Ibum forte

Package leaflet: Information for the user

IBUM FORTE
200 mg/5 ml, oral suspension
Ibuprofenum
Strawberry-flavoured oral suspension
Please read 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 directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

1. What I F is and what it is 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 pack and other information

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

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

• Fever of various origins, including fever associated with influenza, colds, 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 following 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 inflammatory conditions of the middle ear.

If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Information before using Ibum Forte

When not to use Ibum Forte:

• if the patient is allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other components of this medicine (listed in section 6),
• in patients with active or a history of peptic ulceration or gastrointestinal (duodenal) ulcer, perforation (gut wall rupture), or bleeding, including cases previously occurring after NSAID use,
• in patients who have previously experienced allergic symptoms such as rhinitis, urticaria, shortness of breath, or bronchial asthma during treatment with acetylsalicylic acid or other NSAIDs,
• in cases of severe liver, kidney, or heart failure,
• in cases of cerebral haemorrhage (bleeding from cerebral blood vessels) or other bleeding,
• in cases of blood clotting disorders, haemorrhagic diathesis (tendency to bleed), or blood cell production disorders of unknown origin.

If a woman is using this medicine, it must not be taken during the last 3 months of pregnancy.
Warnings and precautions
Before starting treatment with Ibum Forte, discuss this with your doctor or pharmacist.
Exercise particular caution when using Ibum Forte:

• if the patient is taking other painkillers from the NSAID group or acetylsalicylic acid at daily doses above 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 have occurred in the past, as shortness of breath may occur,
• when taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulant drugs (e.g. acenocoumarol), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet drugs (such as acetylsalicylic acid).

Avoid concomitant use of Ibum Forte with other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors such as celecoxib or etoricoxib (increased risk of adverse effects).
Long-term, simultaneous use of painkillers may lead to persistent serious kidney disorders.
Taking anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Ibum Forte, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or has experienced any stroke (including mini-stroke or transient ischaemic attack - TIA),
• the patient suffers from hypertension, diabetes, has elevated cholesterol levels, has a family history of heart disease or stroke, or is a smoker,
• the patient has an infection – see below, section titled "Infections".

Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported.
If any of these symptoms occur, discontinue Ibum Forte immediately and contact a doctor or emergency medical services without delay.
Avoid using Ibum Forte during chickenpox.
Infections
Ibum Forte may mask symptoms of infection such as fever and pain. Therefore, Ibum Forte 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 existing infection and symptoms persist or worsen, immediate medical consultation is required.
Skin reactions
Severe skin reactions associated with the use of Ibum Forte have been reported.
If any skin rash, mucosal lesions, blisters, or other allergic symptoms appear, discontinue taking Ibum Forte immediately and seek medical help promptly, as these may be the first signs of a very serious 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 any of the symptoms related to these serious skin reactions described in section 4 occur, discontinue Ibum Forte immediately and seek medical help.
If any of the above conditions apply to a child, contact a doctor before using Ibum Forte.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may occur without warning symptoms or may occur in patients who previously had such warning symptoms. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately and contact a doctor.
Elderly patients have an increased risk of adverse effects during treatment with NSAIDs, particularly those affecting the stomach and intestines.
Patients who have previously experienced adverse gastrointestinal effects, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.
Children and adolescents
Ibum Forte may be administered to infants under 6 months of age only after consultation with a doctor.
In dehydrated children and adolescents, there is a risk of impaired kidney function.
Ibum Forte and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
Ibum Forte may affect the action of other medicines, or other medicines may affect the action of Ibum Forte.
In particular, before taking ibuprofen, inform your doctor if you are taking any of the following medicines:

• corticosteroids (e.g. prednisolone), as they may increase the risk of gastrointestinal ulceration 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),
• antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan),
• antiplatelet drugs (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of adverse gastrointestinal 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 for the child to drink plenty of fluids throughout the day,
• lithium (a medicine used in depression), as ibuprofen may increase lithium effects,
• methotrexate (a medicine used in cancer or rheumatic diseases), as ibuprofen may increase methotrexate effects,
• tacrolimus (an immunosuppressive medicine), as there is an increased risk of nephrotoxicity,
• cyclosporine (an immunosuppressive medicine), as limited data suggest an increased risk of nephrotoxicity,
• zidovudine (a medicine used in AIDS treatment), as use of Ibum Forte may increase the risk of joint bleeding or bleeding leading to swelling (in patients with haemophilia and positive HIV antibody test),
• sulfonylurea derivatives (antidiabetic medicines): clinical interactions between these medicines and NSAIDs may occur. Blood glucose monitoring is recommended,
• probenecid and sulfinpyrazone (medicines used in gout treatment): 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.

Other medicines may also interact with or be affected by Ibum Forte treatment. Therefore, always consult a doctor or pharmacist before using Ibum Forte with other medicines.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take Ibum Forte during the last 3 months of pregnancy, as it may harm the unborn child or cause delivery complications. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. During the first 6 months of pregnancy, do not use this medicine unless absolutely necessary and prescribed by a doctor. If treatment is necessary 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 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 a 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. When used short-term 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 negligible effect on the ability to drive and operate machinery.
Ibum Forte 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 liquid maltitol in each 5 ml of suspension. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult 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 12.78 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 I F medicine

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is taken orally. Shake the bottle well before use.
The daily dose of I F medicine depends strictly on body weight and is 20–30 mg/kg body weight, given in divided doses according to the following table:

For infants under 6 months of age, the medicine may be administered only after consultation with a physician.
The medicine should be given at intervals of at least six hours.
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 physician immediately (see section 2).
Without consulting a physician, do not use the medicine for longer than 3 days.
For infants aged 3–5 months, if symptoms worsen or persist for longer than 24 hours, consult a physician immediately.
For children over 6 months of age and adolescents, consult a physician if treatment with the medicine is required for more than 3 days or if symptoms worsen.
An oral syringe is included in the package.
Dosing instructions using the oral syringe:

• Before first use, the syringe must be washed thoroughly in warm (not boiling) water with detergent,
• after removing the cap, attach the syringe to the stopper located in the neck of the bottle,
• to fill the syringe, shake the bottle vigorously, turn it upside down, then gently pull the plunger down, drawing the suspension into the syringe to the desired volume indicated on the scale,
• to measure the dose accurately, align the rim 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 stopper (as shown in the illustration),
• place the tip of the syringe into the child's mouth, then slowly press the plunger to gently empty the syringe's contents,
• after use, close the bottle and wash the oral syringe in warm (not boiling) water with detergent, then dry it.

The medicine is intended for short-term use. If symptoms worsen or do not improve within 3 days, or if new symptoms occur, consult a physician.
For patients with sensitive stomachs, it is recommended to take I F medicine during meals.
If the effect of I F medicine seems too strong or too weak, consult a physician.
The medicine does not contain sugar or ethanol. 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 I F medicine or if a child has accidentally ingested the medicine, always consult a physician or go to the nearest hospital for assessment of potential health risks and advice on appropriate actions.
Symptoms may include nausea, stomach pain (abdominal pain), vomiting (possibly with blood), headache, ringing in the ears (tinnitus), disorientation, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, feeling cold, breathing difficulties, eyelid twitching, visual 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.
Discontinuation of medicine I F
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

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 there is any doubt, treatment should be discontinued and medical advice should be sought as soon as possible.
Elderly patients using this medicine belong to a group at increased risk of problems related to adverse effects.
THE TREATMENT MUST BE DISCONTINUED AND IMMEDIATE MEDICAL ADVICE SOUGHT 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 of the medicine. If any of these symptoms occur, immediate medical attention must be sought,
• symptoms of severe skin reactions, such as:
  • red, flat, target-like or circular spots on the trunk, 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 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 (affects 1 to 10 users in 100):

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

Uncommon (affects 1 to 10 users in 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,
• stomach ulcers, which may bleed or perforate,
• oral ulcers and (or) swelling and irritation of the mouth,
• hypersensitivity reactions with rash and itching, asthma attacks (with possible drop in blood pressure).

Rare (affects 1 to 10 users in 10,000):

• tinnitus (ringing in the ears).

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

• inflammation of the oesophagus or pancreas, intestinal obstruction,
• severe skin reactions, including rash with redness and blisters, which may peel and are accompanied by fever, chills, muscle pain, malaise, Stevens-Johnson syndrome. In exceptional cases, severe skin infections have occurred during chickenpox,
• reduced urine output than usual 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 swelling of legs and general malaise),
• problems with blood cell production (early symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose 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, medical advice should be sought,
• swelling, high blood pressure, palpitations, heart failure, heart attack,
• liver function disorders or hepatitis. Liver failure or damage, especially during long-term use, manifesting as yellowing of the skin and eyes, pale stools and dark urine,
• very rarely, during ibuprofen use, symptoms of aseptic meningitis with neck stiffness, headache, malaise, fever or disturbances of consciousness have been observed. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are more susceptible to adverse effects. Immediate medical advice should be sought 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 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, predominantly located in skin folds, trunk and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, treatment with I F should be discontinued and immediate medical help sought. 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 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.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, more information on the safety of the medicine can be collected.

5. How to store I F tablets

Store in the original tightly closed container, 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Ibum Forte contains

• The active substance 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 flavour AR 2157 (containing natural flavouring substances and propylene glycol E 1520), purified water.

What Ibum Forte looks like and contents of the pack
The medicine is a white suspension with a strawberry odour.
The packaging consists of a brown glass bottle with a polyethylene cap with a plug and a tamper-evident ring, containing 100 g of oral suspension, in a cardboard box with a 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]