Ibum Forte

Leaflet accompanying the packaging: patient information

IBUM FORTE

200 mg/5 ml, oral suspension

Ibuprofen

Oral suspension with a strawberry flavor

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

This medicine should always be used 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 I F and what is it used for
• 2. Important information before taking I F
• 3. How to take I F
• 4. Possible side effects
• 5. How to store I F
• 6. Contents of the packaging and other information

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

I F contains ibuprofen, a substance from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), with analgesic, antipyretic, and anti-inflammatory effects. The indications for use of the medicine are:

• fever of various origins, including in the course of flu, colds, as well as in the course of post-vaccination reaction;
• pains of various origins of mild to moderate severity, such as:
• headaches, throat and muscle pains (e.g., in the course of viral infections),
• toothaches, pains after dental procedures, pains due to teething,
• 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 inflammatory conditions of the middle ear.

If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking I F

When not to take I F:

• 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),
• in patients with active or recurrent peptic ulcer disease, perforation (hole) or bleeding, also occurring after the use of NSAIDs,
• in patients who have had allergic symptoms in the past, such as rhinitis, urticaria, dyspnea, or bronchial asthma, during treatment with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs,
• if there is severe liver, kidney, or heart failure,
• if there is bleeding in the brain (cerebral hemorrhage) or other bleeding,
• if there are coagulation disorders, hemorrhagic diathesis (tendency to bleeding), or blood production disorders of unknown origin.

If women are taking this medicine, they should not take it during the last 3 months of pregnancy.

Warnings and precautions

Before starting treatment with I F, the patient should discuss it with a doctor or pharmacist. Special caution should be exercised when taking 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 recent major surgery,
• if there is dehydration due to increased risk of kidney failure,
• in case of current or past asthma, chronic rhinitis, nasal polyps, or allergic diseases, it is possible to experience dyspnea,
• when taking other medicines that may increase the risk of 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).

It is recommended to avoid concomitant use of I F with other nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors such as celecoxib or etoricoxib (increased risk of side effects). Concomitant, long-term use of painkillers may lead to persistent serious kidney diseases. Taking anti-inflammatory/pain-relieving medications, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose and duration of treatment. Before taking I F, the patient should discuss the treatment with a doctor or pharmacist if:

• the patient has heart diseases, 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),
• the patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes,
• the patient has an infection - see below, section entitled "Infections".

During ibuprofen treatment, 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 I F immediately and contact a doctor or emergency medical services immediately. During chickenpox, the patient should avoid taking I F. Infections I F may mask the symptoms of an infection, such as fever and pain. As a result, 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 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. Skin reactions Severe skin reactions have been reported with the use of I F. If any of the following occur: any skin rash, changes in the mucous membranes, blisters, or other signs of allergy, the patient should stop taking I F and seek medical attention immediately, as these may be the first signs of a very severe skin reaction. See section 4. Due to the use of ibuprofen, severe skin reactions have occurred, 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). If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should stop taking I F immediately and seek medical attention. If any of the above conditions apply to a child, the patient should consult a doctor before taking I F. There is a risk of gastrointestinal bleeding, ulcers, or perforation, which does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs. In case of gastrointestinal bleeding or ulcers, the patient should stop taking the medicine and consult a doctor immediately. In elderly patients, there is an increased risk of side effects during the use of NSAIDs, 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.

Children and adolescents

In infants under 6 months of age, the medicine can only be administered after consulting a doctor. In dehydrated children and adolescents, there is a risk of kidney function disorders.

I F 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. I F may affect the action of other medicines or other medicines may affect the action of I F. In particular, before taking ibuprofen, the patient should inform their doctor about taking any of the following medicines:

• corticosteroids (e.g., prednisolone), as they may increase the risk of ulcers or gastrointestinal 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-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),
• antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal side effects,
• medicines used to treat high blood pressure and diuretics, as NSAIDs may weaken their effect and there is a possibility of increased risk of kidney damage. In such cases, it is essential for the child to drink plenty of fluids during the day,
• lithium (a medicine used in depression), as lithium levels may increase,
• methotrexate (a medicine used in the treatment of 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 the treatment of AIDS), as the use of I F may increase the risk of bleeding into the joints or bleeding leading to swelling (in patients with hemophilia with a positive HIV antibody test),
• sulfonylurea derivatives (antidiabetic medicines): clinical interactions may occur between these medicines and NSAIDs. It is recommended to monitor blood glucose levels,
• probenecid and sulfinpyrazone (medicines used in the treatment of gout): 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 NSAIDs,
• voriconazole and fluconazole (antifungal medicines): they may increase the exposure to NSAIDs.

Also, some other medicines may be affected or have an effect on the treatment of I F. Therefore, before taking I F with other medicines, the patient should always consult a 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 a doctor or pharmacist before taking this medicine. Pregnancy The patient should not take I F if they are in 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 patient's and their child's tendency to bleed and cause delayed or prolonged labor. During the first 6 months of pregnancy, the patient should not take the medicine unless it is absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, the patient should use the smallest dose for the shortest possible time. From the 20th week of pregnancy, I F 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 child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child'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. In the case of short-term use of ibuprofen in recommended doses, harmful effects on infants are unlikely. Fertility Ibuprofen may make it more difficult to conceive. If the patient plans to conceive or has problems conceiving, they should inform their doctor.

Driving and using machines

Short-term use of the medicine has no effect or has a negligible effect on the ability to drive vehicles and operate machinery.

I F contains maltitol liquid (E 965), sodium benzoate (E 211), propylene glycol (E 1520), and sodium

Maltitol liquid (E965) 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 12.78 mg of propylene glycol in each 5 ml of suspension. Sodium The medicine contains 18.4 mg of sodium (the main 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 I F

This medicine should always be used 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 oral use. Before use, the bottle should be shaken. The daily dose of I F depends strictly on the patient's body weight and is 20-30 mg/kg body weight, in divided doses, according to the following table:

In infants under 6 months of age, the medicine can only be administered after consulting a doctor. The medicine should be administered at intervals of at least 6 hours. Do not take a higher dose of the medicine than recommended. Use the smallest effective dose for the shortest possible time necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult a doctor immediately (see section 2). Without consulting a doctor, do not use for more than 3 days. In infants aged 3-5 months, if the symptoms worsen or persist for more than 24 hours, the patient should consult a doctor immediately. In children over 6 months of age and adolescents, the patient should consult a doctor if the medicine needs to be administered for more than 3 days or if the symptoms worsen. An oral syringe is 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 cork in the neck of the bottle,
• to fill the syringe, shake the bottle vigorously, turn it upside down, and then carefully push the syringe plunger down, drawing in the desired amount of suspension indicated on the scale,
• to measure the dose accurately, the collar of the syringe body should be set to the scale mark on the plunger,
• turn the bottle back to its original position and carefully remove the syringe from the cork (as shown in the picture),
• place the tip of the syringe in the child's mouth and, slowly pressing the plunger, carefully empty the syringe,
• after use, close the bottle and wash the oral syringe in warm (not boiling) water with a detergent and dry it.

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 I F during meals. If the patient feels that the effect of I F is too strong or too weak, they should consult a doctor. The medicine does not contain sugar and ethanol. It can be used 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 units).

Overdose of I F

If the patient has taken a higher dose of 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 possible health risks and advice on what to do. 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 problems, eyelid twitching, vision disturbances, and rare cases of low blood pressure and changes in blood composition and kidney function disorders.

Missed dose of I F

Do not take a double dose to make up for a missed dose.

Stopping treatment with I F

In case of any further doubts about the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, I F can cause side effects, although not everybody gets them. The occurrence of side effects can be reduced by using the smallest effective dose for the shortest possible time necessary to relieve symptoms. If side effects occur or in case of doubt, the patient should stop taking the medicine and consult a doctor as soon as possible. Elderly patients taking this medicine belong to a group with an increased risk of problems related to side effects.

STOP TAKING I F AND CONSULT A DOCTOR IMMEDIATELY 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 consult a doctor immediately,
• 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).

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

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

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

• gastritis, colitis, and worsening of Crohn's disease (inflammatory bowel disease),
• headaches, dizziness, insomnia, agitation, 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 out of 10,000):

• tinnitus (ringing in the ears).

Very rare(occurring in less than 1 patient out of 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, bad condition, and a feeling of illness, 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 poor condition),
• blood production problems (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 conditions. If symptoms of infection occur or worsen during treatment with I F, the patient should consult a doctor,
• swelling, high blood pressure, palpitations, heart failure, heart attack,
• liver function disorders or liver inflammation. Liver failure or liver 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 stiffness of the neck, headaches, poor condition, 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 consult a doctor immediately if they occur.

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

Taking such medicines as I F may be associated with a slight increase in the 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 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, 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 I F

Store in the original packaging, at a temperature below 25°C. Shelf life after first opening: 6 months. 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 specified 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 does I F contain

• The active substance of the medicine is ibuprofen. 5 ml of suspension contains 200 mg of ibuprofen.
• The other ingredients (excipients) are: maltitol liquid (E 965), glycerol (E 422), xanthan gum, sodium saccharin (E 954), sodium benzoate (E 211), fumaric acid, disodium phosphate dodecahydrate, natural strawberry flavor AR 2157 (contains natural flavoring substances and propylene glycol E 1520), purified water.

What I F looks like and what the packaging contains

The medicine is a white suspension with a strawberry flavor. The packaging consists of a brown glass bottle with a polyethylene cap and a guarantee ring, containing 100 g of oral suspension, in a cardboard box with a patient leaflet and an oral syringe.

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: