a history of gastrointestinal diseases, especially the elderly, should contact their doctor if they experience any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period. During ibuprofen treatment, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck edema, and chest pain. If any of these symptoms are noticed, the medicine Ibumax Forte 600 mg should be discontinued immediately and medical help should be sought. Concomitant use of painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy). Patients with the 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 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 that should not be treated with increased doses of painkillers. Ibuprofen may mask signs or symptoms of infection (fever, pain, and swelling). During chickenpox, this medicine should be avoided. Alcohol consumption should be avoided during treatment with this medicine, as it may exacerbate side effects, especially those related to the gastrointestinal tract and nervous system. In the elderly, there is an increased risk of side effects associated with ibuprofen compared to younger patients. The frequency and severity of side effects can be reduced by using the smallest therapeutic dose for the shortest possible period. If the above warnings apply to past situations, the patient should consult their doctor.

Children

Do not usein children and adolescents under 18 years of age.

Ibumax Forte 600 mg 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. Ibumax Forte 600 mg should not be taken if the patient is taking other NSAIDs (including cyclooxygenase-2 inhibitors, such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (in analgesic doses). Ibumax Forte 600 mg may affect the action of other medicines or other medicines may affect the action of Ibumax Forte 600 mg, for example:

• diuretics and potassium-sparing drugs,
• 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 methotrexate levels may increase,
• lithium (a medicine used to treat depression), as lithium levels may increase,
• cardiac glycosides (e.g., digoxin), as ibuprofen may increase their serum levels,
• phenytoin (an antiepileptic drug), as ibuprofen may increase its serum levels,
• corticosteroids (such as prednisolone or dexamethasone), as they may increase the risk of gastrointestinal ulcers or bleeding,
• tacrolimus (an immunosuppressive drug), as the risk of toxic effects on the kidneys is increased,
• cyclosporine (an immunosuppressive drug), as there is limited data on increased risk of toxic effects on the kidneys,
• zidovudine (a medicine used to treat AIDS), as taking the medicine 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 levels of NSAIDs in the blood,
• antibiotics (quinolones or aminoglycosides),
• sulfonylurea derivatives (oral hypoglycemic agents): clinical interactions may occur between these medicines and NSAIDs; blood glucose levels should be monitored,
• 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 agents): 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 the effect of mifepristone,
• calcium channel blockers: decreased antihypertensive efficacy 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 (i.e., blood thinners or medicines that prevent blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, 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. Concomitant 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 Ibumax Forte 600 mg treatment. Therefore, before taking Ibumax Forte 600 mg with other medicines, the patient should always consult their doctor or pharmacist.

Taking Ibumax Forte 600 mg 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. PregnancyIbumax Forte 600 mg should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibumax Forte 600 mg 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, Ibumax Forte 600 mg should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time. If Ibumax Forte 600 mg is taken by a woman from the 20th week of pregnancy for more than a few days, it may cause kidney problems in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If the patient requires treatment for a longer period, additional fetal monitoring should be recommended. BreastfeedingIbuprofen may pass into breast milk in small amounts. So far, there have been no reports of harmful effects of ibuprofen on infants, so breastfeeding does not need to be discontinued when taking ibuprofen for a short period and in small doses. However, if long-term ibuprofen treatment is necessary, breastfeeding should be considered for discontinuation. FertilityIbuprofen may make it more difficult to become pregnant. If the patient is planning to become pregnant or is having trouble becoming pregnant, they should inform their doctor.

Driving and using machines

Short-term use of Ibumax Forte 600 mg, in accordance with the recommended dosage, has no effect or a negligible effect on the ability to drive vehicles and operate machinery. If the patient experiences blurred vision, fatigue, dizziness, or other nervous system side effects, they should not drive vehicles or operate machinery.

Ibumax Forte 600 mg 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 Ibumax Forte 600 mg

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 intended for oral use only in adults. For short-term use only. The patient should take the smallest effective dose for the shortest possible period necessary to control the 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). If it is necessary to take the medicine for more than 3 days or if the patient's condition worsens, they should contact their doctor. Adults:The recommended dose is 600 mg of ibuprofen (1 tablet) at a time. 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). Ibumax Forte 600 mg should be taken only 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 a case, a dose of 600 mg of ibuprofen can be taken, taking into account the 6-8 hour interval from the administration of the 400 mg dose. Elderly:Not recommended without consulting a doctor. Nonsteroidal anti-inflammatory drugs (NSAIDs) should be used with caution, especially in the elderly, who are more prone to side effects and at risk of potentially fatal gastrointestinal bleeding, ulcers, and perforation. Kidney or liver failure:Not recommended without consulting a doctor. There is no need to modify the dose in patients with mild to moderate kidney or liver function impairment. However, in these patients, the smallest effective dose should be used for the shortest possible time necessary to control the symptoms.

