Ibuprom Zatoki

Leaflet attached to the packaging: patient information

IBUPROM ZATOKI

200 mg + 30 mg, coated tablets

(Ibuprofen + Pseudoephedrine hydrochloride)

You should carefully read the contents of the leaflet 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Ibuprom Zatoki and what is it used for
• 2. Important information before using Ibuprom Zatoki
• 3. How to use Ibuprom Zatoki
• 4. Possible side effects
• 5. How to store Ibuprom Zatoki
• 6. Contents of the packaging and other information

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

Ibuprom Zatoki 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, and muscle pain.

2. Important information before using Ibuprom Zatoki

When not to use Ibuprom Zatoki:

• 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 allergic symptoms after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, such as runny nose, hives, or bronchial asthma;
• in patients with active or recurrent stomach 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 bleeding disorders;
• in patients with severe cardiovascular disorders, tachycardia, angina pectoris;
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension;
• if you have 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

Particular caution should be exercised when using 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 dysfunction;
• if you have kidney dysfunction;
• if you have liver dysfunction;
• if you have blood coagulation disorders;
• if you have a history of bronchial asthma or allergic reactions in the past; 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, ulceration, 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.

If gastrointestinal bleeding or ulceration occurs, the medicine should be discontinued immediately.

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 the patient develops a fever with generalized skin rash and pustular eruption, they should stop taking Ibuprom Zatoki and consult a doctor or seek immediate medical attention. See section 4.

Taking different painkillers for a long time can 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 dysfunction.

Taking anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose and duration of treatment.

During the use of Ibuprom Zatoki, sudden abdominal pain or rectal bleeding may occur due to inflammation of the colon (ischemic colitis). If such gastrointestinal symptoms occur, the use of Ibuprom Zatoki should be discontinued and medical attention should be sought immediately. See section 4.

During the use of Ibuprom Zatoki, a decrease in blood flow in the optic nerve may occur. If sudden vision loss occurs, the use of Ibuprom Zatoki should be discontinued and medical attention should be sought immediately. See section 4.

Before using Ibuprom Zatoki, the patient should discuss the treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, have peripheral arterial disease (poor blood 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 high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or smoke;
• they have an infection - see below, section entitled "Infections".

After taking medicines containing 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 occur that may be symptoms of PRES or RCVS, the use of Ibuprom Zatoki should be discontinued immediately and medical attention should be sought immediately (symptoms, see section 4 "Possible side effects").

Do not use 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 consult a doctor.

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

During the use of ibuprofen, allergic reactions to this medicine have been reported, including respiratory disorders, facial and neck edema (angioedema), chest pain. If these symptoms are observed, the use of Ibuprom Zatoki should be discontinued immediately and medical attention should be sought.

Severe skin reactions have been reported with the use of Ibuprom Zatoki.

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

Infections

Ibuprom Zatoki may mask the symptoms of infection, such as fever and pain. Therefore, Ibuprom Zatoki 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 consult your doctor immediately.

This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is transient and disappears after the end of treatment.

If you have difficulty conceiving, you should consult your doctor before taking ibuprofen.

The medicine should be used with caution in 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 indicated for children under 12 years of age.

Ibuprom Zatoki and other medicines

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

You should not take Ibuprom Zatoki 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 analgesic doses). Concomitant use of Ibuprom Zatoki with these medicines increases the risk of side effects.

Ibuprom Zatoki may affect the action of other medicines or other medicines may affect the action of Ibuprom Zatoki, 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 (an anticancer medicine);
• lithium (an antidepressant medicine);
• zydovudine (an antiviral medicine);
• monoamine oxidase inhibitors (MAOIs), also within 14 days of stopping their use;
• dopamine receptor agonists, ergot alkaloid derivatives - bromocriptine, cabergoline, lisuride, pergolide;
• dopaminergic vasoconstrictor medicines - dihydroergotamine, ergotamine, methylergometrine;
• linezolid;
• quinidine;
• tricyclic antidepressants;
• sympathomimetic medicines that decongest the nose and reduce appetite;
• sympathomimetic medicines of the amphetamine type.

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

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

Pregnancy, breastfeeding, and fertility

You should consult your doctor before using the medicine.

The medicine should not be used during pregnancy and breastfeeding.

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

Driving and using machines

During the use of the medicine, you should be cautious while driving a car and operating machines.

Ibuprom Zatoki contains sucrose, orange yellow (E110), sodium benzoate, and sodium.

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

Orange yellow (E110) and Allura red (E129) may cause allergic reactions.

The medicine contains 0.005 mg of sodium benzoate in each tablet.

The medicine contains less than 1 mmol (23 mg) of sodium per single dose (1 tablet), which means that the medicine is considered sodium-free.

3. How to use Ibuprom Zatoki

Adults and children over 12 years of age: for short-term treatment, 1 to 2 tablets orally every 4 hours (do not take more than 6 tablets per day).

You should 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 consult your doctor immediately (see section 2).

The medicine should not be used in children under 12 years of age.

The elderly: no dose adjustment is 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, you should consult your doctor.

The medicine is intended for short-term use. If symptoms persist or worsen or if new symptoms occur, you should consult your doctor.

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

Using a higher dose of Ibuprom Zatoki than recommended

If you have taken a higher dose of Ibuprom Zatoki 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 the possible risk to your health 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, blood in the urine, feeling cold, and breathing difficulties may occur. There may also be a significant increase in heart rate and blood pressure. If the overdose occurred less than 1 hour ago, you should induce vomiting or perform gastric lavage or administer activated charcoal. Based on numerous reports of pseudoephedrine overdose contained 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

You should 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.

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

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

You should stop using Ibuprom Zatoki and seek medical attention immediately if you experience symptoms that may be symptoms of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

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

Common side effects (occurring in 1 to 10 people in 100):

• 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 people in 1,000):

• hypersensitivity 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 ulceration, exacerbation of colitis and Crohn's disease, gastritis.

Rare side effects (occurring in 1 to 10 people in 10,000):

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

Very rare side effects (occurring in less than 1 in 10,000 people):

• 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 the use of Ibuprom Zatoki, you should seek medical attention immediately to determine if the use of anti-infective medicines/antibiotics is necessary.

• 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). If such symptoms occur, you should seek medical attention immediately.
• 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, nosebleeds). In such cases, treatment should be discontinued and medical attention should be sought immediately. Do not treat these symptoms with painkillers or antipyretics.
• severe generalized hypersensitivity reactions. They can occur as facial edema, tongue edema, internal laryngeal edema with impaired airway patency, respiratory failure, tachycardia, blood pressure drop, leading to life-threatening shock. If you experience these symptoms, you should stop taking Ibuprom Zatoki and seek medical attention immediately.

• psychotic reactions, depression;
• palpitations, heart failure, myocardial infarction;
• hypertension;
• esophagitis, pancreatitis, formation of esophageal-like strictures of the intestine;

In case of sudden abdominal pain, black stools, or bloody vomiting, you should discontinue the use of Ibuprom Zatoki and seek medical attention immediately.

• liver function disorders, particularly during long-term use, liver failure, acute hepatitis;
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, in exceptional cases, during chickenpox infection, severe skin infections and soft tissue 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 cases, the use of Ibuprom Zatoki should be discontinued and medical attention should be sought immediately, as these may be the first signs of kidney damage or failure.

Side effects with unknown frequency (frequency cannot be estimated 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 - AGEP). If such symptoms occur, you should discontinue the use of Ibuprom Zatoki and seek medical attention immediately. See also section 2;
• hypersensitivity reactions to light;
• chest pain, which may be a symptom of a severe allergic reaction called Kounis syndrome.

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

Taking such medicines as Ibuprom Zatoki may be associated with a small increased 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 the use of 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 affecting the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), ischemic colitis; sudden fever, skin rash, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of using Ibuprom Zatoki. See section 2;

decreased blood flow in the optic nerve (ischemic optic neuropathy). If such symptoms occur, you should discontinue the use of Ibuprom Zatoki and seek medical attention immediately.

In case of short-term use of the medicine, side effects occur rarely.

In elderly patients, there is an increased risk of side effects related to the use of ibuprofen compared to younger patients.

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

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

Reporting side effects

If you experience any side effects, including any possible side effects 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 the medicine.

5. How to store Ibuprom Zatoki

Store in a temperature below 25°C.

The medicine should be stored out of sight and reach of children.

Do not use after the expiry date stated on the carton and blister packaging (month/year). The labeling used for the blister is: EXP - expiry date, Lot - batch number.

6. Contents of the packaging and other information

What Ibuprom Zatoki contains

• The active substances of the medicine are ibuprofen and pseudoephedrine hydrochloride.
• The other excipients are: cellulose powder (Elcema P-100), cellulose powder (Elcema F-150), corn starch, pregelatinized starch, guar gum, talc, croscarmellose sodium, crospovidone, colloidal silica, anhydrous, vegetable oil, hardened.
• Coating composition:hydroxypropylcellulose, macrogol 400, talc, gelatin, sucrose, kaolin, confectioner's sugar (a mixture of sucrose and corn starch), calcium carbonate, Opaglos Clear GS-2-0750 (a mixture of carnauba wax, white wax, and ethanol denatured with methanol), arabic gum dispersion dried, corn starch, Opalux Brown AS-16518 (a mixture of sucrose, titanium dioxide (E171), orange yellow lake (E110), Allura red lake (E129), indigo carmine lake (E132), povidone, sodium benzoate (E211)).
• Ink composition:Opacode Black S-1-17823 (a mixture of shellac, black iron oxide (E172), n-butyl alcohol, isopropyl alcohol, ammonium hydroxide 28%, propylene glycol, ethanol).

The medicine is an elipsoidal tablet, reddish-brown in color, with the inscription IB Z on one side.

Presentation of the medicinal product

6 tablets - 1 blister of 6 tablets;

10 tablets - 1 blister of 10 tablets;

12 tablets - 1 blister of 12 tablets;

20 tablets - 2 blisters of 10 tablets;

24 tablets - 2 blisters of 12 tablets;

24 tablets in a bottle.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.

ul. Ziębicka 40

50-507 Wrocław

To obtain more detailed information, please contact:

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