Ibuprofen Alkaloid - Int

Package Leaflet: Information for the User

Ibuprofen Alkaloid-INT, 100 mg/5 mL, Oral Suspension

Ibuprofen

Read the package 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 package leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
• If after 1 day of treatment (infants 3-6 months of age with a body weight over 5 kg) or 3 days (children 6 months of age and older) there is no improvement or the child feels worse, you should contact your doctor. For adolescents, you should consult a doctor if symptoms worsen or do not improve within 3 days. For adults with fever, you should consult a doctor if symptoms worsen or do not improve within 3 days. For pain treatment in adults, you should consult a doctor if symptoms worsen or do not improve within 5 days, unless otherwise advised by your doctor.

Table of Contents of the Package 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 pack and other information

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

This medicine contains ibuprofen. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which reduce pain, inflammation, and fever.

Ibuprofen Alkaloid-INT is used for the short-term symptomatic treatment of:

• mild to moderate pain, such as headache and toothache,
• fever,
• acute pain and fever associated with colds.

2. Important information before taking Ibuprofen Alkaloid-INT

When not to take Ibuprofen Alkaloid-INT:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (see section 6),
• if you have had allergic reactions (such as difficulty breathing, nasal congestion, rash) to acetylsalicylic acid or other anti-inflammatory drugs,
• if you have active stomach ulcers, duodenal ulcers, or bleeding, or if you have had stomach ulcers, duodenal ulcers, or bleeding after taking ibuprofen or similar medicines in the past,
• if you have had bleeding or perforation of the digestive tract due to previous use of NSAIDs,
• if you have severe liver or kidney disease,
• if you have severe heart failure,
• if you have an increased tendency to bleed,
• if the child is under 3 months of age or weighs less than 5 kg,
• if you are in the last 3 months of pregnancy.

In case of doubts about the above conditions, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Ibuprofen Alkaloid-INT, discuss with your doctor or pharmacist:

• if you have an infection - see below "Infections",
• if you have certain immune system diseases (mixed connective tissue disease and systemic lupus erythematosus, immune system disorders affecting connective tissue causing joint pain, skin changes, and disorders of other organs), as there may be an increased risk of aseptic meningitis,
• if you have kidney or liver function disorders,
• if you have heart disease, including heart failure, angina (chest pain), if you have had a heart attack, coronary artery bypass grafting, or if you have peripheral artery disease (poor circulation in the legs due to narrowing or blockage of arteries) or if you have had any stroke (including mini-stroke or transient ischemic attack - TIA),
• if you have high blood pressure, diabetes, high cholesterol, or if there is a history of heart disease or stroke in your family, or if you smoke,
• if you have had stomach or intestinal diseases (including ulcerative colitis or Crohn's disease),
• if you have asthma, chronic nasal congestion (chronic runny nose or stuffy nose), or allergic diseases, as Ibuprofen Alkaloid-INT may cause difficulty breathing, rash, or severe allergic reactions,
• if you have inflammatory bowel disease, or if you have had stomach ulcers or an increased tendency to bleed for other reasons.

Use the lowest possible dose for the shortest possible time to minimize the risk of side effects. Taking higher doses than recommended may increase this risk.

This also means avoiding the use of several NSAIDs at the same time.

Long-term use of painkillers can cause headaches, which should not be treated with more painkillers.

If this situation applies to you, consult your doctor or pharmacist.

Ibuprofen Alkaloid-INT may mask the symptoms of an infection.

During ibuprofen treatment, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), chest pain.

If you notice any of these symptoms, stop taking Ibuprofen Alkaloid-INT and contact your doctor or emergency medical services immediately.

Patients who have had gastrointestinal problems, especially the elderly, should consult a doctor if they experience abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment.

The elderly have an increased risk of side effects, especially bleeding and perforation of the digestive tract, which can be fatal.

Stop treatment and consult a doctor if you experience bleeding or ulcers in the digestive tract during treatment with Ibuprofen Alkaloid-INT.

Taking anti-inflammatory and pain-relieving medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses.

This medicine belongs to a group of NSAIDs that may reduce fertility in women. This effect is reversible upon stopping the medicine. See also section "Pregnancy, breastfeeding, and fertility".

Do not take Ibuprofen Alkaloid-INT if you are planning to become pregnant. Consult your doctor before starting treatment. See also section "Pregnancy, breastfeeding, and fertility".

Stop taking Ibuprofen Alkaloid-INT and contact your doctor immediately if you experience any of the following symptoms (angioedema):

• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing.

Severe skin reactions

Severe skin reactions have occurred with 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 you experience any symptoms related to these severe skin reactions described in section 4, stop taking Ibuprofen Alkaloid-INT and seek medical attention.

Infections

Ibuprofen Alkaloid-INT may hide the signs of an infection, such as fever and pain.

Therefore, Ibuprofen Alkaloid-INT may delay the appropriate treatment of the infection, which may lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox.

If you are taking this medicine while an infection is present, and the symptoms of the infection persist or worsen, consult your doctor immediately.

Avoid taking this medicine if you have chickenpox.

Ibuprofen Alkaloid-INT may reduce the number of white blood cells and immunity to infections.

If you experience an infection with symptoms such as fever and severe deterioration of your general condition or fever with local symptoms such as throat pain, mouth pain, or urinary problems, consult your doctor immediately.

A blood test will be performed to check if there has been a decrease in the number of white blood cells (agranulocytosis). Inform your doctor that you are taking Ibuprofen Alkaloid-INT.

The medicine should be used with caution in patients who are dehydrated, as there is a risk of kidney function disorders, especially in dehydrated children, adolescents, and the elderly.

Ibuprofen Alkaloid-INT and other medicines

Do not take different types of pain-relieving medicines at the same time, unless your doctor advises you to do so.

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines planned for use, including those available without a prescription.

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 to treat or prevent:

• cancer and immune system disorders (methotrexate);
• manic-depressive illness (lithium);
• irregular heartbeat (digoxin);
• pain (acetylsalicylic acid);
• blood clotting disorders (anticoagulant medicines, i.e., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, dicoumarol, warfarin, ticlopidine);
• depression (selective serotonin reuptake inhibitors - SSRIs);
• high blood pressure (blood pressure-lowering medicines, such as ACE inhibitors, such as captopril, beta-adrenergic 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);
• HIV infection (zidovudine).

Also, some other medicines may be affected or have an effect on treatment with Ibuprofen Alkaloid-INT. Therefore, before taking Ibuprofen Alkaloid-INT with other medicines, always consult your doctor or pharmacist.

Ibuprofen Alkaloid-INT with food, drink, and alcohol

Ibuprofen Alkaloid-INT can be taken with food and drink. Patients with sensitive stomachs are advised to take ibuprofen with meals.

To relieve pain more quickly, Ibuprofen Alkaloid-INT can be taken on an empty stomach.

Taking Ibuprofen Alkaloid-INT with alcohol may increase side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Ibuprofen Alkaloid-INT during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery.

Taking Ibuprofen Alkaloid-INT may cause kidney and heart disorders in the unborn child.

It may also affect the tendency to bleed in you and your child and cause delayed or prolonged labor.

During the first 6 months of pregnancy, do not take the medicine unless it is absolutely necessary and advised by your doctor.

If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time.

Ibuprofen Alkaloid-INT taken for more than a few days, starting from the 20th week of pregnancy, may cause kidney disorders in the unborn child, leading to too little amniotic fluid around the baby (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart.

In the case of longer treatment, your doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen passes into breast milk in small amounts. With short-term use of ibuprofen in recommended doses, harmful effects on breastfed babies are unlikely.

Fertility

Ibuprofen may affect fertility. It is not recommended to take ibuprofen if you are planning to become pregnant or if you are undergoing fertility tests.

Driving and using machines

Taking Ibuprofen Alkaloid-INT may impair your reactions to a small extent, due to side effects such as visual disturbances, dizziness, or drowsiness.

This should be taken into account in situations where full physical and mental ability is required, e.g., when driving vehicles or operating machinery, especially when consuming alcohol.

Ibuprofen Alkaloid-INT contains 1.5 g of sorbitol per 5 mL of oral suspension.

Sorbitol is a source of fructose. If you have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should consult your doctor before taking this medicine or giving it to your child.

In adults, due to high doses, sorbitol may cause gastrointestinal discomfort and 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.

This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

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 per maximum single dose (10 mL) used in children, which means the medicine is essentially "sodium-free".

In adults, Ibuprofen Alkaloid-INT contains 40.66 mg (1.768 mmol) of sodium (the main component of common salt) per maximum single dose (20 mL). This corresponds to 2.033% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Ibuprofen Alkaloid-INT

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist.

It is recommended that patients with sensitive stomachs take Ibuprofen Alkaloid-INT with food.

Children and adolescents up to 12 years of age

Doses should be given every 6-8 hours. Wait at least 4 hours between doses. The intervals between doses should be based on the symptoms. Do not exceed the recommended daily dose.

The dose is:

A 5 mL plastic oral syringe is included in the package, which should be used to administer the medicine.

Instructions for using the oral syringe:

• 1. Shake the bottle well before each use.
• 2. Remove the cap from the bottle.
• 3. Remove the syringe cap.
• 4. Place the bottle on a hard, flat surface and insert the syringe into the bottle.
• 5. Slowly pull the syringe plunger to the mark corresponding to the amount of medicine in milliliters (mL) according to the dosage table.
• 6. Remove the syringe from the bottle.
• 7. Make sure the child is held upright.
• 8. Place the end 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 4-9 until the full dose is administered.
• 11. After administration, close the bottle and wash the syringe with warm water and let it dry.

Duration of treatment

This medicine is intended for short-term use only. Give the lowest possible dose for the shortest possible time necessary to relieve the child's symptoms.

In the case of infants 3-6 months of age, the medicine should only be given to the child after consulting a doctor.

In the case of infants 3-6 months of age, consult a doctor if symptoms worsen or do not improve within 24 hours.

If the use of this medicine is necessary for more than 3 days in children 6 months of age and older, or if symptoms worsen, consult a doctor.

Use the lowest effective dose for the shortest possible time to relieve symptoms. If the symptoms of the infection (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 a day.

Maintain an interval of 4 to 6 hours between doses.

Do not take a single dose greater than 20 mL of oral suspension (400 mg of ibuprofen).

Do not take more than 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 with pain, consult a doctor if symptoms worsen or do not improve within 5 days, unless otherwise advised by your doctor.

In adolescents, consult a doctor if symptoms worsen or do not improve within 3 days.

Patient with liver or kidney disease

If you have liver or kidney problems, your doctor will recommend the appropriate dose.

Use the lowest possible dose.

Overdose of Ibuprofen Alkaloid-INT

If you have taken more than the recommended dose of Ibuprofen Alkaloid-INT or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital to assess the risk to your health and for advice on what to do.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, disorientation, and nystagmus. Stimulation, drowsiness, or coma may also occur. In individual cases, seizures have been reported. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, prothrombin time/INR may be prolonged, probably due to disorders of circulating clotting factors in the blood. Acute kidney failure and liver damage may occur. In people with asthma, the disease may worsen. Furthermore, low blood pressure and difficulty breathing may occur.

Missed dose of Ibuprofen Alkaloid-INT

If you miss a dose, take the next dose when it is 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 questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibuprofen Alkaloid-INT can cause side effects, although not everybody gets them.

Very serious side effects

Stop taking Ibuprofen Alkaloid-INT and seek medical attention immediately if you experience any of the following symptoms:

• 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).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Red, peeling rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome (frequency cannot be estimated from the available data).

Other side effects

Frequent(may affect up to 1 in 10 people):

• headache, dizziness
• gastrointestinal side effects (indigestion, diarrhea, nausea, vomiting, stomach pain, bloating with gas, constipation, black stools, gastrointestinal bleeding)
• fatigue
• rash.

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

• runny nose
• allergic reactions
• insomnia, restlessness
• visual disturbances, hearing disturbances
• bronchospasm, asthma
• mouth ulcers
• stomach ulcers, intestinal ulcers, stomach perforation, gastritis
• liver inflammation, jaundice, abnormal liver function
• itching, small bruises on the skin and mucous membranes
• photosensitivity
• kidney function disorders
• blood count changes
• anemia (reduced red blood cell count or hemoglobin, which can cause pale skin and lead to weakness)
• drowsiness
• tingling sensation
• hearing loss.

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

• aseptic meningitis
• allergic reaction
• depression, confusion
• visual disturbances, ringing in the ears, dizziness
• liver damage and fluid retention in the body.

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

• pancreatitis, liver failure.

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

• worsening of ulcerative colitis, Crohn's disease (inflammatory bowel disease).

Remember that Ibuprofen Alkaloid-INT may prolong bleeding time.

In patients with chickenpox, severe skin infections have occasionally occurred.

During the use of NSAIDs, skin infections may occur or worsen (e.g., necrotizing fasciitis, characterized by severe pain, high fever, swelling, and increased skin temperature, blistering, necrosis).

If skin infection symptoms occur or worsen while taking ibuprofen, seek medical attention immediately.

Taking medicines like Ibuprofen Alkaloid-INT may slightly increase the risk of heart attack or stroke.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.

By reporting side effects, you can help 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.

Shelf life after first opening the bottle: 3 months.

Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.

No special precautions for storage are necessary.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, 70% non-crystallizing liquid sorbitol, 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), simethicone emulsion 30%, sodium chloride, purified water. Apricot flavor: propylene glycol, flavoring substances, natural flavoring substance, orange oil, lemon oil. Masking flavor: maltodextrin, flavoring substances, aspartame (E 951), acesulfame potassium (E 950).

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

Ibuprofen Alkaloid-INT is a nearly white or nearly brown, homogeneous suspension with an apricot odor.

The bottle is made of brown glass, with a capacity of 125 mL, and is closed with a PP cap or a PP cap with a child-resistant closure, together with a 5 mL oral syringe, in a cardboard box.

The bottle contains 100 mL of oral suspension.

Marketing authorization 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]

Date of last revision of the package leaflet: