Ibum express forte

Package leaflet: Information for the patient

Ibum Express 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
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, consult a physician.

Table of contents

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

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

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

• Mild to moderate pain of various origins:
  • Headaches (including migraine)
  • Toothache
  • Muscular, joint and bone pain
  • Pain following injuries
  • Neuralgia
  • Pain associated with cold and influenza.
• Painful menstruation.
• Fever of various origins (e.g. associated with influenza, cold or other infectious diseases).

2. Important information before using Ibum Express Forte

When not to use Ibum Express Forte:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• in patients with active or recurrent peptic ulcer or duodenal ulcer, perforation (gastrointestinal perforation), or gastrointestinal bleeding, including cases occurring after use of NSAIDs,
• in patients who during treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs experienced any allergic symptoms such as rhinitis, urticaria, dyspnoea, or bronchial asthma,
• when taking other medicines from the NSAID group (including COX-2 inhibitors such as celecoxib or etoricoxib),
• if the patient has severe liver, kidney, or heart failure,
• if the patient has cerebral bleeding (bleeding from cerebral vessels) or other bleeding,
• if the patient has blood coagulation disorders, haemorrhagic diathesis (tendency to bleed), or blood cell production disorders of unknown origin,
• in dehydrated patients (dehydration caused by vomiting, diarrhoea, or insufficient fluid intake),
• during the last three months of pregnancy.

Warnings and precautions
Before starting to use Ibum Express Forte, discuss this with your doctor or pharmacist.
Exercise special caution when using Ibum Express Forte:

• if the patient is taking other painkillers from the NSAID group or acetylsalicylic acid,
• 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, Leśniowski-Crohn disease),
• if the patient has been diagnosed with high blood pressure and/or heart function disorders,
• if the patient has been diagnosed with kidney function disorders,
• if the patient has been diagnosed with liver diseases,
• after recent major surgery,
• if dehydration is present due to increased risk of kidney failure,
• if the patient has blood coagulation disorders (ibuprofen may prolong bleeding time),
• in case of current or past asthma, chronic rhinitis, nasal polyps, or allergic diseases, as dyspnoea 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 (e.g. acetylsalicylic acid).

Patients who have ever had hypertension and/or heart failure
should exercise particular caution and consult their doctor or pharmacist before
using the medicine, as fluid retention, hypertension, and oedema have been reported during NSAID treatment.
Taking anti-inflammatory/analgesic medicines such as ibuprofen may be associated with
a small increased risk of heart attack or stroke, especially when used in high
doses. Do not exceed the recommended dose or duration of treatment.
Before using Ibum Express 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), has had a heart attack, coronary artery bypass surgery, has 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 suffers from hypertension, diabetes, has elevated cholesterol levels, has a family history of heart disease or stroke, or if the patient smokes,
• the patient has an infection - see below, the section titled "Infections".

During ibuprofen use, symptoms of allergic reaction to this medicine have occurred, including
difficulty breathing, swelling in the face and neck area (angioedema), chest pain.
If any of these symptoms are noticed, discontinue Ibum Express
Forte immediately and contact a doctor or emergency medical services without delay.
Concurrent, long-term use of painkillers may lead to persistent
serious kidney diseases.
There is a risk of kidney failure in dehydrated patients.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which
may be fatal and may not necessarily be preceded by warning symptoms
or may occur in patients who have previously experienced such warning symptoms. In case of
gastrointestinal bleeding or ulceration, discontinue the medicine immediately and
contact a doctor. Patients with a history of gastrointestinal disorders,
especially elderly patients, should report any unusual gastrointestinal symptoms
(particularly bleeding) to their doctor, especially during the initial period
of treatment. Such patients should use the lowest possible dose of the medicine.
Exercise caution when using ibuprofen in patients simultaneously taking other medicines
that may increase the risk of stomach and intestinal disorders or bleeding, such as
corticosteroids or anticoagulants such as warfarin or acenocoumarol, selective
serotonin reuptake inhibitors, or antiplatelet drugs such as acetylsalicylic acid.

Skin reactions
Severe skin reactions associated with the use of Ibum Express
Forte have been reported. If any of the following occur: skin rash,
mucous membrane changes, blisters, or other allergic symptoms, discontinue taking Ibum Express Forte and seek immediate
medical help, 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 generalised exanthematous pustulosis (AGEP) have been reported with ibuprofen use. If the patient develops any of the symptoms
associated with these serious skin reactions described in section 4, discontinue
Ibum Express Forte immediately and seek medical help.

Infections
Ibum Express Forte may mask symptoms of infection such as fever and pain. Therefore, Ibum
Express Forte may delay appropriate treatment of infection 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
takes this medicine during an existing infection and infection symptoms persist or worsen,
consult a doctor immediately.
Avoid using Ibum Express Forte during chickenpox.

Effect on fertility in women
See section "Pregnancy, breastfeeding and effect on fertility".

Children and adolescents
Do not use this medicine in children under 12 years of age.
In dehydrated adolescents aged 12-18 years, there is a risk of kidney function impairment.

Elderly patients
Elderly patients have an increased risk of adverse effects during
NSAID use, particularly those affecting the stomach and intestines.
Taking the medicine at the lowest effective dose for the shortest necessary period to relieve
symptoms reduces the risk of adverse effects.

Ibum Express Forte and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Ibum Express Forte may affect the action of other medicines or other medicines may affect
the action of Ibum Express Forte. For example:

• corticosteroids (e.g. prednisolone): 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/agents preventing clot formation, 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),
• antiplatelet drugs (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants): increase the risk of gastrointestinal adverse effects,
• antihypertensive medicines and diuretics: NSAIDs may weaken the effect of these medicines and there is a possibility of increased risk of kidney damage; in such cases it is important for the patient to drink large amounts of water throughout the day,
• lithium (a medicine used in depression): the effect of lithium may be increased,
• methotrexate (a medicine used in cancer or rheumatic disease treatment): the effect of methotrexate may be increased,
• tacrolimus (an immunosuppressive medicine): increases the risk of nephrotoxic effects,
• cyclosporine (an immunosuppressive medicine): limited data suggest an increased risk of nephrotoxic effects,
• zidovudine (a medicine used in AIDS treatment): using Ibum Express Forte may lead to increased 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 excretion,
• digoxin and phenytoin: ibuprofen may increase plasma concentrations of these medicines,
• quinolone antibiotics: may increase the risk of seizures,
• cholestyramine: may delay and reduce absorption of NSAIDs,
• mifepristone: do not use NSAIDs within 8-12 days after mifepristone administration, as they may weaken the effect of mifepristone,
• voriconazole and fluconazole (antifungal medicines): may increase the risk associated with NSAID use.

Before taking ibuprofen, inform your doctor if you are taking any of the
above-mentioned medicines. Some other medicines may also be affected by or have an effect on
Ibum Express Forte treatment. Therefore, always consult your doctor or pharmacist before using Ibum Express Forte with other medicines.

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

Pregnancy
Do not take Ibum Express Forte if the patient is in the last three 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 cause delayed or
prolonged labour. Do not use the medicine during the first 6 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 week 20 of pregnancy, Ibum Express Forte may cause kidney function disorders in
the unborn child if taken for longer than a few days, which may lead to
reduced amniotic fluid volume surrounding the child (oligohydramnios), or narrowing of the
blood vessel (ductus arteriosus) in the child's heart. If treatment is necessary for
longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen may pass into breast milk in small amounts. After
short-term use of ibuprofen at recommended doses, harmful effects on infants
appear unlikely.

Fertility
Medicines from this group (non-steroidal anti-inflammatory drugs) may adversely affect fertility in
women. This is a reversible effect that resolves after discontinuation of treatment.

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

Ibum Express Forte contains sorbitol, potassium, and sodium
The medicine contains 90 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 does not break down fructose, the patient should contact a doctor before taking the medicine or giving it to a child.
The medicine contains less than 1 mmol (39 mg) of potassium per dose, meaning the medicine is considered "potassium-free".
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 Express Forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by a physician or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for short-term oral use. The recommended dose is:
Adults and adolescents over 12 years of age: initial dose is 1 capsule (400 mg). If necessary, 1 capsule every 4 to 6 hours. Do not exceed a dose greater than 1200 mg (3 capsules) per day, taken in divided doses.
Elderly patients: dosage adjustment is not required (see section "Warnings and precautions").
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. This minimizes the risk of adverse effects. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Seek medical advice 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 Express Forte than recommended
If a patient takes more than the recommended dose of Ibum Express Forte or if a child accidentally ingests the medicine, always consult a doctor or go to the nearest hospital to assess potential health risks and receive advice on appropriate actions.
Symptoms may include nausea, stomach ache (abdominal pain), 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, dizziness, blood in urine, feeling cold, breathing difficulties, eyelid twitching, visual disturbances, rarely low blood pressure, changes in blood composition, and impaired kidney function have been reported.
Missed dose of Ibum Express 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.
Elderly patients taking this medicine belong to a group at increased risk of adverse reactions.
Taking medicines such as Ibum Express Forte may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
THE MEDICINE SHOULD BE DISCONTINUED AND MEDICAL ADVICE SOUGHT IMMEDIATELY IF THE PATIENT 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,
• 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 enlarged 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 reactions 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 or large intestine, exacerbation of Crohn's disease (inflammatory bowel disease),
• headache, dizziness, insomnia, restlessness, irritability or fatigue,
• visual disturbances,
• stomach ulcers which may bleed or perforate,
• mouth ulcers and (or) swelling and irritation of the mouth,
• hypersensitivity reactions with rash and itching, asthma attacks (possibly with drop in 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 during chickenpox (varicella),
• reduced urine output 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 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 Ibum Express Forte, medical advice should be sought,
• swelling, high blood pressure, palpitations, heart failure, heart attack,
• liver function disorders or hepatitis; liver failure or liver damage, especially during prolonged use, manifesting as yellowing of the skin and eyes or pale stools and dark urine,
• very rarely, symptoms of aseptic meningitis with neck stiffness, headache, malaise, fever or disturbances in consciousness have been observed during ibuprofen use; patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are more susceptible to adverse reactions; medical advice should be sought immediately 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, lymph node swelling and increased eosinophil count (a type of white blood cells),
• 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 Ibum Express Forte should be discontinued and immediate medical help sought. 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 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ibum Express Forte

Do not store above 25°C. Keep in the original packaging to protect from light.
Keep the medicine 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Ibum Express 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, quinoline yellow (E 104), patent blue (E 131).

What Ibum Express Forte looks like and contents of the pack
Ibum Express Forte is an oval, transparent green capsule, filled with a solution and having a smooth surface.
One pack contains 6, 12, 24 or 36 capsules in PVC/PVDC/Aluminium blisters, packed 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]