Taking a higher dose of Ibumax Forte 600 mg than recommended

Overdose cases are rare. In severe poisonings, metabolic acidosis may occur, and the prothrombin time (INR) may be increased. Acute kidney failure or liver damage may occur. In patients with asthma, asthma symptoms may worsen. If the patient has taken a higher dose of Ibumax Forte 600 mg than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to assess the potential risk to their health and receive advice on what to do. Symptoms of overdose may include nausea, abdominal pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, tinnitus (ringing in the ears), and disorientation. They may also include agitation, drowsiness, disorientation, or coma. Seizures have been reported in patients. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, as well as blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties have been reported. Additionally, the prothrombin time (INR) may be prolonged, possibly due to interference with the action of blood clotting factors. Acute kidney failure and liver damage may occur. In patients with asthma, asthma symptoms may worsen. Additionally, low blood pressure and breathing difficulties may occur. There is no specific antidote. Symptomatic and supportive treatment is used, which involves removing the medicine from the body. The doctor should monitor vital signs and consider oral administration of activated charcoal within 1 hour of overdose. In case of overdose symptoms, the patient should stop taking the medicine immediately and contact their doctor or hospital emergency department.

Missing a dose of Ibumax Forte 600 mg

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, Ibumax Forte 600 mg can cause side effects, although not everybody gets them. Patients taking this medicine should stop taking it and consult their doctor immediately 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 allergic reactions, weight gain, or edema. If the patient experiences any of the following symptoms, they should stop taking ibuprofen and seek medical help:

• Red, scaly, ring-shaped 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 reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) - very rare.
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome) - frequency not known.
• Red, scaly, rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) - frequency not known.

The most commonly observed side effects 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 signs or may occur in patients who have had such warning signs. The risk of gastrointestinal bleeding is particularly dependent on the dose range and duration of ibuprofen treatment. 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., heart attack or stroke). Common (occurring in 1 to 10 out of 100 treated patients):

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

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

• allergic reactions with skin rash and itching, as well as shortness of breath (possible occurrence in combination with decreased blood pressure); in such cases, the medicine should be discontinued and the doctor should be consulted immediately,
• headache, drowsiness, dizziness, insomnia, agitation, irritability, or fatigue,
• visual disturbances,
• gastrointestinal ulcers, potentially with bleeding and perforation, oral mucosa ulcers, exacerbation of ulcerative colitis, Crohn's disease, gastritis, black stools, bloody vomiting.

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

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

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

• severe, generalized allergic reactions. They may occur, for example, as facial edema, tongue edema, internal edema of the larynx with impaired airway patency, respiratory failure, increased heart rate, decreased blood pressure, up to life-threatening shock. If any of these symptoms occur, immediate medical help is necessary,
• blood system disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms may be fever, sore throat, mouth ulcers, flu-like symptoms, significant weakness, nosebleeds, and subcutaneous bleeding. During long-term treatment with the medicine, regular monitoring of blood morphology is necessary,
• fluid retention, particularly with high blood pressure or kidney failure, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute kidney failure. Therefore, regular monitoring of kidney function is recommended during long-term treatment with the medicine,
• liver function disorders, liver damage (especially after long-term use), liver failure, acute hepatitis. Therefore, regular monitoring of liver function is recommended during long-term treatment with the medicine,
• palpitations, heart failure, myocardial infarction,
• high blood pressure,
• esophageal inflammation, pancreatitis, formation of diaphragm-like narrowing of the intestine,
• psychotic reactions, depression,
• infections related to conditions that are the reason for taking nonsteroidal anti-inflammatory drugs (e.g., occurrence of necrotizing fasciitis). If symptoms of infection worsen or occur during ibuprofen treatment, the patient should immediately consult their doctor. The doctor will assess whether there are indications for antimicrobial treatment (antibiotic therapy). During ibuprofen treatment, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, and changes in consciousness have been observed. Patients with autoimmune diseases (SLE, mixed connective tissue disease) seem to be at risk,
• in rare cases, during chickenpox, severe skin and soft tissue infections may occur.

Frequency not known:

• The skin becomes sensitive to light.
• Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Reporting side effects

If side effects occur, including any possible 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 Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C PL-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 Ibumax Forte 600 mg

There are no special storage precautions. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. 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 Ibumax Forte 600 mg contains

1 coated tablet contains:active substance: ibuprofen, 600 mg. Excipients: maize starch, pregelatinized maize starch, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, stearic acid, colloidal anhydrous silica, coating

• hypromellose, macrogol 4000, polydextrose, titanium dioxide (E 171).

What Ibumax Forte 600 mg looks like and contents of the pack:

Ibumax Forte 600 mg: 10 coated tablets (HDPE container with LDPE closure) in a cardboard box. 10 coated tablets (aluminum/PVC blisters) in a cardboard box.

Marketing authorization holder and manufacturer:

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Tel: +358 3 615 600 In order to obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder: Vitabalans Sp. z.o.o. ul. Narbutta 5 m 1 02-564 Warsaw [email protected]

Date of last revision of the leaflet: