Ibum Zatoki

Patient Information Leaflet: Ibum Zatoki

Ibum Zatoki

200 mg + 30 mg, coated tablets

Ibuprofen + Pseudoephedrine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult your doctor.

Table of Contents of the Leaflet

• 1. What is Ibum Zatoki and what is it used for
• 2. Important information before taking Ibum Zatoki
• 3. How to take Ibum Zatoki
• 4. Possible side effects
• 5. How to store Ibum Zatoki
• 6. Contents of the pack and other information

1. What is Ibum Zatoki and what is it used for

The medicine has a combined effect of two active substances: ibuprofen, belonging to non-steroidal anti-inflammatory drugs (NSAIDs), and pseudoephedrine, a sympathomimetic drug. Ibuprofen has analgesic, antipyretic, and anti-inflammatory effects. Pseudoephedrine is a drug that reduces congestion of the mucous membranes of the upper respiratory tract, clears the nose and sinuses, and reduces the amount of discharge.

Indications for use

The medicine is intended for short-term use to relieve symptoms of nasal and sinus congestion with accompanying headache, sinus-related pain, and fever in the course of flu or cold. If after 3 days there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Ibum Zatoki

When not to take Ibum Zatoki:

if you are allergic to ibuprofen, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6),
in patients who have ever had allergic reactions to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the form of allergic rhinitis, urticaria, or bronchial asthma,
in patients with active or recurrent peptic ulcer disease, perforation (hole) or bleeding, also occurring after taking NSAIDs,
in patients with bleeding disorders (tendency to bleed),
in patients with severe liver or heart failure,
if you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure,
in pregnancy,
during breastfeeding,
in patients taking other NSAIDs at the same time, including COX-2 inhibitors (increased risk of side effects),
in patients with severe cardiovascular disorders, tachycardia (rapid heart rate), angina pectoris,
if you have very high blood pressure (severe hypertension) or uncontrolled hypertension,
in patients who have had urinary retention,
in patients with hyperthyroidism,
in patients with narrow-angle glaucoma,
in patients who have had a hemorrhagic stroke or have risk factors that may increase the risk of a hemorrhagic stroke, such as taking vasoconstrictor medications or other decongestants used orally or nasally (see "Ibum Zatoki and other medicines").

Warnings and precautions

Before taking Ibum Zatoki, discuss it with your doctor or pharmacist.
Particular caution should be exercised when taking Ibum Zatoki in patients:
with systemic lupus erythematosus and mixed connective tissue disease - due to the increased risk of developing aseptic meningitis,
with gastrointestinal diseases (ulcerative colitis, Crohn's disease) - due to the possibility of exacerbating the disease,
with renal impairment - due to the risk of further deterioration of renal function,
with liver function disorders,
with rhythm disturbances, hypertension, myocardial infarction, or heart failure in their medical history,
with active or previously diagnosed bronchial asthma and allergic diseases - due to the possibility of bronchospasm,
in the elderly - due to the risk of increased side effects,
taking medications listed in the "Ibum Zatoki and other medicines" section,
with diabetes,
with benign prostatic hyperplasia,
with glaucoma,
with pyloric stenosis,
with urethral stricture.
During treatment with Ibum Zatoki, a decrease in blood flow in the optic nerve may occur. If sudden vision loss occurs, discontinue Ibum Zatoki and seek medical attention immediately. See section 4.
With the use of pseudoephedrine, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported. PRES and RCVS are rare conditions that can be associated with reduced blood flow to the brain.
If symptoms that may be symptoms of PRES or RCVS occur, discontinue Ibum Zatoki immediately and seek medical attention (symptoms, see section 4 "Possible side effects").
Patients who have ever had hypertension and/or heart failure should exercise particular caution and consult their doctor or pharmacist before taking the medicine, as NSAID treatment has been associated with fluid retention, hypertension, and edema.
Taking anti-inflammatory/pain-relieving medications, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose and duration of treatment.
Before taking Ibum Zatoki, the patient should discuss treatment with their doctor or pharmacist if:
they have heart diseases, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, have peripheral arterial disease (poor circulation in the legs due to narrowing or blockage of arteries) or have had any stroke (including mini-stroke or transient ischemic attack - TIA),
they have hypertension, diabetes, high cholesterol, or a family history of heart disease or stroke, or if they smoke.
they have an infection - see below, the section titled "Infections".
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning signs or may occur in patients who have had such warning signs. If bleeding or ulceration of the digestive tract occurs, discontinue the medicine immediately and consult a doctor. Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period. Such patients should use the smallest effective dose.
During treatment with Ibum Zatoki, sudden abdominal pain or rectal bleeding due to inflammatory bowel disease (ischemic colitis) may occur. If such gastrointestinal symptoms occur, discontinue Ibum Zatoki and seek medical attention immediately. See section 4.
With ibuprofen treatment, allergic reactions to this medication have occurred, including difficulty breathing, facial and neck swelling (angioedema), and chest pain. If any of these symptoms are noticed, discontinue Ibum Zatoki immediately and seek medical attention or emergency services.
Caution should be exercised when taking the medicine in patients taking other medications that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulant medications, such as warfarin (acenocoumarol) or antiplatelet agents, such as acetylsalicylic acid.
Concomitant, long-term use of pain-relieving medications may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).
Infections
Ibum Zatoki may mask the symptoms of an infection, such as fever and pain. Therefore, Ibum Zatoki may delay the use of appropriate infection treatment and consequently lead to increased 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 infection and the symptoms of the infection persist or worsen, consult a doctor immediately.
Skin reactions
Severe skin reactions have been reported with the use of Ibum Zatoki. If any skin rash, mucosal lesions, blisters, or other signs of allergy appear, discontinue Ibum Zatoki and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.
Similarly, as with other central nervous system stimulants, there is a risk of abuse with pseudoephedrine. With increased doses, toxic effects may occur. Long-term use can lead to the development of tachyphylaxis (loss of sensitivity to the drug) with an increased risk of overdose. After sudden discontinuation of the medicine, depression may occur.
The medicine should be used with caution in patients taking tricyclic antidepressants and other sympathomimetic medications (medicines that constrict blood vessels in the nasal mucosa), appetite suppressants, amphetamine-like psychostimulants.
Effect on fertility in women
Ibum Zatoki belongs to a group of medicines that may adversely affect fertility in women. There is evidence that cyclooxygenase inhibitors (prostaglandin synthesis), to which ibuprofen belongs, may cause fertility disorders in women by affecting ovulation. This effect is reversible and disappears after the end of treatment.
Children and adolescents
Do not give to children under 12 years of age.
In dehydrated patients - adolescents aged 12-18 years, there is a risk of renal impairment.
Elderly patients
In elderly patients, there is an increased risk of side effects. To minimize the risk of side effects, the medicine should be taken for the shortest period necessary to relieve symptoms.
Attention for athletes: after taking pseudoephedrine, a positive result of doping tests may occur.
Consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Ibum Zatoki and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Ibum Zatoki may affect the action of other medicines or other medicines may affect the action of Ibum Zatoki. For example:
anticoagulant medications (i.e., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, or corticosteroids (e.g., prednisolone or dexamethasone); concomitant use of these medications with ibuprofen may increase the risk of gastrointestinal side effects;
blood pressure-lowering medications (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
antihypertensive and diuretic medications: ibuprofen (like other NSAIDs) may reduce the effect of these medications;
lithium (antidepressant medication): there is evidence of potential increased lithium levels in the blood during concomitant use of ibuprofen (like other non-steroidal anti-inflammatory drugs);
methotrexate (anticancer medication): there is a risk of increased methotrexate levels in the blood during concomitant use of ibuprofen (like other non-steroidal anti-inflammatory drugs);
zydovudine (antiviral medication): there is evidence of increased risk of bleeding into the joints and hematomas in patients with hemophilia, HIV-positive, taking zydovudine and ibuprofen at the same time;
medications that neutralize stomach acid increase the absorption rate of pseudoephedrine, and kaolin decreases the absorption rate of pseudoephedrine.
Before taking ibuprofen, inform your doctor about taking any of the above-mentioned medications.
Also, some other medications may be affected or have an effect on Ibum Zatoki treatment. Therefore, before taking Ibum Zatoki with other medications, always consult your doctor or pharmacist.
Ibum Zatoki should not be taken with the following medications:
monoamine oxidase inhibitor and within 14 days after stopping this inhibitor. During concomitant use of a monoamine oxidase inhibitor and sympathomimetic medications, hypertensive crises may occur.
Due to the increased risk of vasoconstriction and increased blood pressure, it is not recommended to take Ibum Zatoki (due to the presence of pseudoephedrine) with the following medications:
dopamine receptor agonists, ergot alkaloid derivatives - bromocriptine, cabergoline, lisuride, pergolide;
dopaminergic vasoconstrictor medications - dihydroergotamine, ergotamine, methylergometrine;
linezolid;
medications that reduce nasal congestion (taken orally or nasally) - phenylephrine, ephedrine, phenylpropanolamine.
The following medications are not recommended to be taken with pseudoephedrine:
appetite suppressants (pseudoephedrine may increase their effect);
psychostimulant medications of the amphetamine type (pseudoephedrine may increase their effect);
antihypertensive medications, alpha-methyldopa, mecamylamine, reserpine, ergot alkaloids, guanethidine (pseudoephedrine may decrease their antihypertensive effect);
tricyclic antidepressants (pseudoephedrine may theoretically increase the risk of hypertension and arrhythmias).
During the use of halogenated anesthetics, inhaled general anesthetics, in combination with pseudoephedrine, a severe hypertensive reaction may occur during the perioperative period, similar to the use of these medications in combination with other medications with indirect sympathomimetic action. Therefore, it is recommended to discontinue Ibum Zatoki 24 hours before scheduled general anesthesia.

Taking Ibum Zatoki with food

The medicine should be taken after meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Taking Ibum Zatoki in pregnant women is contraindicated, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the mother and her child and cause delayed or prolonged labor. Ibum Zatoki may also cause a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart.
Breastfeeding
Taking Ibum Zatoki in breastfeeding women is contraindicated.
Fertility
Taking Ibum Zatoki may adversely affect fertility in women. See "Warnings and precautions".

Driving and using machines

During treatment with Ibum Zatoki, caution should be exercised when driving vehicles and operating machinery.

Ibum Zatoki contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Ibum Zatoki

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The medicine is taken orally. The recommended dose is:
Adults and adolescents over 12 years of age: 1 to 2 tablets every 4 hours after meals. Do not take more than 6 tablets per day (maximum daily dose of 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride in divided doses).
Elderly patients: no dose adjustment is required unless renal or hepatic function is impaired. If there are impairments in renal or hepatic function, the doctor should determine the dosage individually.
Use the smallest effective dose for the shortest period necessary to relieve symptoms. This will minimize the risk of side effects. If the symptoms of the infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Consult your doctor if it is necessary to take the medicine for more than 3 days or if the symptoms worsen.

Use in children

Do not give the medicine to children under 12 years of age.

Overdose of Ibum Zatoki

If you have taken more than the recommended dose of Ibum Zatoki or if a child has accidentally taken the medicine, always consult your doctor or go to the nearest hospital to assess the risk to your health and for advice on what to do.
Symptoms may include nausea, stomach pain (abdominal pain), vomiting (may contain blood), headache, ringing in the ears, dizziness, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness may occur, as well as blood in the urine, feeling cold, breathing difficulties, increased blood pressure, and increased heart rate. The doctor will provide symptomatic and supportive treatment. Within one hour of taking the medicine, it is recommended to administer activated charcoal (adults: 50 g; children: 1 g/kg body weight). If the above symptoms occur, check the electrolyte levels and perform an electrocardiogram.

Missed dose of Ibum Zatoki

Do not take a double dose to make up for a missed dose.
In case of further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibum Zatoki can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking ibuprofen and seek medical attention immediately:

• 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 fever, and enlarged lymph nodes (DRESS syndrome).
• red, scaly rash with nodules under the skin and blisters, usually occurring at the beginning of treatment, accompanied by fever (acute generalized exanthematous pustulosis).

Stop taking Ibum Zatoki immediately and seek medical attention if symptoms occur that may indicate posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
severe headache with sudden onset,
nausea,
vomiting,
confusion,
seizures,
changes in vision.
Uncommon(in 1 to 10 patients per 1,000):
headache, indigestion, abdominal pain, nausea, urticaria, and itching.
Rare(in 1 to 10 patients per 10,000):
diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, agitation, irritability, and fatigue,
edema resulting from renal and urinary disorders.
Very rare(in less than 1 patient per 10,000):
black stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease,
gastric and/or duodenal ulcer, gastrointestinal bleeding, and perforation, sometimes with fatal outcome, especially in the elderly,
in individual cases, the following have been reported: depression, psychotic reactions, and tinnitus, aseptic meningitis,
dysuria (difficulty urinating), decreased urine output, kidney failure, renal papillary necrosis, increased urea levels in the blood,
liver function disorders, especially during long-term use,
blood count abnormalities (anemia, leukopenia, thrombocytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g., bruising, petechiae, purpura, nosebleeds),
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
severe hypersensitivity reactions, such as: facial, tongue, and laryngeal edema, dyspnea, tachycardia, hypotension, shock,
exacerbation of asthma and bronchospasm,
in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), individual cases of symptoms of aseptic meningitis have been reported during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever, disorientation.
Frequency not known:

• Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.
• Severe vascular disorders affecting the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
• Severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and an increased number of eosinophils (a type of white blood cell).
• Red, scaly rash with nodules under the skin and blisters, usually occurring at the beginning of treatment, accompanied by fever (acute generalized exanthematous pustulosis). If such symptoms occur, discontinue Ibum Zatoki and seek medical attention immediately. See also section 2.
• Skin becomes sensitive to light.
• Inflammatory bowel disease caused by insufficient blood flow (ischemic colitis).
• Decreased blood flow in the optic nerve (ischemic optic neuropathy).

In connection with the use of NSAIDs in high doses, edema, hypertension, and heart failure have been reported.
Taking medications like Ibum Zatoki may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Side effects due to the presence of pseudoephedrine in the medicine:

posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), indigestion, gastrointestinal disorders, redness, and rash, nausea, vomiting, excessive sweating, dizziness, increased heart rate, arrhythmias, anxiety, insomnia, rarely - uncontrolled urination, muscle weakness, tremors, anxiety, disorientation, thrombocytopenia, ischemic optic neuropathy.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 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 Ibum Zatoki

Keep the medicine out of the sight and reach of children.
Store in the original packaging. Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ibum Zatoki contains

• The active substances of the medicine are ibuprofen and pseudoephedrine hydrochloride: 1 tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
• Other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, siliconized microcrystalline cellulose (a mixture of microcrystalline cellulose and anhydrous colloidal silica), sodium carboxymethylcellulose (type A), anhydrous colloidal silica, magnesium stearate, and Opadry II 85 F1 84 22 White coating. The coating contains: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171).

What Ibum Zatoki looks like and contents of the pack

Ibum Zatoki coated tablets are round, 11 mm in diameter, and white, with a logo (engraving) on one side.
One pack of the medicine contains 10 or 20 coated tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Hasco-Lek Pharmaceutical Company S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

phone: (22) 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: