Ibum Express Forte

Leaflet attached to the packaging: patient information

Ibum Express Forte

400 mg, soft capsules

Ibuprofen

It is essential to carefully read the contents of the leaflet 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 Ibum Express Forte and what is it used for
• 2. Important information before taking Ibum Express Forte
• 3. How to take Ibum Express Forte
• 4. Possible side effects
• 5. How to store Ibum Express Forte
• 6. Package contents and other information

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

Ibum Express Forte contains ibuprofen, a substance from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic, and anti-inflammatory effects.

Indications for use

• Pains of various origins of mild to moderate severity:
• headaches (including migraines)
• toothaches
• muscle, joint, and bone pains
• pains after injuries
• neuralgia
• pains accompanying colds and flu.
• Painful menstruation.
• Febrile conditions of various origins (including flu, colds, or other infectious diseases).

2. Important information before taking Ibum Express Forte

When not to take Ibum Express Forte:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• in patients with active or recurrent gastric and/or duodenal ulcers, perforation (hole) or bleeding, also occurring after taking NSAIDs,
• in patients who have experienced any symptoms of allergy after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, such as runny nose, hives, shortness of breath, or bronchial asthma,
• when taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
• if the patient has severe liver, kidney, or heart failure,
• if the patient has cerebral bleeding (bleeding from brain vessels) or other bleeding,
• if the patient has blood clotting disorders, hemorrhagic diathesis (tendency to bleed) or blood production disorders of unknown origin,
• in dehydrated patients (dehydration caused by vomiting, diarrhea, or insufficient fluid intake),
• during the last 3 months of pregnancy.

Warnings and precautions

Before starting treatment with Ibum Express Forte, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when taking Ibum Express Forte:

• if the patient is taking other painkillers from the NSAID group or acetylsalicylic acid,
• if the patient has been diagnosed with certain skin diseases (systemic lupus erythematosus, 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 high blood pressure and/or heart function disorders,
• if the patient has been diagnosed with kidney function disorders,
• if the patient has been diagnosed with liver diseases,
• after recent major surgery,
• if there is dehydration due to increased risk of kidney failure,
• if the patient has been diagnosed with blood clotting disorders (ibuprofen may prolong bleeding time),
• in case of current or past asthma, chronic runny nose, nasal polyps, or allergic diseases, as shortness of breath may occur,
• when taking other medicines that may increase the risk of stomach and intestinal disorders or bleeding, such as oral corticosteroids (e.g., prednisolone), blood thinners (e.g., acenocoumarol), selective serotonin reuptake inhibitors (antidepressants), or antiplatelet agents (e.g., acetylsalicylic acid).

Patient with a history of high blood pressure and/or heart failure should be cautious and consult their doctor or pharmacist before taking the medicine, as NSAID treatment has been associated with fluid retention, high blood pressure, and edema.
Taking painkillers/anti-inflammatory drugs, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded, and the duration of treatment should be as short as possible.
Before taking Ibum Express Forte, the patient should discuss their treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, have peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries), or have had a stroke (including mini-stroke or transient ischemic attack - TIA),
• they have high blood pressure, diabetes, high cholesterol levels, have a family history of heart disease or stroke, or smoke,
• they have an infection - see below, section "Infections".

When taking ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling in the face and neck (angioedema), chest pain.
If any of these symptoms are noticed, the patient should stop taking Ibum Express Forte and immediately contact their doctor or medical emergency services.
Long-term concurrent use of painkillers may lead to persistent severe kidney disease.
There is a risk of kidney failure in dehydrated patients.
There is a risk of gastrointestinal bleeding, ulcers, or perforation, which can be fatal and may not be preceded by warning signs or may occur in patients who have had such warning signs.
If gastrointestinal bleeding or ulcers occur, the patient should stop taking the medicine and contact their doctor immediately. 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. Such patients should use the lowest possible dose of the medicine.
Care should be exercised when taking ibuprofen in patients taking other medicines that may increase the risk of stomach and intestinal disorders or bleeding, such as corticosteroids or anticoagulants, such as warfarin or acenocoumarol, selective serotonin reuptake inhibitors, or antiplatelet agents, such as acetylsalicylic acid.
Skin reactions
Severe skin reactions have been reported with the use of Ibum Express Forte. If the patient experiences:

any skin rash, changes in the mucous membranes, blisters, or other symptoms of hypersensitivity, they should stop taking Ibum Express 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 the use of ibuprofen. If the patient experiences any symptoms related to these severe skin reactions described in section 4, they should stop taking Ibum Express Forte and seek medical attention immediately.
Infections
Ibum Express Forte may mask the symptoms of an infection, such as fever and pain. Therefore, Ibum Express Forte may delay the use of appropriate infection treatment, which may lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to 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.
Chickenpox should be avoided while taking Ibum Express Forte.
Fertility in women
See section "Pregnancy, breastfeeding, and fertility".
Children and adolescents
The medicine should not be used in children under 12 years of age.
In dehydrated adolescents (12-18 years old), there is a risk of kidney function disorders.
Elderly patients
Elderly patients have an increased risk of adverse reactions when taking NSAIDs, especially those related to the stomach and intestines.
Taking the medicine in the lowest effective dose for the shortest possible duration necessary to relieve symptoms reduces the risk of adverse reactions.

Ibum Express Forte and other medicines

The patient should inform 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 Express Forte may affect the action of other medicines or other medicines may affect the action of Ibum Express Forte. For example:

• corticosteroids (e.g., prednisolone): may increase the risk of stomach or intestinal ulcers or bleeding,
• other NSAIDs (including COX-2 inhibitors, such as celecoxib or etoricoxib),
• anticoagulant medicines (i.e., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),
• antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants): increase the risk of adverse reactions in the gastrointestinal tract,
• blood pressure medicines and diuretics: NSAIDs may weaken the effect of these medicines and increase the risk of kidney damage; in such cases, it is essential for the patient to drink plenty of water throughout the day,
• lithium (a medicine used in depression): the effect of lithium may be increased,
• methotrexate (a medicine used in cancer or rheumatic diseases): the effect of methotrexate may be increased,
• tacrolimus (an immunosuppressive medicine): increases the risk of toxic effects on the kidneys,
• cyclosporin (an immunosuppressive medicine): there is limited data on the increased risk of toxic effects on the kidneys,
• zidovudine (a medicine used in AIDS treatment): taking Ibum Express Forte may increase the risk of bleeding into the joints or bleeding leading to swelling (in patients with hemophilia and a positive HIV antibody test),
• sulfonylurea derivatives (antidiabetic medicines): there may be clinical interactions between these medicines and NSAIDs; blood glucose monitoring is recommended,
• probenecid and sulfinpyrazone (medicines used in gout treatment): may delay the excretion of ibuprofen,
• digitalis glycosides and phenytoin: ibuprofen may increase the levels of these medicines in the blood,
• quinolone antibiotics: may increase the risk of seizures,
• cholestyramine: may delay and reduce the absorption of NSAIDs,
• mifepristone: NSAIDs should not be used within 8-12 days after mifepristone administration, as they may reduce the effect of mifepristone,
• voriconazole and fluconazole (antifungal medicines): may increase the risk associated with NSAID use.

Before taking ibuprofen, the patient should inform their doctor about taking any of the above-mentioned medicines. Other medicines may also be affected or have an effect on Ibum Express Forte treatment. Therefore, before taking Ibum Express Forte with other medicines, the patient should always consult their doctor or pharmacist.

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
Ibum Express Forte should not be taken during the last 3 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 delayed or prolonged labor. During the first 6 months of pregnancy, the medicine should not be used unless absolutely necessary and under medical supervision. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibum Express 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 blood vessel (ductus arteriosus) 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. With short-term use of ibuprofen in recommended doses, harmful effects on breastfed babies seem unlikely.
Fertility
Medicines from this group (nonsteroidal anti-inflammatory drugs) may have a negative effect on female fertility. This effect is temporary and disappears after the end of treatment.

Driving and using machines

Short-term use of the medicine has no effect or negligible effect on the ability to drive and use machines.

Ibum Express Forte contains sorbitol, potassium, and sodium

The medicine contains 90 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 been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to a child.
The medicine contains less than 1 mmol (39 mg) of potassium per dose, which means the medicine is considered "potassium-free".
The yellow dye (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 the medicine is considered "sodium-free".

3. How to take Ibum Express Forte

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 medicine is for short-term oral use. The recommended dose is:
Adults and adolescents over 12 years old:the initial dose is 1 capsule (400 mg). If necessary, 1 capsule 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 patient should use the lowest effective dose for the shortest possible duration necessary to relieve symptoms. This reduces the risk of adverse reactions. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
The patient should consult their doctor if they need to take the medicine for more than 3 days or if the symptoms worsen.

Use in children

The medicine should not be used in children under 12 years of age.

Overdose of Ibum Express Forte

If the patient has taken a larger dose of Ibum Express Forte 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 risk to their health and receive advice on what to do.
Symptoms may include nausea, stomach pain (abdominal pain), 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 difficulties, eyelid twitching, vision disturbances, and rare cases of low blood pressure, changes in blood composition, and kidney function disorders have occurred.

Missed dose of Ibum Express 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 their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibum Express Forte can cause side effects, although not everybody gets them.
Elderly patients taking this medicine are at increased risk of side effects.
Taking medicines like Ibum Express Forte may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

THE PATIENT SHOULD STOP TAKING THE MEDICINE AND IMMEDIATELY CONSULT THEIR DOCTOR IF THEY EXPERIENCE:

• symptoms of gastrointestinal bleeding, such as: severe abdominal pain, black stools, bloody vomiting, or dark particles that resemble coffee grounds,
• symptoms of rare but serious allergic reactions, such as: worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, drop in blood pressure leading to shock. These symptoms may occur even after the first dose of the medicine,
• symptoms of severe skin reactions, such as:
• 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 Express Forte and seek medical attention immediately. See also section 2,

Other possible side effects include:
Common(occurring in 1 to 10 patients in 100):

• heartburn, abdominal pain, nausea, vomiting, bloating with gas, diarrhea, constipation.

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

• gastritis, colitis, and worsening of Crohn's disease (inflammatory bowel disease),
• headaches, dizziness, insomnia, restlessness, or fatigue,
• vision disturbances,
• gastric ulcers, which may bleed or perforate,
• mouth ulcers and/or swelling and irritation of the mouth,
• allergic reactions with rash and itching, asthma attacks (with possible drop in blood pressure).

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

• tinnitus (ringing in the ears).

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

• esophagitis or pancreatitis, intestinal obstruction,
• severe skin reactions, including rash with redness and blisters, which may peel and be accompanied by fever, chills, and muscle pain, feeling unwell, Stevens-Johnson syndrome; in rare cases, severe skin infections have occurred during chickenpox (chickenpox),
• reduced urine output and swelling (possible acute kidney failure or kidney inflammation); kidney damage or increased urea levels in the blood (the first symptoms are reduced urine output, cloudy urine, blood in the urine, back pain, possible swelling of the legs, and general malaise),
• blood disorders (the first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained or unusual bruising),
• psychotic reactions and depression,
• worsening of infectious diseases; if symptoms of infection occur or worsen while taking Ibum Express Forte, the patient should consult their doctor,
• swelling, high blood pressure, rapid heartbeat, heart failure, heart attack,
• liver function disorders or hepatitis; liver failure or damage, especially during long-term use, manifested by yellowing of the skin and eyes or pale stools and dark urine,
• very rarely, during ibuprofen use, symptoms of aseptic meningitis have been observed, accompanied by neck stiffness, headaches, malaise, fever, or changes in consciousness; patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are more likely to experience side effects; the patient should immediately consult their doctor if these symptoms occur.

Frequency not known(frequency cannot be estimated from 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 Express Forte and seek medical attention immediately. See also section 2,
• skin becomes sensitive to light.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist, or nurse. 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw
phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Ibum Express Forte

Do not store above 25°C. Store in the original packaging to protect from light.
The medicine should be kept 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 stated.
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. Package contents and other information

What Ibum Express Forte contains

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

What Ibum Express Forte looks like and contents of the package

Ibum Express Forte is a green, oval, transparent capsule, tightly filled with a solution, with a smooth surface.
One package of the medicine contains 6, 12, 24, or 36 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

phone: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: