Ibuprom zatoki tabs

Package leaflet: Information for the patient

IBUPROM SINUS TABS
200 mg + 6.1 mg, film-coated tablets
(Ibuprofen + Phenylephrine hydrochloride)
Please read this 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 patient leaflet or as directed by a 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 adverse reactions 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 Ibuprom Sinus Tabs is and what it is used for
2. Important information before taking Ibuprom Sinus Tabs
3. How to take Ibuprom Sinus Tabs
4. Possible side effects
5. How to store Ibuprom Sinus Tabs
6. Contents of the pack and other information

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

Ibuprom Sinus Tabs is a combination medicine containing two active substances: ibuprofen (a non-steroidal anti-inflammatory drug, NSAID) and phenylephrine hydrochloride (a nasal decongestant).
Ibuprom Sinus Tabs has analgesic, anti-inflammatory, and antipyretic properties.
It constricts blood vessels, reduces nasal and sinus mucosal congestion and swelling, decreases nasal secretions, clears the airways, and facilitates breathing.
It helps clear the nose and paranasal sinuses.
Indications
For short-term relief of nasal and paranasal sinus congestion accompanied by headache, sinus-related pain, and fever associated with influenza or the common cold.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Ibuprom Zatoki Tabs

When not to use Ibuprom Zatoki Tabs:

• If the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• In patients who have previously experienced allergic reactions after taking acetylsalicylic acid or other NSAIDs, such as bronchial asthma, rhinitis, angioedema, or urticaria.
• In patients taking monoamine oxidase inhibitors (MAO inhibitors) used to treat low blood pressure or depression, and within 14 days after discontinuation of such treatment.
• If the patient has any of the following conditions:
  • active or recurrent peptic ulcer or duodenal ulcer and/or gastrointestinal bleeding,
  • previous gastrointestinal bleeding or perforation after use of NSAIDs,
  • intracranial or other bleeding,
  • severe liver, kidney, or heart failure,
  • coronary artery disease,
  • hypertension,
  • unexplained hematological disorders,
  • bleeding disorders,
  • diabetes,
  • pheochromocytoma,
  • narrow-angle glaucoma,
  • hyperthyroidism,
  • benign prostatic hyperplasia.
• During pregnancy and breastfeeding.
• In children under 12 years of age.

Warnings and precautions
If the patient has any of the diseases or symptoms described below, they should consult a doctor before starting treatment with Ibuprom Zatoki Tabs to discuss appropriate treatment.

• Systemic lupus erythematosus or mixed connective tissue disease.
• Allergic reactions after taking acetylsalicylic acid.
• Gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease).
• Impaired kidney or liver function.
• Blood disorders (e.g. hereditary intermittent porphyria, platelet disorders).
• Active or past history of bronchial asthma or allergic diseases – bronchospasm may occur after taking the medicine.
• Respiratory insufficiency.
• Conditions in which the patient is taking other medicines (especially anticoagulants, diuretics, cardiac drugs, corticosteroids).
• Chickenpox – in exceptional cases, use of the medicine during chickenpox may lead to serious complications such as skin or soft tissue infections.
• Caution is advised in dehydrated patients due to 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, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Ibuprom Zatoki Tabs, the patient should discuss treatment with a doctor or pharmacist if:

• The patient has heart diseases such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor 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, a family history of heart disease or stroke, or is a smoker.
• The patient has an infection – see below under the section titled "Infections".

Concomitant use of Ibuprom Zatoki Tabs with NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Skin reactions
Severe skin reactions associated with the use of Ibuprom Zatoki Tabs have been reported. If any skin rash, mucosal lesions, blisters, or other allergic symptoms appear, the patient should stop taking Ibuprom Zatoki Tabs immediately and seek medical help without delay, as these may be early signs of a very serious skin reaction. See section 4.
Infections
Ibuprom Zatoki Tabs may mask symptoms of infection such as fever and pain. Therefore, Ibuprom Zatoki Tabs 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, immediate medical advice should be sought.
Warnings and precautions regarding adverse effects that may occur during treatment with 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 such a situation occurs or is suspected, treatment should be discontinued and medical advice sought. In patients experiencing frequent or daily headaches despite (or because of) regular use of headache medicines, medication-overuse headache should be suspected.
Lowest effective dose
To minimize the risk of adverse effects, always use the lowest effective dose possible. Using higher than recommended doses may increase the risk of adverse effects.
Elderly patients
In elderly patients, there is an increased risk of gastrointestinal adverse effects, particularly bleeding and perforation, which may be fatal.
Children
This medicine should not be given to children under 12 years of age.
Ibuprom Zatoki Tabs and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, and about any medicines planned for future use.
Ibuprom Zatoki Tabs may affect the action of other medicines, or other medicines may affect the action of Ibuprom Zatoki Tabs. Examples include:

• other NSAIDs, including acetylsalicylic acid (aspirin) – may increase the risk of adverse effects, especially gastrointestinal,
• anticoagulant medicines (i.e. blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid at low dose, warfarin, ticlopidine) – may increase the risk of bleeding,
• antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan, diuretics such as indapamide) – may reduce their effectiveness and worsen kidney function,
• digoxin (cardiac medicine), phenytoin (antiepileptic), lithium (used in manic-depressive illness and depression) – may increase their blood concentration,
• certain potassium-sparing diuretics – may increase blood potassium levels,
• glucocorticosteroids – increased risk of gastrointestinal ulcers or bleeding,
• certain antidepressants (selective serotonin reuptake inhibitors) – increased risk of bleeding,
• methotrexate (used in certain cancers and rheumatic diseases) – may increase its toxicity,
• oral antidiabetic medicines – blood glucose levels should be monitored,
• immunosuppressive medicines (cyclosporine, tacrolimus) – increased risk of kidney damage,
• zidovudine (used in the treatment of AIDS) – increased risk of joint bleeding or bleeding leading to swelling in patients with hemophilia,
• probenecid and sulfinpyrazone – may prolong the effect of ibuprofen,
• antifungal medicines (voriconazole, fluconazole) – may increase ibuprofen blood concentration, and dose reduction of ibuprofen may be necessary,
• monoamine oxidase inhibitors (medicines used to treat depression, e.g. selegiline) and for two weeks after stopping them,
• phenylephrine or pseudoephedrine (medicines used for symptomatic treatment of rhinitis, i.e. nasal congestion),
• indomethacin (a pain-relieving and anti-inflammatory medicine used in rheumatic diseases),
• β-adrenergic receptor antagonists (medicines used in hypertension and cardiovascular diseases) – may cause a significant increase in blood pressure (so-called hypertensive crisis),
• guanethidine, mecamylamine or reserpine (medicines used to treat hypertension) – may reduce their antihypertensive effect.

Other medicines may also interact with or be affected by treatment with Ibuprom Zatoki Tabs. Therefore, always consult a doctor or pharmacist before using Ibuprom Zatoki Tabs with other medicines.
Ibuprom Zatoki Tabs with food or alcohol
Food does not significantly affect drug absorption.
If alcohol is consumed together with this medicine, the likelihood of adverse effects increases.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Use of Ibuprom Zatoki Tabs during pregnancy and breastfeeding is contraindicated.
Ibuprofen may cause fertility disorders in women, as it inhibits prostaglandin synthesis – hormones involved in reproductive processes. This effect is reversible and disappears after discontinuation of treatment. It is unlikely that occasional use of Ibuprom Zatoki Tabs would reduce the chance of becoming pregnant; however, if a woman has difficulty conceiving, she should consult a doctor before using the medicine.
Driving and operating machinery
During treatment, caution should be exercised when driving or operating mechanical equipment. 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 certain sugars, they should consult a doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ibuprom Zatoki Tabs

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Administer orally.
Recommended dose
Adults and adolescents over 12 years of age: 2 tablets three times daily (every 8 hours). At least a 4-hour interval should be maintained between doses. Do not take more than 6 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).
If it is necessary to use the medicine for longer than 3 days or if the patient's condition worsens, contact a doctor.
Use in children
This medicine should not be given to children under 12 years of age.
Overdose of Ibuprom Zatoki Tabs
If a patient has taken more than the recommended dose of Ibuprom Zatoki Tabs or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital to assess possible health risks and receive advice on appropriate actions to take.
Symptoms may include nausea, stomach pain, diarrhoea, 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. Severe poisoning may manifest as metabolic disturbances (acidosis), reduced blood clotting, acute kidney or liver failure. Asthma may also be exacerbated.
If less than one hour has passed since the overdose, induction of vomiting (or gastric lavage) or administration of activated charcoal is recommended. Specialist treatment may be necessary to maintain vital functions.
If in any doubt about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the serious adverse effects described below occur while taking Ibuprom Zatoki Tabs,
discontinue use immediately and contact your doctor without delay.
Serious adverse effects occur very rarely (less frequently than in 1 out of 10,000 patients
taking the medicine)

• Worsening of inflammatory conditions associated with infection (e.g. necrotizing fasciitis) linked to the use of non-steroidal anti-inflammatory drugs. The doctor will determine whether anti-infective treatment (e.g. antibiotics) is necessary.
• Symptoms of aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever, or disturbances in consciousness, mainly in patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease).
• Blood cell production disorders: initial symptoms include fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, fatigue, and bleeding (e.g. bruises, petechiae, purpura, nosebleeds). Do not treat these symptoms with painkillers or antipyretics!
• Severe generalized hypersensitivity reactions. These may include facial swelling, tongue swelling, internal laryngeal swelling with reduced airway patency, respiratory failure, rapid heartbeat, drop in blood pressure, up to life-threatening shock. Immediate medical assistance may be required.
• Palpitations, heart failure, myocardial infarction. If acute chest pain occurs, discontinue use of the medicine and contact your doctor immediately.
• Inflammation of the oesophagus, pancreatitis, formation of diaphragm-like intestinal strictures. If the following occur: acute upper abdominal pain, tarry stools or vomiting blood, discontinue use of the medicine and contact your doctor immediately.
• Reduced urine output and development of oedema, particularly in patients with hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis possibly leading to acute renal failure. These may be the first signs of kidney damage or kidney failure.

Other adverse effects that may occur during treatment with Ibuprom Zatoki Tabs
Adverse effects occurring frequently (in 1 to 10 out of 100 patients taking the medicine)

• Heartburn, abdominal pain, nausea, vomiting, bloating with gas release, diarrhoea, constipation, digestive disturbances, loss of appetite, minor gastrointestinal bleeding, which may exceptionally lead to anaemia.

Adverse effects occurring not frequently (in 1 to 10 out of 1,000 patients taking the medicine)

• Hypersensitivity reactions with skin rash and itching, including episodes of breathlessness (possibly occurring together with a drop in blood pressure).
• Headache, dizziness, insomnia, restlessness, irritability, and fatigue.
• Visual disturbances.
• Gastrointestinal ulceration, with possible bleeding and perforation, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease, gastric mucosal inflammation.

Adverse effects occurring rarely (in 1 to 10 out of 10,000 patients taking the medicine)

• Hypersensitivity reactions, from itching and skin rash up to anaphylactic shock symptoms and bronchospasm.
• Increased blood pressure, rapid heartbeat, cardiac arrhythmias, palpitations, pallor.
• Tinnitus.
• Renal papillary necrosis, increased blood uric acid concentration.

Adverse effects occurring very rarely (less than in 1 out of 10,000 patients
taking the medicine)

• Psychotic reactions, depression, anxiety, restlessness, tremors, nervousness, insomnia, irritability, dizziness and headache, hallucinations.
• Hypertension.
• Liver function disorders, particularly during prolonged use, liver failure, acute hepatitis.
• Severe skin reactions: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis; in exceptional cases, severe skin infections and soft tissue complications may occur during varicella virus infection.

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

• Urinary retention.
• Red scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, discontinue use of Ibuprom Zatoki Tabs immediately and seek medical help without delay. See also section 2.
• Skin becomes sensitive to light.

Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymphadenopathy, and increased eosinophil count (a type of white blood cell).
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.
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
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 provide 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 in the original packaging to protect from light.
Store in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the cardboard box and primary packaging (month/year).
Blister labelling: EXP – expiry date, Lot – batch number.

6. Contents of the pack and other information

What Ibuprom Zatoki Tabs contains
The active substances are: ibuprofen and phenylephrine hydrochloride. Each film-coated 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 anhydrous silica, sucrose, calcium carbonate, Macrogol 6000, povidone K90,
Macrogol 4000, TER LMF M FICHTENGRÜN (sodium sulphate (E 514), tartrazine (E 102), brilliant blue (E 133)),
titanium dioxide (E 171), shellac, cocoa butter.
What Ibuprom Zatoki Tabs looks like and contents of the pack
Round, biconvex, green tablets.
Pack sizes: 6, 12, 16, 24 film-coated tablets in PVC/PVDC/Aluminium blister packs in a cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
ul. Ziębicka 40,
50-507 Wrocław
For further information, please contact the representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel. +48 (22) 543 60 00