Ibum Forte

Leaflet attached to the packaging: patient information

Ibum Forte

400 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 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 a doctor.

Table of contents of the leaflet

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

1. What is Ibum Forte and what is it used for

Ibum Forte contains ibuprofen, a substance from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), with analgesic, antipyretic, and anti-inflammatory effects. Indications for use are:

• Pain of various origins of mild to moderate severity:
• headaches (including migraines)
• toothaches
• muscle, joint, and bone pain
• post-traumatic pain
• neuralgia
• pain accompanying colds and flu.
• Painful menstruation.
• Febrile conditions of various origins (including flu, colds, or other infectious diseases).

2. Important information before taking Ibum Forte

When not to take Ibum Forte:

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• in patients with active or past peptic ulcer disease of the stomach and/or duodenum, perforation (hole) or bleeding, also occurring after taking NSAIDs;
• in patients who have had symptoms of allergy in the form of rhinitis, urticaria, or bronchial asthma while taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
• in patients with severe liver failure, severe kidney failure, or severe heart failure;
• in patients taking other nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of side effects);
• in the last three months of pregnancy;
• in patients with a bleeding disorder (tendency to bleed).

Warnings and precautions

Before starting treatment with Ibum Forte, the patient should discuss it with their doctor or pharmacist.

Particular caution should be exercised when taking Ibum Forte:

• in case of symptoms of allergic reactions after taking acetylsalicylic acid;
• if the patient has been diagnosed with systemic lupus erythematosus and mixed connective tissue disease;
• if the patient has been diagnosed with gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• if the patient has been diagnosed with hypertension and/or heart dysfunction;
• if the patient has been diagnosed with kidney dysfunction;
• if the patient has been diagnosed with liver dysfunction;
• if the patient has been diagnosed with blood coagulation disorders (ibuprofen may prolong bleeding time);
• if the patient has been diagnosed with active or past bronchial asthma or symptoms of allergic reactions in the past; taking the medicine may cause bronchospasm;
• in the case of patients taking other medicines (especially anticoagulant, diuretic, cardiac, or corticosteroid medicines).

Patients who have ever had hypertension and/or heart failure should be particularly cautious and consult a doctor or pharmacist before taking the medicine, as NSAID treatment has been associated with fluid retention, hypertension, and edema.

Taking anti-inflammatory/pain-relieving medicines like ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, especially when taken in high doses. The recommended dose should not be exceeded, and the duration of treatment should be as short as possible.

Before taking Ibum Forte, the patient should discuss the treatment 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 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, has a family history of heart disease or stroke, or smokes;
• the patient has an infection - see below, section "Infections".

During ibuprofen treatment, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), and chest pain.

If any of these symptoms are noticed, the patient should stop taking Ibum Forte immediately and seek medical attention.

Concomitant, long-term use of pain-relieving medicines may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).

Infections

Ibum Forte may mask the symptoms of infection, such as fever and pain. Therefore, Ibum Forte may delay the use of appropriate infection treatment and consequently lead to an 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 a doctor immediately.

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be stopped immediately and a doctor consulted. Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period. Such patients should use the lowest effective dose of the medicine.

Caution should be exercised when taking the medicine in patients who are also taking other medicines that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulant medicines, such as warfarin or acenocoumarol, or antiplatelet agents, such as acetylsalicylic acid.

Skin reactions

Severe skin reactions have been reported with Ibum Forte. If any of the following occur: any skin rash, changes in the mucous membranes, blisters, or other symptoms of allergy, the patient should stop taking Ibum Forte and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.

Severe 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. If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should stop taking Ibum Forte immediately and seek medical attention.

The patient should consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Fertility in women

See the section "Pregnancy, breastfeeding, and fertility".

Children and adolescents

The medicine is not recommended for use in children under 12 years of age.

In dehydrated patients - adolescents aged 12-18 years, there is a risk of kidney dysfunction.

Elderly patients

In elderly patients, there is an increased risk of side effects.

To minimize the risk of side effects, the medicine should be taken for the shortest period necessary to alleviate symptoms.

Ibum Forte 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 Forte may affect the action of other medicines or other medicines may affect the action of Ibum Forte. For example:

• medicines with anticoagulant action (i.e., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Other medicines may also be affected or have an effect on Ibum Forte treatment. Therefore, before taking Ibum Forte with other medicines, the patient should always consult a doctor or pharmacist.

In particular, before taking Ibum Forte, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• acetylsalicylic acid in a low dose (75 mg), once a day,
• other nonsteroidal anti-inflammatory drugs (NSAIDs),
• antihypertensive or diuretic medicines,
• medicines that reduce blood clotting (anticoagulants, e.g., acenocoumarol or antiplatelet agents),
• corticosteroids (such as prednisolone or dexamethasone),
• methotrexate (an anticancer medicine),
• lithium (an antidepressant),
• zydovudine (an antiviral medicine).

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 a doctor or pharmacist before taking this medicine.

Pregnancy

Ibum Forte should not be taken 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 mother and child and cause prolonged or delayed labor. During the first six months of pregnancy, the medicine should not be taken unless absolutely necessary and under medical supervision. If treatment is necessary during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibum Forte may cause kidney problems in the unborn child if taken for more than a few days, which may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) 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 may pass into breast milk in small amounts. Since there are no reports of harmful effects of ibuprofen on infants, breastfeeding does not need to be discontinued when taking ibuprofen in small doses for a short period.

Fertility

This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may have a negative effect on female fertility. This effect is temporary and disappears after the end of treatment.

Driving and using machines

There is no data on the effect of Ibum Forte on the ability to drive vehicles and operate machinery, as well as on psychophysical fitness during treatment with the recommended doses and for the recommended duration.

Ibum Forte contains sorbitol, potassium, and sodium

The medicine contains 125.72 mg of sorbitol 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, fructose intolerance, they should consult a doctor before taking the medicine or giving it to a child.

The medicine contains 1.07 mmol (41.81 mg) of potassium per dose, which should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake.

Quinoline yellow (E 104) and patent blue (E 131) in the capsule shell contain sodium. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Ibum Forte

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 a doctor or pharmacist.

The medicine is for short-term oral use. The recommended dose is:

Adults and adolescents over 12 years of age:initial dose 400 mg (1 capsule), if necessary, every 4 to 6 hours. The dose should not exceed 1200 mg (3 capsules) per day in divided doses.

Elderly patients:no dose adjustment is required (see section "Warnings and precautions").

The lowest effective dose should be used for the shortest period necessary to alleviate symptoms. This minimizes the risk of side effects. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult a doctor immediately (see section 2).

The patient should consult a doctor if it is necessary to take the medicine for more than 3 days or if the symptoms worsen.

Use in children

The medicine should not be taken by children under 12 years of age.

Taking a higher dose of Ibum Forte than recommended

If the patient has taken a higher dose of Ibum Forte than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on the potential health risk and advice on what to do.

Symptoms may include nausea, stomach pain (abdominal pain), less frequently diarrhea, vomiting (which may contain blood), headaches, ringing in the ears (tinnitus), 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, breathing problems, and gastrointestinal bleeding have occurred.

Severe poisoning can cause central nervous system disorders, manifested by drowsiness, very rarely also excitement and disorientation or coma. Seizures can also occur. During severe poisonings, the following may occur: acute kidney failure or liver damage.

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

The doctor will provide symptomatic and supportive treatment. Within 1 hour of taking the medicine, activated charcoal should be administered and vital signs monitored.

Missing a dose of Ibum Forte

A double dose should not be taken to make up for a missed dose.

If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibum Forte can cause side effects, although not everybody gets them.

With NSAID treatment in high doses, edema, hypertension, and heart failure have been reported.

Taking medicines like ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, especially when taken in high doses.

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

• red, non-raised, target-like or circular patches on the torso, often with blisters in the center, peeling of the 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 fever, and swollen lymph nodes (DRESS syndrome),
• red, scaly rash with nodules under the skin and blisters, usually located in skin folds, on the torso, 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 Forte and seek medical attention immediately. See also section 2,

Other possible side effects include:

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

• headache, nausea, abdominal pain, diarrhea, urticaria, itching,

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

• diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, agitation, irritability, and fatigue,
• edema resulting from kidney and urinary disorders,

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

• tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease,
• peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding, and perforation (hole), sometimes with a fatal outcome, especially in the elderly,
• in individual cases, the following have been reported: depression, psychotic reactions, and tinnitus, aseptic meningitis,
• reduced urine output, edema, acute kidney failure, renal papillary necrosis, increased sodium levels in the blood (sodium retention),
• liver function disorders, especially during long-term use,
• blood count abnormalities (anemia, leukopenia, thrombocytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, fatigue, bleeding tendency (e.g., bruising, petechiae, purpura, nosebleeds),
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
• severe hypersensitivity reactions, such as: facial swelling, tongue and laryngeal edema, dyspnea, tachycardia, hypotension, shock, worsening of asthma, and bronchospasm,
• in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), individual cases of symptoms of aseptic meningitis have been reported during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever, disorientation.

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

• chest pain, which may be a sign of a potentially serious allergic reaction known as Kounis syndrome,
• severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell),
• red, scaly rash with nodules under the skin and blisters, usually located in skin folds, on the torso, 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 Forte and seek medical attention immediately. See also section 2,
• skin sensitivity to light.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181 C, 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 Forte

The medicine should be stored out of sight and reach of children.

Do not store above 25°C. Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the carton. 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 Ibum Forte contains

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

What Ibum Forte looks like and contents of the pack

Ibum Forte is a green, transparent, soft capsule, filled with a solution, with a smooth and shiny surface.

One pack of the medicine contains 6, 12, 24, or 36 soft capsules, 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: 04/2024