Patient Information Leaflet

Ibuprofen Alkaloid-INT, 100 mg/5 mL, oral suspension
Ibuprofenum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if the child feels worse after 1 day of treatment (infants aged 3–6 months weighing over 5 kg) or after 3 days (children aged 6 months and older), consult a doctor. Adolescents should consult a doctor if symptoms worsen or do not improve within 3 days. Adults being treated for fever should consult a doctor if symptoms worsen or do not improve within 3 days. Adults being treated for pain should consult a doctor if symptoms worsen or do not improve within 5 days, unless otherwise directed by a physician.

Leaflet Contents

What Ibuprofen Alkaloid-INT is and what it is used for
What you need to know before using Ibuprofen Alkaloid-INT
How to use Ibuprofen Alkaloid-INT
Possible side effects
How to store Ibuprofen Alkaloid-INT
Contents of the pack and other information

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

This medicine contains ibuprofen. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which reduce pain and inflammation-related swelling and lower body temperature during fever.
Ibuprofen Alkaloid-INT is used in children from the age of 3 months (weighing over 5 kg) and older, for short-term symptomatic treatment of:

mild to moderate pain, such as headache and toothache,
fever,
acute pain and fever associated with the common cold.

2. Important information before using Ibuprofen Alkaloid-INT

When not to give Ibuprofen Alkaloid-INT:

if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
if the patient has had allergic reactions (e.g. difficulty breathing, nasal congestion, rash) to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
in patients with active gastric ulcer, duodenal ulcer, or gastrointestinal bleeding; if the patient has previously experienced gastric or duodenal ulceration or bleeding after taking Ibuprofen Alkaloid-INT or a similar medicine,
if the patient currently has or has previously had gastrointestinal bleeding or perforation (a hole in the digestive tract) due to prior use of NSAIDs,
if the patient has severe liver or kidney disease,
if the patient has severe heart failure,
if the patient has an increased tendency to bleed,
if the child is under 3 months of age or weighs less than 5 kg,
if the patient is in the last 3 months of pregnancy.

If in doubt about any of the above conditions, consult a doctor or pharmacist before using this
medicine.
Warnings and precautions
Before starting treatment with Ibuprofen Alkaloid-INT, discuss with your doctor or
pharmacist:

if the patient has an infection – see section below entitled “Infections”,
if the patient has certain immune system disorders (such as mixed connective tissue disease or systemic lupus erythematosus), which are autoimmune conditions affecting connective tissue and causing joint pain, skin changes, and organ dysfunction, as there may be an increased risk of aseptic meningitis,
in case of impaired kidney or liver function,
if the patient has heart disease, including heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in the legs due to narrowed or blocked arteries), or if the patient has previously had a stroke (including mini-stroke or transient ischemic attack - TIA),
if the patient has high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes,
if the patient currently has or has previously had stomach or intestinal disorders (including ulcerative colitis or Crohn’s disease),
if the patient has asthma, chronic inflammation of the nasal mucosa (chronic nasal congestion or rhinitis), or allergic conditions, as in such cases Ibuprofen Alkaloid-INT may cause difficulty breathing, rash, or severe allergic reactions,
if the patient has inflammatory bowel disease, previous gastric ulceration, or an increased tendency to bleed for other reasons.

The lowest effective dose should be used for the shortest possible duration to minimize the risk of
adverse effects. Using higher than recommended doses may increase such risks.
This also means avoiding the simultaneous use of multiple NSAID medicines.
Long-term use of painkillers may lead to headaches, which should not be treated by increasing the
dose of painkillers. If this applies to the patient, medical advice should be sought from a doctor or
pharmacist.
Ibuprofen Alkaloid-INT may mask symptoms of infection.
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported.
If any of these symptoms occur, discontinue Ibuprofen Alkaloid-INT immediately and contact a
doctor or emergency medical services without delay.
Patients who have gastrointestinal problems, especially elderly individuals, should consult a doctor
if abdominal symptoms occur (particularly gastrointestinal bleeding), especially at the beginning of
treatment.
Elderly patients have an increased risk of adverse effects, especially gastrointestinal bleeding and
perforation, which may be fatal.
Treatment should be discontinued and a doctor contacted immediately if gastrointestinal bleeding
or ulceration occurs during treatment with Ibuprofen Alkaloid-INT.
Taking anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with
a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed
the recommended dose or duration of treatment (1 day for infants aged 3–6 months weighing over 5 kg, or 3 days for children aged 6 months and older).
This medicine belongs to the group of NSAIDs, which may reduce fertility in women. This effect
reverses after stopping the medicine. See also section “Pregnancy, breastfeeding and fertility”.
Do not use Ibuprofen Alkaloid-INT in women planning pregnancy. Consult a doctor before starting
treatment. See also section “Pregnacy, breastfeeding and fertility”.
Discontinue Ibuprofen Alkaloid-INT and contact a doctor immediately if the patient experiences
any of the following symptoms (signs of angioedema):

swelling of the face, tongue, or throat,
difficulty swallowing,
urticaria (hives) and difficulty breathing.

Serious skin reactions
Serious skin reactions have occurred with the use of ibuprofen, 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). If the patient develops any symptoms related to these serious skin reactions described in section 4, Ibuprofen Alkaloid-INT should be stopped immediately and medical help sought.
Infections
Ibuprofen Alkaloid-INT may mask objective signs 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 takes this medicine during an ongoing infection and symptoms persist or worsen, immediate medical advice should be sought.
This medicine should be avoided in patients with chickenpox.
Ibuprofen Alkaloid-INT may cause a decrease in white blood cell count and impair resistance to infections. If the patient develops signs of infection such as fever and significant worsening of general condition, or fever with local symptoms such as sore throat, mouth pain, or urinary tract symptoms, medical attention should be sought immediately. A blood test may be performed to check for reduced white blood cell count (agranulocytosis). Inform the doctor that the patient is taking Ibuprofen Alkaloid-INT.
This medicine should be used with caution in dehydrated patients, as there is a risk of impaired kidney function, especially in dehydrated children, adolescents, and elderly individuals.
Ibuprofen Alkaloid-INT and other medicines
Do not take different types of painkillers simultaneously unless directed by a doctor.
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use, including over-the-counter medicines.
Ibuprofen Alkaloid-INT may affect the action of other medicines, or other medicines may affect the action of Ibuprofen Alkaloid-INT. This applies to medicines used in the treatment or prevention of:

cancer and immune system disorders (methotrexate);
bipolar disorder (lithium);
irregular heartbeat (digoxin);
pain (acetylsalicylic acid);
thrombotic and embolic disorders (anticoagulant medicines, i.e. blood thinners/preventing clot formation, such as aspirin/acetylsalicylic acid, dicumarol, warfarin, ticlopidine);
depression (medicines called selective serotonin reuptake inhibitors - SSRIs);
high blood pressure (medicines that lower blood pressure, i.e. ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, diuretics);
organ rejection after transplantation (immunosuppressive medicines such as cyclosporine or tacrolimus);
inflammation (corticosteroids);
bacterial infections (some antibiotics, including aminoglycosides);
fungal infections (e.g. voriconazole or fluconazole);
diabetes (sulfonylurea derivatives);
high cholesterol (cholestyramine);
human immunodeficiency virus (HIV) infection (zidovudine).

Some other medicines may also interact with or affect treatment with Ibuprofen Alkaloid-INT. Therefore, always consult a doctor or pharmacist before using Ibuprofen Alkaloid-INT with other medicines.
Ibuprofen Alkaloid-INT with food, drink, and alcohol
Ibuprofen Alkaloid-INT may be taken with food and drink. Patients with a sensitive stomach are advised to take ibuprofen with meals. For faster pain relief, Ibuprofen Alkaloid-INT may be taken on an empty stomach. Taking Ibuprofen Alkaloid-INT with alcohol may increase the risk of 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 use Ibuprofen Alkaloid-INT during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Ibuprofen Alkaloid-INT may cause kidney and heart problems in the unborn child. It may also affect bleeding tendency in the mother and her child and may delay or prolong labor.
During the first 6 months of pregnancy, do not use this medicine unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time.
Use of Ibuprofen Alkaloid-INT for longer than a few days from week 20 of pregnancy may cause kidney problems in the unborn child, leading to low amniotic fluid levels (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment lasts longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts. Short-term use at recommended doses is unlikely to cause harm to breastfed infants.
Fertility
Ibuprofen may affect fertility. Ibuprofen is not recommended for women planning pregnancy or undergoing fertility investigations.
Driving and using machines
Use of Ibuprofen Alkaloid-INT may impair reaction time in some patients due to adverse effects such as visual disturbances, dizziness, or drowsiness. This should be considered in situations requiring full psycho-physical performance, such as driving motor vehicles, and is of greater concern when alcohol is also consumed.
Ibuprofen Alkaloid-INT contains 1.5 g of sorbitol per 5 mL of oral suspension.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, the patient should consult a doctor before taking the medicine or giving it to a child. In adults, high doses of sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Ibuprofen Alkaloid-INT contains 0.19 mg of aspartame per 5 mL of oral suspension. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
Ibuprofen Alkaloid-INT contains 0.50 mg of sodium benzoate per 5 mL of oral suspension.
Ibuprofen Alkaloid-INT contains 12 mg of propylene glycol per 5 mL of oral suspension.
Ibuprofen Alkaloid-INT contains less than 1 mmol (23 mg) of sodium in the maximum single dose (10 mL) used in children, meaning the medicine is considered "sodium-free".
When used in adults, Ibuprofen Alkaloid-INT contains 40.66 mg (1.768 mmol) of sodium (the main component of table salt) per maximum single dose (20 mL). This corresponds to 2.033% of the maximum recommended daily sodium intake in the adult diet.
3. How to take Ibuprofen Alkaloid-INT
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Patients with a sensitive stomach are advised to take Ibuprofen Alkaloid-INT with food.
Children and adolescents up to 12 years of age
Doses should be given every 6–8 hours. At least 4 hours should elapse between consecutive doses. The interval between doses should depend on the symptoms present. Do not exceed the recommended daily dose.
The dose is:

Age (body weight)	Frequency of administration	Single dose	Maximum daily dose
3–6 months (5–7.6 kg)	3 times daily	50 mg (2.5 mL)	150 mg (7.5 mL)
6–12 months (7.7–9 kg)	3 to 4 times daily	50 mg (2.5 mL)	150–200 mg (7.5–10 mL)
1–3 years (10–15 kg)	3 times daily	100 mg (5 mL)	300 mg (15 mL)
4–6 years (16–20 kg)	3 times daily	150 mg (7.5 mL)	450 mg (22.5 mL)
7–9 years (21–29 kg)	3 times daily	200 mg (10 mL)	600 mg (30 mL)
10–12 years (30–40 kg)	4 times daily	200 mg (10 mL)	800 mg (40 mL)

A plastic oral syringe with a capacity of 5 mL is attached to the package and should be used
for administering the medicine.
Instructions for using the oral syringe:

Shake the bottle vigorously before each use.
Unscrew the bottle cap.
Remove the syringe cap.
Place the bottle on a hard, flat surface and insert the syringe into the bottle.
Slowly pull back the syringe plunger to the mark on the scale corresponding to the required dose in millilitres (mL), according to the dosing table.
Remove the syringe from the bottle.
Ensure the child is held in an upright position.
Place the tip of the syringe into the child's mouth and slowly push the plunger to gently release the medicine.
Wait until the child swallows the medicine.
Repeat steps 4 to 9 until the full dose has been administered.
After administering the medicine, close the bottle tightly. Wash the syringe with warm water and leave it to dry.

Duration of treatment
This medicine is intended for short-term use only. The lowest possible dose should be given for the shortest possible time necessary to relieve symptoms in the child.
For infants aged 3 to 6 months, the medicine should only be given after consultation with a doctor.
For infants aged 3 to 6 months, consult a doctor if symptoms worsen or do not improve within a maximum of 24 hours.
If this medicine needs to be used in children aged 6 months or older for longer than 3 days, or if symptoms worsen, consult a doctor.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Adults and adolescents over 12 years of age
Take 10 mL or 20 mL of oral suspension (200 mg or 400 mg of ibuprofen), if necessary, up to three times daily.
Allow 4 to 6 hours between doses.
Do not take a single dose exceeding 20 mL of oral suspension (400 mg of ibuprofen).
Do not exceed 60 mL of oral suspension (1200 mg of ibuprofen) in 24 hours.
Duration of treatment
In adults with fever, consult a doctor if symptoms worsen or do not improve within 3 days. In adults being treated for pain, consult a doctor if symptoms worsen or do not improve within 5 days, unless otherwise advised by a doctor.
In adolescents, consult a doctor if symptoms worsen or do not improve within 3 days.
Patients with liver or kidney disease
If the patient has liver or kidney problems, the doctor will recommend the appropriate dose. Use the lowest possible dose.
Taking more than the recommended dose of Ibuprofen Alkaloid-INT
If a patient takes more than the recommended dose of Ibuprofen Alkaloid-INT or if a child accidentally ingests the medicine, always contact a doctor or go to the nearest hospital to assess potential health risks and receive advice on the necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Agitation, drowsiness, or coma may also occur. In isolated cases, seizures may occur in patients. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, cold sensation, and breathing difficulties may be reported. Additionally, prothrombin time/INR may be prolonged, likely due to disturbances in circulating blood coagulation factors. Acute kidney failure and liver damage may also occur. In individuals with asthma, the condition may worsen. Additionally, low blood pressure and breathing difficulties may occur.
Missing a dose of Ibuprofen Alkaloid-INT
If a dose is missed, take the next dose when needed, provided that the last dose was taken at least 4 hours earlier.
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Most serious adverse reactions
Stop taking Ibuprofen Alkaloid-INT and seek immediate medical help if any of the following symptoms occur:

Red, flat, target-like or circular skin rashes, often with blisters in the center, peeling 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).
Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).
Red, peeling rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome (frequency cannot be determined from available data).

Other adverse reactions
Common (may occur in up to 1 in 10 people):

Headache, dizziness
Gastrointestinal adverse reactions (dyspepsia, diarrhea, nausea, vomiting, abdominal pain, bloating with gas release, constipation, black tarry stools, gastrointestinal bleeding, vomiting blood)
Feeling of fatigue
Rash.

Uncommon (may occur in up to 1 in 100 people):

Nasal congestion
Hypersensitivity
Insomnia, restlessness
Vision disturbances, hearing disturbances
Bronchospasm, asthma
Oral ulceration
Gastric ulcer, intestinal ulcer, gastric ulcer perforation, gastric mucosal inflammation
Hepatitis, jaundice, abnormal liver function
Itching, minor bruising of the skin and mucous membranes
Photosensitivity reaction
Kidney function disorders
Changes in blood cell counts
Anemia (reduced number of red blood cells or hemoglobin, which may cause paleness of the skin and lead to weakness)
Somnolence
Tingling sensation
Hearing loss.

Rare (may occur in up to 1 in 1,000 people):

Non-bacterial meningitis
Allergic reaction
Depression, confusion
Vision disturbances, tinnitus (ringing in the ears), dizziness
Liver damage and fluid retention.

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

Pancreatitis, liver failure.

Frequency not known (frequency cannot be determined from available data):

Exacerbation of ulcerative colitis, colitis, and Leśniowski-Crohn's disease (disease of the large intestine).

It should be noted that Ibuprofen Alkaloid-INT may prolong bleeding time.
In patients with chickenpox, severe skin infections have occurred sporadically. During treatment with NSAIDs, skin inflammation associated with infection may occur or worsen (e.g., necrotizing fasciitis, characterized by severe pain, high fever, swelling, increased skin temperature, blister formation, and necrosis). If signs of infection occur or worsen during ibuprofen treatment, immediate medical consultation is recommended.
Use of medicines such as Ibuprofen Alkaloid-INT may slightly increase the risk of heart attack or stroke.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ibuprofen Alkaloid-INT

Keep the medicine out of sight and reach of children.
The shelf life after first opening the bottle: 3 months.
Do not use this medicine after the expiry date stated on the packaging after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen Alkaloid-INT contains

The active substance is ibuprofen. 5 mL of oral suspension contains 100 mg of ibuprofen.
The other ingredients are: glycerol, sorbitol 70% liquid non-crystallizing, xanthan gum, microcrystalline cellulose and sodium carmellose, polysorbate 80, disodium edetate, sodium saccharin (E 954), citric acid monohydrate, sodium citrate dihydrate, sodium benzoate (E 211), simeticone emulsion 30%, sodium chloride, purified water.
Apricot flavour: propylene glycol, flavouring substances, natural flavouring substance, orange oil, lemon oil.
Masking flavour: maltodextrin, flavouring substances, aspartame (E 951), potassium acesulfame (E 950).

What Ibuprofen Alkaloid-INT looks like and contents of the pack
Ibuprofen Alkaloid-INT is an almost white or almost brown, homogeneous oral suspension with an apricot odour.
A 125 mL amber neutral glass bottle with a PP cap or a child-resistant PP cap, together with a 5 mL oral syringe, packed in a cardboard box.
The bottle contains 100 mL of oral suspension.

Marketing Authorisation Holder and Importer
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]