Ibuprofen alkaloid-int

Patient Information Leaflet: Information for the User

Ibuprofen Alkaloid-INT, 40 mg/ml, oral suspension
Ibuprofenum
For use in children with body weight from 7 kg (6 months) to 40 kg (12 years)
Please read this leaflet carefully before giving this medicine to your child, as it
contains important information for you.
This medicine should always be given exactly as described in this patient leaflet or as advised by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the child's condition worsens, consult your doctor.

Leaflet Contents

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

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

Ibuprofen Alkaloid-INT contains the active substance ibuprofen.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
These medicines work by reducing pain and lowering 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 body weight from 7 kg (6 months) to 40 kg (12 years).

2. Important information before using Ibuprofen Alkaloid-INT

Do not give Ibuprofen Alkaloid-INT to children:

• who are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• who have ever had allergic reactions such as breathlessness, asthma, rhinitis, facial and (or) hand swelling, or urticaria after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs);
• who have ever experienced gastrointestinal bleeding or perforation related to previous use of NSAIDs;
• who currently have or have previously had peptic ulceration of the stomach or duodenum, or gastrointestinal bleeding (two or more episodes of confirmed ulceration or bleeding);
• who currently have cerebral haemorrhage (bleeding from brain blood vessels) or any other active bleeding;
• who have severe liver or severe kidney failure;
• who have severe heart failure;
• who have unexplained disorders of blood formation;
• who are severely dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake).

Do not use this medicine in women during the last three months of pregnancy.
Warnings and precautions
Before starting to give Ibuprofen Alkaloid-INT to a child, consult a doctor or pharmacist if:

• the child has a genetic disorder affecting red blood cell pigment, i.e. haemoglobin (e.g. acute intermittent porphyria);
• the child has blood clotting disorders;
• the child has certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
• the child currently has or has previously had bowel disease (ulcerative colitis or Crohn's disease), as these conditions may worsen (see section 4. "Possible side effects");
• the child currently has or has previously had high blood pressure and (or) heart failure;
• the child has reduced kidney function;
• the child has impaired liver function;
• the child currently has or has previously had asthma or allergic diseases, as breathlessness may occur;
• the child has hay fever, nasal polyps, or chronic obstructive respiratory disorders, as these patients have an increased risk of allergic reactions, which may present as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema, or urticaria;
• the child has recently undergone major surgery, as medical supervision is required;
• the child is dehydrated, as dehydrated children have an increased risk of kidney function disorders;
• the child is taking another NSAID (including COX-2 inhibitors such as celecoxib or etoricoxib), as simultaneous use of these medicines should be avoided (see section 2., "Ibuprofen Alkaloid-INT and other medicines");
• the patient has an infection — see below, section titled "Infections".

Caution is advised if the patient is taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used to treat depression), or antiplatelet agents (e.g. acetylsalicylic acid) (see section 2., "Ibuprofen Alkaloid-INT and other medicines").

Do not use this medicine 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 headache may increase its severity. If this occurs or is suspected, inform the doctor and discontinue use of this medicine. Medication-overuse headache (rebound headache) may occur in patients who frequently or daily experience headaches despite (or because of) regular use of headache medicines.

The occurrence of adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.

If ibuprofen is used long-term, regular monitoring of liver function, kidney function, and blood morphology is necessary.

Severe skin reactions
Severe skin reactions have been reported with ibuprofen use, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP). Discontinue use of Ibuprofen Alkaloid-INT immediately and seek medical help promptly if any symptoms of severe skin reactions described in section 4 occur.

Infections
Ibuprofen Alkaloid-INT may mask symptoms of infection such as fever and pain. Therefore, Ibuprofen Alkaloid-INT may delay appropriate treatment of infection and consequently increase the 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 ongoing infection and symptoms of infection persist or worsen, seek immediate medical advice.

During chickenpox, the use of ibuprofen is not recommended.

NSAIDs may mask symptoms of infection and fever.

In case of gastrointestinal bleeding or gastrointestinal ulcers, discontinue use of this medicine immediately. During treatment with all NSAIDs, gastrointestinal bleeding (even fatal), ulcers, or perforation of the gastrointestinal tract have been reported at any stage of treatment, with or without warning symptoms or history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulcers, or gastrointestinal perforation increases with higher NSAID doses, in patients with a history of ulcers, especially if they have previously experienced complications such as bleeding or perforation (see section 2., "When not to take Ibuprofen Alkaloid-INT"), and in elderly patients. These patients should start treatment with the lowest available dose. In these patients and in patients taking low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal adverse effects, concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when high doses are used. Do not exceed the recommended dose or duration of treatment.

Before starting treatment with Ibuprofen Alkaloid-INT, discuss with a doctor or pharmacist if the patient:

• has heart problems, including heart failure, angina pectoris (chest pain), or has had a heart attack, peripheral arterial bypass surgery, peripheral artery disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini" stroke or transient ischaemic attack).
• has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or is a smoker.

Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported during ibuprofen use. If the patient experiences any of these symptoms, they should immediately stop taking Ibuprofen Alkaloid-INT and contact a doctor or emergency services.

Before administering Ibuprofen Alkaloid-INT, inform the doctor if any of the above conditions apply to the child.

Elderly patients
Elderly patients have a higher risk of experiencing adverse effects when taking NSAIDs, particularly gastrointestinal side effects.
For more information, see section 4. "Possible side effects".

Patients who have previously experienced gastrointestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial treatment period.

Ibuprofen Alkaloid-INT and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken by the child, as well as any medicines the child may take in the future.

Ibuprofen Alkaloid-INT may affect the action of other medicines, and other medicines may affect the action of Ibuprofen Alkaloid-INT, for example:

• medicines that reduce blood clotting (i.e. anticoagulants/blood thinners, e.g. acetylsalicylic acid, warfarin, ticlopidine);
• medicines used to lower high blood pressure (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 treatment with Ibuprofen Alkaloid-INT may affect the action of other medicines. Therefore, always consult a doctor or pharmacist before taking Ibuprofen Alkaloid-INT with other medicines.

In particular, inform the doctor if the child is taking the following medicines:

Ibuprofen Alkaloid-INT and alcohol
Alcohol should not be consumed during treatment with Ibuprofen Alkaloid-INT. Some adverse effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when alcohol and Ibuprofen Alkaloid-INT are taken simultaneously.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, 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
This medicine should not be used during the last 3 months of pregnancy. This medicine may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in both the mother and child and may delay or prolong labour. Use of this medicine should be avoided during the first 6 months of pregnancy unless otherwise advised by a doctor. From the 20th week of pregnancy, Ibuprofen Alkaloid-INT may cause kidney function disorders in the unborn child if used for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. Ibuprofen Alkaloid-INT may be used during breastfeeding if administered at the recommended doses and for the shortest possible duration.

Fertility
Ibuprofen Alkaloid-INT belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible upon discontinuation of the medicine.

Driving and operating machinery
Short-term use of this medicine has no effect or has a negligible effect on the ability to drive and operate machinery.

Ibuprofen Alkaloid-INT contains sodium benzoate and sodium
The medicine contains 2 mg of sodium benzoate per ml.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Ibuprofen Alkaloid-INT

This medicine should always be used exactly as advised by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If, during an infection, its symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
The recommended dose for the treatment of pain and fever is:

*Single doses should be administered approximately every 6–8 hours.
The use of this medicinal product is not recommended in children under 6 months of age or weighing less than 7 kg.
The occurrence of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
WARNING: Do not exceed the specified dose.

Administration method
Oral administration.
For patients with gastric hypersensitivity, it is recommended to take Ibuprofen Alkaloid-INT during a meal.
An oral syringe with a capacity of 5 ml is included in the package and should be used to administer the medicine.

Instructions for use:

1. Shake the bottle well before each use.
2. Unscrew the cap from the bottle.
3. Remove the protective cap from the oral syringe.
4. Place the bottle on a hard, flat surface and insert the oral syringe into the bottle.
5. Slowly pull back the plunger of the oral syringe to the graduation mark on the syringe corresponding to the required volume in milliliters (ml), according to the dosing table.
6. Remove the syringe from the bottle.
7. Ensure the child is held in an upright position.
8. Place the tip of the syringe into the child’s mouth and slowly push the plunger to gently release the medicine.
9. Wait until the child swallows the medicine.
10. Repeat steps 4 to 9 in the same manner until the entire dose has been administered.
11. After use, close the bottle with the cap. Wash the syringe with warm water and allow it to dry.

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

Administration of a higher than recommended dose of Ibuprofen Alkaloid-INT to a child
If a patient has taken more than the recommended dose of Ibuprofen Alkaloid-INT, or if a child has accidentally ingested this medicine, always contact a doctor or go to the nearest hospital to assess potential health risks and receive advice on appropriate actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding, headache, tinnitus, confusion, and nystagmus, or, less commonly, diarrhea. Excitement, drowsiness, confusion, or coma may also occur. Additionally, after ingestion of large doses, systemic dizziness, visual disturbances, hypotension, hypokalemia (low blood potassium levels), psychomotor agitation, hyperkalemia (elevated potassium levels in the body), prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis (bluish or purplish discoloration of the skin or mucous membranes), exacerbation of asthma in asthmatic patients, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, cold sensation, and breathing difficulties have been reported.

Missed dose of Ibuprofen Alkaloid-INT in a child
Do not administer a double dose to make up for a missed dose. If a patient forgets to take or administer a dose, administer it as soon as remembered, then continue with the next dose according to the dosing interval described above.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The occurrence of side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
In children, any of the known side effects associated with NSAIDs may occur. If side effects occur or if you have any doubts, stop giving the medicine to the child and consult a doctor as soon as possible.
In elderly patients using this medicine, there is an increased risk of side effects.
Medicines such as this one may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke.

STOP USING THIS MEDICINE AND SEEK IMMEDIATE MEDICAL HELP IF THE CHILD EXPERIENCES:

• Severe abdominal pain, black tarry stools, vomiting blood or vomiting material resembling dark granules or coffee grounds [symptoms of gastrointestinal bleeding].
• Worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, or a drop in blood pressure leading to shock. These symptoms may occur even after the first dose. If any of these symptoms occur, contact a doctor immediately [symptoms of a rare but serious allergic reaction].
• Red, flat or round spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genital organs, or eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell) [DRESS syndrome].
• Red, scaly widespread rash with subcutaneous nodules and blisters, mainly appearing in skin folds, trunk, and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment [acute generalized exanthematous pustulosis]. If such symptoms occur in the patient, stop using Ibuprofen Alkaloid-INT and seek immediate medical help. See also section 2.
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Inform the doctor if the child experiences any of the following side effects,
if they worsen, or if you notice any side effect not listed in this leaflet.

Common (may affect up to 1 in 10 people)

• Gastrointestinal symptoms such as heartburn, abdominal pain, nausea, indigestion, diarrhoea, vomiting, bloating (gas), and constipation, as well as minor gastrointestinal bleeding which, in rare cases, may lead to anaemia.

Uncommon (may affect up to 1 in 100 people)

• Gastrointestinal ulcers, perforation or bleeding, oral mucosal inflammation with ulceration, exacerbation of existing bowel disease (colitis or Crohn's disease), gastric mucosal inflammation;
• Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability, or fatigue;
• Visual disturbances;
• Various skin rashes;
• Allergic reactions presenting with urticaria and itching.

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

• Tinnitus (ringing in the ears);
• Increased blood urea levels, pain in the side of the chest and/or abdominal pain, blood in the urine, and fever – may indicate kidney damage (renal papillary necrosis);
• Increased blood uric acid levels;
• Decreased haemoglobin concentration.

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

• Oesophagitis, pancreatitis, formation of diaphragm-like intestinal strictures;
• Heart failure, myocardial infarction, and facial and hand swelling (oedema);
• Reduced urine output compared to normal and oedema (especially in patients with high blood pressure or impaired kidney function), oedema and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms occur or if there is a general feeling of discomfort, stop taking Ibuprofen Alkaloid-INT immediately and contact a doctor without delay, as these may be the first signs of kidney damage or kidney failure;
• Psychotic reactions, depression;
• High blood pressure, vasculitis;
• Palpitations;
• Liver function disorders, liver damage (early signs may include skin discoloration), particularly with long-term treatment, liver failure, acute hepatitis;
• Problems with blood cell production – early signs include: fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, marked fatigue, nose and skin bleeding, and unexplained bruising. In such cases, the patient must immediately stop using this medicine and contact a doctor. Avoid self-treatment with painkillers or antipyretics;
• Severe skin infections and complications involving subcutaneous tissue during chickenpox infection;
• Cases of worsening inflammation due to infections (e.g. necrotizing fasciitis) have been reported with the use of certain painkillers (NSAIDs). If symptoms of infection appear or worsen, the patient should seek immediate medical attention;
• During ibuprofen use, symptoms of aseptic meningitis, including neck stiffness, headache, nausea, vomiting, fever, or altered consciousness, have been observed. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) may be more predisposed. If such symptoms occur, contact a doctor immediately;
• Hair loss.

Not known (frequency cannot be estimated from available data)

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

Reporting of side effects
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C, 02-222 Warsaw,
Tel.: +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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ibuprofen Alkaloid-INT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
After first opening, use within 6 months.
Medicines must 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 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 flavour (containing propylene glycol E1520 and flavouring substances), taste-masking flavour (containing propylene glycol E1520 and flavouring substances), simethicone emulsion 30%, sodium chloride, purified water.

What Ibuprofen Alkaloid-INT looks like and contents of the pack
Ibuprofen Alkaloid-INT is an oral suspension, almost white to creamy white in colour, with a grape odour.
100 ml of oral suspension is packed in a 125 ml amber glass bottle closed with a child-resistant screw cap (made of PP).
The cardboard box contains one bottle and one oral dosing syringe.
The oral dosing syringe has a capacity of 5 ml and is graduated to measure doses of 1.25 ml, 2.5 ml, 3.75 ml and 5 ml.
Marketing Authorisation Holder and Manufacturer
Alkaloid-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče, Slovenia
Tel.: + 386 1 300 42 90
Fax: + 386 1 300 42 91
email: [email protected]
This medicinal product is authorised for sale in the European Economic Area countries 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 oralna suspenzija
Czech Republic Ibuprofen Alkaloid-INT
Poland Ibuprofen Alkaloid-INT
Slovenia Ibuprofen Alkaloid-INT 40 mg/ml peroralna suspenzija