Ibuprom zatoki max

Package leaflet: Information for the patient

IBUPROM ZATOKI MAX
400 mg + 60 mg, coated tablets
Ibuprofenum + Pseudoephedrini hydrochloridum
Please read the entire 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 as directed by a
physician or pharmacist.

• Keep this leaflet, so you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your physician 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 Ibuprom Zatoki Max is and what it is used for
2. Important information before taking Ibuprom Zatoki Max
3. How to take Ibuprom Zatoki Max
4. Possible side effects
5. How to store Ibuprom Zatoki Max
6. Contents of the pack and other information

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

Ibuprom Zatoki Max is a medicine intended for short-term use to relieve symptoms associated with cold and flu, such as: headache, pain and nasal sinus congestion, runny nose, fever, sore throat, and muscle aches.
Short-term treatment of symptoms of sinusitis, such as headache, nasal and sinus congestion accompanied by pain, resulting from complications of cold, flu, or allergic rhinitis.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Ibuprom Zatoki Max

When not to use Ibuprom Zatoki Max:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6), or to other non-steroidal anti-inflammatory drugs (NSAIDs);
• if symptoms of allergy such as runny nose, urticaria or bronchial asthma have ever occurred in the past after taking acetylsalicylic acid or other NSAIDs;
• in patients with active or previous gastric or duodenal ulcer, perforation or gastrointestinal bleeding, including cases occurring after use of NSAIDs;
• in patients with severe liver failure or severe heart failure;
• in patients taking other NSAIDs simultaneously, including COX-2 inhibitors (increased risk of adverse effects);
• during pregnancy and breastfeeding;
• in patients with bleeding disorders;
• in patients with severe cardiovascular disorders, tachycardia, or angina pectoris;
• in patients with very high blood pressure (severe hypertension) or hypertension that cannot be controlled with medication;
• in patients with severe acute (sudden) or chronic (long-term) kidney disease or renal failure;
• in patients with hyperthyroidism;
• in patients with diabetes;
• in patients with narrow-angle glaucoma;
• in patients with benign prostatic hyperplasia;
• in patients with pheochromocytoma;
• in children under 12 years of age.

Warnings and precautions
Before starting treatment with Ibuprom Zatoki Max, consult your doctor or
pharmacist.
Exercise special caution when using this medicine:

• if the patient has systemic lupus erythematosus or mixed connective tissue disease;
• if allergic reactions occurred after taking acetylsalicylic acid;
• if the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• if the patient has hypertension and/or heart function disorders;
• if the patient has kidney function disorders;
• if the patient has liver function disorders;
• if the patient has blood coagulation disorders;
• if the patient has active or previous bronchial asthma or past history of allergic reactions; bronchospasm may occur after taking the medicine;
• if the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).

There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and which may occur without warning symptoms or in patients who previously experienced such warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately.
Patients with a history of gastrointestinal disorders, particularly elderly individuals, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial treatment period.
If fever with generalized skin redness and blistering rash occurs, stop taking Ibuprom Zatoki Max immediately and contact a doctor or seek immediate medical help. See section 4.
Concurrent, long-term use of various painkillers may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Exercise caution in dehydrated patients (especially in young people) due to increased risk of kidney function disorders.
Use of anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment.
During treatment with Ibuprom 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 Ibuprom Zatoki Max and seek immediate medical advice or assistance. See section 4.
During treatment with Ibuprom Zatoki Max, reduced blood flow in the optic nerve may occur. If sudden vision loss occurs, discontinue use of Ibuprom Zatoki Max immediately and contact a doctor or seek immediate medical help. See section 4.
Before using Ibuprom Zatoki Max, the patient should discuss treatment with a doctor or pharmacist if:

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

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 Ibuprom Zatoki Max immediately and seek immediate medical help (symptoms, see section 4 "Possible side effects").
Pseudoephedrine - one of the active substances in Ibuprom Zatoki Max - may be abused, and high doses of pseudoephedrine may be toxic. Continuous use may lead to taking higher doses than the recommended dose to achieve the desired effect, increasing the risk of overdose. Do not take more than the maximum recommended dose or exceed the recommended duration of treatment (see section 3).
Do not use higher doses or longer treatment duration than recommended.
If symptoms persist, worsen or do not resolve after 3 days, or if new symptoms occur,
contact a doctor.
In case of heart function disorders, history of stroke, or suspected risk of such disorders (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), discuss treatment options with a doctor or pharmacist.
Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported during treatment. If these symptoms occur, discontinue Ibuprom Zatoki Max immediately and seek medical help.
Skin reactions
Severe skin reactions have been reported with ibuprofen use, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If any of the symptoms associated with these severe skin reactions described in section 4 occur, discontinue Ibuprom Zatoki Max immediately and seek medical help.
Infections
Ibuprom Zatoki Max may mask symptoms of infection such as fever and pain. Therefore, Ibuprom 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 the patient takes this medicine during an existing infection and symptoms persist or worsen, seek immediate medical advice.
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.
If difficulty in becoming pregnant occurs, consult a doctor before taking ibuprofen.
Athletes should be informed that pseudoephedrine use may result in a positive doping test.
This medicine should be used with caution in patients taking tricyclic antidepressants and other sympathomimetic medicines (vasoconstrictive medicines acting on mucous membranes), appetite suppressants, amphetamine-like medicines, and psychotropic drugs.
Children
This medicine is not indicated for children under 12 years of age.
Ibuprom Zatoki Max and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Do not take Ibuprom Zatoki Max simultaneously with other NSAIDs (including cyclooxygenase-2 inhibitors such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (at analgesic doses). Concurrent use of Ibuprom Zatoki Max with these medicines increases the risk of adverse effects.
Ibuprom Zatoki Max may affect the action of other medicines or other medicines may affect the action of Ibuprom Zatoki Max, for example:

• anticoagulant medicines (i.e. blood thinners/preventing blood clots), such as aspirin/acetylsalicylic acid, warfarin, ticlopidine;
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as medicines containing atenolol, angiotensin II receptor antagonists such as losartan);
• diuretics;
• corticosteroids (such as prednisolone or dexamethasone);
• methotrexate (an anticancer medicine);
• lithium (an antidepressant medicine);
• zidovudine (an antiviral medicine);
• MAO inhibitors (e.g. selegiline), including within 14 days after discontinuation;
• dopamine receptor agonists, ergot alkaloid derivatives such as bromocriptine, cabergoline, lisuride, pergolide;
• vasoconstrictive dopaminergic medicines such as dihydroergotamine, ergotamine, methylergonovine;
• linezolid;
• quinidine;
• tricyclic antidepressants;
• sympathomimetic nasal decongestants and appetite suppressants;
• amphetamine-type sympathomimetic drugs.

Some other medicines may also influence or be influenced by treatment with Ibuprom Zatoki Max. Therefore, always consult a doctor or pharmacist before using Ibuprom Zatoki Max with other medicines.
Pregnancy, breastfeeding and effects on fertility
Consult a doctor before using this medicine.
Do not use this medicine during pregnancy or breastfeeding.
Effect of the medicinal product on fertility - see section Warnings and precautions.
Driving and operating machinery
Exercise caution when driving a car or operating machinery during treatment with this medicine.
Ibuprom Zatoki Max contains carmine (E 124)
This medicine may cause allergic reactions.

3. How to use Ibuprom Zatoki Max

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose: Adults and adolescents aged over 12 years: for short-term treatment, 1 tablet orally every 6–8 hours (do not use more than 3 tablets per day).
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Elderly patients: no dosage adjustment is required, provided renal or hepatic function is not impaired.
Do not exceed the recommended dose.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
This medicine is intended for short-term use only. If symptoms persist or worsen, or if new symptoms occur, contact a doctor.
Do not take this medicine for more than 3 days without consulting a doctor.
Use in children
This medicine must not be used in children under 12 years of age.
Taking more than the recommended dose of Ibuprom Zatoki Max
If a patient has taken more than the recommended dose of Ibuprom Zatoki Max, or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital for assessment of potential health risks and advice on necessary actions. If less than 1 hour has passed since the overdose, induce vomiting or perform gastric lavage, or administer activated charcoal.
Symptoms of overdose may include nausea, stomach pain, increased heart rate, elevated blood pressure, vomiting (possibly with blood), gastrointestinal bleeding (see section 4 below), diarrhoea, headache, tinnitus, confusion and nystagmus. There may also be agitation, drowsiness, disorientation or coma.
Seizures may occur rarely in patients. After large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold and breathing difficulties may occur. In addition, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In asthmatic patients, asthma may worsen. In addition, low blood pressure and breathing difficulties may occur.
Missed dose of Ibuprom Zatoki Max
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment with Ibuprom Zatoki Max must be stopped immediately and medical help must be sought immediately if symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:

• sudden, severe headache,
• nausea,
• vomiting,
• confusion,
• seizures,
• visual disturbances.

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 skin lesions, often with blisters in the center, skin peeling, and mucosal ulcers in the mouth, throat, nose, genital organs, and eyes. These severe skin reactions 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 subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Common adverse effects (may occur in up to 1 in 10 patients):

• heartburn, abdominal pain, nausea, vomiting, bloating with gas release, diarrhoea, constipation, and minor gastrointestinal bleeding, which may exceptionally lead to anaemia.

Uncommon adverse effects (may occur in up to 1 in 100 patients):

• hypersensitivity reactions with skin rash and itching, as well as episodes of breathlessness (may occur together with a drop in blood pressure);
• headache, dizziness, insomnia, restlessness, irritability, and fatigue;
• visual disturbances;
• gastrointestinal ulcers, potentially with bleeding and perforation, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease, gastric mucositis.

Rare adverse effects (may occur in up to 1 in 1,000 patients):

• tinnitus;
• renal papillary necrosis, increased serum uric acid levels.

Very rare adverse effects (may occur in up to 1 in 10,000 patients):

• worsening of inflammatory conditions associated with infection (e.g. necrotizing fasciitis) related to the use of non-steroidal anti-inflammatory drugs. If symptoms of infection occur or worsen during treatment with Ibuprom Zatoki Max, consult a doctor immediately to determine whether antimicrobial/antibiotic treatment is necessary.
• symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever, or altered consciousness, mainly in patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease). In case of such symptoms, contact a doctor immediately.
• blood cell production disorders: initial symptoms include fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, and bleeding (e.g. bruising, petechiae, purpura, nosebleeds). In such cases, treatment must be discontinued and a doctor must be contacted immediately. These symptoms must not be treated with painkillers or antipyretics.
• severe generalized hypersensitivity reactions. These may present as: facial swelling, tongue swelling, laryngeal oedema with impaired airway patency, respiratory failure, rapid heartbeat, hypotension, up to life-threatening shock. If any of the above symptoms occur, discontinue the medicine and seek immediate medical help.
• psychotic reactions, depression;
• palpitations, heart failure, myocardial infarction;
• hypertension;
• oesophagitis, pancreatitis, formation of diaphragm-like intestinal strictures; In case of acute upper abdominal pain, tarry stools, or bloody vomit, discontinue the medicine and contact a doctor immediately.
• liver function disorders, particularly during long-term use, liver failure, acute hepatitis;
• in exceptional cases, during varicella virus infection, severe skin infections and soft tissue complications may occur;
• reduced urine output and development of oedema, particularly in patients with hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure. In such cases, discontinue the medicine and contact a doctor without delay, as these may be the first signs of kidney damage or failure.

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• skin becomes light-sensitive;
• chest pain, which may be a symptom of a severe allergic reaction known as Kounis syndrome.

With NSAID treatment, oedema, hypertension, and heart failure have been reported.
The use of medicines such as Ibuprom Zatoki Max may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Due to the limited number of reports on adverse effects related to pseudoephedrine hydrochloride, the exact frequency of occurrence cannot be determined. However, these reactions appear to occur:

• rarely or very rarely: increased thirst, hallucinations (especially in children), insomnia, restlessness, anxiety, dizziness, muscle weakness, tremors, cardiac arrhythmias, tachycardia, dyspepsia, gastrointestinal disturbances, nausea, vomiting, dry mouth, flushing, rash, excessive sweating, urinary retention (mainly in men);
• frequency unknown: serious conditions affecting cerebral blood vessels, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), colitis due to insufficient blood supply (ischaemic colitis), sudden fever, skin redness, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of taking Ibuprom Zatoki Max (see section 2), reduced blood flow in the optic nerve (ischaemic optic neuropathy). If such symptoms occur, discontinue Ibuprom Zatoki Max and contact a doctor or seek immediate medical help.

With short-term use of the medicine, adverse effects occur rarely.
In elderly patients, the risk of adverse effects associated with ibuprofen use is increased compared to younger patients. The frequency and severity of adverse effects can be reduced by using the lowest therapeutic dose for the shortest possible duration.
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Ibuprom Zatoki Max

Store below 25°C.
Keep the medicine in a place out of sight and reach of children.
Do not use after the expiry date stated on the carton and immediate packaging (month/year).
The blister labelling indicates: EXP - expiry date, Lot - batch number.
Medicines must 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 Ibuprom Zatoki Max contains

• The active substances are ibuprofen and pseudoephedrine hydrochloride: 1 coated tablet contains 400 mg of ibuprofen and 60 mg of pseudoephedrine hydrochloride.
• Other excipients: calcium hydrogen phosphate, corn starch, sodium carboxymethyl starch (type A), hypromellose E-5, magnesium stearate.
• Coating composition: hypromellose E-5, polyethylene glycol 6000, talc, titanium dioxide (E 171), carmine red (E 124).

What Ibuprom Zatoki Max looks like and contents of the pack
Dark red, round, biconvex coated tablets.
Available pack sizes:
Aluminium/PVC/PVC blisters in cardboard boxes.
6 tablets (1 blister with 6 tablets)
10 tablets (1 blister with 10 tablets)
12 tablets (1 blister with 12 tablets)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Importer:
US Pharmacia Sp. z o.o.
ul. Ziębicka 40,
50-507 Wrocław
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel.: +48 (22) 543 60 00