Package leaflet: Information for the patient

Ibum Forte
400 mg, soft capsules
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, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions 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, you should consult a doctor.

Table of contents of the leaflet

What Ibum Forte is and what it is used for
Important information before taking Ibum Forte
How to take Ibum Forte
Possible side effects
How to store Ibum Forte
Contents of the pack and other information

1. What Ibum Forte is and what it is used for

Ibum Forte contains ibuprofen – a substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic and anti-inflammatory properties. The indications for use are:

Mild to moderate pain of various origins:
- headaches (including migraines)
- toothache
- muscular, joint and bone pain
- pain following injuries
- neuralgia
- pain associated with colds and influenza.
Painful menstruation.
Fever of various origins (e.g. during influenza, colds or other infectious diseases).

2. Important information before using Ibum Forte

When not to use Ibum Forte:

if the patient is allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
in patients with active or a history of peptic ulceration or gastrointestinal bleeding, perforation (gastrointestinal perforation), or bleeding, including those occurring after use of NSAIDs;
in patients who have previously experienced allergic reactions such as rhinitis, urticaria, or bronchial asthma during treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
in patients with severe hepatic insufficiency, severe renal insufficiency, or severe heart failure;
in patients taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of adverse effects);
during the last three months of pregnancy;
in patients with haemorrhagic diathesis (tendency to bleed).

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 has symptoms of allergic reactions after taking acetylsalicylic acid;
if the patient has systemic lupus erythematosus or mixed connective tissue disease;
if the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Leśniowski-Crohn disease);
if the patient has hypertension and/or heart function disorders;
if the patient has kidney function disorders;
if the patient has liver function disorders;
if the patient has blood coagulation disorders (ibuprofen may prolong bleeding time);
if the patient has active or a history of bronchial asthma or previous allergic reactions; bronchospasm may occur after administration of the drug;
in patients taking other medications (especially anticoagulants, diuretics, cardiac glycosides, or corticosteroids).

Patients who have previously experienced hypertension and/or heart failure
should exercise particular caution and consult a doctor or pharmacist before
using Ibum Forte, as fluid retention, hypertension, and oedema have been reported during NSAID treatment.
Taking anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with
a small increased risk of myocardial infarction 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 the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack - TIA);
the patient has hypertension, diabetes, high cholesterol levels, 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 difficulty breathing, 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.
Concurrent, long-term use of painkillers may lead to kidney damage
with risk of renal failure (analgesic nephropathy).
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 infection and symptoms persist or worsen, immediate consultation with a doctor is required.
There is a risk of gastrointestinal haemorrhage, ulceration, or perforation, which may be fatal and which may occur without warning symptoms or in patients with previous warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately and contact a doctor. Patients with a history of gastrointestinal disorders,
especially elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial treatment period. These patients should use the lowest effective dose of the medicine.
Exercise caution when administering the medicine to patients taking other drugs that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids
or anticoagulants such as warfarin or acenocoumarol, or antiplatelet agents such as
acetylsalicylic acid.
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 Ibum Forte immediately and seek immediate medical attention, as these may be early 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 been reported with ibuprofen use. If the patient experiences any of the symptoms related to these serious skin reactions described in section 4, discontinue Ibum Forte immediately and seek medical help.
Consult a doctor, even if the above warnings refer to conditions previously experienced.
Effect on fertility in women
See section “Pregnancy, breastfeeding and effect on fertility”.
Children and adolescents
This medicine is not indicated for use in children under 12 years of age.
In dehydrated adolescents aged 12–18 years, there is a risk of impaired kidney function.
Elderly patients
In elderly patients, there is an increased risk of adverse effects.
To minimise the risk of adverse effects, the medicine should be taken for the shortest duration necessary to relieve symptoms.
Ibum Forte and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Ibum Forte may affect the action of other medicines or other medicines may affect
the action of Ibum Forte. For example:

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-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan).

Also, some other medicines may be affected by or may affect Ibum Forte treatment. Therefore,
always consult a doctor or pharmacist before taking Ibum Forte with other medicines.
In particular, before taking Ibum Forte, inform your doctor or pharmacist if you are taking any of the following medicines:

low-dose (75 mg) acetylsalicylic acid once daily,
other NSAIDs,
antihypertensive or diuretic medicines,
medicines reducing blood coagulation (anticoagulants, e.g. acenocoumarol, or antiplatelet agents),
corticosteroids (such as prednisolone or dexamethasone),
methotrexate (an anticancer medicine),
lithium (an antidepressant),
zidovudine (an antiviral medicine).

Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take Ibum Forte if you are in the last three 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 the mother and the child and may delay or prolong labour. Do not use Ibum Forte during the first six months of pregnancy unless absolutely necessary and recommended 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 the 20th week of pregnancy, Ibum Forte may cause kidney dysfunction in the unborn child if taken for more than a few days, which may lead to reduced amniotic fluid volume (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment for longer than a few days is necessary, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts. As there are no reports of harmful effects of ibuprofen on infants, interruption of breastfeeding is not necessary for short-term use of ibuprofen at low doses.
Fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) which may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.
Driving and operating machinery
There is no data available on the effect of Ibum Forte on the ability to drive or operate machinery or on psycho-physical performance when used at the recommended doses and for the recommended duration.
Ibum Forte contains sorbitol, potassium, and sodium
The medicine contains 125.72 mg of sorbitol per capsule. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should contact a doctor before taking the medicine or giving it to a child.
The medicine contains 1.07 mmol (41.81 mg) of potassium per dose, which should be taken into account in patients with impaired kidney function and in patients monitoring potassium intake in their diet.
Quinoline yellow (E 104) and patent blue (E 131) present in the capsule shell contain sodium. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Ibum Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for short-term oral use only. The recommended dose is:
Adults and adolescents over 12 years of age: initial dose of 400 mg (1 capsule), if necessary, every 4 to 6 hours. Do not exceed a dose of 1200 mg (3 capsules) per day, taken in divided doses.
Elderly patients: dose adjustment is not required (see section "Warnings and precautions").
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. This helps reduce the risk of adverse effects. If symptoms of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Consult a doctor if the medicine needs to be used for more than 3 days or if symptoms worsen.
Use in children
This medicine must not be used in children under 12 years of age.
Taking more Ibum Forte than recommended
If a patient takes more than the recommended dose of Ibum Forte or if a child accidentally ingests the medicine, always contact a doctor or go to the nearest hospital for assessment of potential health risks and advice on necessary actions.
Symptoms may include nausea, stomach pain (epigastric pain), less commonly diarrhoea, vomiting (possibly with blood), headache, tinnitus (ringing in the ears), 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 cold, breathing difficulties, and gastrointestinal bleeding have been reported.
Severe poisoning may cause central nervous system disturbances, such as drowsiness, very rarely excitement and disorientation, or coma. Seizures may very rarely occur. During severe poisoning, acute kidney failure or liver damage may occur.
In patients with asthma, worsening of asthma symptoms may occur.
The doctor will provide symptomatic and supportive treatment. Within 1 hour after ingestion of the medicine, administration of activated charcoal is recommended, along with monitoring of vital signs.
If you forget to take Ibum Forte
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Cases of oedema, hypertension and heart failure have been reported with the use of high-dose NSAIDs.
The use of medicines such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If any of the following symptoms occur in a patient, ibuprofen must be discontinued immediately and medical help should be sought:

Red, flat, target-like or circular rashes on the trunk, often with blisters in the centre, 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, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalised exanthematous pustulosis).

Other possible adverse reactions include:
Not very common (in 1 to 10 out of 1,000 patients):

Headache, dyspepsia, abdominal pain, nausea, urticaria, itching,

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

Diarrhoea, flatulence, constipation, vomiting, gastritis, dizziness, insomnia, restlessness, irritability and feeling of fatigue,
Oedema due to kidney and urinary tract disorders,

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

Black, tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease,
Gastric and (or) duodenal ulcer, gastrointestinal bleeding and perforation (gut wall rupture), sometimes fatal, particularly in elderly patients,
In isolated cases: depression, psychotic reactions and tinnitus, aseptic meningitis,
Decreased urine output, oedema, acute renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention),
Liver function disorders, particularly during prolonged use,
Blood morphology abnormalities (anaemia, leukopenia - reduced white blood cell count, thrombocytopenia - reduced platelet count, agranulocytosis - reduced granulocyte count). Initial symptoms include: fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, haemorrhagic purpura (e.g. bruises, petechiae, purpura, nosebleeds),
Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
Severe hypersensitivity reactions such as: facial, tongue and laryngeal swelling, dyspnoea, tachycardia - rapid heartbeat, hypotension - sudden drop in blood pressure, shock, worsening of asthma and bronchospasm,
In patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms occurring in aseptic meningitis have been reported, such as:

neck stiffness, headache, nausea, vomiting, fever, disorientation.
Frequency unknown (frequency cannot be estimated from available data):

Chest pain, which may be a symptom of a potentially serious allergic reaction known as 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, on the trunk and upper limbs, with fever occurring at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, treatment with Ibum Forte must be discontinued immediately and medical help sought without delay. See also section 2,
Skin becomes sensitive to light.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ibum Forte

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton. 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Ibum Forte contains

The active substance is ibuprofen. One capsule contains 400 mg of ibuprofen.
The other ingredients (excipients) are: macrogol 400, potassium hydroxide 50%, gelatin, sorbitol liquid partially dehydrated, purified water, quinoline yellow (E 104), patent blue (E 131).

What Ibum Forte looks like and contents of the pack
Ibum Forte is in the form of elongated, transparent green soft capsules, hermetically filled with a solution, having a smooth and glossy surface.
One pack contains 6, 12, 24 or 36 soft capsules in a cardboard box.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Product Information
tel.: 22 742 00 22
e-mail: [email protected]