Description

Ibuprom Sinus is a drug for the immediate treatment of sinusitis symptoms.

Composition

The active substances of the drug are ibuprofen ( Ibuprofenum) and pseudoephedrine hydrochloride ( Pseudoephedrini hydrochloridum ).

1 tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine.

Excipients: tablet core: cellulose powder (Elcema P-100), cellulose powder (Elcema F-150), corn starch, pregelatinized starch, guar gum, talc, croscarmellose sodium, crospovidone, colloidal hydrated silica, hydrogenated vegetable oil; coating composition: hydroxypropylcellulose, macrogol 400, talc, gelatin, sucrose, kaolin, confectioned sugar (mixture of sucrose and corn starch), calcium carbonate, Opaglos Clear GS-2-0750 (mixture of carnauba wax, white wax and ethanol denatured with methanol), acacia gum, corn starch, Opalux Brown AS-16518 (mixture of sucrose, titanium dioxide (E171), sunset yellow lake (E110), allura red lake (E129), indigo carmine lake (E132), povidone, sodium benzoate (E211)); printing ink composition: Opacode Black S-1-17823 (mixture of shellac, black iron oxide (E172), n-butyl alcohol, isopropyl alcohol, ammonium hydroxide 28%, propylene glycol, ethanol).

Dosage

This is a medicine. For safety, use it according to the package leaflet. Do not exceed the maximum dose. If in doubt, consult your doctor or pharmacist.

Adults and children over 12 years of age : 1 to 2 tablets orally every 4 hours after meals . Do not exceed 6 tablets per day.

• The medicinal product should not be administered to children under 12 years of age.
• Elderly: No dosage adjustment is required unless renal or hepatic function is impaired. In such cases, the physician should determine the dosage individually for each patient.
• Side effects may be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
• If the medicinal product requires use for longer than 3 days or the patient's condition worsens, the patient should be referred to a doctor.

Action

Ibuprom Sinus is a medicinal product with analgesic, anti-inflammatory, and antipyretic effects. It reduces swelling of the nasal mucosa and reduces the amount of secretions. It unclogs the nose and paranasal sinuses.

Indications

Ibuprom Zatoki is indicated for the short-term relief of symptoms associated with colds and flu, such as headache, sinus pain and congestion, runny nose, fever, sore throat, and muscle aches. It is also indicated for the short-term treatment of sinusitis symptoms, such as headache, sinus and nasal congestion with pain, resulting from complications of colds, flu, or allergic rhinitis.

Contraindications

When not to use Ibuprom Sinus:

• if you are allergic to the active substances or any of the other ingredients of this medicine and to other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have ever had allergy symptoms such as a runny nose, hives or bronchial asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• in patients with active stomach and/or duodenal ulcer or history of perforation or bleeding, including those occurring after the use of NSAIDs;
• in patients with severe hepatic failure, severe renal failure or severe heart failure;
• in patients taking other non-steroidal anti-inflammatory drugs concomitantly, including COX-2 inhibitors (increased risk of side effects);
• during pregnancy and breastfeeding;
• in patients with bleeding diathesis;
• in patients with severe cardiovascular disorders, tachycardia, arterial hypertension, angina pectoris;
• in patients with hyperthyroidism;
• in patients with diabetes;
• in patients with angle-closure glaucoma;
• in patients with prostatic hyperplasia;
• in patients with pheochromocytoma.

Side effects

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

Common (in 1 to 10 patients out of 100 taking the medicine):

• heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation and minor gastrointestinal bleeding, which may lead to anemia in exceptional cases.

Uncommon (1 to 10 out of 1,000 patients taking the medicine):

• hypersensitivity reactions with skin rash and itching, as well as attacks of shortness of breath (possibly occurring in combination with a drop in blood pressure);
• headaches, dizziness, insomnia, agitation, irritability and fatigue;
• visual disturbances;
• gastrointestinal ulcers, potentially with bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis.

Rare (1 to 10 out of 10,000 patients taking the medicine):

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

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

• Exacerbation of infection-related inflammation (e.g., necrotizing fasciitis) associated with the use of nonsteroidal anti-inflammatory drugs. If symptoms of infection occur or worsen while using Ibuprom Zatoki, consult a doctor immediately to determine whether the use of anti-infective drugs/antibiotics is necessary.
• symptoms of aseptic meningitis such as stiff neck, headache, nausea, vomiting, fever, or impaired consciousness, mainly in patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease). If such symptoms occur , contact your doctor immediately .
• Blood cell production disorders: the first symptoms include fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, and bleeding. In this case, treatment should be discontinued and a doctor should be consulted immediately .
• Severe generalized hypersensitivity reactions. These may include facial swelling, tongue swelling, internal swelling of the larynx with airway obstruction, respiratory failure, rapid heart rate, low blood pressure, and even life-threatening shock. If these symptoms occur, discontinue use and consult a doctor immediately.
• psychotic reactions, depression;
• palpitations, heart failure, myocardial infarction;
• hypertension;
• esophagitis, pancreatitis, formation of diaphragm-like intestinal strictures; If you experience severe epigastric pain, tarry stools or vomiting blood, stop taking the drug and contact your doctor immediately .
• liver function disorders, especially during long-term use, liver failure, acute hepatitis;
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, in exceptional cases, severe skin infections and soft tissue complications may occur during varicella infection;
• Decreased urine output and edema formation, particularly in patients with hypertension or renal failure, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure. In such cases, stop taking the drug and contact your doctor immediately, as these may be the first signs of kidney damage or failure.

Frequency unknown:

increased thirst, hallucinations (especially in children), insomnia, restlessness, anxiety, dizziness, muscle weakness, tremors, heart rhythm disturbances, tachycardia, dyspepsia, gastrointestinal disorders, nausea, vomiting, dry mouth, redness, rash, excessive sweating, urinary retention (mainly in men).

• Edema, hypertension and heart failure have been reported in association with NSAID treatment.
• Taking medicines such as Ibuprom Zatoki may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
• When the drug is used on an occasional basis, side effects are rare.
• Elderly patients may be at greater risk of experiencing adverse reactions to ibuprofen than younger patients. The frequency and severity of adverse reactions may be reduced by using the lowest therapeutic dose for the shortest possible duration.

Warnings and precautions

• This medicine contains sucrose, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• The presence of sunset yellow (E110) may cause allergic reactions.
• Store below 25ºC.
• Keep the medicine out of the sight and reach of children.

Use of other medications

Please tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take, including medicines obtained without a prescription.

Ibuprom Zatoki may interact with:

• anticoagulant drugs (acetylsalicylic acid, warfarin, ticlopidine);
• drugs that lower blood pressure,
• diuretics;
• corticosteroids, methotrexate, lithium, zidovudine;
• MAO inhibitors, also within 14 days of stopping taking them;
• dopamine receptor agonists, ergot alkaloid derivatives – bromocriptine, cabergoline, lisuride, pergolide;
• dopaminergic vasoconstrictor drugs – dihydroergotamine, ergotamine, methylergometrine;
• linezolid, quinidine;
• tricyclic antidepressants;
• sympathomimetic drugs that clear the nose and reduce appetite;
• amphetamine-type sympathomimetic drugs.

Taking the medicine with food and drink

The medicine should be taken after meals.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The drug should not be used during pregnancy and breastfeeding.

Impact on fertility

This medication belongs to a group of drugs (NSAIDs) that may adversely affect female fertility. This effect is temporary and disappears after treatment is discontinued.

Use of the drug in children and adolescents

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

Driving and operating machinery

While taking this medicine, be careful when driving or operating machinery.