Ibuprom Zatoki Max

Package Leaflet: Information for the Patient

IBUPROM ZATOKI MAX

400 mg + 60 mg, coated tablets

(Ibuprofen + Pseudoephedrine hydrochloride)

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.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, ask 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, contact your doctor.

Table of Contents of the Leaflet

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

Ibuprom Zatoki Max is a medicine intended for short-term use to relieve symptoms of colds and flu such as: headache, pain and congestion of the paranasal sinuses, runny nose, fever, sore throat, muscle aches.

Short-term treatment of sinusitis symptoms such as: headache, congestion of the sinuses and nose, accompanied by pain, which are complications of a cold, flu, or allergic rhinitis.

If after 3 days there is no improvement or you feel worse, you should consult a doctor.

2. Important information before taking Ibuprom Zatoki Max

When not to take Ibuprom Zatoki Max:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6) and to other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have ever had symptoms of an allergic reaction after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, such as rhinitis, urticaria, or bronchial asthma;
• in patients with active or recurrent gastric and/or duodenal ulcers, perforation or bleeding, also those that occurred after taking NSAIDs;
• in patients with severe liver or heart failure;
• in patients taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of side effects);
• in pregnancy and breastfeeding;
• in patients with a bleeding disorder;
• in patients with severe cardiovascular disorders, tachycardia, angina pectoris;
• in patients with very high blood pressure (severe hypertension) or uncontrolled hypertension;
• in patients with severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• in patients with hyperthyroidism;
• in patients with diabetes;
• in patients with glaucoma;
• in patients with prostatic hyperplasia;
• in patients with pheochromocytoma.

Warnings and precautions

Before starting treatment with Ibuprom Zatoki Max, you should discuss it with your doctor or pharmacist.

Special caution should be exercised when taking the medicine:

• if you have systemic lupus erythematosus and mixed connective tissue disease;
• if you have experienced allergic reactions after taking acetylsalicylic acid;
• if you have gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• if you have hypertension and/or heart rhythm disorders;
• if you have kidney function disorders;
• if you have liver function disorders;
• if you have blood clotting disorders;
• if you have a history of asthma or allergic reactions; taking the medicine may cause bronchospasm;
• if you are taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).

There is a risk of gastrointestinal bleeding, ulcers, or perforation, which can be fatal and does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs.

In case of gastrointestinal bleeding or ulcers, you should immediately stop taking the medicine.

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.

If you experience fever with generalized skin rash and pustular eruption, you should stop taking Ibuprom Zatoki Max and contact your doctor or seek medical attention immediately. See section 4.

Concomitant, long-term use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).

Care should be taken in dehydrated patients (children and adolescents) due to the increased risk of kidney function disorders.

Taking anti-inflammatory/pain-relieving medications, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, especially when taken in high doses.

Do not exceed the recommended dose and duration of treatment.

During treatment with Ibuprom Zatoki Max, sudden abdominal pain or rectal bleeding may occur due to inflammation of the colon (ischemic colitis).

If such gastrointestinal symptoms occur, you should stop taking Ibuprom Zatoki Max and seek medical attention immediately. See section 4.

Before taking Ibuprom Zatoki Max, you should discuss your treatment with your doctor or pharmacist if:

• you have heart disease, such as heart failure, angina pectoris (chest pain), you have had a heart attack, coronary artery bypass grafting, you have peripheral artery disease (poor blood 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);
• 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;
• you have an infection - see below, section "Infections".

After taking pseudoephedrine-containing medications, 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.

In case of symptoms that may be symptoms of PRES or RCVS, you should immediately stop taking Ibuprom Zatoki Max and seek medical attention (symptoms, see section 4 "Possible side effects").

Do not take higher doses or longer treatment than recommended.

If symptoms persist, worsen, or do not improve after 3 days, or if new symptoms occur, you should contact your doctor.

In case of heart problems, stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), you should discuss your treatment with your doctor or pharmacist.

During ibuprofen treatment, allergic reactions to this medicine have been reported, including respiratory disorders, facial and neck edema (angioedema), chest pain.

If you experience these symptoms, you should immediately stop taking Ibuprom Zatoki Max and contact your doctor or go to the emergency department.

Skin reactions

Severe skin reactions associated with Ibuprom Zatoki Max have been reported.

If you experience any skin rash, mucosal lesions, blisters, or other signs of hypersensitivity, you should stop taking Ibuprom Zatoki Max and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.

Infections

Ibuprom Zatoki Max may mask the symptoms of an infection, such as fever and pain.

Therefore, Ibuprom Zatoki Max may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications.

This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.

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

This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect female fertility.

This effect is temporary and disappears after the end of treatment.

If you have difficulty getting pregnant, you should contact your doctor before taking ibuprofen.

Athletes should be informed that pseudoephedrine may cause a positive result in doping tests.

The medicine should be taken with caution by patients taking tricyclic antidepressants and other sympathomimetic medicines (medicines that constrict blood vessels in mucous membranes), appetite suppressants, amphetamine-like medicines, psychotropic medicines.

Children

The medicine is not intended for children under 12 years of age.

Ibuprom Zatoki Max and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Do not take Ibuprom Zatoki Max at the same time as other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors, such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (in pain-relieving doses).

Concomitant use of Ibuprom Zatoki Max with these medicines increases the risk of side 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-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• diuretics;
• corticosteroids (such as prednisolone or dexamethasone);
• methotrexate (anticancer medicine);
• lithium (antidepressant);
• zydovudine (antiviral medicine);
• MAO inhibitors (e.g., selegiline), also during the 14 days after stopping their use;
• dopamine receptor agonists, ergot alkaloid derivatives - bromocriptine, cabergoline, lisuride, pergolide;
• dopaminergic vasoconstrictor medicines - dihydroergotamine, ergotamine, methylergonovine;
• linezolid;
• quinidine;
• tricyclic antidepressants;
• sympathomimetic medicines that decongest the nose and reduce appetite;
• sympathomimetic amphetamine-like medicines.

Also, some other medicines may be affected or have an effect on treatment with Ibuprom Zatoki Max.

Therefore, before taking Ibuprom Zatoki Max with other medicines, you should always consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

Before taking the medicine, consult your doctor.

Do not take the medicine during pregnancy and breastfeeding.

Effect of the medicinal product on fertility - see section Warnings and precautions.

Driving and using machines

During treatment, be careful when driving a car and operating machinery.

Ibuprom Zatoki Max contains E 124 (Ponceau 4R)

The medicine may cause allergic reactions.

3. How to take Ibuprom Zatoki Max

This medicine should always be taken exactly as directed by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist.

Recommended dose:Adults and children over 12 years: for short-term treatment, 1 tablet orally every 6-8 hours (do not take more than 3 tablets per day).

Use the smallest effective dose for the shortest duration necessary to relieve symptoms.

If the symptoms of the infection (such as fever and pain) persist or worsen, you should immediately consult your doctor (see section 2).

Use in children

The medicine should not be taken by children under 12 years of age.

Elderly:dose adjustment is not required unless kidney or liver function is impaired.

Do not exceed the recommended dose.

If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

The medicine is intended for short-term use.

If symptoms persist or worsen or if new symptoms occur, you should contact your doctor.

Do not take the medicine for more than 3 days without consulting your doctor.

Taking a higher dose of Ibuprom Zatoki Max than recommended

If you have taken a higher dose of Ibuprom Zatoki Max than recommended or if a child has accidentally taken the medicine, you should always consult your doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do.

Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, 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, and breathing difficulties.

There may also be a significant increase in heart rate and blood pressure.

If the overdose occurred no more than 1 hour ago, you should induce vomiting or perform gastric lavage or administer activated charcoal.

Based on numerous studies on the effects of pseudoephedrine overdose in combination products used for colds and allergies, gastric lavage is recommended if the amount of the substance taken exceeds the equivalent of 3-4 maximum daily doses (i.e., 720-960 mg).

Missing a dose of Ibuprom Zatoki Max

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should immediately stop taking Ibuprom Zatoki Max and seek medical attention if you experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), including:

• severe headache with sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures,
• vision changes.

The frequency of possible side effects listed below is defined as follows:

• very common: occurs in more than 1 in 10 patients;
• common: occurs in 1 to 10 in 100 patients;
• uncommon: occurs in 1 to 10 in 1,000 patients;
• rare: occurs in 1 to 10 in 10,000 patients;
• very rare: occurs in less than 1 in 10,000 patients;
• frequency not known: frequency cannot be estimated from the available data.

Common side effects (occurring in 1 to 10 in 100 patients taking the medicine):

• heartburn, stomach pain, nausea, vomiting, bloating with gas, diarrhea, constipation, and minor gastrointestinal bleeding, which may lead to anemia in exceptional cases.

Uncommon side effects (occurring in 1 to 10 in 1,000 patients taking the medicine):

• allergic reactions with skin rash and itching, as well as asthma attacks (may occur in combination with a drop in blood pressure);
• headache, dizziness, insomnia, agitation, irritability, and fatigue;
• vision disorders;
• gastrointestinal ulcers, potentially with bleeding and perforation, oral mucosal ulcers, exacerbation of colitis and Crohn's disease, gastritis.

Rare side effects (occurring in 1 to 10 in 10,000 patients taking the medicine):

• tinnitus;
• renal papillary necrosis, increased uric acid levels in the blood.

Very rare side effects (occurring in less than 1 in 10,000 patients taking the medicine):

• worsening of inflammatory conditions associated with infection (e.g., occurrence of necrotizing fasciitis) related to the use of NSAIDs.

If you experience any symptoms of infection or if they worsen during treatment with Ibuprom Zatoki Max, you should immediately consult your doctor to determine if it is necessary to use anti-infective medicines/antibiotics.

• symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever, or changes in consciousness, mainly in patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease).

In case of such symptoms, you should immediately contact your doctor.

• disorders of blood cell production: the first symptoms are fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, bleeding (e.g., bruising, petechiae, purpura, nosebleeds). In such a case, you should stop the treatment and immediately contact your doctor. Do not treat these symptoms with painkillers or antipyretics.
• severe generalized allergic reactions. They can occur as facial edema, tongue edema, internal laryngeal edema with impaired airway patency, respiratory failure, tachycardia, blood pressure drop, up to life-threatening shock. If you experience the above symptoms, you should stop taking the medicine and immediately contact your doctor.
• psychotic reactions, depression;
• palpitations, heart failure, myocardial infarction;
• hypertension;
• esophagitis, pancreatitis, formation of circumferential intestinal strictures;

In case of sudden abdominal pain, black stools, or bloody vomiting, you should stop taking the medicine and immediately contact your doctor.

• liver function disorders, especially during long-term use, liver failure, acute hepatitis;
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, in exceptional cases, during viral infections such as chickenpox, severe skin and soft tissue infections and complications may occur;
• reduced urine output and edema formation, especially in patients with hypertension or kidney failure, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute kidney failure. In such a case, you should stop taking the medicine and immediately contact your doctor, as these may be the first signs of kidney damage or failure.

Side effects with unknown frequency (frequency cannot be determined from the available data)

• red scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop taking Ibuprom Zatoki Max and seek medical attention immediately. See also section 2.
• skin sensitivity to light;
• chest pain, which may be a symptom of a severe allergic reaction called Kounis syndrome.

Due to the use of NSAIDs, reports of edema, hypertension, and heart failure have been made.

Taking such medicines as Ibuprom Zatoki Max may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.

Severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include skin rash, fever, lymph node swelling, and an increased number of eosinophils (a type of white blood cell).

Due to the small number of reports of side effects related to pseudoephedrine hydrochloride, it is impossible to determine the exact frequency of their occurrence, but it seems that these reactions occur:

• rarely or very rarely: increased thirst, hallucinations (especially in children), insomnia, anxiety, fear, dizziness, weakness, tremors, heart rhythm disorders, tachycardia, nausea, vomiting, dry mouth, redness, rash, excessive sweating, urinary retention (mainly in men);
• frequency not known: severe vascular disorders in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), ischemic colitis, sudden fever, skin redness, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP). See section 2, reduced blood flow in the optic nerve (ischemic optic neuropathy). If such symptoms occur, you should stop taking Ibuprom Zatoki Max and seek medical attention immediately.

In case of short-term use of the medicine, side effects are rare.

In elderly patients, there is an increased risk of side effects associated with ibuprofen compared to younger patients.

The frequency and severity of side effects can be reduced by using the smallest effective therapeutic dose for the shortest possible duration.

If you experience any side effects, including those not listed in this leaflet, you should consult your doctor or pharmacist.

Reporting side effects

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

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

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 Ibuprom Zatoki Max

Store in a temperature below 25°C.

Keep the medicine out of the sight and reach of children.

Do not use after the expiry date stated on the carton and blister pack.

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 Ibuprom Zatoki Max contains

• The active substances of the medicine are ibuprofen and pseudoephedrine hydrochloride: 1 coated tablet contains 400 mg of ibuprofen and 60 mg of pseudoephedrine hydrochloride.
• The other ingredients are: calcium phosphate, corn starch, sodium carboxymethylcellulose (type A), hypromellose E-5, magnesium stearate.
• Coating:hypromellose E-5, macrogol 6000, talc, titanium dioxide (E 171), Ponceau 4R (E 124).

What Ibuprom Zatoki Max looks like and contents of the pack

Dark red, round, biconvex coated tablets.

Available packs:

Aluminum/PVC/PVC blister pack in a cardboard box.

6 tablets (1 blister pack of 6 tablets)

10 tablets (1 blister pack of 10 tablets)

12 tablets (1 blister pack of 12 tablets)

Not all pack sizes may be marketed.

Marketing authorization holder and importer:

US Pharmacia Sp. z o.o.

ul. Ziębicka 40,

50-507 Wrocław

To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:

USP Zdrowie Sp. z o.o.

ul. Poleczki 35

02-822 Warsaw

tel.: +48 (22) 543 60 00

Date of last revision of the leaflet: June 2024