Description

Ibum Zatoki is a drug intended for occasional use to relieve symptoms occurring in colds and flu, such as: headache, pain and obstruction of the sinuses, runny nose, fever, sore throat, and muscle pain.

Composition

The active substances of the drug are ibuprofen and pseudoephedrine hydrochloride.

Other excipients are : 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

Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Adults and children over 12 years of age: For acute treatment, take 1 to 2 tablets orally every 4 hours (do not exceed 6 tablets per day). This medicine should not be used in children under 12 years of age.

Elderly: no dosage adjustment is required unless renal or hepatic function is impaired.

Do not increase the recommended dose.

If you feel that the effect of the medicine is too strong or too weak, talk to your doctor.
This medicine is intended for short-term use. If symptoms persist or worsen, or if new symptoms occur, consult your doctor.
Do not take the medicine for more than 3 days without consulting your doctor.

Indications

Emergency 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 Ibum Zatoki:

• 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.

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

• Common side effects (affecting 1 to 10 patients in 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 side effects (occurring in 1 to 10 out of 1,000 patients taking the medicine): hypersensitivity reactions with skin rash and itching, as well as shortness of breath attacks (possibly in combination with a drop in blood pressure); headache, 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 side effects (affecting 1 to 10 users 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 patients taking the medicine): exacerbation of inflammation associated with infection (e.g. development of necrotizing fasciitis) associated with the use of non-steroidal anti-inflammatory drugs, 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), disorders of blood cell production: first symptoms are fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g. bruising, petechiae, purpura, epistaxis), severe generalized hypersensitivity reactions, psychotic reactions, depression; palpitations, heart failure, myocardial infarction; hypertension; esophagitis, pancreatitis, formation of diaphragm-like intestinal strictures; 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, especially in patients with hypertension or renal failure, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure.

Warnings and precautions

• Ibum Zatoki contains sucrose and sunset yellow (E110). 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 at room temperature.
Protect from light and moisture.
Store out of reach of small children.

Use of other medications

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

Do not take Ibum Zatoki concomitantly with other nonsteroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors such as celecoxib or etoricoxib), other pain relievers, or acetylsalicylic acid (in pain-relieving doses). Taking Ibum Zatoki concomitantly with these drugs increases the risk of side effects.

Pregnancy and breastfeeding

Please consult your doctor before using this medicine.

The drug should not be used during pregnancy and breastfeeding.

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.