IBUXAL 40 mg /Ml Suspension

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Ibuxal Forte For Children, 40 mg/mL, oral suspension
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Ibuxal Forte For Children and what is it used for
4. Important information before taking Ibuxal Forte For Children
   1. When not to take Ibuxal Forte For Children:
   2. Warnings and precautions
   3. Infections
   4. Ibuxal Forte For Children with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Ibuxal Forte For Children contains sorbitol 70% (E 420)
   8. Ibuxal Forte For Children contains propylene glycol
   9. Ibuxal Forte For Children contains sodium benzoate (E 211)
   10. Ibuxal is considered sodium-free
5. How to take Ibuxal Forte For Children
   1. Use in children and adolescents
   2. Use in adults
   3. Taking a higher dose of Ibuxal Forte For Children than recommended
   4. Missing a dose of Ibuxal Forte For Children
6. Possible side effects
   1. STOP taking the medicine and seek medical attention immediately if the patient experiences:
   2. In addition, if the patient experiences any of the following side effects, they should stop taking the medicine and seek medical attention immediately:
   3. Other possible side effects:
   4. Reporting side effects
7. How to store Ibuxal Forte For Children
8. Contents of the pack and other information
   1. What Ibuxal Forte For Children looks like and what the pack contains
   2. Marketing authorization holder
   3. Manufacturer
   4. Date of the last revision of the leaflet:

Leaflet accompanying the packaging: information for the user

Ibuxal Forte For Children, 40 mg/mL, oral suspension

Ibuprofen

Read the leaflet carefully before taking the 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 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 more information, you should speak to your pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 Ibuxal Forte For Children and what is it used for
• 2. Important information before taking Ibuxal Forte For Children
• 3. How to take Ibuxal Forte For Children
• 4. Possible side effects
• 5. How to store Ibuxal Forte For Children
• 6. Contents of the pack and other information

1. What is Ibuxal Forte For Children and what is it used for

Ibuxal Forte For Children contains ibuprofen, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which work by reducing pain, inflammation, and fever. Ibuxal Forte For Children is used in the following cases:

• fever of various origins (also in the course of viral infections, in the course of post-vaccination reactions);
• pains of various origins of mild to moderate severity, such as:
• headaches, throat and muscle pains, e.g., in the course of viral infections;
• muscle, joint, and bone pains due to injuries to the musculoskeletal system (sprains, strains);
• pains due to soft tissue injuries, post-operative pains;
• pains due to teething, toothaches, pains after dental procedures;
• headaches (including migraines);
• ear pains occurring in inflammatory conditions of the middle ear.

2. Important information before taking Ibuxal Forte For Children

When not to take Ibuxal Forte For Children:

• 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, hay fever, 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 bleeding disorders;
• if the patient has or has had stomach or duodenal ulcers, 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 vomit containing blood or dark particles resembling coffee grounds or black, tarry stools containing blood);
• if the patient has an increased tendency to bleed 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.

Warnings and precautions

Before starting treatment with Ibuxal Forte For Children, the patient should discuss it with their doctor, pharmacist, or nurse. This is especially important:

• if the patient has systemic lupus erythematosus and mixed connective tissue disease
• if the patient has gastrointestinal diseases and chronic inflammatory bowel diseases, such as: Crohn's disease or ulcerative colitis;
• if the patient has hypertension and (or) heart failure in the past;
• if the patient has kidney or liver dysfunction;
• if the patient has recently undergone surgery;
• if the patient is taking anticoagulant medications;
• if the patient is dehydrated (especially in children and adolescents), as there is a risk of kidney dysfunction;
• if the patient has chickenpox;
• if the patient has an infection - see below, section entitled "Infections".

In patients with asthma or a history of allergic diseases, bronchospasm may occur. In elderly patients, there is an increased risk of adverse reactions during treatment with NSAIDs, particularly those affecting the stomach and intestines. Patients who have previously experienced adverse reactions in the gastrointestinal tract, especially elderly patients, should report any unusual symptoms in the abdominal cavity (especially gastrointestinal bleeding), especially in the initial stages of treatment. Concomitant, long-term use of painkillers may lead to kidney disease. Serious skin reactions have been reported with the use of Ibuxal Forte For Children. If the following occur: any skin rash, changes in the mucous membranes, blisters, or other signs of allergy, the patient should stop taking Ibuxal Forte For Children and seek medical attention immediately, as these may be the first signs of a very serious skin reaction. See section 4. Taking painkillers and anti-inflammatory drugs, such as Ibuxal Forte For Children, 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. With the use of ibuprofen, serious skin reactions have occurred, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP). If the patient experiences any of the symptoms associated with these serious skin reactions described in section 4, they should stop taking Ibuxal Forte For Children and seek medical attention immediately. Before taking Ibuxal Forte For Children, the patient should consult their doctor or pharmacist if:

• the patient has heart diseases, such as heart failure, angina pectoris (chest pain), has had a heart attack, has had a bypass operation, 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 hypertension, diabetes, has high cholesterol levels, has a family history of heart disease or stroke, or smokes.

Ibuxal Forte For Children may cause vision disturbances (blind spots, color vision disturbances). In such cases, the patient should stop taking the medicine and have an eye examination. 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. If any of these symptoms are noticed, the patient should stop taking Ibuxal Forte For Children and contact their doctor or emergency medical services immediately.

Infections

Ibuxal Forte For Children may mask the symptoms of an infection, such as fever and pain. Therefore, Ibuxal Forte For Children may delay the use of appropriate infection treatment, which can lead to an increased risk of complications. This has been observed in the course of 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 consult their doctor immediately.

Ibuxal Forte For Children with food, drink, and alcohol

The medicine should be taken preferably after a meal. The patient should avoid consuming alcohol while taking Ibuxal Forte For Children, as it may increase the risk of adverse reactions.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. PregnancyDO NOTtake Ibuxal Forte For Children if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibuxal Forte For Children may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the patient and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Ibuxal Forte For Children should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibuxal Forte For Children may cause the unborn child to have a narrowed blood vessel (ductus arteriosus) in the heart or kidney problems, which can lead to a low level 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. BreastfeedingIbuprofen passes into breast milk in small amounts and is unlikely to affect the baby, especially if used for a short period. FertilityIbuprofen belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is reversible after stopping the medicine. Before taking the medicine, the patient should inform their doctor if they have problems conceiving.

Driving and using machines

During short-term use, the medicine does not affect or has a negligible effect on the ability to drive and use machines.

Ibuxal Forte For Children contains sorbitol 70% (E 420)

The medicine contains 40 mg of sorbitol 70% in each 1 mL of oral suspension. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has been diagnosed with 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.

Ibuxal Forte For Children contains propylene glycol

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

Ibuxal Forte For Children contains sodium benzoate (E 211)

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

Ibuxal is considered sodium-free

The medicine contains less than 1 mmol (23 mg) of sodium per maximum single dose (i.e., 7.5 mL), which means the medicine is considered "sodium-free".

3. How to take Ibuxal Forte For Children

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse. The patient should use the smallest effective dose for the shortest duration necessary to relieve the symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2). The medicine is intended for short-term use. The patient should not take a higher dose of the medicine than recommended. 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, so it can be taken by patients with diabetes. Information for people with diabetes: 1 mL of Ibuxal Forte For Children suspension contains 40 mg of sorbitol, which corresponds to approximately 0.003 carbohydrate exchange units. Before use, the bottle should be shaken well.

Use in children and adolescents

Ibuxal Forte For Children is not recommended for children under 3 months old or weighing less than 5 kg, due to a lack of sufficient data on its use in this age group. Children under 6 months old should only be given the medicine 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 after 24 hours. The medicine should not be used in children over 6 months old for more than 3 days without consulting a doctor. If the symptoms worsen or do not improve after 3 days of taking the medicine, the patient should consult a doctor. The recommended daily dose is 20 to 30 mg/kg of body weight, given in 3 or 4 divided doses. There should be at least 6 hours between doses.

• Infants from 3 to 6 months old (weighing over 5 kg): 1.25 mL (50 mg of ibuprofen) - 3 times a day.
• Infants from 6 to 12 months old (weighing 7-9 kg): 1.25 mL (50 mg of ibuprofen) - 3-4 times a day.
• Children from 1 to 3 years old (weighing 10-15 kg): 2.5 mL (100 mg of ibuprofen) - 3 times a day.
• Children from 4 to 6 years old (weighing 16-20 kg): 3.75 mL (150 mg of ibuprofen) - 3 times a day.
• Children from 7 to 9 years old (weighing 21-29 kg): 5 mL (200 mg of ibuprofen) - 3 times a day.
• Children from 10 to 12 years old (weighing 30-40 kg): 7.5 mL (300 mg of ibuprofen) - 3 times a day.
• Children over 12 years old (weighing over 40 kg): 7.5 mL (300 mg of ibuprofen) - 3-4 times a day.

Use in adults

For adult patients, it is recommended to use other pharmaceutical forms of ibuprofen in doses 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 (which corresponds to 300 mg of ibuprofen). For adult patients and adolescents, the maximum recommended dose is 1200 mg of ibuprofen 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 their doctor. Elderly patientsThere is no need to adjust the dosage, except in cases of kidney or liver failure. In such cases, the dose should be determined individually. A measuring spoon or a dosing device in the form of an oral syringe with a capacity of 5 mL and a scale to facilitate dosing is attached to the packaging.

• 1. Before use, the bottle should be shaken vigorously to mix its contents.
• 2. The cap of the bottle should be unscrewed (pressed down and turned in the opposite direction to the arrow - as shown on the cap).
• 3. The syringe should be firmly inserted into the opening in the neck of the bottle.
• 4. To fill the syringe, the bottle should be turned upside down and then carefully move the plunger down, drawing the suspension up to the desired mark on the scale.
• 5. The bottle should be turned back to its original position and the syringe carefully removed from the bottle.
• 6. The tip of the syringe should be placed in the patient's mouth, and then, slowly pressing the plunger, the contents of the dosing device should be carefully emptied.
• 7. If, according to the information above, the dose of the medicine should be larger than 5 mL, steps 2 to 6 should be repeated to administer the appropriate amount of medicine.
• 8. After use, the bottle should be closed by screwing the cap back on, and the syringe should be washed and dried.

Taking a higher dose of Ibuxal Forte For Children than recommended

If the patient has taken a higher dose of Ibuxal Forte For Children than recommended or if a child has accidentally taken the medicine, they should always consult their 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), headaches, 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 problems have occurred.

Missing a dose of Ibuxal Forte For Children

The patient should not take a double dose to make up for a missed dose. If a dose is missed, the next dose should be taken as needed, according to the dosing interval described above. If the patient has any questions or doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ibuxal Forte For Children can cause side effects, although not everybody gets them. The risk of side effects can be minimized by using the smallest effective dose for the shortest duration necessary to relieve the symptoms. In children, one of the known side effects of NSAIDs may occur. If side effects occur or if the patient is in doubt, they should stop taking the medicine and talk to their doctor as soon as possible. Elderly patients taking this medicine belong to a group with an increased risk of side effects.

STOP taking the medicine and seek medical attention immediately if the patient experiences:

• 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) (frequency not known - frequency cannot be estimated from the available data).
• Severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, swelling of the lymph nodes, and an increased number of eosinophils (a type of white blood cell); severe skin and soft tissue infections as complications during chickenpox (frequency not known - frequency cannot be estimated from the available data).
• A red, scaly rash with nodules under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency not known - frequency cannot be estimated from the available data).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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

• presence of blood in the stool or black, tarry stools;
• bloody vomiting or vomiting containing particles resembling coffee grounds;
• severe allergic reactions manifesting as: swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, fainting, dizziness, or loss of consciousness;
• 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;
• severe allergic skin reactions, which may include: peeling, blisters, and skin damage;
• worsening of existing severe skin infections;
• stomach and duodenal ulcers, as well as gastrointestinal bleeding;
• kidney diseases, which 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, has swollen ankles);
• high blood pressure, heart failure (the patient may be overly tired, have difficulty breathing, or have swelling of the legs).

In addition, if the patient experiences any of the following side effects, they should stop taking the medicine and seek medical attention immediately:

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

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

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

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

Very rare( occur in fewer 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, mouth ulcers, flu-like symptoms, including fever. This may be caused by changes in blood morphology.

Other possible side effects:

Common( affect 1 to 10 in 100 patients)

• fatigue.

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

• headache.

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

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

Very rare( affect fewer 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;
• skin becomes sensitive to light.

Medicines like Ibuxal Forte For Children may cause a small increased risk of heart attack (myocardial infarction) or stroke. Fluid retention (edema), high blood pressure, and heart failure have been observed with the use of NSAIDs.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. 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, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ibuxal Forte For Children

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 first opening the bottle: 3 months. Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month stated. 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 pack and other information

What Ibuxal Forte For Children contains

• The active substance of the medicine 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 (E 954), sodium citrate (E 331), sorbitol 70% (E 420), glycerol (E 422), xanthan gum, polysorbate 80, orange flavor (Aroma Narnja 61.0282/202600 with the composition: ethanol, purified water, orange oil, citral, dodecanal), purified water.

What Ibuxal Forte For Children looks like and what the pack contains

Ibuxal Forte For Children is a white or almost white, homogeneous suspension after shaking, with an orange flavor. The bottle has a capacity of 100 mL or 200 mL, made of orange glass type III, with a PP cap securing against children (with an LDPE or PP connector), with a measuring spoon made of polypropylene (PP) with a capacity of 5 mL and a scale, or an oral syringe with a capacity of 5 mL with a non-transparent plunger made of high-density polyethylene (HDPE) and a cylinder with a scale made of polypropylene (PP), in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

Biofarm Sp. z o.o. ul. Wałbrzyska 13 60-198 Poznań phone: +48 61 66 51 500 fax: +48 61 66 51 505 e-mail: [email protected]

Manufacturer

Laboratórios Basi – Indústria Farmacêutica, S.A. Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16 3450-232 Mortágua Portugal

Date of the last revision of the leaflet: