Ibuprofen Alkaloid-int

Leaflet attached to the packaging: information for the user

Ibuprofen Alkaloid-INT, 40 mg/ml, oral suspension

Ibuprofen

For use in children with a body weight of 7 kg (6 months) to 40 kg (12 years)

You should carefully read the contents of the leaflet before giving this medicine to your child, as it contains important information for the patient.

This medicine should always be given exactly as described in the patient leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If your child experiences any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or your child feels worse, you should contact your doctor.

Table of contents of the leaflet

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

1. What is Ibuprofen Alkaloid-INT and what is it used for

Ibuprofen Alkaloid-INT contains the active substance ibuprofen.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
The action of these medicines is to reduce the feeling of pain and lower high body temperature.
Ibuprofen Alkaloid-INT is intended for short-term, symptomatic treatment of:

• mild to moderate pain,
• fever.

Ibuprofen Alkaloid-INT is indicated for use in children with a body weight of 7 kg (6 months)
to 40 kg (12 years).

2. Important information before taking Ibuprofen Alkaloid-INT

Do not give Ibuprofen Alkaloid-INT to children:

• who are hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• who have had allergic reactions, such as shortness of breath, asthma, runny nose, facial and/or hand swelling, or hives, after taking acetylsalicylic acid or other similar painkillers (NSAIDs);
• who have had gastrointestinal bleeding or perforation of the gastrointestinal tract in connection with previous use of NSAIDs;
• who currently have or have had stomach or duodenal ulcers, or bleeding from the stomach (two or more episodes of confirmed ulcers or bleeding);
• who have cerebral bleeding (cerebral hemorrhage) or other active bleeding;
• who have severe liver failure or severe kidney failure;
• who have severe heart failure;
• who have unexplained blood clotting disorders;
• who are in a state of severe dehydration (due to vomiting, diarrhea, or inadequate fluid intake).

Do not use this medicine in women in the last 3 months of pregnancy.

Warnings and precautions

Before starting to give Ibuprofen Alkaloid-INT to your child, you should discuss this with your doctor
or pharmacist if:
your child has a genetic disorder that affects the red blood cell pigment, i.e., hemoglobin (e.g., acute intermittent porphyria);
your child has bleeding disorders;
your child has certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
your child has or has had gastrointestinal disease (ulcerative colitis or Crohn's disease), as these diseases may worsen (see section 4, "Possible side effects");
your child has or has had high blood pressure and/or heart failure;
your child has reduced kidney function;
your child has liver function disorders;
your child has or has had asthma or allergic diseases, as they may experience shortness of breath;
your child has hay fever, nasal polyps, or chronic obstructive respiratory disease, as these patients are at increased risk of allergic reactions. They may have asthma attacks (so-called analgesic asthma), Quincke's edema, or hives;
your child has recently undergone major surgery, as medical supervision is required;
your child is dehydrated, as dehydrated children are at increased risk of kidney function disorders;
your child is taking another NSAID (including COX-2 inhibitors, such as celecoxib or etoricoxib), as you should avoid taking these medicines at the same time (see section 2, "Ibuprofen Alkaloid-INT and other medicines");
the patient has an infection - see below, the section entitled "Infections".
Caution is recommended if the patient is taking other medicines that may increase the risk of developing ulcers or gastrointestinal bleeding, such as oral corticosteroids (e.g., prednisolone), blood thinners (e.g., warfarin), selective serotonin reuptake inhibitors (antidepressants), or antiplatelet agents (e.g., acetylsalicylic acid) (see section 2, "Ibuprofen Alkaloid-INT and other medicines").
This medicine should not be used routinely, as habitual use (of several types) of painkillers may lead to permanent kidney function disorders. This risk is increased by physical exertion associated with loss of electrolytes and dehydration.
Long-term use of any painkillers for headaches may increase their severity. If such a situation occurs or is suspected, you should tell your doctor and stop taking this medicine. Headache caused by overuse of painkillers (medication-overuse headache) may occur in patients who frequently or daily experience headaches despite (or due to) regular use of painkillers.
The occurrence of side effects can be minimized by using the smallest effective dose for the shortest duration.
During long-term use of ibuprofen, regular monitoring of liver function, kidney function, and blood morphology is necessary.
Severe skin reactions
Severe skin reactions, including 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 the use of ibuprofen. You should stop taking Ibuprofen Alkaloid-INT and seek medical attention immediately if you experience any symptoms associated with severe skin reactions described in section 4.
Infections
Ibuprofen Alkaloid-INT may mask the symptoms of infection, such as fever and pain. Therefore, Ibuprofen Alkaloid-INT may delay the use of appropriate infection treatment and lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox.
If your child is taking this medicine during an infection and the symptoms of the infection persist or worsen, you should consult your doctor immediately.
It is recommended to avoid the use of ibuprofen during chickenpox.
NSAIDs may mask the symptoms of infection and fever.
In the event of gastrointestinal bleeding or ulcers, you should stop taking this medicine immediately. During the use of all NSAIDs, gastrointestinal bleeding, ulcers, or perforation of the gastrointestinal tract have been reported at any stage of treatment, even with fatal outcomes, with or without warning signs or a history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulcers, or perforation of the gastrointestinal tract increases with the dose of NSAIDs, in patients with a history of ulcers, especially if they have had complications in the form of bleeding or perforation (see section 2, "When not to take Ibuprofen Alkaloid-INT"), and in the elderly. These patients should start treatment with the smallest available dose. In these patients and in patients taking low doses of acetylsalicylic acid or other medicines that may increase the risk of adverse effects on the gastrointestinal tract, it is recommended to consider concurrent use of protective agents (e.g., misoprostol or proton pump inhibitors).
Painkillers/anti-inflammatory drugs, such as ibuprofen, may be associated with a slightly increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.
Before starting to give Ibuprofen Alkaloid-INT, you should discuss treatment with your doctor
or pharmacist if your child:
has heart problems, including heart failure, angina pectoris (chest pain), or if your child has had a heart attack, coronary artery bypass grafting, peripheral artery disease (poor circulation in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini" stroke or "transient ischemic attack").
has high blood pressure, diabetes, high cholesterol, or if there is a history of heart disease or stroke in your child's family, or if your child is a smoker.
During the use of ibuprofen, symptoms of an allergic reaction to this medicine have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. If your child experiences any of these symptoms, they should stop taking Ibuprofen Alkaloid-INT and contact a doctor or emergency services immediately.
Before giving Ibuprofen Alkaloid-INT, you should tell your doctor if any of these conditions apply to your child.
Elderly
Elderly patients are at increased risk of adverse effects when taking NSAIDs, particularly gastrointestinal adverse effects.
See section 4, "Possible side effects".
Patients who have had toxic effects on the gastrointestinal tract in the past, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially during the initial treatment period.

Ibuprofen Alkaloid-INT and other medicines

You should tell your doctor or pharmacist about all medicines your child is taking or has recently taken, as well as any medicines your child may be taking.
Ibuprofen Alkaloid-INT may affect the action of other medicines, and other medicines may affect the action of Ibuprofen Alkaloid-INT, e.g.,
medicines that reduce blood clotting (e.g., blood thinners/anticoagulants, e.g., acetylsalicylic acid, warfarin, ticlopidine);
medicines that lower high blood pressure (e.g., ACE inhibitors such as captopril, beta-blockers containing atenolol, angiotensin II receptor antagonists such as losartan).
Also, some other medicines may affect treatment with Ibuprofen Alkaloid-INT or Ibuprofen Alkaloid-INT may affect the action of other medicines. Therefore, before taking Ibuprofen Alkaloid-INT with other medicines, you should always consult your doctor or pharmacist.
In particular, you should tell your doctor if your child is taking any of the following medicines:

Ibuprofen Alkaloid-INT with alcohol

Do not consume alcohol while taking Ibuprofen Alkaloid-INT. Some adverse effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when taking alcohol and Ibuprofen Alkaloid-INT together.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, you should ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use this medicine during the last 3 months of pregnancy. This medicine may cause problems with the kidneys and heart of the unborn child. It may also increase the risk of bleeding in the mother and child and prolong labor. You should avoid using this medicine during the first 6 months of pregnancy, unless your doctor advises otherwise. From the 20th week of pregnancy, Ibuprofen Alkaloid-INT may cause kidney function disorders in the unborn child if taken for more than a few days. This may lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is required for a longer period, your doctor may recommend additional monitoring.
Breastfeeding
Only small amounts of ibuprofen and its breakdown products pass into breast milk. Ibuprofen Alkaloid-INT can be used during breastfeeding if given in the recommended doses and for the shortest possible time.
Fertility
Ibuprofen Alkaloid-INT belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible after stopping the medicine.

Driving and using machines

Short-term use of this medicine does not have a significant effect on the ability to drive or use machines.

Ibuprofen Alkaloid-INT contains sodium benzoate and sodium

The medicine contains 2 mg of sodium benzoate per 1 ml.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Ibuprofen Alkaloid-INT

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
You 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, you should consult your doctor immediately (see section 2).
The recommended dose for the treatment of pain and fever is:

*Single doses should be given approximately every 6-8 hours.
It is not recommended to use this medicine in children under 6 months or with a body weight below 7 kg.
The occurrence of side effects can be minimized by using the smallest effective dose for the shortest duration necessary to relieve the symptoms.
WARNING: do not exceed the recommended dose.

Method of administration

Oral administration.
In patients with stomach hypersensitivity, it is recommended to take Ibuprofen Alkaloid-INT with food.
The packaging includes a 5 ml oral syringe for measuring the dose.
Instructions for use:

• 1. Shake the bottle well before each use.
• 2. Remove the cap from the bottle.
• 3. Remove the protective cover from the oral syringe.
• 4. Place the bottle on a hard, flat surface and insert the oral syringe into the bottle.
• 5. Slowly pull the plunger of the oral syringe to the graduation mark on the syringe corresponding to the volume in milliliters (ml) according to the dosage table.
• 6. Remove the syringe from the bottle.
• 7. Make sure the child is in an upright position.
• 8. Place the tip of the syringe in the child's mouth and slowly press the plunger to gently release the medicine.
• 9. Wait until the child swallows the medicine.
• 10. Repeat steps 4 to 9 in the same way until the entire dose is given.
• 11. After use, replace the cap on the bottle. Wash the syringe with warm water and let it dry.

Duration of treatment
This medicine is intended for short-term use only. If it is necessary to use this medicine for more than 3 days or if the symptoms worsen, you should consult your doctor.

Administration of a higher dose of Ibuprofen Alkaloid-INT to a child

If your child has taken a higher dose of Ibuprofen Alkaloid-INT than recommended or if your child has accidentally taken this medicine, you should always consult your doctor or go to the nearest hospital to get an opinion on the possible risk to health and advice on what to do.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding, headache, ringing in the ears, disorientation, and nystagmus or, less commonly, diarrhea. It may also cause agitation, drowsiness, disorientation, or coma. Additionally, after taking large doses, systemic vertigo, visual disturbances, low blood pressure, low potassium levels, hyperkalemia (elevated potassium levels in the body), increased prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis (blue or purple discoloration of the skin and mucous membranes), and worsening of asthma in asthmatic patients, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and breathing difficulties.

Missing a dose of Ibuprofen Alkaloid-INT

Do not give a double dose to make up for a missed dose. If you forget to give or take a dose, you should give or take it as soon as you remember, and then give or take the next dose at the recommended interval as described above.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The occurrence of side effects can be minimized by using the smallest effective dose for the shortest duration necessary to relieve the symptoms. Your child may experience any of the known side effects of NSAIDs. If side effects occur or if you are unsure, you should stop giving the medicine to your child and talk to your doctor as soon as possible.
Elderly patients taking this medicine are at increased risk of side effects.
Medicines like this one may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke.

STOP TAKING THIS MEDICINE AND SEEK MEDICAL ATTENTION IMMEDIATELY IF YOUR CHILD EXPERIENCES:

• severe stomach pain, black tarry stools, vomiting blood or coffee-ground-like vomit [symptoms of gastrointestinal bleeding].
• worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, and low blood pressure leading to shock. These symptoms may occur even after the first use of the medicine. If any of these symptoms occur, you should contact your doctor immediately [symptoms of a rare but serious allergic reaction].
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, mouth ulcers, genital ulcers, and eye inflammation. These severe skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• widespread rash, high body temperature, swollen lymph nodes, and increased eosinophils (a type of white blood cell) [drug reaction with eosinophilia and systemic symptoms (DRESS)].
• red, scaly, widespread rash with bumps under the skin and blisters, mainly on skin folds, torso, and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment [acute generalized exanthematous pustulosis (AGEP)]. If your child experiences any of these symptoms, you should stop taking Ibuprofen Alkaloid-INT and seek medical attention immediately. See also section 2.
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

TELL YOUR DOCTOR IF YOUR CHILD EXPERIENCES ANY OF THE FOLLOWING SIDE EFFECTS, IF THEY WORSEN, OR IF YOU NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET.

Common (may affect up to 1 in 10 people)

• •gastrointestinal symptoms, such as heartburn, stomach pain, and nausea, indigestion, diarrhea, vomiting, bloating (gas), and constipation, as well as minor gastrointestinal bleeding that may rarely lead to anemia.

Uncommon (may affect up to 1 in 100 people)

• •gastrointestinal ulcers, perforation, or bleeding, mouth ulcers, worsening of existing gastrointestinal diseases (ulcerative colitis and Crohn's disease), stomach inflammation;
• •central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability, or fatigue;
• •visual disturbances;
• •various skin rashes;
• •allergic reactions with hives and itching.

Rare (may affect up to 1 in 1,000 people)

• •ringing in the ears (tinnitus);
• •increased urea levels in the blood, pain in the side of the chest and/or stomach, blood in the urine, and fever - may be symptoms of kidney damage (renal papillary necrosis);
• •increased uric acid levels in the blood;
• •decreased hemoglobin levels.

Very rare (may affect up to 1 in 10,000 people)

• •esophagitis, pancreatitis, formation of diaphragm-like intestinal strictures;
• •heart failure, heart attack, and facial and hand swelling (edema);
• •decreased urine output and swelling (especially in patients with high blood pressure or reduced kidney function), swelling, and cloudy urine (nephrotic syndrome); kidney inflammation (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms occur or if you experience general discomfort, you should stop taking Ibuprofen Alkaloid-INT and contact your doctor immediately, as these may be the first signs of kidney damage or kidney failure;
• •psychotic reactions, depression;
• •high blood pressure, vasculitis;
• •rapid heartbeat;
• •liver function disorders, liver damage (first symptoms may be skin discoloration), especially with long-term treatment, liver failure, acute hepatitis;
• •blood disorders - the first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, significant fatigue, nosebleeds, and unexplained bruising. In such cases, the patient must stop taking this medicine and contact their doctor immediately. You should avoid self-medication with painkillers or antipyretics;
• •severe skin and soft tissue infections during chickenpox;
• •in connection with the use of some painkillers (NSAIDs), cases of worsening of inflammatory conditions (e.g., development of necrotizing fasciitis) have been reported. If symptoms of infection appear or worsen, the patient should contact their doctor immediately;
• •during the use of ibuprofen, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or changes in consciousness have been observed. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) may be more susceptible. If such symptoms occur, you should contact your doctor immediately;
• •hair loss.

Unknown (frequency cannot be estimated from available data)

• respiratory system reactivity, including asthma, bronchospasm, or shortness of breath.
• skin becomes sensitive to light.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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 181 C, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuprofen Alkaloid-INT

The medicine should be stored out of the sight and reach of children.
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.
There are no special storage instructions for this medicine.
After first opening, use within 6 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Ibuprofen Alkaloid-INT contains

• The active substance is ibuprofen. 1 ml of oral suspension contains 40 mg of ibuprofen.
• The other ingredients are: glycerol, xanthan gum, microcrystalline cellulose, sodium carmellose, polysorbate 80, disodium edetate, sucralose, citric acid monohydrate (E 330), sodium citrate dihydrate (E 330), sodium benzoate (E211), grape flavor (contains propylene glycol E1520 and flavorings), masking flavor (contains propylene glycol E1520 and flavorings), simethicone emulsion 30%, sodium chloride, purified water.

What Ibuprofen Alkaloid-INT looks like and contents of the pack

Ibuprofen Alkaloid-INT is a white to off-white oral suspension with a grape flavor.
100 ml of oral suspension is packaged in a 125 ml brown glass bottle with a child-resistant closure (PP).
The carton contains one bottle and one 5 ml oral syringe for measuring the dose.
The oral syringe is graduated to measure doses of 1.25 ml, 2.5 ml, 3.75 ml, and 5 ml.

Marketing authorization holder and manufacturer

Alkaloid-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče, Slovenia
Phone: +386 1 300 42 90
Fax: +386 1 300 42 91
Email: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany
Ibuprofen Alkaloid-INT 40 mg/ml Suspension zum Einnehmen
Bulgaria
BlokMAX forte for kids 200 mg/5 ml oral suspension
Croatia
Ibuprofen forte Alkaloid 40 mg/ml oral suspension
Czech Republic
Ibuprofen Alkaloid-INT
Poland
Ibuprofen Alkaloid-INT
Slovenia
Ibuprofen Alkaloid-INT 40 mg/ml peroralna suspenzija
Date of last revision of the leaflet:10/2024