Ibum zatoki max

Patient Information Leaflet

Ibum Zatoki Max
400 mg + 60 mg, coated tablets
Ibuprofenum + Pseudoephedrini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or according to the instructions provided by the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• 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 after 3 days, or if you feel worse, consult your doctor.

Table of Contents

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

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

Ibum Zatoki Max exerts a combined action of two active ingredients: ibuprofen, which belongs to non-steroidal anti-inflammatory drugs (NSAIDs), and pseudoephedrine, a sympathomimetic agent.
Ibuprofen has analgesic, antipyretic, and anti-inflammatory properties. Pseudoephedrine is a drug that reduces congestion of the mucous membranes of the upper respiratory tract. It clears nasal passages and sinuses and reduces mucus secretion.
Indications
The medicine is intended for short-term use to relieve symptoms of nasal and paranasal sinus congestion accompanied by headache, pain associated with sinus congestion, and fever in the course of influenza or common cold.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Ibum Zatoki Max

When not to use Ibum Zatoki Max

• if the patient is allergic to ibuprofen, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6),
• in patients who have ever experienced allergic reactions such as rhinitis, urticaria or bronchial asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients with active or past peptic ulcer disease of the stomach and/or duodenum, perforation (gastrointestinal perforation) or bleeding, including events occurring after use of NSAIDs,
• in patients with bleeding disorders (tendency to bleed),
• in patients with severe liver failure or severe heart failure,
• if the patient has severe acute or chronic kidney disease or renal failure,
• during pregnancy,
• during breastfeeding,
• in patients with severe cardiovascular disorders, tachycardia (rapid heartbeat), or angina pectoris,
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension,
• in patients who have experienced urinary retention,
• in patients with hyperthyroidism,
• in patients with narrow-angle glaucoma,
• in patients who have had a hemorrhagic stroke or have risk factors increasing the risk of hemorrhagic stroke, for example due to taking vasoconstrictive drugs or other drugs reducing nasal congestion, taken orally or nasally (see section "Ibum Zatoki Max with other medicines").

Warnings and precautions
Before starting treatment with Ibum Zatoki Max, discuss this with your doctor or pharmacist.
Exercise particular caution when using Ibum Zatoki Max in patients:

• with systemic lupus erythematosus or mixed connective tissue disease – due to increased risk of developing aseptic meningitis,
• with gastrointestinal disorders (ulcerative colitis, Crohn's disease) – due to possible worsening of the disease,
• with impaired kidney function – due to risk of further deterioration of renal function,
• with impaired liver function,
• with cardiac arrhythmias, hypertension, history of myocardial infarction or heart failure,
• with active or past history of bronchial asthma or allergic diseases – due to possible occurrence of bronchospasm,
• in elderly patients – due to increased risk of adverse effects,
• taking medicines listed in section "Ibum Zatoki Max with other medicines",
• with diabetes,
• with mild benign prostatic hyperplasia,
• with glaucoma,
• with pyloric stenosis,
• with bladder neck obstruction,
• taking other NSAIDs, including COX-2 inhibitors (increased risk of adverse effects).

During treatment with Ibum Zatoki Max, reduced blood flow in the optic nerve may occur. If sudden vision loss occurs, discontinue use of Ibum Zatoki Max immediately and contact your doctor or seek medical help without delay. See section 4.
Patients who have ever had hypertension and/or heart failure should exercise particular caution and consult their doctor or pharmacist before using this medicine, as fluid retention, hypertension and edema have been reported with NSAID treatment.
Taking anti-inflammatory and analgesic 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.
Before using Ibum Zatoki Max, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart disease such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA),
• the patient has hypertension, diabetes, high cholesterol levels, family history of heart disease or stroke, or is a smoker,
• the patient has an infection – see below, section titled "Infections".

There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and may occur without warning symptoms or in patients who previously experienced such symptoms. If gastrointestinal bleeding or ulceration occurs, stop the medicine immediately and contact your doctor. Patients with a history of gastrointestinal disorders, especially elderly individuals, should inform their doctor about any unusual gastrointestinal symptoms (particularly bleeding), especially during initial treatment. These patients should use the lowest effective dose.
During treatment with Ibum Zatoki Max, sudden abdominal pain or rectal bleeding may occur due to inflammation of the large intestine (ischemic colitis). If such gastrointestinal symptoms occur, discontinue use of Ibum Zatoki Max immediately and seek medical advice without delay. See section 4.
Allergic reactions to ibuprofen have been reported, including difficulty breathing, facial and neck swelling (angioedema), chest pain. If any of these symptoms occur, stop taking Ibum Zatoki Max immediately and contact your doctor or emergency medical services without delay.
Exercise caution when using this medicine in patients taking other medicines that may increase the risk of stomach and intestinal disorders or bleeding, such as corticosteroids or anticoagulants such as warfarin (acenocoumarol), or antiplatelet agents such as acetylsalicylic acid.
Long-term, concurrent use of painkillers may lead to kidney damage with risk of renal failure (analgesic nephropathy).

Infections
Ibum Zatoki Max may mask symptoms of infection such as fever and pain. Therefore, Ibum Zatoki Max 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 this medicine is taken during an existing infection and symptoms persist or worsen, consult a doctor immediately.

Skin reactions
Severe skin reactions associated with use of Ibum Zatoki Max have been reported. If any skin rash, mucosal lesions, blisters or other allergic symptoms appear, stop taking Ibum Zatoki Max immediately and seek medical help promptly, as these may be early signs of a very serious skin reaction. See section 4.
Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have occurred with ibuprofen use. If any of the symptoms related to these serious skin reactions described in section 4 occur, discontinue Ibum Zatoki Max immediately and seek medical help.

Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after use of medicines containing pseudoephedrine.
PRES and RCVS are rare conditions that may involve reduced blood flow to the brain.
If symptoms suggestive of PRES or RCVS occur, discontinue Ibum Zatoki Max immediately and seek immediate medical help (symptoms, see section 4 "Possible side effects").

As with other medicines stimulating the central nervous system, there is a risk of abuse during pseudoephedrine use. Toxic effects may occur with increased doses. Long-term use may lead to tachyphylaxis (loss of sensitivity to the drug effect), increasing the risk of overdose. Depression may occur after abrupt discontinuation.
This medicine should be used cautiously in patients taking tricyclic antidepressants and other sympathomimetic medicines (medicines constricting blood vessels in mucous membranes), appetite suppressants, and amphetamine-like psychotropic medicines.

Effect on fertility in women
Ibum Zatoki Max belongs to a group of medicines that may adversely affect fertility in women. Evidence suggests that substances inhibiting cyclooxygenase (prostaglandin synthesis), including ibuprofen, may cause fertility disorders in women by affecting ovulation. This effect is reversible and resolves after discontinuation of treatment.

Children and adolescents
Do not give to children under 12 years of age.
In dehydrated adolescents aged 12–18 years, there is a risk of impaired kidney function.

Elderly patients
Elderly patients have an increased risk of adverse effects.
To minimize the risk of adverse effects, the medicine should be taken for the shortest duration necessary to relieve symptoms.

Note for athletes: After taking pseudoephedrine, a positive result in doping tests may occur.

Consult your doctor, even if the above warnings refer to conditions experienced in the past.

Ibum Zatoki Max with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take.
Ibum Zatoki Max may affect the action of other medicines or other medicines may affect the action of Ibum Zatoki Max. For example:

• anticoagulant medicines (i.e., blood thinners preventing clot formation, 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 medicines with ibuprofen may increase the risk of gastrointestinal adverse effects;
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan);
• antihypertensive medicines and diuretics: ibuprofen (like other NSAIDs) may reduce the effectiveness of these medicines;
• lithium (antidepressant medicine): evidence suggests potential increase in serum lithium levels during concomitant use of ibuprofen (similar to other NSAIDs);
• methotrexate (anticancer medicine): risk of increased methotrexate serum levels during concomitant use of ibuprofen (similar to other NSAIDs);
• zidovudine (antiviral medicine): evidence suggests increased risk of joint bleeding and hematomas in hemophilic, HIV-positive patients taking zidovudine and ibuprofen concurrently;
• antacids increase the absorption rate of pseudoephedrine, while kaolin decreases the absorption rate of pseudoephedrine.

Before taking ibuprofen, inform your doctor if you are taking any of the medicines listed above.
Other medicines may also interact with or be affected by Ibum Zatoki Max treatment.
Therefore, always consult your doctor or pharmacist before using Ibum Zatoki Max with other medicines.

Ibum Zatoki Max should not be used simultaneously with:
monoamine oxidase inhibitors (MAOIs), or within 14 days after stopping such treatment. Concomitant use of MAOIs and sympathomimetic medicines may cause hypertensive crisis.

Due to increased risk of vasoconstriction and elevated blood pressure, concomitant use of Ibum Zatoki Max (due to pseudoephedrine content) with the following medicines is not recommended:
dopamine receptor agonists, ergot alkaloid derivatives – bromocriptine, cabergoline, lisuride, pergolide;
vasoconstrictive dopaminergic medicines – dihydroergotamine, ergotamine, methylergonovine;
linezolid;
medicines reducing nasal mucosal congestion (taken orally or nasally):

• phenylephrine, ephedrine, phenylpropanolamine.

Concomitant use of the following medicines with pseudoephedrine is not recommended:
appetite suppressants (pseudoephedrine may enhance their effect);
amphetamines-type psychostimulants (pseudoephedrine may enhance their effect);
antihypertensive medicines, alpha-methyldopa, mecamylamine, reserpine, belladonna alkaloids, guanethidine (pseudoephedrine may reduce their antihypertensive effect);
tricyclic antidepressants (pseudoephedrine may theoretically increase the risk of hypertension and cardiac arrhythmias).

During use of halogenated gases and inhalational general anesthetics, concomitant use with pseudoephedrine may cause acute hypertensive reaction in the perioperative period, similar to other medicines with indirect sympathomimetic action. Therefore, it is recommended to discontinue Ibum Zatoki Max 24 hours before planned general anesthesia.

Taking Ibum Zatoki Max with food
Take the medicine after meals.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Use of Ibum Zatoki Max 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 tendency to bleeding in both mother and child and may delay or prolong labor. Ibum Zatoki Max may also cause reduced amniotic fluid volume surrounding the fetus (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the fetal heart.

Breastfeeding
Use of Ibum Zatoki Max in women during breastfeeding is contraindicated.

Fertility
Use of Ibum Zatoki Max may adversely affect female fertility. See section "Warnings and precautions".

Driving and using machines
Exercise caution when driving or operating machinery during treatment with Ibum Zatoki Max.

Ibum Zatoki Max contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Ibum Zatoki Max

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use. The recommended dose is:
Adults and adolescents over 12 years of age: 1 tablet every 4 hours after meals. Do not exceed a dose greater than 3 tablets per day (maximum daily dose 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride in divided doses).
The single dose may be reduced to ½ tablet if this is sufficient to relieve symptoms.
Elderly patients: dosage adjustment is not required unless renal or hepatic function is impaired. If renal or hepatic impairment is present, the doctor should determine the dosage individually.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. This helps reduce the risk of adverse effects. If symptoms of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Consult your doctor if this medicine needs to be used for more than 3 days or if symptoms worsen.
Use in children
This medicine must not be given to children under 12 years of age.
Taking more Ibum Zatoki Max than recommended
If a patient takes more than the recommended dose of Ibum Zatoki Max or if a child accidentally ingests the medicine, always contact a doctor or go to the nearest hospital to assess possible health risks and receive advice on necessary actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, disorientation, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties may occur. Increased blood pressure and increased heart rate may also occur.
The doctor will provide symptomatic and supportive treatment. Activated charcoal is recommended within one hour of ingestion (adults: 50 g; children: 1 g/kg body weight). If the above symptoms occur, electrolyte levels should be checked and an electrocardiogram should be performed.
If you forget to take Ibum Zatoki Max
Do not take a double dose to make up for a missed dose.
If you have any further doubts about using 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.
If any of the following symptoms occur in a patient, ibuprofen must be discontinued immediately and medical help must be sought:

• Red, flat, non-raised, target-like or circular spots on the trunk, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genital organs 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, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Immediately discontinue use of Ibum Zatoki Max and seek immediate medical attention if symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:

• Severe headache with sudden onset,
• Nausea,
• Vomiting,
• Confusion,
• Seizures,
• Visual disturbances.

Not very common (in 1 to 10 patients out of 1,000):
Headache, dyspepsia, abdominal pain, nausea, urticaria and itching.
Rare (in 1 to 10 patients out of 10,000):

• Diarrhea, bloating, constipation, vomiting, gastric mucosal inflammation, dizziness, insomnia, restlessness, irritability and feeling of fatigue,
• Edema due to kidney and urinary tract disorders.

Very rare (occurring in less than 1 patient out of 10,000):

• Tarry stools, vomiting blood, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease,
• Gastric and (or) duodenal ulcer disease, gastrointestinal bleeding and perforation, sometimes with fatal outcome, particularly in elderly patients,
• In isolated cases: depression, psychotic reactions and tinnitus, aseptic meningitis,
• Dysuria (difficulty in urination), decreased urine output, renal failure, renal papillary necrosis, increased serum urea concentration,
• Liver function disorders, particularly during prolonged use,
• Blood morphology abnormalities (anemia, leukopenia, thrombocytopenia, agranulocytosis). Initial symptoms include: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g. bruises, petechiae, purpura, nosebleeds),
• Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
• Severe hypersensitivity reactions such as: facial, tongue and laryngeal swelling, shortness of breath, tachycardia (rapid heartbeat), hypotension (sudden drop in blood pressure), shock; worsening of asthma and bronchospasm,
• In patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms typical 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 serious allergic reaction called Kounis syndrome.
• Severe disorders affecting cerebral blood vessels, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell).
• Red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, discontinue taking Ibum Zatoki Max immediately and seek medical help without delay. See also section 2.
• Skin becomes sensitive to light.
• Inflammation of the large intestine caused by insufficient blood supply (ischemic colitis).
• Reduced blood flow in the optic nerve (ischemic optic neuropathy).

Treatment with NSAIDs at high doses has been associated with the occurrence of edema, hypertension, and heart failure.
Use of medicines such as Ibum Zatoki Max may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Adverse reactions due to the presence of pseudoephedrine in the medicine:
Posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), dyspepsia, gastrointestinal dysfunction, flushing and skin rash, nausea, vomiting, excessive sweating, dizziness, increased thirst, tachycardia (rapid heartbeat), cardiac arrhythmias, anxiety, insomnia, rarely - uncontrolled urination, muscle weakness, tremors, anxiety, disorientation, thrombocytopenia, ischemic optic neuropathy.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 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 Ibum Zatoki Max

Keep this medicine out of 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 specified month.
Medicines must not be disposed of via the sewage system 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 Ibum Zatoki Max contains

• The active substances are ibuprofen and pseudoephedrine hydrochloride: 1 tablet contains 400 mg of ibuprofen and 60 mg of pseudoephedrine hydrochloride.
• The other ingredients (excipients) are: monohydrate lactose, microcrystalline cellulose, microcrystalline cellulose silicified (a mixture of microcrystalline cellulose and colloidal anhydrous silica), sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate, Opadry II White 85F18422 coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171).

What Ibum Zatoki Max looks like and contents of the pack
Ibum Zatoki Max coated tablets are white, oval-shaped, biconvex tablets with a division line on both sides.
One pack contains 6 or 12 coated tablets in a cardboard box.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicinal product information
tel.: (22) 742 00 22
e-mail: [email protected]