Ibum forte (banana flavor)

Package leaflet: Information for the patient

IBUM FORTE
200 mg/5 ml, oral suspension
Ibuprofen
Banana-flavoured oral suspension
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

Leaflet contents

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

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

I F medicine contains ibuprofen – a substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic, and anti-inflammatory properties.
Indications

• Fever of various origins, including influenza, common cold, and post-vaccination reactions.
• Mild to moderate pain of various origins, such as:
  • Headache, sore throat, and muscle pain (e.g. during viral infections),
  • Toothache, pain after dental procedures, teething pain,
  • Joint and bone pain due to musculoskeletal injuries (e.g. sprains),
  • Pain due to soft tissue injuries,
  • Postoperative pain,
  • Ear pain occurring in middle ear inflammatory conditions.

2. Important information before using Ibum Forte (o smaku bananowym)

When not to use Ibum Forte (o smaku bananowym):

• 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 non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients with active or previous peptic ulcer disease of the stomach and/or duodenum, perforation (puncture) or bleeding, including those occurring after use of NSAIDs,
• in patients who previously experienced allergic reactions during treatment with acetylsalicylic acid or other NSAIDs, such as rhinitis, urticaria, shortness of breath or bronchial asthma,
• when taking other medicines from the NSAID group (including COX-2 inhibitors such as celecoxib or etoricoxib),
• in case of severe liver, kidney or heart failure,
• if cerebral hemorrhage (bleeding from brain vessels) or other bleeding is present,
• if blood clotting disorders, hemorrhagic diathesis (tendency to bleed) or blood formation disorders of unknown origin are present.

If adults use this medicine, it should not be taken during the last 3 months of pregnancy.
Warnings and precautions
Before starting to use Ibum Forte (o smaku bananowym), discuss this with your doctor, pharmacist or
nurse.
Exercise particular caution when using Ibum Forte (o smaku bananowym):

• if the patient is taking other painkillers from the NSAID group or acetylsalicylic acid at a daily dose exceeding 75 mg,
• if the patient has been diagnosed with certain skin diseases (systemic lupus erythematosus, mixed connective tissue disease),
• if the patient has gastrointestinal disorders or 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 dehydration is present due to increased risk of kidney failure,
• if asthma, chronic rhinitis, nasal polyps or allergic diseases are currently present or occurred in the past, bronchospasm may occur,
• when taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. acenocoumarol), selective serotonin reuptake inhibitors (antidepressants) and antiplatelet drugs (such as acetylsalicylic acid).

During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including
difficulty breathing, swelling of the face and neck (angioedema), chest pain.
If any of these symptoms occur, discontinue Ibum Forte (o smaku bananowym) immediately and
contact your doctor or emergency medical services without delay.
Inform your pharmacist or doctor if the patient has an infection — see below,
section titled “Infections”.
Concurrent, long-term use of painkillers may lead to persistent
serious kidney problems.
Infections
Ibum Forte (o smaku bananowym) may mask symptoms of infection, such as fever and pain. Therefore, Ibum Forte (o smaku bananowym)
may delay appropriate treatment of infection and consequently increase the
risk of complications. This has been observed in bacterial pneumonia and bacterial
skin infections associated with chickenpox. If the patient takes this medicine
during an ongoing infection and infection symptoms persist or worsen, consult a doctor
immediately.
Taking medicines such as Ibum Forte (o smaku bananowym) 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 use higher doses or longer treatment duration than recommended (3 days).
If the patient has heart problems, a history of stroke, or suspects risk of these
conditions (high blood pressure, diabetes, elevated cholesterol, smoking),
discuss the treatment approach with a doctor or pharmacist.
Avoid using Ibum Forte (o smaku bananowym) during chickenpox.
Skin reactions
Severe skin reactions associated with the use of Ibum Forte (o smaku bananowym) have been reported.
If any skin rash, mucosal changes, blisters or other allergic symptoms occur, discontinue taking Ibum Forte (o smaku bananowym) and
seek immediate medical help, as these may be the first signs of a very severe skin reaction. See section
4.
Serious 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 occurred with ibuprofen use. If the patient develops any of the symptoms related to these severe skin reactions described in section 4, discontinue Ibum Forte (o smaku bananowym) immediately and seek medical help.
If any of the above conditions apply to a child, contact a
doctor before using Ibum Forte (o smaku bananowym).
In elderly patients, there is an increased risk of adverse effects during
treatment with NSAIDs, particularly those affecting the stomach and intestines.
Patients who previously experienced adverse effects in the gastrointestinal tract,
especially elderly patients, should report any unusual symptoms in the abdominal
area (especially gastrointestinal bleeding), particularly during the initial phase
of treatment.
Ibum Forte (o smaku bananowym) and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken,
and about medicines the patient plans to take:

• corticosteroids (e.g. prednisolone), as they may increase the risk of gastrointestinal ulceration or bleeding,
• other medicines from the NSAID group (including COX-2 inhibitors such as celecoxib or etoricoxib),
• certain anticoagulants (e.g. acetylsalicylic acid, acenocoumarol, ticlopidine),
• certain antihypertensive medicines (ACE inhibitors, e.g. captopril), certain other medicines that may be affected by or affect ibuprofen treatment,
• antiplatelet drugs (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal adverse effects,
• antihypertensive medicines and diuretics, as NSAIDs may reduce the effectiveness of these medicines and increase the risk of kidney damage. In such cases, it is important that the child drinks plenty of water throughout the day,
• lithium (a medicine used in depression), as the effect of lithium may increase,
• methotrexate (a medicine used in cancer or rheumatic diseases), as the effect of methotrexate may increase,
• tacrolimus (an immunosuppressive medicine), as there is an increased risk of kidney toxicity,
• cyclosporine (an immunosuppressive medicine), as limited data suggest an increased risk of kidney toxicity,
• zidovudine (a medicine used in the treatment of AIDS), as using Ibum Forte (o smaku bananowym) may increase the risk of joint bleeding or bleeding leading to swelling (in patients with hemophilia and positive HIV antibody test),
• sulfonylurea derivatives (antidiabetic medicines): clinical interactions between these medicines and NSAIDs may occur. Monitoring of blood glucose levels is recommended,
• probenecid and sulfinpyrazone (medicines used in the treatment of gout): may delay ibuprofen elimination,
• digoxin, phenytoin and lithium: ibuprofen may increase plasma concentrations of these medicines,
• quinolone antibiotics: may increase the risk of seizures,
• cholestyramine: may delay and reduce absorption of NSAIDs,
• voriconazole and fluconazole (antifungal medicines): may increase exposure to NSAIDs.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to
become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Do not take Ibum Forte (o smaku bananowym) 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 tendency to bleeding in both the mother and her child and may delay or
prolong labor. Do not use this medicine during the first 6 months of pregnancy unless
absolutely necessary and prescribed by a doctor. If treatment is required during this period
or when trying to conceive, use the lowest possible dose for the shortest possible
time. From week 20 of pregnancy, Ibum Forte (o smaku bananowym) may cause kidney dysfunction in the
unborn child if taken for longer than a few days, which may lead to
reduced amniotic fluid volume surrounding the baby (oligohydramnios), or narrowing of the
blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for
longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts. After short-term
use of ibuprofen at recommended doses, harmful effects on infants seem
unlikely.
Fertility
Ibuprofen may impair fertility. If the patient is planning pregnancy or has difficulty
conceiving, she should inform her doctor.
Driving and operating machinery
Short-term use of this medicine has no effect or a negligible effect on the ability to drive
and operate machinery.
Ibum Forte (o smaku bananowym) contains liquid maltitol, sodium benzoate (E 211), propylene glycol (E 1520)
and sodium
Liquid maltitol
The medicine contains 1.119 g of liquid maltitol in each 5 ml of suspension. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this 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 4.532 mg of propylene glycol in each 5 ml of suspension.
Sodium
The medicine contains 18.4 mg of sodium (main component of table salt) in each 5 ml of suspension.
This corresponds to 0.92% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Ibum Forte (o smaku bananowym)

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
Ibum Forte (o smaku bananowym) is for oral use. Shake the bottle well before use.
The daily dose of Ibum Forte (o smaku bananowym) depends strictly on body weight and is 20–30 mg/kg b.w. in divided doses, according to the table below.

The medicine should be administered at intervals of at least six hours.
In infants under 6 months of age, the medicine should only be used after consultation with a doctor.
Do not use a higher dose than recommended.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Do not use without consulting a doctor for longer than 3 days.
An oral syringe is included in the package.
Instructions for dosing with the oral syringe:

• Before first use, the syringe must be washed thoroughly in warm (not boiling) water with a cleaning agent,
• After removing the cap, attach the syringe to the closure located in the neck of the bottle,
• To fill the syringe, shake the bottle vigorously, turn it upside down, and then carefully push the plunger down, drawing the suspension into the syringe to the desired volume indicated on the scale,
• To accurately measure the dose, align the flange of the syringe barrel with the mark on the plunger scale,
• Return the bottle to its upright position and carefully remove the syringe from the closure,
• Place the tip of the syringe into the child's mouth, then slowly press the plunger to carefully empty the syringe's contents,
• After use, close the bottle and wash the oral syringe in warm (not boiling) water with a cleaning agent, then dry it.

The medicine is intended for short-term use; therefore, if symptoms worsen or do not improve after 3 days, or if new symptoms occur, consult a doctor.
In patients with sensitive stomachs, it is recommended to take medicine I F during meals.
The medicine does not contain sugar or alcohol. It may be used by diabetic patients (5 ml of I F suspension contains 1.119 g of liquid maltitol, equivalent to approximately 0.07 carbohydrate exchange unit).
Use of a higher than recommended dose of medicine I F
If a patient has taken a higher than recommended dose of medicine I F, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital to assess possible health risks and receive advice on appropriate actions.
Symptoms may include nausea, stomach pain (abdominal pain), vomiting (blood traces may occur), headache, ringing in the ears (tinnitus), disorientation, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, feeling of cold, breathing difficulties, eyelid twitching, vision disturbances, rarely low blood pressure, changes in blood composition, and kidney function disorders have been reported.
Missed dose of medicine I F
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The risk of adverse effects can be reduced by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
If any adverse effects occur, or if you have any concerns, you should stop taking this medicine and consult a doctor as soon as possible.
Elderly patients using this medicine belong to a group at increased risk of complications related to adverse effects.
YOU MUST STOP TAKING THE MEDICINE AND IMMEDIATELY CONTACT A DOCTOR IF THE CHILD EXPERIENCES:

• symptoms of gastrointestinal bleeding, such as severe abdominal pain, black stools, vomiting blood or dark particles resembling coffee grounds,
• symptoms of rare but serious allergic reactions, such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, palpitations, drop in blood pressure leading to shock. Symptoms may occur even after the first dose. If any of these symptoms occur, contact a doctor immediately,
• symptoms of severe skin reactions, such as:
  • red, flat, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs 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, scaling rash with subcutaneous nodules and blisters, accompanied by fever.
  • Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

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

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

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

• inflammation of the stomach, large intestine, and exacerbation of Crohn's disease (inflammatory bowel disease),
• headache, dizziness, insomnia, restlessness, irritability or fatigue,
• visual disturbances,
• gastric ulcers which may bleed or perforate,
• oral mucosal ulceration and (or) swelling and irritation of the mouth,
• hypersensitivity reactions with rash and itching, asthma attacks (possibly with low blood pressure).

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

• tinnitus (ringing in the ears).

Very rare (occur in less than 1 patient out of 10,000):

• oesophagitis or pancreatitis, intestinal obstruction,
• severe skin reactions, including rash with redness and blisters which may peel, accompanied by fever, chills, muscle pain, malaise, Stevens-Johnson syndrome. In exceptional cases, severe skin infections have occurred during chickenpox,
• reduced urine output compared to normal and swelling (possible acute kidney failure or inflammation). Kidney damage or increased blood urea levels (early signs include reduced urination, cloudy urine, blood in urine, back pain, possible leg swelling and general malaise),
• problems related to blood cell production (early symptoms include fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained or unusual bruising),
• psychotic reactions and depression,
• worsening of inflammatory condition due to infection. If signs of infection occur or worsen during treatment with I F, consult a doctor,
• swelling, high blood pressure, palpitations, heart failure, heart attack,
• liver function disorders or hepatitis. Liver failure or damage, especially during prolonged use, manifesting as yellowing of the skin and eyes, pale stools and dark urine,
• very rarely, during ibuprofen use, symptoms of aseptic meningitis have been observed, including neck stiffness, headache, malaise, fever or disturbances in consciousness. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are at higher risk of adverse effects. Immediate medical attention should be sought if such symptoms occur.

Frequency not known (frequency cannot be estimated 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. Symptoms of DRESS syndrome include skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell),
• red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, stop taking I F and seek immediate medical help. See also section 2,
• skin becomes sensitive to light.

Taking medicines such as I F may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store I F medicine

Keep in the original tightly closed container, at a temperature below 25 °C.
Storage period after first opening: 6 months.
The medicine should be stored in a place inaccessible and out of sight 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine I F contains

• The active substance is ibuprofen. 5 ml of suspension contains 200 mg of ibuprofen.
• The other ingredients (excipients) are: liquid maltitol, glycerol, xanthan gum, sodium saccharin, sodium benzoate (E 211), fumaric acid, disodium phosphate dodecahydrate, banana flavour (containing propylene glycol E 1520), purified water.

What I F looks like and contents of the pack
The medicine is packed in a coloured glass bottle with a screw cap, stopper and tamper-evident ring, containing 130 g or 100 g of oral suspension with banana flavour. The bottle is placed in a cardboard box together with the patient leaflet and an oral syringe.

Marketing Authorisation 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]