Ibum Forte

Leaflet accompanying the packaging: patient information

IBUM FORTE

200 mg/5 ml, oral suspension

Ibuprofen

Oral suspension with a raspberry flavor

Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

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

• Keep this leaflet, so you can read it again if necessary.
• 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 inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is the medicine I F and what is it used for
• 2. Important information before taking the medicine I F
• 3. How to take the medicine I F
• 4. Possible side effects
• 5. How to store the medicine I F
• 6. Package contents and other information

1. What is the medicine I F and what is it used for

The medicine I F contains ibuprofen, a substance from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic, and anti-inflammatory effects.

Indications for use

• feverish conditions of various origins, including influenza, colds, and post-vaccination reactions,
• pains of various origins with mild to moderate severity, such as:
• headaches, throat and muscle pains (e.g., with viral infections),
• toothaches, pains after dental procedures, teething pains,
• joint and bone pains due to injuries to the musculoskeletal system (e.g., sprains),
• pains due to soft tissue injuries,
• post-operative pains,
• ear pains occurring in middle ear inflammatory conditions.

2. Important information before taking the medicine I F

When not to take the medicine I F

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to other nonsteroidal anti-inflammatory drugs (NSAIDs),
• in patients with active or past stomach and/or duodenal ulcers, perforation (hole) or bleeding, also occurring after taking NSAIDs,
• in patients who have had any symptoms of allergy in the past, such as runny nose, hives, shortness of breath, or asthma, while taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs,
• when taking other NSAID medicines (including COX-2 inhibitors such as celecoxib or etoricoxib),
• if there is severe liver, kidney, or heart failure,
• if there is bleeding in the brain (cerebral hemorrhage) or other bleeding,
• if there are blood clotting disorders, bleeding tendency, or unexplained blood disorders.

If adults take this medicine, it should not be taken in the last 3 months of pregnancy.

Warnings and precautions

Before starting to take I F, discuss it with a doctor, pharmacist, or nurse.

Particular caution should be exercised when taking the medicine I F:

• 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 certain skin diseases (systemic lupus erythematosus, mixed connective tissue disease),
• 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 diseases,
• after a recent major surgery,
• if there is dehydration due to increased risk of kidney failure,
• if there is a history of asthma, chronic runny nose, nasal polyps, or allergic diseases, it is possible to experience shortness of breath,
• when taking other medicines that may increase the risk of stomach ulcers or bleeding, such as oral corticosteroids (e.g., prednisolone), blood thinners (e.g., acenocoumarol), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet agents (such as acetylsalicylic acid).

With the use of ibuprofen, severe skin reactions have occurred, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms related to these severe skin reactions described in section 4, they should immediately stop taking the medicine I F and seek medical attention.

During the use of ibuprofen, 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 medicine I F should be stopped immediately and medical help should be sought.

The patient should inform the pharmacist or doctor if they have an infection - see below, the section titled "Infections".

Taking painkillers for a long time can lead to persistent serious kidney problems.

Infections

I F may mask the symptoms of an infection, such as fever and pain. Therefore, I F 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 related to chickenpox. If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should immediately consult a doctor.

Taking such medicines as I F may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not take higher doses or for longer than recommended (3 days).

In case of heart problems, a history of stroke, or suspected risk of these disorders (high blood pressure, diabetes, high cholesterol, smoking), the patient should discuss the treatment with a doctor or pharmacist.

During chickenpox, the patient should avoid taking the medicine I F.

Skin reactions

Severe skin reactions have been reported with the use of the medicine I F.

If the following occur: any skin rash, changes in the mucous membranes, blisters, or other symptoms of an allergic reaction, the patient should stop taking the medicine I F and seek medical attention immediately, as these may be the first signs of a very severe skin reaction. See section 4.

• 4.

If any of the above conditions apply to a child, the patient should consult a doctor before taking the medicine I F.

In elderly patients, there is an increased risk of side effects when taking NSAID medicines, particularly those related to the stomach and intestines.

Patients who have previously experienced side effects in the gastrointestinal tract, especially elderly patients, should report any unusual symptoms in the abdominal cavity (especially gastrointestinal bleeding), especially in the initial stage of treatment.

Medicine I F and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, have recently taken, or plan to take:

• corticosteroids (e.g., prednisolone), as they may increase the risk of stomach ulcers or bleeding,
• other NSAID medicines (including COX-2 inhibitors, such as celecoxib or etoricoxib),
• certain anticoagulant medicines (e.g., acetylsalicylic acid, acenocoumarol, ticlopidine),
• certain antihypertensive medicines (ACE inhibitors, e.g., captopril), other medicines that may be affected by or affect the treatment with ibuprofen,
• antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of side effects in the gastrointestinal tract,
• medicines used to treat high blood pressure and diuretics, as NSAID medicines may weaken their effect and increase the risk of kidney damage. In such cases, it is essential for the child to drink plenty of water during the day,
• lithium (a medicine used in depression), as lithium levels may increase,
• methotrexate (a medicine used in cancer or rheumatic diseases), as methotrexate levels may increase,
• tacrolimus (an immunosuppressive medicine), as the risk of toxic effects on the kidneys increases,
• cyclosporin (an immunosuppressive medicine), as there are limited data on the increased risk of toxic effects on the kidneys,
• zydovudine (a medicine used in AIDS treatment), as taking the medicine I F may increase the risk of bleeding into the joints or bleeding leading to swelling (in patients with hemophilia and a positive HIV test result),
• sulfonylurea derivatives (antidiabetic medicines): clinical interactions may occur between these medicines and NSAID medicines. Blood glucose monitoring is recommended,
• probenecid and sulfinpyrazone (medicines used in gout treatment): they may delay the excretion of ibuprofen,
• digitalis glycosides, phenytoin, and lithium: ibuprofen may increase the levels of these medicines in the blood,
• quinolone antibiotics: they may increase the risk of seizures,
• cholestyramine: it may delay and reduce the absorption of NSAID medicines,
• voriconazole and fluconazole (antifungal medicines): they may increase the exposure to NSAID medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine.

Pregnancy

The medicine I F should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in the unborn baby.

It may increase the risk of bleeding in the patient and their child and cause delayed or prolonged labor. During the first 6 months of pregnancy, the medicine should not be taken unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose should be used for the shortest possible time. From the 20th week of pregnancy, the medicine I F may cause kidney problems in the unborn baby 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 passes into breast milk in small amounts. With short-term use of ibuprofen in recommended doses, harmful effects on infants are unlikely.

Fertility

Ibuprofen may make it harder to get pregnant. If the patient plans to get pregnant or is having trouble getting pregnant, they should tell their doctor.

Driving and using machines

Short-term use of the medicine does not have a significant effect on the ability to drive and use machines.

Medicine I F contains maltitol liquid, sodium benzoate (E 211), propylene glycol (E 1520), and sodium

Maltitol liquid

The medicine contains 1.119 g of maltitol liquid in each 5 ml of suspension. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

Sodium benzoate (E 211)

The medicine contains 3.357 mg of sodium benzoate in each 5 ml of suspension.

Propylene glycol (E 1520)

The medicine contains 12.589 mg of propylene glycol in each 5 ml of suspension.

Sodium

The medicine contains 18.4 mg of sodium (a major component of table salt) in each 5 ml of suspension.

This corresponds to 0.92% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take the medicine I F

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult a doctor, pharmacist, or nurse.

The medicine is taken orally. Before use, the bottle should be shaken.

The daily dose of the medicine I F strictly depends on the patient's body weight and is: 20-30 mg/kg body weight, in divided doses, according to the table below.

The medicine should be given at intervals of at least 6 hours.

In infants under 6 months of age, the medicine can only be given after consulting a doctor.

Do not take a higher dose of the medicine than recommended.

Use the smallest effective dose for the shortest possible time to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult a doctor (see section 2).

Without consulting a doctor, do not take the medicine for more than 3 days.

A measuring cup or a measuring spoon and a plug and an oral syringe are attached to the packaging.

Instructions for dosing with an oral syringe:

• before the first use of the syringe, it must be washed in warm (not boiling) water with a detergent,
• after unscrewing the cap, put the syringe on the plug in the neck of the bottle,
• to fill the syringe, the bottle should be shaken vigorously, turned upside down, and then the syringe plunger should be carefully pushed down, drawing the suspension in the desired amount indicated on the scale,
• to accurately measure the dose, the collar of the syringe body should be set to the scale mark on the plunger,
• the bottle should be turned back to its original position and the syringe should be carefully removed from the plug,
• the tip of the syringe should be placed in the child's mouth, and then, slowly pressing the plunger, the contents of the syringe should be carefully emptied,
• after use, the bottle should be closed, and the oral syringe should be washed in warm (not boiling) water with a detergent and dried.

The medicine is intended for occasional use, so if the symptoms worsen or do not improve after 3 days, or if new symptoms occur, the patient should consult a doctor.

In patients with sensitive stomachs, it is recommended to take the medicine I F during meals.

The medicine does not contain sugar and alcohol. It can be taken by people with diabetes (5 ml of I F suspension contains 1.119 g of maltitol liquid, which corresponds to approximately 0.07 carbohydrate exchange).

Taking a higher dose of the medicine I F than recommended

If the patient has taken a higher dose of the medicine I F 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 possible risk to their health and advice on what actions to take.

Symptoms may include nausea, stomach pain (abdominal pain), vomiting (which may contain blood), headaches, ringing in the ears (tinnitus), dizziness, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness may occur, as well as blood in the urine, feeling cold, breathing difficulties, eyelid twitching, vision disturbances, and rarely low blood pressure and changes in blood composition and kidney function disorders.

Missing a dose of the medicine I F

Do 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 a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The occurrence of side effects can be reduced by taking the smallest effective dose for the shortest possible time to relieve symptoms.

If side effects occur or in case of doubts, the patient should stop taking the medicine and talk to a doctor as soon as possible.

Elderly patients taking this medicine belong to a group with an increased risk of side effects.

STOP TAKING THE MEDICINE AND IMMEDIATELY CONSULT A DOCTOR IF THE CHILD EXPERIENCES:

• 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, palpitations, and a drop in blood pressure leading to shock. Symptoms may occur even after the first use of the medicine. If any of these symptoms occur, the patient should immediately contact a doctor,

and

• 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 the medicine I F 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, irritability, or fatigue,
• vision disturbances,
• stomach 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 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 inflammatory conditions due to infection. If symptoms of infection occur or worsen while taking the medicine I F, the patient should consult a doctor.
• swelling, high blood pressure, palpitations, 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 light-colored stools and dark urine,
• very rarely, during the use of ibuprofen, 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 a doctor if these symptoms occur.

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,
• 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 the medicine I F and seek medical attention immediately. See also section 2,
• the skin becomes sensitive to light.

Taking such medicines as I F may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products

Aleje Jerozolimskie 181C, 02-222 Warsaw

tel.: 22 49 21 301, fax: 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 the medicine I F

Store in the original packaging, at a temperature below 25°C.

Shelf life after first opening: 6 months.

Keep the medicine out of the 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 the medicine I F contains

• The active substance of the medicine is ibuprofen. 5 ml of suspension contains 200 mg of ibuprofen.
• The other ingredients (excipients) are: maltitol liquid, glycerol, xanthan gum, sodium saccharin, sodium benzoate (E 211), fumaric acid, disodium phosphate dodecahydrate, natural raspberry flavor WONF L783 (contains natural flavoring substances and propylene glycol E 1520), purified water.

What the medicine I F looks like and what the package contains

The packaging of the medicine is a brown glass bottle with a nominal capacity of 100 ml, containing at least 100 g of the product, or a brown glass bottle with a nominal capacity of 125 ml, containing at least 130 g of the product, or a brown glass bottle with a nominal capacity of 160 ml, containing at least 150 g of the product, closed with an aluminum cap with a polyethylene foam insert and a guarantee ring or an HDPE cap with an LDPE plug and a guarantee seal. The bottle is placed in a cardboard box with a patient leaflet and a measuring cup or a measuring spoon, or a plug and an oral syringe.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.

51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel.: 22 742 00 22

e-mail: [email protected]

Date of the last update of the leaflet: