Description

Acatar Sinuses is a medicinal product in the form of coated tablets used to combat symptoms such as pain and blockage of sinuses, runny nose, and headache.

Composition

The active substances are ibuprofen (Ibuprofenum) and pseudoephedrine hydrochloride (Pseudoephedrini hydrochloridum)

1 film-coated tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.

Excipients : core composition: cellulose powder (Elcema P-100), cellulose powder (Elcema F-150), corn starch, pregelatinized starch, Guar gum, talc, croscarmellose sodium, crospovidone, colloidal silica, hydrogenated vegetable oil; Coating: hydroxypropylcellulose, macrogol, 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 AC lake (E129), indigo carmine lake (E132), povidone, sodium benzoate (E211).

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: orally 1 to 2 tablets every 4 to 6 hours after meals.

Do not exceed the dose of 6 tablets per day.

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

If after 3 days there is no improvement or the patient feels worse, contact your doctor.

Action

Acatar Sinus Relief decongests the nose by reducing swelling and congestion in the nasal mucosa and sinuses (pseudoephedrine). It also has analgesic, anti-inflammatory, and antipyretic effects (ibuprofen).

Indications

Acatar Sinuses is intended for occasional use to relieve the symptoms of flu and colds, such as: pain and congestion of the paranasal sinuses, rhinitis (runny nose), headache, fever, and joint and muscle pain.

Contraindications

When not to use Acatar 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); in patients who have ever had allergy symptoms such as runny nose, hives or bronchial asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; in patients with active or past stomach and/or duodenal ulcer, perforation or bleeding, also after taking NSAIDs; in patients with severe liver failure, severe renal failure or severe heart failure; in patients taking other non-steroidal anti-inflammatory drugs concomitantly, including COX-2 inhibitors; during pregnancy and breast-feeding; in patients with bleeding diathesis; in patients with severe cardiovascular disorders, tachycardia, hypertension, angina pectoris; in patients with hyperthyroidism; in patients with diabetes; in patients with closed-angle 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.

Uncommon side effects (affecting 1 to 10 users in 1,000): headache, indigestion, abdominal pain, nausea, hives, itching.

Rare side effects (occurring in 1 to 10 out of 10,000 patients taking the medicine): diarrhea, flatulence, constipation, vomiting, gastritis, dizziness, insomnia, agitation, irritability and fatigue; swelling resulting from kidney and urinary tract disorders.

Very rare side effects (affecting less than 1 in 10,000 patients taking the medicine): tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease; stomach and/or duodenal ulcer, gastrointestinal bleeding and perforation, sometimes fatal, particularly in the elderly;

• in isolated cases the following have been reported: depression, psychotic reactions and tinnitus, aseptic meningitis;
• decreased urine output, edema, acute renal failure, renal papillary necrosis, increased serum sodium concentration;
• liver dysfunction, especially with long-term use;
• Blood count abnormalities. Initial symptoms include fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, and bleeding diathesis.
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis;
• severe hypersensitivity reactions such as: swelling of the face, tongue and larynx, shortness of breath, cardiac arrhythmia, sudden drop in blood pressure, shock; exacerbation of asthma and bronchospasm;
• In patients with existing autoimmune diseases, during treatment with ibuprofen, single cases of symptoms occurring in aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever, and disorientation, have been reported.

Warnings and precautions

Side effects may be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms.

The drug should not be taken concomitantly with other non-steroidal anti-inflammatory drugs.

Store at room temperature.

Protect from light and moisture.

Store out of reach of small 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.

Acatar Zatoki may interact with: anticoagulants (aspirin/acetylsalicylic acid, warfarin, ticlopidine); blood pressure lowering drugs; diuretics; corticosteroids; methotrexate; lithium; zidovudine; MAO inhibitors, up to 14 days after stopping their use; dopamine receptor agonists, ergot alkaloid derivatives; dopaminergic vasoconstrictor drugs; linezolid; quinidine; tricyclic antidepressants; sympathomimetic drugs that clear nasal passages and reduce appetite, amphetamine-type drugs.

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 impair female fertility. This effect is temporary and disappears after treatment is discontinued. If you are having trouble getting pregnant, consult your doctor before taking ibuprofen.

Use of the drug in children and adolescents

Do not give to children under 12 years of age.

Driving and operating machinery

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