Ibum forte pure

Patient Information Leaflet

IBUM FORTE PURE
200 mg/5 ml, oral suspension
Ibuprofenum
Please read the entire 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 for future reference.
• 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 1 day (infants aged 3–5 months) or 3 days (children over 6 months of age, adolescents, and adults), or if symptoms worsen, consult a doctor.

Leaflet Contents

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

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

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

• Fever of various causes, including influenza, common cold, and post-vaccination reactions;
• Mild to moderate pain of various origins, such as:
  • headaches, 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 associated with middle ear inflammation.

2. Important information before using Ibum Forte Pure

When not to use Ibum Forte Pure:

• if the patient is allergic 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 past peptic ulcer disease of the stomach and/or duodenum, perforation (gastrointestinal perforation), or bleeding, including events occurring after use of NSAIDs,
• in patients who previously experienced allergic symptoms during treatment with acetylsalicylic acid or other NSAIDs, such as runny nose, urticaria, shortness of breath, or bronchial asthma,
• in patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake),
• when taking other medicines from the NSAID group (including COX-2 inhibitors such as celecoxib or etoricoxib),
• in case of severe liver failure or severe kidney failure,
• if the patient has severe heart failure (NYHA class IV),
• if there is bleeding in the brain (cerebral hemorrhage) or other bleeding,
• if the patient has blood clotting disorders, hemorrhagic diathesis (tendency to bleed), or blood cell production disorders of unknown origin,
• if the patient is in the last 3 months of pregnancy.

Warnings and precautions
Before starting treatment with Ibum Forte Pure, consult a doctor or pharmacist:

• if the patient is taking other pain-relieving NSAIDs 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 disease,
• after recent major surgery,
• if dehydration is present (especially in children and adolescents) due to increased risk of kidney failure,
• if the patient currently has or has a history of asthma, chronic rhinitis, nasal polyps, or allergic conditions, as shortness of breath may occur,
• when taking other medicines that may increase the risk of ulceration or gastrointestinal bleeding, such as oral corticosteroids (e.g., prednisolone), anticoagulants (e.g., acenocoumarol), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet drugs (such as acetylsalicylic acid).

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 the use of ibuprofen. If any of the symptoms related to these serious skin reactions described in section 4 occur, Ibum Forte Pure must be discontinued immediately and medical help should be sought.
Concurrent, long-term use of painkillers may lead to persistent serious kidney diseases.
Ibum Forte Pure may mask symptoms of existing infection or fever.
Taking anti-inflammatory or pain-relieving 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 Pure, 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 the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• the patient has hypertension, diabetes, elevated cholesterol levels, 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 difficulty breathing, facial and neck swelling (angioedema), and chest pain, have occurred during treatment. If any of these symptoms are observed, Ibum Forte Pure should be discontinued immediately and the patient should contact a doctor or emergency medical services without delay.
Ibum Forte Pure should be avoided during chickenpox.
If any of the above conditions apply to a child, consult a doctor before using Ibum Forte Pure.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may occur without warning symptoms or in patients with prior warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately and contact a doctor.

Infections
Ibum Forte Pure may mask symptoms of infection such as fever and pain. Therefore, Ibum Forte Pure 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 is taking this medicine during an ongoing infection and symptoms persist or worsen, immediate medical consultation is required.

Skin reactions
Severe skin reactions have been reported with the use of Ibum Forte Pure. If any skin rash, mucosal lesions, blisters, or other allergic symptoms appear, discontinue Ibum Forte Pure immediately and seek urgent medical help, as these may be early signs of a very serious skin reaction. See section 4.

Elderly patients have 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 abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial phase of treatment.

Children and adolescents
In infants under 6 months of age, the medicine should be administered only after consultation with a doctor.
In dehydrated children and adolescents, there is a risk of impaired kidney function.

Ibum Forte Pure and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
In particular, inform your doctor or pharmacist if the patient is taking:

• corticosteroids (e.g., prednisolone), as they may increase the risk of gastrointestinal ulceration or bleeding,
• other NSAIDs,
• antiplatelet drugs (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal adverse effects,
• antihypertensive drugs and diuretics, as NSAIDs may reduce the effectiveness of these drugs 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 drug used in depression), as ibuprofen may increase lithium levels,
• methotrexate (a drug used in cancer or rheumatic diseases), as ibuprofen may increase methotrexate levels,
• tacrolimus (an immunosuppressive drug), as there is an increased risk of nephrotoxicity,
• cyclosporine (an immunosuppressive drug), as limited data suggest an increased risk of nephrotoxicity,
• zidovudine (a drug used in AIDS treatment), as use of Ibum Forte Pure may increase the risk of joint bleeding or bleeding leading to swelling (in hemophilia patients with positive HIV antibody test),
• sulfonylurea derivatives (antidiabetic drugs): clinical interactions between these drugs and NSAIDs may occur. Blood glucose monitoring is recommended;
• probenecid and sulfinpyrazone (drugs used in gout treatment): may delay ibuprofen elimination,
• digoxin, phenytoin, and lithium: ibuprofen may increase plasma concentrations of these drugs,
• quinolone antibiotics: may increase the risk of seizures,
• cholestyramine: may delay and reduce absorption of NSAIDs,
• voriconazole and fluconazole (antifungal drugs): may increase exposure to NSAIDs,
• baclofen (a muscle relaxant): toxic effects of baclofen may occur after starting ibuprofen,
• ritonavir (a drug used in HIV therapy): ritonavir may increase plasma concentrations of NSAIDs,
• aminoglycosides (a class of antibiotics): NSAIDs may reduce aminoglycoside elimination,
• mifepristone: NSAIDs should not be used within 8–12 days after mifepristone administration, as they may reduce mifepristone's effectiveness,
• calcium channel blockers: reduced antihypertensive efficacy and increased risk of gastrointestinal bleeding,
• desipramine: increased desipramine toxicity typical of tricyclic antidepressants,
• levofloxacin and ofloxacin: increased risk of serious central nervous system effects,
• thienopyridine derivatives: increased risk of bleeding due to additive antiplatelet and anticoagulant effects,
• bisphosphonates: increased risk of gastrointestinal adverse effects,
• anticoagulant drugs (i.e., blood thinners or those preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering drugs (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan).
  Other medicines may also interact with or be affected by treatment with Ibum Forte Pure. Always consult a doctor or pharmacist before using Ibum Forte Pure with other medicines.

Concomitant use of ibuprofen with herbal products containing Ginkgo biloba or Filipendula ulmaria may increase the risk of bleeding due to additive antiplatelet effects. Concurrent use of ibuprofen and products containing Ephedra sinica may increase the risk of gastrointestinal mucosal damage.

Use of Ibum Forte Pure with food, drink, and alcohol
In patients with sensitive stomachs, Ibum Forte Pure should be taken with food. Food slows the absorption of ibuprofen from the gastrointestinal tract.
When taking high-dose ibuprofen together with alcohol, symptoms such as fatigue and headache may occur.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take Ibum Forte Pure if you 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 tendency to bleeding in both mother and child and may delay or prolong labor. Do not use the medicine during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, use the lowest effective dose for the shortest possible time. From the 20th week of pregnancy, Ibum Forte Pure may cause kidney dysfunction in the unborn child if used for more than a few days, which may lead to reduced amniotic fluid volume (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the fetal heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts. Short-term use at recommended doses appears unlikely to cause harm to the infant.

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 the medicine has no effect or negligible effect on the ability to drive or operate machinery. However, if visual disturbances, fatigue, dizziness, or other nervous system adverse effects occur, driving and operating machinery are not recommended.

Ibum Forte Pure contains maltitol
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Ibum Forte Pure contains 3.357 mg of sodium benzoate in 5 ml of suspension.

3. How to use Ibum Forte Pure

This medicine should always be taken exactly as described in the patient leaflet or as advised by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is taken orally. An oral syringe is included in the packaging.
Before use, shake the bottle vigorously.
The daily dose of Ibum Forte Pure depends strictly on body weight and is 20–30 mg/kg b.w., given in divided doses, according to the table below:

In infants under 6 months of age, the medicine should 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).
I F P does not contain flavours, colourings or sugar.
Information for diabetic patients: 5 ml of I F P suspension contains approximately 1119.00 mg of maltitol, equivalent to approximately 0.07 carbohydrate exchange unit.
Information for individuals with allergies: does not contain flavours or colourings.

Duration of use
I F P medicine is intended for short-term use.
If there is no improvement after 1 day (infants aged 3–5 months) or 3 days (children over 6 months of age, adolescents and adults), or if the patient feels worse, consult a physician.

Instructions for dosing 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 oral syringe onto the closure located in the neck of the bottle.
• To fill the oral syringe, shake the bottle vigorously, turn it upside down, and then slowly pull the plunger down to draw the required amount of suspension as indicated on the syringe scale.
• To measure the dose accurately, align the flange of the oral syringe barrel with the mark on the plunger scale.
• Return the bottle to its upright position and carefully remove the oral syringe from the closure (as shown in the figure).
• Place the tip of the oral syringe into the child's mouth and slowly push the plunger to gently empty its contents (the child should be held in an upright or sitting position).
• After use, close the bottle and wash the oral syringe with warm (not boiling) water and detergent, then dry it thoroughly.

Use of a higher than recommended dose of I F P
If a patient has taken more than the recommended dose of I F P or if a child has accidentally ingested the medicine, seek immediate advice from a physician or go to the nearest hospital to assess potential health risks and receive guidance on necessary actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood traces), headache, tinnitus, disorientation and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, feeling cold and breathing difficulties have been reported.

Missed dose of I F P
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding 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 MEDICINE SHOULD 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. These symptoms may occur even after the first dose of the medicine. If any of these symptoms occur, immediate medical attention is required;
• symptoms of severe skin reactions, such as:
  • red, flat, target-like or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. 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, peeling 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, 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;
• stomach ulcers, which may bleed or perforate;
• oral 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):

• inflammation of the oesophagus or pancreas, intestinal obstruction;
• severe skin reactions, including rashes 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 urine output, cloudy urine, blood in urine, back pain, possible leg swelling and general malaise);
• problems with blood cell production (early symptoms include fever, sore throat, superficial oral ulceration, 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 P, 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 or pale stools and dark urine;
• symptoms of aseptic meningitis, including neck stiffness, headache, malaise, fever or altered consciousness. 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 symptom of a potentially serious allergic reaction called Kounis syndrome;
• severe skin reactions known as DRESS syndrome may occur. 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, treatment with I F P should be stopped immediately and medical help sought without delay. See also section 2;
• skin becomes sensitive to light.

Taking medicines such as I F P 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store I F P

No special requirements for storage of the medicinal product.
Shelf life after first opening of the immediate packaging: 12 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What the medicine I F P contains

• The active substance is ibuprofen. 5 ml of the suspension contains 200 mg of ibuprofen.
• The other ingredients (excipients) are: liquid maltitol (E 965), glycerol (E 422), xanthan gum, sodium saccharin (E 954), sodium benzoate (E 211), fumaric acid, disodium phosphate dodecahydrate, purified water.

What I F P looks like and contents of the pack
The medicine is a white suspension.
The packaging consists of a brown glass bottle of type III with a capacity of 100 mL, closed with a PE cap with an insert and tamper-evident seal, containing 100 g of oral suspension, packed in a cardboard box. An oral syringe is supplied with the package.

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]