Ibutact: detailed information

Package leaflet: Information for the patient

Ibutact 40 mg/mL, oral suspension
Ibuprofen
Please read all of 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
the doctor, pharmacist, or nurse.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
If there is no improvement within 24 hours (in children under 6 months of age) or within 3 days (in patients over 6 months of age), or if the patient feels worse, consult a doctor.

Contents of the leaflet

What Ibutact is and what it is used for
What you need to know before taking Ibutact
How to take Ibutact
Possible side effects
How to store Ibutact
Contents of the pack and other information

1. What Ibutact is and what it is used for

Ibutact contains the active substance ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines have analgesic, anti-inflammatory and antipyretic properties.
Ibutact is indicated for:

Fever of various causes, including influenza, common cold, and post-vaccination reactions;
Mild to moderate pain of various origins, such as:
- Headache, sore throat, and muscle pain (e.g. during viral infections),
- Toothache, pain following dental procedures, pain associated with teething,
- Joint and bone pain due to musculoskeletal injuries (e.g. sprains),
- Pain due to soft tissue injuries,
- Postoperative pain,
- Ear pain occurring in middle ear inflammation.

If there is no improvement after 3 days or if the patient feels worse, medical advice should be sought.
Ibutact is indicated for children weighing over 5 kg (over 3 months of age), adolescents, and adults.

2. Important information before using Ibutact

When not to use Ibutact:

if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), or to other non-steroidal anti-inflammatory drugs (NSAIDs);
if the patient has ever experienced hypersensitivity reactions such as bronchial 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 non-steroidal anti-inflammatory drugs (NSAIDs);
if the patient has blood clotting disorders;
if the patient currently has or has previously had gastric or duodenal ulcer disease with perforation or bleeding, or if the patient has experienced two or more such episodes in the past;
if the patient has had gastrointestinal bleeding or perforation related to previous use of non-steroidal anti-inflammatory drugs (NSAIDs) (the child may vomit blood or dark particles resembling coffee grounds, or have tarry stools containing blood);
if the patient has an increased tendency to bleed or problems with production of certain blood components (such as thrombocytopenia - low platelet count);
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 of age;
if the patient has a bleeding disorder;
if the patient has cerebral haemorrhage (bleeding from brain vessels) or any other active bleeding.

Warnings and precautions
Inform the pharmacist or doctor if:

the patient has been diagnosed with certain skin diseases (systemic lupus erythematosus, mixed connective tissue disease);
the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
the patient has been diagnosed with high blood pressure and/or heart function disorders;
the patient has impaired kidney or liver function;
dehydration is present due to increased risk of kidney failure;
the patient has blood clotting disorders or is taking anticoagulant medicines;
the patient suffers from or has suffered from bronchial asthma or other allergic conditions;
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 doses above 75 mg);
the patient has an infection – see below, section titled “Infections”.

During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), and chest pain.
If any of these symptoms occur, discontinue Ibutact immediately and contact a doctor or emergency medical services without delay.
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 generalized exanthematous pustulosis (AGEP), have been reported with ibuprofen use. If any of the symptoms associated with these serious skin reactions described in section 4 occur, discontinue Ibutact immediately and seek medical help.

Infections
Ibutact may mask signs of infection such as fever and pain. Therefore, Ibutact may delay appropriate treatment of infection, thereby increasing the 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, immediate medical consultation is required.
Avoid concomitant use of Ibutact and other painkillers from the NSAID group (including COX-2 inhibitors).
If the patient experiences gastrointestinal bleeding, skin rash, or mucosal damage, discontinue use of this medicine and consult a doctor.
Like other anti-inflammatory medicines, Ibutact may mask symptoms of infection (such as fever, pain, swelling).
Taking pain-relieving and anti-inflammatory medicines such as Ibutact may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment (see section 3).
During long-term, high-dose treatment with painkillers, headaches may occur, which should not be treated with increased doses of medication. Generally, chronic use of painkillers, especially in combination with other painkillers, may lead to permanent kidney damage and risk of kidney failure.

Before using Ibutact, the patient should consult a doctor or pharmacist if:

the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or if the patient has had any stroke (including mini-stroke or transient ischaemic attack - TIA);
the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

Ibutact may cause visual disturbances (scotoma, colour vision disturbances).
In such cases, discontinue the medicine and undergo ophthalmological examination.

Ibutact with other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
This is particularly important if the patient is taking:

other medicines containing ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs), including those available without prescription;
acetylsalicylic acid (aspirin) used to prevent heart attacks and strokes – after taking ibuprofen, this protection may be reduced;
anticoagulant medicines (e.g. warfarin);
antiplatelet medicines (e.g. dipyridamole, clopidogrel);
mifepristone (used for medical termination of pregnancy);
zidovudine (used in HIV treatment);
sulfonylurea derivatives such as glibenclamide (used in diabetes treatment);
methotrexate (used in psoriasis, arthritis, and certain types of cancer);
cardiac glycosides (e.g. digoxin used in treatment of certain heart conditions);
diuretics;
antihypertensive medicines (e.g. captopril, atenolol, losartan);
corticosteroids (anti-inflammatory medicines);
SSRIs (antidepressants used in depression);
aminoglycoside antibiotics (used in infections);
lithium (used in mood disorders);
cyclosporine or tacrolimus (used to prevent transplant rejection);
cholestyramine (used to lower cholesterol levels);
voriconazole or fluconazole (types of antifungal medicines);
probenecid and sulfinpyrazone (used in gout treatment);
baclofen (a muscle relaxant);
ritonavir (used in HIV treatment);
products containing Gingko biloba, as they may increase the risk of bleeding.

If in doubt whether any of the above situations apply, consult a doctor or pharmacist before using the medicine.
If the patient or caregiver is unsure about which medicines are being taken, show them to the doctor or pharmacist.
Ibutact may affect the action of other medicines, or other medicines may affect the action of Ibutact. For example:

anticoagulant medicines (i.e. blood thinners, preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
medicines lowering blood pressure (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan).

Also, some other medicines may be affected by or may influence treatment with Ibutact. Therefore, always consult a doctor or pharmacist before using Ibutact with other medicines.

Ibutact with food, drink, and alcohol
The medicine should preferably be taken after a meal.
Avoid consuming alcohol during treatment with Ibutact, as it may worsen adverse effects.

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
Do not take Ibutact 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 tendency to bleeding in both mother and child and may delay or prolong labour. During the first 6 months of pregnancy, Ibutact should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibutact may cause narrowing of a blood vessel (ductus arteriosus) in the child's heart or kidney problems, which may lead to low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts. With short-term use at recommended doses, harmful effects on infants are unlikely.

Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible after stopping the medicine. It is unlikely that this medicine, when used occasionally, will affect the ability to conceive; however, if the patient has difficulty conceiving, inform the doctor before using the medicine.

Driving and operating machinery
Ibutact has no effect or negligible effect on the ability to drive and operate machinery when used short-term and according to recommendations.

Ibutact contains non-crystallizing liquid sorbitol
The medicine contains 40 mg of non-crystallizing liquid sorbitol in each 1 mL of oral suspension.
Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in an adult or child, or if hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, has been diagnosed, contact a doctor before taking the medicine or giving it to a 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, meaning the medicine is considered "sodium-free".

3. How to use Ibutact

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
This medicine is intended for short-term use only.
The dosage of this medicine may vary depending on the patient, their age, and the condition being treated.
Each 5 mL of suspension contains 200 mg of ibuprofen.
This medicine does not contain sugar.
Shake the bottle well before use.

Use in children and adolescents
Ibutact is not recommended for children under 3 months of age or weighing less than 5 kg due to insufficient data on use in this age group.
Children under 6 months of age should receive Ibutact only after consultation with a doctor.
For children aged 3 to 6 months, consult a doctor if symptoms worsen or do not improve within 24 hours.
For children aged 6 months and older and adolescents, consult a doctor if this medicine needs to be used for more than 3 days or if symptoms worsen.
Do not exceed the recommended dose.
The recommended daily dose is 20 to 30 mg/kg body weight, administered in 3 or 4 divided doses. At least 6 hours should elapse between consecutive doses.

Child's age (child's body weight)	Single dose	Maximum daily dose
3 – 6 months (5 – 7.6 kg)	1.25 mL (50 mg)	3 times 1.25 mL = 150 mg
6 – 12 months (7.7 – 9 kg)	1.25 mL (50 mg)	3-4 times 1.25 mL = 150-200 mg
1 – 3 years (10 – 15 kg)	2.5 mL (100 mg)	3 times 2.5 mL = 300 mg
4 – 6 years (16 – 20 kg)	3.75 mL (150 mg)	3 times 3.75 mL = 450 mg
7 – 9 years (21 – 29 kg)	5 mL (200 mg)	3 times 5 mL = 600 mg
10 – 12 years (30 – 40 kg)	7.5 mL (300 mg)	3 times 7.5 mL = 900 mg
over 12 years (over 40 kg)	7.5 mL – 10 mL (300–400 mg)	3-4 times 7.5 mL = 900–1200 mg

Use in adult patients
For adult patients, it is recommended to use other ibuprofen pharmaceutical forms
at a dose of 200 mg, 400 mg or 600 mg. However, in case of existing swallowing difficulties,
the medication in suspension form may be administered 4 times daily at 7.5 mL (corresponding to a single dose
of 300 mg ibuprofen).
For adult and adolescent patients, the maximum recommended dose of Ibutact is 1200 mg
per day.
If it is necessary to use the medication longer than 3 days for fever reduction
or longer than 4 days for pain treatment, or if the patient's condition worsens, medical advice
should be sought.
If symptoms do not improve or worsen, contact a doctor.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
Do not exceed the recommended dose of the medication.
An oral dosing spoon or an oral syringe dosing device with a capacity of 5 mL and marked graduations
is included in the package to facilitate accurate dosing.
Overdose of Ibutact
If a patient has taken more than the recommended dose of Ibutact or if a child has accidentally ingested the medication,
immediate medical advice should always be sought from a doctor or at the nearest hospital to assess potential health risks
and receive guidance on appropriate actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood traces), headache, tinnitus, disorientation, and nystagmus.
After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children),
weakness and dizziness, blood in urine, feeling cold, and breathing difficulties may occur.
Missed dose of Ibutact
Do not take a double dose to make up for a missed dose.
If a dose is missed, the next dose should be administered as needed, provided that the last dose was given at least 4 hours earlier.
Discontinuation of Ibutact
If you have any further doubts regarding the use of this medication, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Ibutact may cause adverse effects, although not everyone will experience them.
Medicines such as Ibutact may cause a small increase in the risk of heart attack
(myocardial infarction) or stroke.
Fluid retention (oedema), increased blood pressure and heart failure have been observed in association with the use of NSAIDs.
If the patient experiences any of the serious adverse effects described below,
treatment with this medicine should be discontinued immediately and medical advice
should be sought without delay:
Very rare (occur in no more than 1 in 10,000 patients):

blood in the stool or black, tar-like stools;
vomiting blood or material resembling ground coffee;
severe allergic reactions manifesting as: swelling of the face, tongue, neck or throat, difficulty breathing, rapid heartbeat, fainting, dizziness or collapse;
wheezing (asthma), worsening of asthma attacks, difficulty breathing;
symptoms of meningitis such as: neck stiffness, fever, disorientation, headache, nausea, vomiting. The risk of meningitis is increased in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus or mixed connective tissue disease;
red, flat, disc-shaped or circular rashes on the trunk, often with blisters in the centre, skin peeling, 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);
worsening of pre-existing severe skin infections;
gastric and/or duodenal ulcers and gastrointestinal bleeding;
kidney disorders which may lead to kidney failure (the patient may pass more or less urine, blood in the urine or cloudy urine may occur, the patient may have shortness of breath, feel weak and fatigued, have loss of appetite, or swollen ankles);
hypertension, heart failure (the patient may feel excessively tired, have difficulty breathing or leg oedema);
blood count abnormalities (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include: fever, sore throat, superficial mucosal ulcers in the mouth, flu-like symptoms, fatigue, bleeding (e.g. bruising, petechiae, purpura, nosebleeds).

Frequency unknown (frequency cannot be estimated from available data):

chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome;
severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include widespread skin rash, high fever, swollen lymph nodes and increased eosinophil count (a type of white blood cell);
red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis);
severe skin and soft tissue infections as complications during chickenpox;
photosensitivity.

Furthermore, if the patient experiences any of the serious adverse effects described below,
treatment with this medicine should be discontinued immediately and medical advice
should be sought without delay:
Uncommon (occur in 1 to 10 in 1,000 patients)

skin allergic reactions such as: itching, urticaria (red rash);
visual disturbances;
abdominal pain, indigestion, nausea.

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

dizziness, insomnia, restlessness, irritability, feeling tired;
optic nerve damage;
vomiting;
tinnitus.

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

yellowing of the skin or eyes, pale stools or upper abdominal pain (these symptoms may be due to liver function disorders);
fatigue, unusual bruising or unexplained bleeding, sore throat, mouth ulcers, flu-like symptoms including fever. These may be caused by changes in blood counts;
infections associated with inflammation (e.g. development of necrotising fasciitis); in exceptional cases, severe skin and soft tissue infections as complications may occur during chickenpox infection.

Other possible adverse effects:
Common (affects 1 to 10 in 100 patients)

feeling tired.

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

headache.

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

oedema, diarrhoea, bloating, constipation. Consult a doctor if bloating persists for more than a few days and is bothersome.

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

exacerbation of ulcerative colitis and Crohn's disease;
oedema or ulcers of the oral mucosa.

Frequency unknown (frequency cannot be estimated from available data)

fluid retention, which may cause swelling of the limbs;
hypertension;
increased risk of heart attack or stroke (may be caused by long-term use of high-dose ibuprofen). At the dose used in children, the likelihood of these adverse effects is low.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of 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: http://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ibutact
Do not store above 25 °C.
Keep the medicine out of sight and reach of children.
Shake well before use.
Shelf-life after first opening of the bottle: 3 months.
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 should 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 Ibutact contains

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

What Ibutact looks like and contents of the pack
Ibutact is an orange-flavoured white oral suspension.
Pack:
A 200 mL amber glass bottle of type III, closed with an HDPE screw-cap with or without a liner, with child-resistant closure, contained in a cardboard box. The pack includes a measuring spoon made of PP with a capacity of 5 mL, marked at 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 marked every 0.25 mL.
The pack contains: 200 mL of oral suspension.
Marketing Authorisation Holder
TACTICA Pharmaceuticals Sp. z o.o.
Królowej Jadwigi Street 148a/1a
30-212 Kraków
Tel.: +48 889 388 538
{Logo of the Marketing Authorisation Holder}
Manufacturer
Laboratórios Basi - Indústria Farmacêutica S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8,15 e 16
3450-232 Mortágua - Portugal