Ibutrixen

Package leaflet: Information for the patient

Ibutrixen, 400 mg, coated tablets
Ibuprofenum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken 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, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if your condition worsens, consult your doctor.

Table of contents

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

1. What Ibutrixen is and what it is used for

Ibutrixen contains ibuprofen – a substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen has anti-inflammatory, analgesic and antipyretic properties.
Ibutrixen is indicated for the treatment of mild to moderate pain of various origins:

• headaches (including migraine headaches);
• back pain;
• toothache, e.g. after tooth extraction;
• neuralgia;
• muscle and joint pain;
• painful menstruation and fever associated with influenza and common cold.

Ibutrixen is indicated for use in adults and adolescents aged 12 years and older with a body weight of at least 40 kg.

2. Important information before using Ibutrixen

When not to use Ibutrixen:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6) or to other non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients with active or past peptic ulcer disease of the stomach and/or duodenum, perforation or bleeding, including those occurring after use of NSAIDs,
• in patients who have previously experienced allergic symptoms such as rhinitis, urticaria or bronchial asthma during treatment with acetylsalicylic acid or other NSAIDs,
• in severe hepatic insufficiency, severe renal insufficiency or severe heart failure,
• when taking other non-steroidal anti-inflammatory drugs simultaneously, including COX-2 inhibitors (increases the risk of adverse reactions),
• during the last three months of pregnancy,
• in bleeding disorders,
• in children under 12 years of age or in patients with body weight below 40 kg.

Warnings and precautions
Before starting to use Ibutrixen, discuss this with your doctor or pharmacist.

• if the patient has systemic lupus erythematosus or mixed connective tissue disease,
• if the patient has experienced allergic reactions after taking acetylsalicylic acid,
• if the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• if the patient has hypertension and/or heart function disorders,
• if the patient has renal function disorders,
• if the patient has hepatic function disorders,
• if the patient has blood coagulation disorders (ibuprofen may prolong bleeding time),
• if the patient has active or past bronchial asthma or history of allergic reactions, bronchospasm may occur after administration of the drug,
• patients taking other medicines (especially anticoagulants, diuretics, cardiac medications or corticosteroids).

There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and which may occur without warning symptoms or may occur even when such warning symptoms were present. If gastrointestinal bleeding or ulceration occurs, ibuprofen treatment must be discontinued.
Patients with a history of gastrointestinal disorders, particularly elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial treatment period. Concurrent, long-term use of painkillers may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Taking anti-inflammatory/analgesic 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 Ibutrixen, 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 myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or if the patient has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• the patient has hypertension, diabetes, high cholesterol levels, family history of heart disease or stroke, or if the patient smokes;
• the patient has an infection - see below, section titled "Infections".

Skin reactions
Severe skin reactions associated with the use of Ibutrixen have been reported.
If any skin rash, mucosal lesions, blisters or other signs of allergy appear, the use of Ibutrixen must be stopped immediately and medical help should be sought without delay, as these may be the first signs of a very serious skin reaction. See section 4.

Infections
Ibutrixen may mask signs of infection such as fever and pain. Therefore, this medicine 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 symptoms of infection persist or worsen, medical advice should be sought immediately.

Elderly patients have an increased risk of adverse reactions associated with ibuprofen use compared to younger patients.
The frequency and severity of adverse reactions can be minimized by using the lowest therapeutic dose for the shortest possible duration.
Consult a doctor even if the above warnings refer to conditions that occurred in the past.

Children
The medicine is not indicated for use in children under 12 years of age or in patients with body weight below 40 kg.
There is a risk of renal failure in dehydrated adolescents.

Ibutrixen and other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use.
Do not take Ibutrixen if you are taking other medicines from the group of non-steroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors such as celecoxib or etoricoxib), other analgesics or acetylsalicylic acid (in analgesic doses).
Ibutrixen may affect the action of other medicines or other medicines may affect the action of Ibutrixen. In particular:

• anticoagulant medicines (i.e. blood thinners/preventing clot formation), such as acetylsalicylic acid (aspirin), warfarin, ticlopidine,
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan),
• diuretics (e.g. furosemide, bumetanide, thiazides),
• corticosteroids (such as prednisolone or dexamethasone),
• methotrexate (an anticancer medicine),
• lithium (an antidepressant medicine),
• zidovudine (an antiviral medicine),
• cardiac glycosides (i.e. digoxin),
• mifepristone,
• CYP2C9 inhibitors (antifungal medicines) such as voriconazole, fluconazole,
• sulfonylurea derivatives (medicines lowering blood glucose levels),
• cyclosporine and tacrolimus (immunosuppressive medicines, e.g. after transplants),
• cholestyramine (a cholesterol-lowering medicine),
• SSRIs (antidepressants such as fluoxetine, sertraline),
• aminoglycosides.

Other medicines may also be affected by or have an effect on treatment with Ibutrixen.
Therefore, always consult a doctor or pharmacist before using Ibutrixen with other medicines.

Pregnancy and breastfeeding and effect on fertility

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

Pregnancy
Do not take Ibutrixen if you are in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibutrixen may lead to disturbances in kidney and heart function in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. During the first 6 months of pregnancy, do not use Ibutrixen unless your doctor strictly recommends it. If treatment is necessary during this period or during attempts to become pregnant, use the lowest possible dose for the shortest possible time. If Ibutrixen is taken by women beyond 20 weeks of pregnancy for longer than a few days, it may cause disturbances in kidney function in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of the ductus arteriosus in the baby's heart. If treatment is required for longer than a few days, additional monitoring should be recommended.

Breastfeeding
Ibuprofen may pass into breast milk in small amounts. Since there have been no reports of harmful effects of ibuprofen on infants, interruption of breastfeeding is not necessary during short-term use of ibuprofen at low doses. However, if longer-term treatment is recommended, interruption of breastfeeding should be considered.

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 disappears after discontinuation of treatment. In case of difficulty in becoming pregnant, consult your doctor before taking ibuprofen.

Driving and operating machinery
The use of Ibutrixen may affect reaction time in some patients. This should be taken into account in situations requiring full psychophysical performance, e.g. when driving a car. This applies to a greater extent to patients who have also consumed alcohol.

Ibutrixen contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

3. How to use Ibutrixen

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.
Treatment should be initiated with the lowest effective dose, which may then be adjusted according to
the response to treatment and any adverse effects.
This medicine is intended for oral use only, in adults and adolescents aged 12 years and older,
and weighing at least 40 kg.
Adults and adolescents aged 12 years and older, and weighing at least 40 kg:
1 tablet every 4-6 hours. The interval between doses should be at least 4 hours.
Do not exceed the total dose of 1200 mg of ibuprofen (3 tablets) within 24 hours.
To achieve a faster onset of action, the medicine may be taken on an empty stomach. Patients with
a sensitive stomach are advised to take ibuprofen with food.
Ibutrixen should be taken with a glass of water. The tablets should be swallowed whole and must
not be chewed, broken, crushed, or sucked, to avoid oral discomfort and throat irritation.
If the medicine needs to be taken for more than 3 days, or if symptoms worsen or new symptoms
appear, medical advice should be sought.

Elderly patients
In elderly patients, there is an increased risk of serious adverse effects. If treatment with an NSAID
(non-steroidal anti-inflammatory drug) is considered necessary, the lowest effective dose should be
used for the shortest possible duration. During treatment with NSAIDs, patients should be regularly
monitored for gastrointestinal bleeding.
Dosage should be individually adjusted in patients with impaired kidney or liver function.
Do not exceed the recommended dose! If you feel that the effect of Ibutrixen is too strong or too weak,
consult your doctor.
This medicine is intended for short-term use only. The lowest effective dose should be used for the
shortest possible duration to minimize the risk of adverse effects.

Taking more Ibutrixen than recommended
In case of suspected overdose, contact your doctor immediately.
If a patient has taken more than the recommended dose of Ibutrixen, or if a child has accidentally
ingested the medicine, always consult a doctor or go to the nearest hospital to assess potential health
risks and receive advice on necessary actions.
Symptoms may include nausea, stomach 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 (especially in children), weakness, dizziness, blood
in urine, feeling cold, and breathing difficulties may occur.
Gastrointestinal bleeding, diarrhoea, and restlessness may also occur.
There is no specific antidote. In case of suspected overdose, contact a doctor immediately, even if the
patient feels well. Treatment includes removal of the drug from the body (e.g. gastric lavage, activated
charcoal within 1 hour of overdose, antacids if the drug has already been absorbed) and symptomatic
treatment.

If you forget to take Ibutrixen
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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following undesirable effects may occur:
Common (occur in no more than 1 in 10 patients):

• headache, dizziness, feeling of fatigue;
• gastrointestinal disorders such as indigestion, diarrhoea, nausea, vomiting, abdominal pain, bloating with gas release, constipation, tarry stools, vomiting blood, gastrointestinal bleeding;
• rash.

Uncommon (occur in no more than 1 in 100 patients):

• blood count abnormalities (leukopenia, thrombocytopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia);
• hypersensitivity reactions such as facial swelling, tongue and larynx swelling, shortness of breath;
• insomnia, restlessness;
• inflammation of the stomach lining, duodenal ulcer, gastric ulcer, oral mucosal ulceration, gastrointestinal perforation;
• hepatitis, jaundice, abnormal liver function;
• tingling sensation, drowsiness;
• visual disturbances (scotoma), blurred vision, double vision;
• shortness of breath, bronchospasm, asthma;
• urticaria, itching, small bruises on skin and mucous membranes, photosensitivity;
• nephrotoxicity in various forms, e.g. interstitial nephritis, nephrotic syndrome and renal failure;
• hearing impairment;
• nasal mucosal irritation.

Rare (occur in no more than 1 in 1,000 patients):

• diarrhoea, bloating, constipation, vomiting, gastritis;
• liver damage;
• depression, disorientation;
• impaired vision, colour vision disturbances;
• tinnitus, vertigo;
• symptoms of anaphylactic reaction such as swelling, cough, shortness of breath, diarrhoea;
• general disorders and local reactions at the site of administration such as oedema;
• symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever or disorientation.

Very rare (occur in no more than 1 in 10,000 patients):

• liver failure;
• pancreatitis;
• severe forms of skin reactions (e.g. erythema multiforme, bullous lesions, including Stevens-Johnson syndrome and toxic epidermal necrolysis).

Frequency not known (frequency cannot be estimated from available data):

• severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymphadenopathy, 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, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis);
• exacerbation of colitis and Crohn's disease. If such symptoms occur, treatment with Ibutrixen should be discontinued immediately and medical help should be sought without delay. See also section 2;
• heart failure, myocardial infarction;
• arterial hypertension (high blood pressure).

Treatment with NSAIDs at high doses has been associated with the occurrence of oedema, arterial hypertension and heart failure.
The use of drugs such as Ibutrixen 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 possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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
PL 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 provide more information on the safety of this medicine.

5. How to store Ibutrixen

No special storage instructions required.
The medicine should be stored in a place inaccessible and out of sight 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 in use. This will help protect the environment.

6. Contents of the package and other information

What Ibutrixen contains

• The active substance is ibuprofen. One coated tablet contains 400 mg of ibuprofen.
• The other ingredients are: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, colloidal anhydrous silica, polyvinylpyrrolidone, corn starch, sodium lauryl sulfate, magnesium stearate. Coating composition: hydroxypropylmethylcellulose (E 463), hypromellose-3cps (E 464), hypromellose-6cps (E 464), macrogol 400, titanium dioxide (E 171).

What Ibutrixen looks like and contents of the pack
Ibutrixen is a white, capsule-shaped, film-coated tablet, smooth on both sides.
PVC/Aluminium blisters in cardboard packaging.
Pack sizes:
Blisters: 10, 12, 20, 24, 30, 36, 48, 50, 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Promedo Pharma Products GmbH
Anklamer Strasse 28
10115 Berlin
Germany

Manufacturer and Importer
Medezin Sp. z o.o.
ul. Ks. Kazimierza Janika 14
95-050 Konstantynów Łódzki
Poland

For further information, please contact the local representative of the Marketing Authorisation Holder:
Promedo Pharma Products GmbH
Anklamer Strasse 28
10115 Berlin
Germany
email: [email protected]
tel: +48 22 329 65 00