Acatar Zatoki

Leaflet accompanying the packaging: patient information

Acatar Zatoki

200 mg + 30 mg, coated tablets

(Ibuprofen + Pseudoephedrine hydrochloride)

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
The medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Acatar Zatoki and what is it used for
• 2. Important information before taking Acatar Zatoki
• 3. How to take Acatar Zatoki
• 4. Possible side effects
• 5. How to store Acatar Zatoki
• 6. Contents of the pack and other information

1. What is Acatar Zatoki and what is it used for

Acatar Zatoki is a medicine intended for short-term use to relieve symptoms of flu and colds such as: pain and congestion of the paranasal sinuses, runny nose, headache, fever, muscle and joint pain.

2. Important information before taking Acatar Zatoki

When not to take Acatar Zatoki:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6) and to other non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients who have experienced allergic symptoms after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the past, such as rhinitis, urticaria or bronchial asthma,
• in patients with active or recurrent peptic ulcer or perforation, also those that occurred after taking NSAIDs,
• in patients with severe liver or heart failure,
• in patients taking other non-steroidal anti-inflammatory drugs at the same time, including COX-2 inhibitors (increased risk of side effects),
• in pregnancy and breastfeeding,
• in patients with bleeding disorders,
• in patients with severe cardiovascular disorders, tachycardia, angina pectoris,
• in patients with very high blood pressure (severe hypertension) or uncontrolled hypertension,
• in patients with severe acute (sudden) or chronic (long-term) kidney disease or kidney failure,
• in patients with hyperthyroidism,
• in patients with diabetes,
• in patients with glaucoma with a closed angle,
• in patients with prostatic hyperplasia,
• in patients with pheochromocytoma.

Warnings and precautions

Before starting treatment with Acatar Zatoki, the patient should discuss it with their doctor or pharmacist.

Special caution should be exercised when taking the medicine:

• if the patient has been diagnosed with lupus erythematosus and mixed connective tissue disease,
• if allergic reactions have occurred after taking acetylsalicylic acid,
• if the patient has been diagnosed with gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• if the patient has been diagnosed with hypertension and/or heart dysfunction,
• if the patient has been diagnosed with kidney dysfunction,
• if the patient has been diagnosed with liver dysfunction,
• if the patient has been diagnosed with blood coagulation disorders,
• if the patient has been diagnosed with active or recurrent asthma or a history of allergic reactions; after taking the medicine, bronchospasm may occur,
• if the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).

There is a risk of gastrointestinal bleeding, ulceration or perforation, which can be fatal and does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be discontinued immediately. Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period. Concurrent, long-term use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy). Taking the medicine by dehydrated patients (children and adolescents) increases the risk of kidney dysfunction. Taking anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. The recommended dose should not be exceeded, and the duration of treatment should not be prolonged. During treatment with ibuprofen, symptoms of an allergic reaction to this medicine have been reported, including respiratory disorders, facial and neck edema (angioedema), chest pain. If these symptoms are observed, the medicine should be discontinued immediately, and medical help should be sought. Before taking Acatar Zatoki, the patient should discuss the treatment with their doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has peripheral artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• the patient has hypertension, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes;
• the patient has an infection - see below, section entitled "Infections".

Do not take a higher dose or longer treatment than recommended. If symptoms persist, worsen, or do not improve after 3 days, or if new symptoms appear, the patient should contact their doctor. Skin reactions Serious skin reactions have been reported with the use of Acatar Zatoki. If the following symptoms occur: any skin rash, changes in the mucous membranes, blisters, or other signs of allergy, the patient should stop taking Acatar Zatoki and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4. Infections Acatar Zatoki may mask the symptoms of an infection, such as fever and pain. Therefore, Acatar Zatoki may delay the use of appropriate infection treatment, which may lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection, and the symptoms of the infection persist or worsen, they should consult their doctor immediately. The medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and reverses after the end of treatment. If the patient is having difficulty conceiving, they should consult their doctor before taking ibuprofen. The medicine should be taken with caution by patients taking tricyclic antidepressants and other sympathomimetic medicines (medicines that constrict blood vessels in mucous membranes), appetite suppressants, amphetamine-like medicines, and psychotropic medicines. If the patient experiences fever with generalized redness of the skin and a pustular rash, they should stop taking Acatar Zatoki and consult their doctor or seek medical attention immediately. See section 4. During treatment with Acatar Zatoki, sudden abdominal pain or rectal bleeding may occur due to inflammatory bowel disease (ischemic colitis). If such gastrointestinal symptoms occur, the patient should stop taking Acatar Zatoki and seek medical attention immediately. See section 4. During treatment with Acatar Zatoki, a decrease in blood flow in the optic nerve may occur. If sudden vision loss occurs, the patient should stop taking Acatar Zatoki and seek medical attention immediately. See section 4. After taking medicines containing pseudoephedrine, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported. PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain. If symptoms that may be signs of PRES or RCVS occur, the patient should stop taking Acatar Zatoki immediately and seek medical attention (symptoms, see section 4 "Possible side effects"). The patient should consult their doctor, even if the above warnings refer to past situations.

Children

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

Acatar Zatoki and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. The patient should not take Acatar Zatoki at the same time as other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors, such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (in pain-relieving doses). Concurrent use of Acatar Zatoki with these medicines increases the risk of side effects. Acatar Zatoki may affect the action of other medicines or other medicines may affect the action of Acatar Zatoki, for example:

• anticoagulant medicines (e.g., blood thinners/anti-clotting agents, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• diuretics;
• corticosteroids (e.g., prednisolone or dexamethasone);
• methotrexate (an anticancer medicine);
• lithium (an antidepressant medicine);
• zydovudine (an antiviral medicine);
• monoamine oxidase inhibitors (MAOIs), also within 14 days of stopping their use,
• dopamine receptor agonists, ergot alkaloid derivatives - bromocriptine, cabergoline, lisuride, pergolide;
• dopaminergic vasoconstrictor medicines - dihydroergotamine, ergotamine, methylergometrine;
• linezolid;
• quinidine;
• tricyclic antidepressants;
• sympathomimetic medicines that decongest the nose and reduce appetite;
• sympathomimetic medicines of the amphetamine type.

Also, some other medicines may be affected or have an effect on treatment with Acatar Zatoki. Therefore, before taking Acatar Zatoki with other medicines, the patient should always consult their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

In pregnancy, breastfeeding, or if the patient is planning to become pregnant, they should consult their doctor before taking this medicine. The medicine should not be taken during pregnancy or breastfeeding. The effect of the medicinal product on fertility - see section Warnings and precautions.

Driving and using machines

While taking the medicine, the patient should be cautious when driving vehicles and operating machinery.

Acatar Zatoki contains sucrose and orange yellow (E110)

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine contains biologically active excipients. The presence of orange yellow (E110) may cause allergic reactions. The medicine contains 0.005 mg of sodium benzoate (E 211) per tablet. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Acatar Zatoki

Adults and children over 12 years of age: for short-term treatment, 1 to 2 tablets orally every 4 hours after meals. The smallest effective dose should be used for the shortest duration necessary to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2). The maximum dose should not exceed 6 tablets per day. The medicine should not be given to children under 12 years of age. Elderly patients: no dose adjustment is required unless kidney or liver function is impaired. The recommended dose should not be exceeded. If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor. The medicine is intended for short-term use. If symptoms persist, worsen, or new symptoms appear, the patient should consult their doctor. The medicine should not be taken for more than 3 days without consulting a doctor.

Taking a higher dose of Acatar Zatoki than recommended

If the patient has taken a higher dose of Acatar Zatoki than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on the possible health risk and advice on what to do. Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and breathing difficulties may occur. There may also be a significant increase in heart rate and blood pressure. If the overdose occurred less than 1 hour ago, vomiting should be induced or gastric lavage should be performed, or activated charcoal should be given. Based on numerous studies on the symptoms of pseudoephedrine overdose in combination products used for colds and allergies, gastric lavage is recommended if the amount of the substance taken exceeds the equivalent of 3-4 maximum daily doses (i.e., 720-960 mg).

Missing a dose of Acatar Zatoki

A double dose should not be taken to make up for a missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Acatar Zatoki can cause side effects, although not everybody gets them. The patient should stop taking Acatar Zatoki immediately and seek medical attention if they experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with a sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures,
• vision changes.

Uncommon side effects(affecting 1 to 10 in 1000 patients taking the medicine):

• headache, nausea, abdominal pain, nausea, urticaria, itching.

Rare side effects(affecting 1 to 10 in 10,000 patients taking the medicine):

• diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, agitation, irritability, and fatigue;
• edema resulting from kidney and urinary disorders.

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

• tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease;
• peptic ulcer and/or duodenal ulcer, gastrointestinal bleeding, and perforation, sometimes fatal, especially in the elderly;
• in individual cases, the following have been reported: depression, psychotic reactions, and tinnitus, aseptic meningitis;
• reduced urine output, edema, acute kidney failure, renal papillary necrosis, increased sodium levels in the serum (sodium retention);
• liver function disorders, especially during long-term use;
• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia). The first symptoms are: fever, sore throat, superficial oral mucosa ulcers, flu-like symptoms, fatigue, bleeding disorder (e.g., bruising, petechiae, purpura, nosebleeds);
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis;
• severe hypersensitivity reactions such as: facial edema, tongue and pharynx edema, dyspnea, tachycardia, hypotension, shock; exacerbation of asthma and bronchospasm;
• in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) during ibuprofen treatment, individual cases of symptoms of aseptic meningitis have been reported, such as neck stiffness, headache, nausea, vomiting, fever, disorientation.

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome,
• serious vascular disorders affecting the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS),
• a red scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis - AGEP). If such symptoms occur, the patient should stop taking Acatar Zatoki and seek medical attention immediately. See also section 2; decreased blood flow in the optic nerve (ischemic optic neuropathy). If such symptoms occur, the patient should stop taking Acatar Zatoki and consult their doctor or seek medical attention immediately.

  In connection with the treatment of NSAIDs, reports of edema, hypertension, and heart failure have been made. Taking medicines like Acatar Zatoki may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and an increased number of eosinophils (a type of white blood cell). Due to the presence of pseudoephedrine in the medicine, the following side effects may occur: nausea, gastrointestinal disorders, redness, and rash, nausea, vomiting, excessive sweating, dizziness, increased thirst, tachycardia, arrhythmias, anxiety, insomnia, rarely uncontrolled urination, muscle weakness, tremors, anxiety, hallucinations, thrombocytopenia. Unknown frequency: ischemic colitis; sudden fever, skin redness, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of taking Acatar Zatoki. See section 2; decreased blood flow in the optic nerve (ischemic optic neuropathy). If such symptoms occur, the patient should stop taking Acatar Zatoki and consult their doctor or seek medical attention immediately.

  Reporting side effects

  If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181 C 02-222 Warsaw tel.: +48 22 49-21-301 fax: +48 22 49-21-309 website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

  5. How to store Acatar Zatoki

  Store in a temperature below 25°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister packaging (month/year). The labeling used for the blister is: EXP - expiry date, Lot - batch number. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Contents of the pack and other information

  What Acatar Zatoki contains

  • The active substances of the medicine are ibuprofen and pseudoephedrine hydrochloride. One coated tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
  • The other excipients are: powdered cellulose (Elcema P-100), powdered cellulose (Elcema F-150), corn starch, pregelatinized starch, guar gum, talc, sodium croscarmellose, crospovidone, colloidal silica, anhydrous, vegetable oil, hardened. Coating: hydroxypropylcellulose, macrogol 400, talc, gelatin, sucrose, kaolin, confectioner's sugar (a mixture of sucrose and corn starch), calcium carbonate, Opaglos Clear GS-2-0750 (a mixture of carnauba wax, white wax, and denatured ethanol), arabic gum dispersion, dried, corn starch, Opalux Brown AS-16518 (a mixture of sucrose, titanium dioxide (E171), orange yellow lake (E110), Allura red AC lake (E129), indigo carmine lake (E132), povidone, sodium benzoate (E 211)).

  What Acatar Zatoki looks like and what the pack contains

  Coated tablet for oral use, packaged in a blister or bottle and carton.

  Available packs

  6 pieces - 1 blister of 6 pieces; 12 pieces - 1 blister of 12 pieces; 24 pieces - 2 blisters of 12 pieces; 24 pieces in a bottle.

  Marketing authorization holder and manufacturer

  US Pharmacia Sp. z o.o., ul. Ziębicka 40, 50-507 Wrocław In order to obtain more detailed information, the patient should contact: USP Zdrowie Sp. z o.o. ul. Poleczki 35 02-822 Warszawa tel.: +48 (22) 543 60 00

  Date of last revision of the leaflet: May 2024