Ibutrixen Fast

Patient Information Leaflet: Information for the Patient

Ibutrixen Fast, 400 mg, Soft Capsules

Ibuprofen

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This medication should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist.
• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days in adolescents or adults with migraine headache or fever, or after 4 days in adults with pain, there is no improvement or you feel worse, consult your doctor.

Table of Contents of the Leaflet:

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

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

• mild to moderate pain, such as headaches, menstrual cramps, toothaches.
• acute migraine headaches with or without aura
• fever.

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

2. Important information before taking Ibutrixen Fast

When Not to Take Ibutrixen Fast:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if you have had allergic reactions such as difficulty breathing, asthma, angioedema, hives, or runny nose after taking acetylsalicylic acid or similar painkillers (NSAIDs)
• if you have severe liver, kidney, or heart failure
• if you are in the last three months of pregnancy (see "Pregnancy and Breastfeeding")
• if you have active or recurrent stomach or duodenal ulcers (peptic ulcer disease) or bleeding (at least 2 different confirmed episodes of ulceration or bleeding)

if you have had bleeding from the gastrointestinal tract or perforation in connection with the use of NSAIDs

• if you have had bleeding from the blood vessels in the brain (cerebrovascular bleeding) or other active bleeding
• if you are severely dehydrated (e.g., due to vomiting, diarrhea, or insufficient fluid intake)
• if you have unexplained disorders of blood cell production (hematopoietic system)

Warnings and Precautions

Taking anti-inflammatory and pain-relieving medications like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose and duration of treatment.
When taking ibuprofen, symptoms of allergic reactions to this medication have occurred, including difficulty breathing, swelling around the face and neck (angioedema), chest pain. If you notice any of these symptoms, stop taking Ibuprofen and seek medical help immediately.
Before starting treatment with Ibutrixen Fast, consult your doctor or pharmacist if:

you have heart disease, such as heart failure, angina pectoris (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack, "TIA")

you have high blood pressure, diabetes, high cholesterol, or if there is a history of heart disease or stroke in your family, or if you smoke

you have liver or kidney problems. Generally, habitual use of painkillers can lead to lasting kidney problems. This risk may be increased in the case of physical exertion associated with loss of salts and dehydration (e.g., caused by vomiting, diarrhea, or insufficient fluid intake).

you have or have had gastrointestinal problems or chronic inflammatory bowel disease, such as ulcerative colitis or Crohn's disease.

caution is advised if you are taking other medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids (e.g., prednisolone), blood thinners (e.g., warfarin), or anti-platelet agents (e.g., acetylsalicylic acid).

you are taking another NSAID (including COX-2 inhibitors, such as celecoxib or etoricoxib), as concurrent use should be avoided (see "Ibutrixen Fast and other medications").

you have mixed connective tissue disease (an autoimmune disease) or systemic lupus erythematosus (an autoimmune disease)

you have certain genetic blood cell production disorders (such as acute intermittent porphyria)

you have bleeding disorders

you have recently undergone major surgery

you are dehydrated

you have or have had asthma or any allergic diseases, as breathing difficulties may occur.

you have hay fever, nasal polyps, or chronic obstructive pulmonary disease, there is an increased risk of allergic reactions. Allergic reactions can manifest as asthma attacks (so-called analgesic asthma), angioedema, or hives.

you have infections - see "Infections" below.

Long-term use of any type of pain reliever for headaches can lead to their worsening. If this occurs or is suspected, consult your doctor and discontinue treatment.

Skin Reactions

Severe skin reactions have occurred with ibuprofen, 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). Discontinue Ibutrixen Fast capsules and seek medical help immediately if you notice any symptoms related to skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

The risk of side effects is minimized by using the smallest effective dose for the shortest possible duration. Elderly patients are at increased risk of side effects from NSAIDs, particularly gastrointestinal bleeding and perforation, which can be fatal. Do not take different pain relievers at the same time unless your doctor has told you to do so.

Gastrointestinal bleeding, ulcers, or perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning signs or a history of serious gastrointestinal events. If gastrointestinal bleeding or ulcers occur, treatment should be discontinued immediately. The risk of gastrointestinal bleeding, ulcers, or perforation is higher when increasing NSAID doses, in patients with a history of ulcers, especially if complicated with bleeding or perforation (see section 2), and in the elderly. These patients should start treatment with the lowest available dose. For these patients, as well as those requiring concurrent use of low-dose acetylsalicylic acid or other medications that may increase the risk of gastrointestinal adverse effects, consideration should be given to concomitant therapy with protective agents (e.g., misoprostol or proton pump inhibitors).

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

Infections

Ibutrixen Fast may mask the signs of infection, such as fever and pain. Therefore, taking Ibutrixen Fast may delay the start of appropriate treatment for the infection, potentially leading to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you are taking this medication during an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

During chickenpox, it is recommended to avoid taking this medication.

Consult your doctor if any of the above conditions apply to you.

Children and Adolescents

In adolescents who are dehydrated, there is a risk of kidney function disorder.
This medication is not intended for use in children under 12 years of age and adolescents with a body weight below 40 kg.

Ibutrixen Fast and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Ibutrixen Fast may affect the action of other medications or other medications may affect the action of Ibutrixen Fast.
For example:

anticoagulant medications (i.e., blood thinners and/or anti-clotting agents, such as acetylsalicylic acid, warfarin, ticlopidine)

blood pressure-lowering medications (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Other medications may also affect treatment with Ibutrixen Fast capsules. Therefore, before taking Ibutrixen Fast with other medications, always consult your doctor or pharmacist.
In particular, inform your doctor or pharmacist if you are taking:

Ibutrixen Fast and Alcohol
Do not drink alcohol while taking Ibutrixen Fast. Some side effects, such as those related to the gastrointestinal system or central nervous system, may be more likely if alcohol is consumed with Ibutrixen Fast.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Pregnancy
Do not take Ibutrixen Fast if you are 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 risk of bleeding in the mother and child and cause prolongation or delay of labor. During the first six months of pregnancy, do not take Ibutrixen Fast unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the smallest dose for the shortest possible duration. From the 20th week of pregnancy, Ibutrixen Fast may cause the unborn child's arterial duct to narrow or kidney problems, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios).
If treatment is required for a longer period, your doctor may recommend additional monitoring.
If you have taken this medication while pregnant, you must talk to your doctor/obstetrician to consider appropriate monitoring.
Breastfeeding
Ibuprofen passes into breast milk, but it is unlikely to affect the baby.
Brief use of this medication is allowed during breastfeeding. Consult your doctor if there is a need for longer use during breastfeeding.
Fertility
This medication belongs to a group of NSAIDs that may affect female fertility. This effect is reversible after stopping the medication.
Consult your doctor if any of the above conditions apply to you.

Driving and Using Machines

Ibuprofen usually has no or negligible influence on the ability to drive and use machines.
However, as side effects from the central nervous system, such as fatigue and dizziness, may occur, especially with higher doses, the ability to react and participate in traffic or operate machinery may be impaired in individual cases. This is more pronounced when the medication is taken with alcohol.

Ibutrixen Fast Contains Soy

Ibutrixen Fast contains soy lecithin. Do not use if you have a known hypersensitivity to peanuts or soy.

Ibutrixen Fast Contains Potassium

This medication contains 28 mg of potassium per capsule. This should be taken into account in patients with reduced kidney function or those controlling their potassium intake.

Ibutrixen Fast Contains Sorbitol

Contains sorbitol (E 420). Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should consult your doctor before taking or using this medication.

3. How to Take Ibutrixen Fast

Always take this medication exactly as described in this patient leaflet or as advised by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The smallest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
Adults and adolescents with a body weight of at least 40 kg (from 12 years of age and above):
The recommended single dose is 1 capsule of ibuprofen (400 mg). If necessary, an additional dose of 1 capsule of ibuprofen (400 mg) can be taken. The interval between doses should be determined based on observed symptoms and the maximum recommended daily dose.
It should not be less than 6 hours. Do not take more than 3 capsules of Ibutrixen Fast (1200 mg) in 24 hours.
This medication is intended for short-term use only.
Method of Administration
Swallow the capsules whole with a large amount of fluid. For people with sensitive stomachs, it is recommended to take Ibutrixen Fast with food.
Consult your doctor:

• Adults - if migraine headache or fever treatment is required for more than 3 days, or if pain treatment is required for more than 4 days, or if symptoms worsen.
• Adolescents from 12 to 17 years old - if treatment is required for more than 3 days or if symptoms worsen.

Use in Children and Adolescents
This medication is not intended for use in children under 12 years of age and adolescents with a body weight below 40 kg.

Overdose of Ibutrixen Fast

In case of overdose, seek medical help immediately. Symptoms of overdose may include nausea, abdominal pain, vomiting (which may be bloody), gastrointestinal bleeding (see section 4), diarrhea, headache, ringing in the ears, confusion, and tremors of the eyeballs, as well as exacerbation of asthma in asthmatic patients. Additionally, there may be agitation, sleepiness, disorientation, or coma. Seizures have also been reported.
In cases of overdose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Blood in the urine and low potassium levels in the blood may also occur, as well as feeling cold and breathing difficulties. Furthermore, the prothrombin time/INR may be prolonged, likely due to the disruption of circulating clotting factors. Acute kidney failure and liver damage may also occur, as well as low blood pressure and slowed breathing.

If You Miss a Dose of Ibutrixen Fast

Do not take a double dose to make up for a forgotten dose.
In case of further doubts about the use of this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Ibutrixen Fast can cause side effects, although not everybody gets them.

• With NSAID treatment, fluid retention, high blood pressure, and heart failure have been reported.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

The most commonly observed side effects are related to the gastrointestinal system. They may include stomach ulcers and (or) duodenal ulcers (peptic ulcer disease), perforation, or bleeding, sometimes fatal, especially in elderly patients (see section 2 "Warnings and Precautions"). After taking the medication, the following have been reported: nausea, vomiting, diarrhea, bloating, gas, constipation, gastrointestinal upset, abdominal pain, hair loss (alopecia), and inflammation of the mouth and throat (stomatitis).

Stop Taking Ibutrixen Fast and Seek Medical Help Immediately if You Experience Any of the Following Symptoms:

• severe abdominal pain, especially after starting Ibutrixen Fast (uncommon: may affect up to 1 in 100 people).
• black stools, bloody diarrhea, or vomiting blood (uncommon: may affect up to 1 in 100 people).
• skin rash, severe scaling of the skin, or blisters, mucosal lesions, or any signs of allergy (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 mouth ulcers, flu-like symptoms, fatigue, nosebleeds, and skin bleeding. This could be due to a decrease in the number of white blood cells in the body (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 of the hands and soles of the feet (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, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell) (frequency not known: cannot be estimated from the available data).
• A red, scaly, widespread rash with unevenness under the skin and blisters mainly in skin folds, on the torso, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, discontinue Ibutrixen Fast and seek medical help immediately. See also section 2 (frequency not known: cannot be estimated from the available data).
• Reddened, flat, target-like, or circular patches on the torso, often with blisters in the center, scaling of the skin, mouth ulcers, throat ulcers, genital ulcers, and 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, scaly rash with bumps under the skin and blisters, with fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Other Side Effects That May Occur

• Common: may affect up to 1 in 10 people gastrointestinal disorders, such as heartburn, abdominal pain, and nausea, diarrhea, vomiting, bloating, gas, and constipation; minor gastrointestinal bleeding, which can rarely lead to anemia.
• Uncommon: may affect up to 1 in 100 people gastrointestinal ulcers, potentially with bleeding and perforation, mouth ulcers, worsening of existing bowel disease (ulcerative colitis or Crohn's disease), stomach inflammation.
• allergic reactions with skin rash and itching, as well as asthma attacks (possibly with a drop in blood pressure).

central nervous system disorders, such as headache, dizziness, insomnia, excitement, irritability, and fatigue.
visual disturbances

• Rare: may affect up to 1 in 1,000 people ringing in the ears, hearing loss. Side pain and (or) upper abdominal pain, and blood in the urine and fever may be signs of kidney damage (papillary necrosis). Elevated uric acid levels in the blood, elevated urea levels in the blood.
• Very Rare: may affect up to 1 in 10,000 people If you experience symptoms of infection while taking Ibutrixen Fast, consult your doctor immediately. It should be investigated whether there are indications for antimicrobial and/or antibiotic therapy. After taking ibuprofen, symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, and changes in consciousness have been observed. Patients with autoimmune disorders (systemic lupus erythematosus (SLE), mixed connective tissue disease) seem to be predisposed. blood cell production problems (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) - the first symptoms are: fever, sore throat, mouth ulcers, flu-like symptoms, fatigue, nosebleeds, and skin bleeding. In such cases, therapy should be discontinued immediately and a doctor consulted. Do not take pain relievers or antipyretic medications on your own. severe allergic reactions (hypersensitivity reactions) - symptoms may include: facial swelling, tongue and throat swelling, difficulty breathing, rapid heartbeat, blood pressure drop, and potentially life-threatening shock. If any of these symptoms occur, which can happen even with the first use, immediate medical help is necessary. psychotic reactions, depression in connection with high-dose NSAID treatment, palpitations, heart failure, myocardial infarction, edema, hypertension, and heart failure. high blood pressure, vasculitis, asthma, difficulty breathing, bronchospasm, esophageal inflammation, pancreatitis, intestinal strictures. If you experience severe abdominal pain, vomiting blood, or black stools, discontinue treatment and consult your doctor. kidney damage (first signs may include decreased urine output and swelling), kidney failure, nephrotic syndrome; interstitial nephritis, which may lead to acute kidney failure. severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), and hair loss (alopecia).
• Frequency Not Known(frequency cannot be estimated from the available data): Skin becomes sensitive to light.

Taking medications like Ibutrixen Fast may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke (see section 2 "Other Warnings").

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Ibutrixen Fast

Keep this medication out of the sight and reach of children.
Do not use Ibutrixen Fast after the expiration date (EXP) stated on the carton and blister.
The expiration date refers to the last day of the month.
Do not store above 25°C.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer needed. This will 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.
• Other ingredients are: Capsule contents: Macrogol 600, Purified water, Potassium hydroxide, Capsule shell: Gelatin, Sorbitol, liquid, partially dehydrated (E 420) Erythrosine (E 127), Purified water Soybean 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 viscous liquid with a color ranging from clear to pale pink.
Pack sizes: PVDC/PVC/aluminum blisters of 2, 4, 10, 12, 16, 20, 24, 30, 50 soft capsules. Blisters are packaged in cartons.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Promedo Pharma Products GmbH
Anklamer Strasse 28
10115 Berlin
Germany
biuro@promedopharma.de

Importer

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

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

Austria
Ibuprofen-Fairmed Healthcare 400 mg Soft Capsules
France
Ibuprofene Strides 400 mg capsules molles
Spain
Ibuprofeno Strides 400 mg soft capsules EFG
Netherlands
Ibuprofen Strides 400 mg soft capsules
Germany
Ibu-Fairmed Healthcare 400 mg Soft Capsules
Poland
Ibutrixen Fast
Czech Republic
Ibuprofen Strides
Romania
Ibuprofen Heaton 400 mg soft capsules
Italy
Ibuprofene Strides

Date of Last Revision of the Leaflet: