Ibutrixen fast

Package leaflet: Information for the patient

Ibutrixen Fast, 400 mg, soft capsules
Ibuprofenum
Please read this leaflet carefully before taking this medicine, because 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, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days in adolescents or adults for migraine headaches or fever, or after 4 days in adults for pain treatment, or if symptoms worsen, consult a doctor.

Table of contents:

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

1. What Ibutrixen Fast is and what it is used for

Ibutrixen Fast belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and contains ibuprofen. Ibuprofen reduces pain and fever.
Ibutrixen Fast is used for short-term symptomatic treatment of:

• mild to moderate pain, e.g. headache, menstrual pain, toothache;
• acute migraine attacks with or without aura;
• fever.

Ibutrixen Fast is indicated for adults and adolescents with a body weight of at least 40 kg (aged 12 years and above).

2. Important information before using Ibutrixen Fast

When not to take Ibutrixen Fast:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if the patient has experienced allergic reactions such as asthma, angioedema, urticaria, or rhinitis after taking acetylsalicylic acid or similar pain-relieving medicines (NSAIDs)
• if the patient has severe liver failure, severe kidney failure, or severe heart failure
• if the patient is in the last three months of pregnancy (see section "Pregnancy and breastfeeding")
• if the patient currently has or has a history of active or recurrent peptic ulceration or bleeding of the stomach and/or duodenum (peptic ulcer disease) or gastrointestinal bleeding (at least two separate confirmed episodes of ulceration or bleeding)
• if the patient has previously experienced gastrointestinal bleeding or perforation related to the use of NSAIDs
• if the patient has cerebral hemorrhage (cerebrovascular bleeding) or any other active bleeding
• if the patient is severely dehydrated (e.g. due to vomiting, diarrhea, or insufficient fluid intake)
• if the patient has unexplained disorders of blood cell production (haematopoietic system)

Warnings and precautions
The use of anti-inflammatory and/or pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when high doses are used. Do not exceed the recommended dose or duration of treatment.
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 Ibutrixen Fast immediately and contact a doctor or emergency medical services without delay.

Before starting treatment with Ibutrixen Fast, consult a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of 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 impaired liver or kidney function. In general, regular use (of several types) of pain-relieving medicines may lead to permanent kidney problems. This risk may be increased during physical exertion associated with loss of salts and dehydration (e.g. caused by vomiting, diarrhea, or insufficient fluid intake)
• the patient has or has had gastrointestinal disorders or chronic inflammatory bowel disease, such as ulcerative colitis or Crohn's disease
• caution is required if the patient is taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants), or antiplatelet agents (e.g. acetylsalicylic acid)
• the patient is taking another medicine from the NSAID group (including COX-2 inhibitors such as celecoxib or etoricoxib), since concomitant use should be avoided (see section "Ibutrixen Fast and other medicines")
• the patient has mixed connective tissue disease (autoimmune disease) or systemic lupus erythematosus (autoimmune disease)
• the patient has certain genetic disorders affecting blood cell production (such as acute intermittent porphyria)
• the patient has blood clotting disorders
• the patient has recently undergone major surgery
• the patient is dehydrated
• the patient has asthma or any allergic conditions, as difficulty in breathing may occur
• the patient has hay fever, nasal polyps, or chronic obstructive pulmonary disease, as there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), Quincke's edema, or urticaria
• the patient has an infection – see section "Infections" below

Prolonged use of any type of pain-relieving medicine for headaches may worsen the headaches. If headache worsens or this is suspected, medical advice should be sought and treatment discontinued.

Skin reactions
Severe skin reactions have been reported with the use of ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Discontinue ibuprofen capsules and seek immediate medical attention if you notice any symptoms such as skin rash, mucosal lesions, blisters, or other allergic symptoms, as these may be early signs of a serious skin reaction. See section 4.

The risk of adverse effects is minimized by using the lowest effective dose for the shortest possible duration. Elderly patients are at increased risk of adverse effects from NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Do not take different pain-relieving medicines simultaneously unless specifically advised by a doctor.

Gastrointestinal bleeding, ulceration, or perforation, which may be fatal, have been reported during treatment with all NSAIDs at any time during therapy, with or without warning symptoms or previous serious gastrointestinal events in the patient's history. If gastrointestinal bleeding or ulceration occurs, treatment must be stopped immediately. The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher NSAID doses, in patients with a history of peptic ulcer disease, especially complicated by bleeding or perforation (see section 2), and in elderly patients. These patients should start treatment with the lowest available dose. In such patients, and in patients requiring concomitant use of low-dose acetylsalicylic acid or other drugs that may increase gastrointestinal risk, concomitant gastroprotective treatment (e.g. misoprostol or proton pump inhibitors) should be considered.

Patients with a history of gastrointestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial phase of treatment.

Infections
Ibutrixen Fast may mask symptoms of infection such as fever and pain. Therefore, the use of Ibutrixen Fast may delay the initiation of appropriate treatment for infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with varicella (chickenpox). If the patient is taking this medicine during an infection and symptoms persist or worsen, immediate medical advice should be sought. During varicella (varicella), the use of this medicine should be avoided.

Consult a doctor if any of the above conditions apply to the patient.

Children and adolescents
In dehydrated adolescents, there is a risk of impaired kidney function.
This medicine is not intended for use in adolescents weighing less than 40 kg or in children under 12 years of age.

Ibutrixen Fast and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Ibutrixen Fast may affect the action of other medicines, and other medicines may affect the action of Ibutrixen Fast.

For example:

• anticoagulant medicines (i.e. blood thinners and/or preventing blood clots, such as acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan)

Other medicines may also influence treatment with Ibutrixen Fast capsules. Therefore, always consult a doctor or pharmacist before using Ibutrixen Fast with other medicines.

In particular, inform your doctor or pharmacist if you are taking:

Ibutrixen Fast and alcohol
Do not drink alcohol while taking Ibutrixen Fast. Some adverse effects, such as those affecting the gastrointestinal tract or central nervous system, may be more likely if alcohol is consumed at the same time as Ibutrixen Fast.

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
Ibutrixen Fast should not be taken during 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 also increase the tendency for bleeding in both the mother and child and may delay or prolong labour. During the first six months of pregnancy, Ibutrixen Fast should not be used unless the doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, Ibutrixen Fast may cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart or kidney problems, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios).

If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

If the patient has taken this medicine during pregnancy, she must speak immediately with her doctor or midwife so that appropriate monitoring can be arranged.

Breastfeeding
Ibuprofen passes into breast milk, but is unlikely to affect the infant. Short-term use of this medicine at recommended doses is acceptable during breastfeeding. Consult a doctor if prolonged use of the medicine is required during breastfeeding.

Fertility
This medicine belongs to the group of NSAIDs, which may impair fertility in women. This effect is reversible after discontinuation of the medicine.

Patients should consult their doctor if any of the above conditions apply.

Driving and operating machinery
Ibuprofen usually has no effect or has negligible effect on the ability to drive and operate machinery.

However, at higher doses, adverse effects on the central nervous system such as fatigue and dizziness may occur, which in individual cases may impair reaction ability and the capacity to actively participate in road traffic or operate machinery. This is more likely when the medicine is taken together with alcohol.

Ibutrixen Fast contains soya
Ibutrixen Fast contains soya lecithin. Do not use if known hypersensitivity to peanuts or soya has been diagnosed.

Ibutrixen Fast contains potassium
This medicine contains 28 mg of potassium in one capsule. This should be taken into account in patients with impaired renal function or in patients who are controlling potassium intake in their diet.

Ibutrixen Fast contains sorbitol
Contains sorbitol (E 420). Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should consult a doctor before taking or using this medicine.

3. How to use Ibutrixen Fast

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If an infection is present, contact a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents with body weight of at least 40 kg (aged 12 years and above):
The recommended single dose is 1 capsule of ibuprofen (400 mg). If needed, an additional dose of 1 capsule of ibuprofen (400 mg) may be taken. The appropriate interval between doses should be determined according to observed symptoms and the maximum recommended daily dose.
The interval should not be less than 6 hours. Do not take more than 3 capsules of Ibutrixen Fast (1200 mg) within 24 hours.
This medicine is intended for short-term use only.

Instructions for administration
Capsules should be swallowed whole with a large amount of liquid. Patients with sensitive stomachs are advised to take Ibutrixen Fast with food.

Consult a doctor:

• Adults – if migraine headache or fever requires treatment for more than 3 days, or if pain requires treatment for more than 4 days, or if symptoms worsen.
• Adolescents aged 12 to 17 years – if treatment is needed for longer than 3 days or if symptoms worsen.

Use in children and adolescents
This medicine is not intended for use in children under 12 years of age or in adolescents weighing less than 40 kg.

Overdose of Ibutrixen Fast
If more capsules than recommended are taken, or if this medicine is accidentally ingested by children, contact a doctor immediately or go to the nearest hospital for assessment of potential health risks and advice on necessary actions.
Symptoms of overdose may include nausea, abdominal pain, vomiting (which may be bloody), gastrointestinal bleeding (see section 4), diarrhoea, headache, tinnitus, confusion, and nystagmus, as well as worsening of asthma in patients with asthma. Additionally, agitation, drowsiness, disorientation, or coma may occur. Seizures sometimes occur in patients.
When large doses are taken, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, presence of blood in urine, low blood potassium levels, feeling of coldness, and breathing difficulties may be reported. Furthermore, prothrombin time/INR may be prolonged, probably due to interference with circulating clotting factors. Acute kidney failure and liver damage may also occur. In addition, low blood pressure and respiratory depression may develop.

If a dose of Ibutrixen Fast is missed
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, Ibutrixen Fast can cause adverse reactions, although not everyone will experience them.

• Fluid retention (edema), high blood pressure, and heart failure have been reported with treatment using NSAIDs.
• Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

The most commonly observed adverse reactions are gastrointestinal. Gastric and/or duodenal ulcers (peptic ulcer disease), perforation, or bleeding, sometimes fatal, may occur, particularly in elderly patients (see section 2 "Warnings and precautions"). After administration of the medicine, the following have been reported: nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, oral and pharyngeal ulcers (ulcerative stomatitis), exacerbation of colitis and Crohn's disease (see section 2 "Warnings and precautions"). Less frequently, inflammation of the gastric mucosa (gastritis) has been observed. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment.

Ibutrixen Fast should be discontinued and medical advice sought immediately if any of the following symptoms occur:

• Severe abdominal pain, especially after starting treatment with Ibutrixen Fast (uncommon: may affect up to 1 in 100 people).
• Black stools, bloody diarrhoea or vomiting blood (uncommon: may affect up to 1 in 100 people).
• Skin rash, severe skin peeling or blistering, mucosal lesions (very rare: may affect up to 1 in 10,000 people), or any signs of hypersensitivity (uncommon: may affect up to 1 in 100 people).
• Fever, sore throat and oral pain, flu-like symptoms, fatigue, nosebleeds and skin bleeding. These may be due to a reduction in white blood cells (agranulocytosis) (very rare: may affect up to 1 in 10,000 people).
• Severe or persistent headache (very rare: may affect up to 1 in 10,000 people).
• Blisters on the palms and soles (Stevens-Johnson syndrome) (very rare: may affect up to 1 in 10,000 people).
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling and increased eosinophil count (a type of white blood cell) (frequency unknown: cannot be estimated from available data).
• Red, scaly, widespread rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, Ibutrixen Fast should be discontinued and immediate medical help sought. See also section 2 (frequency unknown: cannot be estimated from available data).
• Red, non-elevated, target-like or circular lesions on the trunk, often with blisters in the centre, skin peeling, and ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin reactions 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 generalised exanthematous pustulosis).

Other possible adverse reactions

• Common: gastrointestinal disorders such as heartburn, abdominal pain and nausea, diarrhoea, vomiting, flatulence (wind) and constipation may occur in up to 1 in 10 people. Minor gastrointestinal bleeding, which in rare cases may lead to anaemia, may also occur.
• Uncommon: may affect up to 1 in 100 people: gastrointestinal ulceration, potentially with bleeding and perforation, ulcerative stomatitis, worsening of pre-existing bowel disease (colitis or Crohn's disease), gastric mucosal inflammation.
  • Hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly with low blood pressure).

Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability and fatigue.
Visual disturbances

• Rare: may affect up to 1 in 1,000 people: tinnitus, hearing loss. Pain in the flanks and/or epigastrium, blood in urine and fever may be symptoms of kidney damage (papillary necrosis). Increased blood uric acid levels, increased blood urea levels.
• Very rare: may affect up to 1 in 10,000 people: If signs of infection occur or worsen during treatment with Ibutrixen Fast, immediate medical advice should be sought. The need for anti-infective and/or antibiotic therapy should be evaluated. Aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or altered consciousness has been observed after ibuprofen administration. Patients with autoimmune disorders (systemic lupus erythematosus (SLE), mixed connective tissue disease) appear to be predisposed. Problems with blood cell production (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) – initial symptoms include: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding. In such cases, treatment should be stopped immediately and medical advice sought. Do not self-medicate with analgesics or antipyretic medicinal products. Severe generalised allergic reactions (hypersensitivity reactions) – symptoms may include: facial, tongue and throat swelling, shortness of breath, rapid heartbeat, low blood pressure, up to life-threatening anaphylactic shock. Immediate medical help is required if any of these symptoms occur, even after first use. Psychotic reactions, depression. Palpitations, heart failure, myocardial infarction, oedema, hypertension and heart failure have been reported with high-dose NSAID treatment. Arterial hypertension, vasculitis. Asthma, dyspnoea, bronchospasm. Oesophagitis, pancreatitis, formation of diaphragm-like strictures in the small intestine. If relatively severe epigastric pain, vomiting blood or black stools occur, treatment should be discontinued and medical advice sought. Liver damage (initial symptoms may include skin discolouration), especially with long-term therapy, liver failure, acute hepatitis, impaired liver function. Reduced urine output and oedema (particularly in patients with high blood pressure or reduced kidney function); oedema (swelling) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis), which may lead to acute renal failure. If any of the above symptoms or general malaise occur, Ibutrixen Fast should be discontinued and immediate medical advice sought, as these may be early signs of kidney damage or kidney failure. Severe forms of skin reactions, including rash with redness and blisters, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), hair loss (alopecia).
• Frequency not known (cannot be estimated from available data): Skin becomes sensitive to light.

The use of medicines such as Ibutrixen Fast may be associated with a small increased risk of myocardial infarction ("heart attack") or stroke (see section 2 "Other warnings").

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ibutrixen Fast

This medicine should be stored in a place inaccessible and out of sight of children.
Do not use Ibutrixen Fast after the expiry date (EXP) stated on the carton and blister pack.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
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 pack and other information

What Ibutrixen Fast contains

• The active substance is ibuprofen. Each capsule contains 400 mg of ibuprofen.
• The other components are:
  Capsule contents: Macrogol 600, Purified water, Potassium hydroxide
  Capsule shell: Gelatin, Sorbitol, liquid, partially dehydrated (E 420), Erythrosine (E 127), Purified water, Soy lecithin, Medium-chain triglycerides, Macrogol 600

What Ibutrixen Fast looks like and contents of the pack
Ibutrixen Fast is a transparent, reddish-pink, oval, soft gelatin capsule containing a sticky liquid ranging in colour from clear to pale pink.
Pack sizes: PVDC/PVC/aluminium blisters containing 2, 4, 10, 12, 16, 20, 24, 30, or 50 soft capsules. The blisters are packed in cardboard boxes.
Not all pack sizes may be available on the market.

Marketing Authorisation Holder
Promedo Pharma Products GmbH
Anklamer Strasse 28
10115 Berlin
Germany
[email protected]

Importer
Fairmed Healthcare GmbH
Maria-Goeppert-Straße 3
23562 Lübeck
Germany

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria: Ibuprofen-Fairmed Healthcare 400 mg Weichkapseln
France: Ibuprofene Strides 400 mg capsules molle
Spain: Ibuprofeno Strides 400 mg capsulas blandas EFG
Netherlands: Ibuprofen Strides 400 mg zachte capsules
Germany: Ibu-Fairmed Healthcare 400 mg Weichkapseln
Poland: Ibutrixen Fast
Czech Republic: Ibuprofen Strides
Romania: Ibuprofen Heaton 400 mg capsule moi
Italy: Ibuprofene Strides