Description

Ibum Zatoki Max is a medicinal product used to treat pain associated with sinus congestion.

Composition

The active substances of the drug are ibuprofen and pseudoephedrine.

1 tablet contains 400 mg of ibuprofen (Ibuprofenum) and 60 mg of pseudoephedrine hydrochloride (Pseudoephedrini hydrochloridum).

Excipients : lactose monohydrate, microcrystalline cellulose, silicified microcrystalline cellulose (a mixture of microcrystalline cellulose and colloidal anhydrous silica), sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate, Opadry II 85 F1 84 22 White coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171).

Dosage

Always take this medicine exactly as described in the package leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The drug is administered orally. The recommended dose is:

Adults and adolescents over 12 years: 1 tablet every 4 hours after meals. Do not exceed 3 tablets per day (maximum daily dose of 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride in divided doses). Reduce the single dose to ½ tablet if it is sufficient to relieve symptoms.

Elderly: No dosage adjustment is required unless renal or hepatic function is impaired. If renal or hepatic function is impaired, the doctor should determine the dosage individually.

The lowest effective dose should be used for the shortest duration necessary to alleviate symptoms. This reduces the risk of side effects.

Consult a doctor if this medicine is required for more than 3 days or if symptoms worsen.

Action

Ibum Zatoki Max combines the action of two ingredients: ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), and pseudoephedrine, a sympathomimetic drug. Ibuprofen has analgesic, antipyretic, and anti-inflammatory effects. Pseudoephedrine decongests the mucous membranes of the upper respiratory tract. It unclogs the nose and paranasal sinuses and reduces secretions.

Indications

Ibum Zatoki Max is intended for occasional use to relieve the symptoms of nasal and paranasal sinus congestion accompanied by headache, pain associated with sinus congestion and fever associated with flu or cold.

Contraindications

When not to use Ibum Zatoki Max

• if you are allergic to ibuprofen, pseudoephedrine or any of the other ingredients of this medicine,
• in patients who have ever experienced allergy symptoms such as rhinitis, urticaria or bronchial asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• in patients with active or history of stomach and/or duodenum ulcer, perforation (hole) or bleeding, also after the use of NSAIDs,
• in patients with bleeding diathesis (bleeding tendency),
• in patients with severe hepatic failure, severe renal failure or severe heart failure,
• in patients with severe cardiovascular disorders, tachycardia (increased heart rate), hypertension, angina pectoris,
• in patients who experience urinary retention,
• in patients with hyperthyroidism,
• in patients with narrow-angle glaucoma,
• in patients with a history of hemorrhagic stroke or with risk factors that may increase the risk of hemorrhagic stroke, for example, taking vasoconstrictor drugs or other oral or nasal decongestants

Side effects

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

Uncommon (1 to 10 patients in 1,000):

• headaches, indigestion, abdominal pain, nausea, hives and itching.

Rare (1 to 10 patients in 10,000):

• diarrhea, flatulence, constipation, vomiting, gastritis,
• dizziness, insomnia, agitation, irritability and fatigue,
• swelling resulting from kidney and urinary tract disorders.

Very rare (occurring in less than 1 in 10,000 patients):

• tarry stools, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease - gastric and/or duodenal ulcer, gastrointestinal bleeding and perforation, sometimes fatal, particularly in the elderly
• in isolated cases, depression, psychotic reactions and tinnitus, aseptic meningitis were reported
• dysuria (difficulty urinating), decreased urine output, renal failure, renal papillary necrosis, increased serum urea concentration
• liver function disorders, especially during long-term use
• Blood count abnormalities (anemia, leukopenia, thrombocytopenia, agranulocytosis). The first symptoms include fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g., bruises, petechiae, purpura, nosebleeds).
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
• severe hypersensitivity reactions such as swelling of the face, tongue and larynx, shortness of breath, tachycardia (increased heart rate), hypotension (sudden drop in blood pressure), shock; exacerbation of asthma and bronchospasm
• In patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms occurring in aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever, disorientation, have been reported.

Warnings and precautions

• This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• Edema, hypertension, and heart failure have been reported in association with high-dose NSAID therapy. Taking medications such as Ibum Zatoki Max may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke.
• Concomitant, long-term use of painkillers may lead to kidney damage with the risk of kidney failure (resolute nephropathy).
• As with other central nervous system stimulants, there is a risk of drug abuse when using pseudoephedrine.
• People taking other NSAIDs at the same time, including COX-2 inhibitors, and the elderly are at greater risk of side effects.

Use of other medications

Tell your doctor about all the medicines you are taking, have recently taken or are planning to take.

Ibum Zatoki Max may interact with:

• anticoagulant drugs
• acetylsalicylic acid, other nonsteroidal anti-inflammatory drugs or corticosteroids
• antihypertensive drugs and diuretics
• nasal decongestants (oral or intranasal) – phenylephrine, ephedrine, phenylpropanolamine
• lithium
• methotrexate
• antacids
• monoamine oxidase inhibitor and for up to 14 days after stopping taking this inhibitor
• dopamine receptor agonists, ergot alkaloid derivatives – bromocriptine, cabergoline, lisuride, pergolide
• dopaminergic vasoconstrictor drugs – dihydroergotamine, ergotamine, methylergometrine
• linezolid
• appetite suppressants
• amphetamine-type psychostimulants
• tricyclic antidepressants

Taking the medicine with food and drink

The medicine should be taken after meals.

Pregnancy and breastfeeding

The drug is contraindicated for use in pregnant and breastfeeding women.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, talk to your doctor. Your doctor will decide whether you can take this medicine during this time.

Impact on laboratory tests

Note for athletes: Pseudoephedrine may cause positive doping test results.

Impact on fertility

This medication may adversely affect ovulation. This effect is transient and disappears after treatment is discontinued.

Use of the drug in children and adolescents

Do not administer to children under 12 years of age. In dehydrated patients – adolescents aged 12-18 years – there is a risk of renal impairment.

Driving and operating machinery

While taking this medicine, caution should be exercised when driving or operating machinery.