Ibuprom Zatoki Tabs

Leaflet attached to the packaging: patient information

IBUPROM ZATOKI TABS

200 mg + 6.1 mg, effervescent tablets

(Ibuprofen + Phenylephrine 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 the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

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

Ibuprom Zatoki Tabs is a combination medicine containing two active substances: ibuprofen (a non-steroidal anti-inflammatory drug, NSAID) and phenylephrine hydrochloride (a nasal decongestant).
Ibuprom Zatoki Tabs has analgesic, anti-inflammatory, and antipyretic effects.
It constricts blood vessels, reduces congestion and swelling of the nasal mucosa and sinuses, reduces the amount of discharge, and facilitates breathing by decongesting the airways.
It decongests the nose and paranasal sinuses.

Indications for use

It is used to temporarily relieve symptoms of nasal and paranasal sinus congestion with accompanying headache, sinus-related pain, and fever in the course of influenza or a cold.
If there is no improvement after 3 days or if the patient feels worse, they should contact a doctor.

2. Important information before taking Ibuprom Zatoki Tabs

When not to take Ibuprom Zatoki Tabs:

• If the patient is hypersensitive to the active substances or any of the other ingredients of this medicine (listed in section 6).
• In patients who have experienced allergic symptoms after taking acetylsalicylic acid or other NSAIDs in the past, such as asthma, rhinitis, angioedema, or urticaria.
• In patients taking monoamine oxidase inhibitors (MAOIs) used to treat hypertension and depression, and for 14 days after stopping their use.
• If the patient has any of the following conditions:
• active or recurrent gastric and/or duodenal ulcer or gastrointestinal bleeding,
• previous gastrointestinal bleeding or perforation after taking NSAIDs,
• intracranial bleeding or other bleeding,
• severe liver, kidney, or heart failure,
• coronary artery disease,
• hypertension,
• unexplained blood disorders (hematologic),
• hemophilia,
• diabetes,
• pheochromocytoma,
• glaucoma with closed-angle glaucoma,
• hyperthyroidism,
• prostatic hyperplasia.
• During pregnancy and breastfeeding.
• In children under 12 years of age.

Warnings and precautions

If the patient has any of the following diseases or symptoms, they should consult a doctor before starting treatment with Ibuprom Zatoki Tabs.

• Systemic lupus erythematosus or mixed connective tissue disease.
• Allergic reactions after taking acetylsalicylic acid.
• Gastrointestinal diseases or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease).
• Impaired kidney or liver function.
• Blood disorders (e.g., intermittent porphyria, platelet disorders).
• Active or past asthma or allergic diseases - taking the medicine may cause bronchospasm.
• Respiratory failure.
• Diseases for which the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).
• Chickenpox, as taking the medicine in the course of chickenpox may lead to serious complications in the form of skin or soft tissue infections.
• Caution should be exercised in dehydrated patients due to the increased risk of worsening kidney function.

Taking anti-inflammatory/pain-relieving medicines, 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 Ibuprom Zatoki Tabs, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, or has peripheral arterial disease (poor blood circulation in the 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, or a family history of heart disease or stroke, or if the patient smokes.
• the patient has an infection - see below, section "Infections".

It is recommended to avoid taking the medicine simultaneously with NSAIDs, including selective cyclooxygenase-2 inhibitors.
Skin reactions
Severe skin reactions have been reported with Ibuprom Zatoki Tabs. If the following occur: any skin rash, changes in the mucous membranes, blisters, or other signs of hypersensitivity, the patient should stop taking Ibuprom Zatoki Tabs and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.
Infections
Ibuprom Zatoki Tabs may mask the symptoms of infection, such as fever and pain. Therefore, Ibuprom Zatoki Tabs may delay the use of appropriate infection treatment and lead to an 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, they should consult a doctor immediately.
Warnings and precautions regarding side effects that may occur in patients taking Ibuprom Zatoki Tabs - see also section 4. Possible side effects.

Worsening of headache

Prolonged use of any pain-relieving medicine for headache may worsen the headache.
If this occurs or is suspected, treatment should be discontinued and medical advice sought. In patients with frequent or daily headaches despite (or due to) regular use of headache medicines, medication-overuse headache should be suspected.

Smallest effective dose

To minimize the risk of side effects, the smallest effective dose should always be used. Taking higher doses than recommended may increase the risk of side effects.

Elderly patients

Elderly patients have an increased risk of side effects related to the gastrointestinal tract, especially bleeding and perforation, which can be fatal.

Children

The medicine should not be given to children under 12 years of age.

Ibuprom Zatoki Tabs and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Ibuprom Zatoki Tabs may affect the action of other medicines or other medicines may affect the action of Ibuprom Zatoki Tabs. These include, for example:

• other NSAIDs, including acetylsalicylic acid (aspirin) - may increase the risk of side effects, especially those related to the gastrointestinal tract,
• anticoagulant medicines (e.g., blood thinners/anti-clotting agents, such as aspirin/acetylsalicylic acid in low doses, warfarin, ticlopidine); may increase the risk of bleeding,
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan, diuretics, such as indapamide) - may reduce their effect and worsen kidney failure,
• digoxin (a heart medicine), phenytoin (an antiepileptic medicine), lithium (used in manic-depressive illness and depression) - may increase their blood levels,
• certain diuretics (so-called potassium-sparing diuretics) - may increase potassium levels in the blood,
• corticosteroids - may increase the risk of gastrointestinal ulcers or bleeding,
• certain antidepressants (so-called selective serotonin reuptake inhibitors) - may increase the risk of bleeding,
• methotrexate (used in certain cancers and rheumatic diseases) - may increase its toxicity,
• oral antidiabetic medicines - blood glucose levels should be monitored,
• immunosuppressants (cyclosporine, tacrolimus) - may increase the risk of kidney damage,
• zydovudine (used in AIDS treatment) - may increase the risk of bleeding into the joints or bleeding leading to swelling in patients with hemophilia,
• probenecid and sulfinpyrazone - may prolong the action of ibuprofen,
• antifungal medicines (voriconazole, fluconazole) - may increase the blood levels of ibuprofen and may require a dose reduction of ibuprofen,
• monoamine oxidase inhibitors (medicines used in depression treatment) and for two weeks after stopping their use,
• phenylephrine or pseudoephedrine (medicines used in symptomatic treatment of rhinitis),
• indomethacin (a pain-relieving and anti-inflammatory medicine used in rheumatic diseases),
• beta-adrenergic receptor blockers (medicines used in hypertension and cardiovascular diseases) - may significantly increase blood pressure (so-called hypertensive crisis),
• guanethidine, mecamylamine, or reserpine (medicines used in hypertension treatment) - may reduce their antihypertensive effect.

Other medicines may also be affected or have an effect on treatment with Ibuprom Zatoki Tabs. Therefore, before taking Ibuprom Zatoki Tabs with other medicines, the patient should always consult a doctor or pharmacist.

Ibuprom Zatoki Tabs with food or alcohol

Food does not significantly affect the absorption of the medicine.
If the patient consumes alcohol while taking this medicine, there is a higher likelihood of side effects.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Taking Ibuprom Zatoki Tabs during pregnancy and breastfeeding is contraindicated.
Ibuprofen may cause fertility problems in women, as it inhibits the synthesis of prostaglandins - hormones involved in reproductive processes. This effect is temporary and disappears after the end of therapy. It is unlikely that occasional use of Ibuprom Zatoki Tabs will reduce the chance of becoming pregnant, but if a woman has problems becoming pregnant, she should consult a doctor before taking the medicine.

Driving and using machines

While taking the medicine, the patient should be cautious when driving a car and operating machinery. Ibuprofen may rarely cause dizziness and fatigue.

The medicine contains tartrazine (E 102) and sucrose

Tartrazine (E 102) may cause allergic reactions.
One tablet contains 31.66 mg of sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Ibuprom Zatoki Tabs

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist.
Take orally.
Recommended dose
Adults and children over 12 years: 2 tablets 3 times a day (every 8 hours). The patient should maintain at least a 4-hour interval between doses. Do not take more than 6 tablets per day.
Use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult a doctor immediately (see section 2).
If it is necessary to take the medicine for more than 3 days or if the patient's condition worsens, they should contact a doctor.

Use in children

The medicine should not be given to children under 12 years of age.

Taking a higher dose of Ibuprom Zatoki Tabs than recommended

If the patient has taken a higher dose of Ibuprom Zatoki Tabs than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what actions to take.
Symptoms may include nausea, stomach pain, diarrhea, vomiting (which may contain blood), headaches, 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 problems may occur. Severe poisonings may be characterized by metabolic disorders (acidosis), decreased blood coagulability, acute kidney or liver failure. Asthma may also worsen.
If the overdose occurred no more than an hour ago, it is recommended to induce vomiting (or gastric lavage) or administer activated charcoal. Specialized treatment may be necessary to maintain vital functions.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

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

If the following serious side effects occur while taking Ibuprom Zatoki Tabs, the patient should stop taking the medicine and contact a doctor immediately.

Very rare side effects (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 non-steroidal anti-inflammatory drugs.

The doctor will determine if the use of anti-infective medicines (e.g., 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).
• Disorders of blood cell production: the first symptoms are fever, sore throat, superficial oral mucosa ulcers, flu-like symptoms, fatigue, bleeding (e.g., bruising, petechiae, nosebleeds).

Do not treat these symptoms with pain-relieving or antipyretic medicines!

• Severe generalized hypersensitivity reactions. This may be facial edema, tongue edema, internal edema of the larynx with reduced airway patency, respiratory failure, tachycardia, blood pressure drop, up to life-threatening shock. Immediate medical attention may be necessary.
• Palpitations, heart failure, myocardial infarction.

If acute chest pain occurs, the patient should stop taking the medicine and contact a doctor immediately.

• Esophagitis, pancreatitis, formation of intestinal strictures.

If the following occur: acute abdominal pain, black stools, or bloody vomiting, the patient should stop taking the medicine and contact a doctor immediately.

• Decreased urine output and edema formation, especially in patients with hypertension or kidney failure, nephrotic syndrome, interstitial nephritis with possible acute kidney failure.

These may be the first signs of kidney damage or failure.

Other side effects that may occur when taking Ibuprom Zatoki Tabs

Frequent side effects (1 in 10 to 1 in 100 patients taking the medicine)

• Heartburn, stomach pain, nausea, vomiting, bloating with gas, diarrhea, constipation, digestive disorders, loss of appetite, minor gastrointestinal bleeding, which may rarely lead to anemia.

Uncommon side effects (1 in 100 to 1 in 1,000 patients taking the medicine)

• Hypersensitivity reactions with skin rash and itching, also asthma attacks (possible occurrence in combination with a drop in blood pressure).
• Headaches, dizziness, insomnia, agitation, irritability, and fatigue.
• Visual disturbances.
• Ulcers of the gastrointestinal tract, with possible bleeding and perforation, oral mucosa ulcers, worsening of colitis and Crohn's disease, gastritis.

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

• Hypersensitivity reactions, from itching and rash to anaphylactic shock and bronchospasm.
• Increased blood pressure, accelerated heart rate, arrhythmias, palpitations, pallor.
• Tinnitus.
• Necrosis of renal papillae, increased uric acid levels in the blood.

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

• Psychotic reactions, depression, anxiety, agitation, tremors, nervousness, insomnia, irritability, dizziness, and headaches, hallucinations.
• Hypertension.
• Liver function disorders, especially during long-term use, liver failure, acute hepatitis.
• Severe skin reactions: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis; in rare cases, during chickenpox infection, severe skin and soft tissue infections may occur.

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

• Urinary retention.
• A 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, the patient should stop taking Ibuprom Zatoki Tabs and seek medical attention immediately. See also section 2.
• Skin becomes sensitive to light.

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).
In the case of occasional use of the medicine, side effects are rare.
Elderly patients have an increased risk of side effects related to ibuprofen use 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.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should consult a doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ibuprom Zatoki Tabs

Store the medicine at a temperature below 25°C.
Keep the medicine in its original packaging to protect it from light.
Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiration date stated on the carton and blister packaging (month/year).
Blister packaging labeling: EXP - expiration date, Lot - batch number.

6. Contents of the packaging and other information

What Ibuprom Zatoki Tabs contains

The active substances of the medicine are ibuprofen and phenylephrine hydrochloride. 1 effervescent tablet contains 200 mg of ibuprofen and 6.1 mg of phenylephrine hydrochloride.
The other ingredients are calcium hydrogen phosphate dihydrate, sodium croscarmellose, powdered cellulose, talc, simethicone, colloidal silica, anhydrous, sucrose, calcium carbonate, Macrogol 6000, Povidone K90, Macrogol 4000, TER LMF FICHTENGRÜN (sodium sulfate (E 514), tartrazine (E 102), brilliant blue (E 133)), titanium dioxide (E 171), shellac, cocoa oil.

What Ibuprom Zatoki Tabs looks like and what the packaging contains

The tablets are round, biconvex, and green in color.
Packaging:6, 12, 16, 24 effervescent tablets in PVC/PVDC/Aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
Ziębicka 40,
50-507 Wrocław
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
Poleczki 35
02-822 Warsaw
tel. +48 (22) 543 60 00
Date of the last update of the leaflet: March 2022