Ibutact

Leaflet attached to the packaging: patient information

Ibutact 40 mg/mL, oral suspension

Ibuprofen

You should carefully read the contents of the leaflet 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 your doctor, pharmacist, or nurse.

• ‒You should keep this leaflet, so you can read it again if you need to.
• ‒If you need advice or additional information, you should consult a pharmacist.
• ‒If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• ‒If: after 24 hours (if the child is under 6 months old) or after 3 days (if the patient is over 6 months old) there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Ibutact and what is it used for

Ibutact contains the active substance ibuprofen, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs), with analgesic, anti-inflammatory, and antipyretic effects.
The indications for use of the medicine are:

• fever of various origins, including flu, colds, and post-vaccination reactions;
• pains of various origins of mild to moderate severity, such as:
• ‒headache, throat, and muscle pain (e.g., in viral infections),
• ‒toothache, pain after dental procedures, pain due to teething,
• ‒joint and bone pain due to injuries to the musculoskeletal system (e.g., sprains),
• ‒pain due to soft tissue injuries,
• ‒post-operative pain,
• ‒ear pain occurring in middle ear infections.

If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.
Ibutact is indicated for children with a body weight over 5 kg (over 3 months old), adolescents, and adults.

2. Important information before taking Ibutact

When not to take Ibutact:

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6) and to other nonsteroidal anti-inflammatory drugs (NSAIDs);
• if the patient has ever had a hypersensitivity reaction, such as: asthma, rhinitis, itchy skin rash, or swelling of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid (such as aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• if the patient has coagulation disorders;
• if the patient has or has had stomach or duodenal ulcer with perforation or bleeding, or if the patient has had two or more such episodes in the past;
• if the patient has had bleeding or perforation of the gastrointestinal tract associated with previous use of nonsteroidal anti-inflammatory drugs (NSAIDs) (the child may have vomiting with blood or dark particles resembling coffee grounds or black, tarry stools with blood);
• if the patient has an increased tendency to bleeding or problems with the production of certain blood components (such as platelet deficiency - thrombocytopenia);
• if the patient has severe liver, kidney, or heart failure;
• if the patient is in the third trimester of pregnancy;
• if the patient is dehydrated;
• if the child weighs less than 5 kg and is under 3 months old;
• if the patient has hemophilia;
• if the patient has had intracranial bleeding (bleeding from brain vessels) or other active bleeding.

Warnings and precautions

You should inform your pharmacist or doctor if:

• ‒the patient has certain skin diseases (systemic lupus erythematosus, mixed connective tissue disease);
• ‒the patient has gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• ‒the patient has high blood pressure and/or heart function disorders;
• ‒the patient has kidney or liver function disorders;
• ‒there is dehydration due to increased risk of kidney failure;
• ‒the patient has coagulation disorders or is taking anticoagulant medications;
• ‒the patient has asthma or other allergic diseases;
• ‒the patient has symptoms of allergic reactions after taking acetylsalicylic acid;
• ‒the patient has chickenpox;
• ‒the patient is taking other painkillers from the NSAID group or acetylsalicylic acid (in a dose above 75 mg).
• ‒the patient has an infection - see below, section entitled "Infections".

During treatment with ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), chest pain.
In case of noticing any of these symptoms, you should immediately stop taking Ibutact and contact your doctor or emergency medical services immediately.
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have occurred with ibuprofen use. If the patient experiences any symptoms related to these severe skin reactions described in section 4, they should immediately stop taking Ibutact and seek medical attention.

Infections

Ibutact may mask the symptoms of an infection, such as fever and pain. Therefore, Ibutact may delay the use of appropriate infection treatment, which can lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection, and the symptoms of the infection persist or worsen, they should immediately consult a doctor.
You should avoid taking Ibutact and other NSAID painkillers (including COX-2 inhibitors) at the same time.
If the patient experiences gastrointestinal bleeding, skin rash, or mucosal damage, they should stop taking this medicine and consult a doctor.
Like other anti-inflammatory medicines, Ibutact may mask the symptoms of an infection (such as: fever, pain, swelling).
Taking painkillers and anti-inflammatory medicines, such as Ibutact, 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 (see section 3).
During long-term treatment with high doses of painkillers, headaches may occur, which should not be treated with increased doses of painkillers. Generally, habitual use of painkillers, especially in combination with other painkillers, can cause permanent kidney damage and increase the risk of kidney failure.
Before taking Ibutact, the patient should consult 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 grafting, has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• ‒the patient has high blood pressure, diabetes, has high cholesterol levels, has a family history of heart disease or stroke, or smokes.

Ibutact may cause vision disturbances (blind spots, color vision disturbances).
In such a case, the patient should stop taking the medicine and undergo an ophthalmological examination.

Ibutact with food, drink, and alcohol

The medicine should be taken preferably after a meal.
The patient should avoid consuming alcohol while taking Ibutact, as it may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Ibutact should not be taken during the last 3 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 prolong labor. During the first 6 months of pregnancy, Ibutact should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibutact may cause the unborn child to have narrowed blood vessels (ductus arteriosus) in the heart or kidney problems, which can lead to low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment is necessary for a longer period than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts. With short-term use of ibuprofen in recommended doses, harmful effects on breastfed infants are unlikely.
Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is reversible after stopping the medicine. It is unlikely that this medicine, when used occasionally, will affect fertility, but the patient should inform their doctor if they have problems conceiving.

Driving and using machines

Ibutact has no influence or negligible influence on the ability to drive and use machines if used for a short period and in accordance with the recommendations.

Ibutact contains liquid sorbitol

The medicine contains 40 mg of liquid sorbitol in each 1 mL of oral suspension.
Sorbitol is a source of fructose. If fructose intolerance has been previously diagnosed in the patient, or if the patient has hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child.

Ibutact contains propylene glycol

The medicine contains 10 mg of propylene glycol in each 1 mL of oral suspension.

Ibutact contains sodium benzoate (E 211)

The medicine contains 2 mg of sodium benzoate (E 211) in each 1 mL of oral suspension.

Ibutact contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 10 mL of oral suspension, which means the medicine is considered "sodium-free".

3. How to take Ibutact

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. In case of doubt, you should consult your doctor, pharmacist, or nurse.
The patient should use the smallest effective dose for the shortest possible time necessary to relieve the symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should immediately consult a doctor (see section 2).
The medicine is intended for short-term use.
The dosage of the medicine may vary depending on the patient, their age, and the disease.
Each 5 mL of suspension contains 200 mg of ibuprofen.
The medicine does not contain sugar.
Before use, the bottle should be shaken well.

Use in children and adolescents

Ibutact is not recommended for children under 3 months old or with a body weight below 5 kg, due to the lack of sufficient data on its use in this age group.
Children under 6 months old should only be given Ibutact after consulting a doctor.
For children between 3 and 6 months old, the patient should consult a doctor if the symptoms worsen or do not improve within 24 hours.
For children over 6 months old and adolescents, the patient should consult a doctor if it is necessary to give this medicine for more than 3 days or if the symptoms worsen.
The patient should not exceed the recommended dose of the medicine.
The recommended daily dose of the medicine is 20 to 30 mg/kg of body weight, given in 3 or 4 divided doses. There should be at least 6 hours between consecutive doses.

Use in adults

For adults, it is recommended to use other pharmaceutical forms of ibuprofen in a dose of 200 mg, 400 mg, or 600 mg. However, in case of swallowing problems, the medicine in the form of a suspension can be given 4 times a day at a dose of 7.5 mL (corresponding to a single dose of 300 mg of ibuprofen).
For adults and adolescents, the maximum recommended dose of Ibutact is 1200 mg per day.
If it is necessary to use the medicine for more than 3 days to reduce fever or for more than 4 days to treat pain, or if the patient's condition worsens, they should consult a doctor.

Elderly patients

There is no need to adjust the dosage, except in cases of kidney or liver failure.
In such a case, the dose should be determined individually.
If the symptoms do not improve or worsen, the patient should contact their doctor.
The patient should use the smallest effective dose for the shortest possible time necessary to relieve the symptoms.
The patient should not exceed the recommended dose of the medicine.
A measuring spoon or an oral syringe with a capacity of 5 mL and a graduated cylinder is attached to the packaging.

Taking a higher dose of Ibutact than recommended

If the patient has taken a higher dose of Ibutact than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what to do in such a case.
Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and breathing difficulties may occur.

Missing a dose of Ibutact

The patient should not take a double dose to make up for a missed dose.
In case of missing a dose, the next dose should be taken as needed, provided that the last dose was taken at least 4 hours earlier.

Stopping treatment with Ibutact

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibutact can cause side effects, although not everybody gets them.
Medicines like Ibutact may cause a small increase in the risk of heart attack (myocardial infarction) or stroke.
Fluid retention (edema), increased blood pressure, and heart failure have been observed with the use of NSAIDs.

If the patient experiences any of the following serious side effects, they should stop taking the medicine and immediately contact their doctor:

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

• ‒blood in the stool or black, tarry stools;
• ‒vomiting blood or coffee ground-like particles;
• ‒serious allergic reactions, manifested by: swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, fainting, dizziness, or collapse;
• ‒wheezing (asthma), worsening of asthma attacks, difficulty breathing;
• ‒symptoms of meningitis, such as: stiffness of the neck, fever, disorientation, headache, nausea, vomiting. The risk of meningitis is increased in patients with existing autoimmune diseases, such as systemic lupus erythematosus or mixed connective tissue disease;
• ‒red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, 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);
• ‒worsening of existing severe skin infections;
• ‒stomach and duodenal ulcers and gastrointestinal bleeding;
• ‒kidney diseases that can lead to kidney failure (the patient may urinate more or less, may have blood in the urine, or the urine may be cloudy, may have shortness of breath, is weak and tired, has no appetite, and has swollen ankles);
• ‒high blood pressure, heart failure (the patient may be overly tired, have difficulty breathing, or have swelling of the legs);
• ‒blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g., bruising, petechiae, purpura, nosebleeds).

Frequency not known(frequency cannot be estimated from the 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. The symptoms of DRESS syndrome include: widespread skin rash, high body temperature, and swollen lymph nodes, as well as an increased number of eosinophils (a type of white blood cell);
• ‒red, peeling rash with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis);
• ‒severe skin and soft tissue infections as complications that can occur during chickenpox;
• ‒hypersensitivity to light.

In addition, if the patient experiences any of the following serious side effects, they should stop taking the medicine and immediately contact their doctor:

Uncommon(occurring in 1 to 10 in 1,000 patients)

• ‒allergic skin reactions, such as: itching, hives (red rash);
• ‒vision disturbances;
• ‒abdominal pain, nausea.

Rare(occurring in 1 to 10 in 10,000 patients)

• ‒dizziness, insomnia, agitation, irritability, fatigue;
• ‒optic nerve damage;
• ‒vomiting;
• ‒tinnitus.

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

• ‒yellowing of the skin or eyes, pale stools, or abdominal pain (these symptoms may be caused by liver function disorders);
• ‒fatigue, unusual bruising, or unexplained bleeding, sore throat, oral ulcers, flu-like symptoms, including fever. This may be caused by changes in blood morphology;
• ‒infections associated with necrotizing fasciitis (e.g., development of necrotizing fasciitis), and in exceptional cases, severe skin and soft tissue infections as complications that can occur during chickenpox.

Other possible side effects:
Common(affecting 1 to 10 in 100 patients)

• ‒feeling tired.

Uncommon(affecting 1 to 10 in 1,000 patients)

• ‒headache.

Rare(affecting 1 to 10 in 10,000 patients)

• ‒swelling, diarrhea, bloating, constipation. The patient should consult their doctor if bloating persists for more than a few days and is troublesome.

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

• ‒worsening of ulcerative colitis and Crohn's disease;
• ‒swelling or ulcers of the oral mucosa.

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

• ‒fluid retention, which can cause swelling of the limbs;
• ‒high blood pressure;
• ‒increased risk of heart attack or stroke (may be caused by long-term use of ibuprofen in high doses). At the dose level given to children, the likelihood of these side effects is small.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: http://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Ibutact

Do not store above 25°C.
The medicine should be stored out of sight and reach of children.
Before use, shake well.
Shelf life after opening the bottle: 3 months.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ibutact contains

• ‒The active substance of the medicine is ibuprofen. 1 mL of oral suspension contains 40 mg of ibuprofen.
• ‒The other ingredients of the medicine are: propylene glycol, anhydrous citric acid, sodium benzoate (E 211), sodium saccharin, sodium citrate, liquid sorbitol, glycerol, xanthan gum, polysorbate 80, purified water, orange flavor.

What Ibutact looks like and contents of the packaging

Ibutact is a white oral suspension with an orange flavor
Packaging:
A 200 mL bottle made of orange glass type III, closed with an HDPE cap with a cork or without, with a child-resistant closure, in a cardboard box. A 5 mL measuring spoon made of PP with a graduated scale: 1.25 mL, 2.5 mL, 3.75 mL, and 5 mL or an oral syringe made of PE with a capacity of 5 mL with a graduated cylinder made of PP is attached to the packaging.
The packaging contains: 200 mL of oral suspension.

Marketing authorization holder

TACTICA Pharmaceuticals Sp. z o.o.
ul. Królowej Jadwigi 148a/1a
30-212 Kraków
phone: +48 889 388 538
{Logo of the marketing authorization holder}

Manufacturer

Laboratórios Basi - Indústria Farmacêutica S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8,15 e 16
3450-232 Mortágua - Portugal
Date of last revision of the leaflet: