Acatar Zatoki Tabs

Leaflet attached to the packaging: patient information

ACATAR ZATOKI TABS

200 mg + 6.1 mg, Chewable Tablets

(Ibuprofen + Phenylephrine 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 after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Acatar Zatoki Tabs is a combination medicine containing two active substances: ibuprofen (a non-steroidal anti-inflammatory drug, NSAID) and phenylephrine hydrochloride (a nasal decongestant).
Acatar Zatoki Tabs has analgesic, anti-inflammatory, and antipyretic effects.
It constricts blood vessels, reduces swelling and congestion of the nasal mucosa and sinuses, reduces the amount of discharge, and facilitates breathing. It decongests the nose and paranasal sinuses.

Indications for use

It is used to temporarily relieve symptoms of nasal and paranasal sinus congestion with accompanying headache, sinus-related pain, and fever in the course of flu or cold.
If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

2. Important information before taking Acatar Zatoki Tabs

When not to take Acatar Zatoki Tabs:

• If the patient is hypersensitive to the active substances or any of the other ingredients of this medicine (listed in section 6).
• In patients who have experienced allergic symptoms after taking acetylsalicylic acid or other NSAIDs in the past, such as asthma, rhinitis, angioedema, or urticaria.

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• In patients taking monoamine oxidase inhibitors (MAOIs) used to treat hypertension and depression, and for 14 days after stopping their use.
• If the patient has any of the following conditions:
• active or recurrent gastric and/or duodenal ulcer or gastrointestinal bleeding,
• previous gastrointestinal bleeding or perforation after taking NSAIDs,
• intracranial bleeding or other bleeding,
• severe liver, kidney, or heart failure,
• coronary artery disease,
• hypertension,
• unexplained blood disorders (hematological),
• hemophilia,
• diabetes,
• pheochromocytoma,
• glaucoma with closed-angle glaucoma,
• hyperthyroidism,
• prostatic hyperplasia.
• During pregnancy and breastfeeding.
• In children under 12 years of age.

Warnings and precautions

If the patient has any of the following diseases or symptoms, they should consult their doctor before starting treatment with Acatar Zatoki Tabs.

• Systemic lupus erythematosus or mixed connective tissue disease.
• Allergic reactions after taking acetylsalicylic acid.
• Gastrointestinal diseases or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease).
• Kidney or liver function disorders.
• Blood disorders (e.g., intermittent porphyria, platelet disorders).
• Asthma, allergic diseases - after taking the medicine, bronchospasm may occur.
• Respiratory failure. Diseases in which the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).
• Chickenpox, in rare cases, taking the medicine during chickenpox may lead to serious complications in the form of skin or soft tissue infections.
• Caution should be exercised in dehydrated patients due to the increased risk of worsening kidney function
• Skin reactions. Serious skin reactions have been reported with the use of Acatar Zatoki Tabs. If any skin rash, mucosal lesions, blisters, or other symptoms of hypersensitivity occur, the patient should stop taking Acatar Zatoki Tabs and seek medical attention immediately, as these may be the first symptoms of a very serious skin reaction. See section 4.

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Taking anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with
a small increased risk of heart attack or stroke, especially when used in high doses. The recommended dose and duration of treatment should not be exceeded.
Before taking Acatar Zatoki Tabs, the patient should discuss treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, have had a coronary artery bypass graft, have peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries), or have had a stroke (including a mini-stroke or transient ischemic attack - TIA). they have high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if they smoke. they have an infection - see below, section "Infections".

Taking Acatar Zatoki Tabs with other medicines may increase the risk of side effects.
Infections
Acatar Zatoki Tabs may mask the symptoms of an infection, such as fever and pain. Therefore, Acatar Zatoki Tabs may delay the use of appropriate infection treatment and, as a result, 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.
Warnings and precautions regarding side effects that may occur in patients taking Acatar Zatoki Tabs - see also section 4. Possible side effects.

Worsening of headache

Prolonged use of any pain-relieving medicine for headache may worsen the headache.
If this occurs or is suspected, treatment should be discontinued and medical advice sought. In patients with frequent or daily headaches despite (or due to) regular use of headache medicines, medication-overuse headache should be suspected.

Smallest effective dose

To minimize the risk of side effects, the smallest effective dose should always be used. Taking higher doses than recommended may increase the risk of side effects.

Elderly patients

In elderly patients, there is an increased risk of side effects related to the gastrointestinal tract, especially bleeding and perforation, which can be fatal.

Children

The medicine should not be given to children under 12 years of age.

Acatar Zatoki Tabs and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Acatar Zatoki Tabs may affect the action of other medicines or other medicines may affect the action of Acatar Zatoki Tabs. These medicines include, for example:

• other NSAIDs, including acetylsalicylic acid (aspirin) - may increase the risk of side effects, especially those related to the gastrointestinal tract,
• anticoagulant medicines (e.g., aspirin/acetylsalicylic acid in low doses, warfarin, ticlopidine); may increase the risk of bleeding,
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan, diuretics, such as indapamide) - may reduce their effect and worsen kidney function,
• digoxin (a heart medicine), phenytoin (an antiepileptic medicine), lithium (used in manic-depressive illness and depression) - may increase their levels in the blood,
• certain diuretics (so-called potassium-sparing diuretics) - may increase potassium levels in the blood,
• corticosteroids - may increase the risk of gastrointestinal ulcers or bleeding,
• certain antidepressants (so-called selective serotonin reuptake inhibitors) - may increase the risk of bleeding,
• methotrexate (used in certain cancers and rheumatic diseases) - may increase its toxicity,
• oral antidiabetic medicines - blood glucose levels should be monitored,
• immunosuppressants (cyclosporine, tacrolimus) - may increase the risk of kidney damage,
• zydovudine (used in AIDS treatment) - may increase the risk of bleeding into joints or bleeding leading to swelling in patients with hemophilia,
• probenecid and sulfinpyrazone - may prolong the action of ibuprofen,
• antifungal medicines (voriconazole, fluconazole) - may increase the level of ibuprofen in the blood and may require a reduction in the dose of ibuprofen,
• monoamine oxidase inhibitors (medicines used in depression treatment) and for two weeks after stopping their use,
• phenylephrine or pseudoephedrine (medicines used in symptomatic treatment of rhinitis),
• indomethacin (a pain-relieving and anti-inflammatory medicine used in rheumatic diseases),
• beta-adrenergic receptor blockers (medicines used in hypertension and cardiovascular diseases) - may significantly increase blood pressure (so-called hypertensive crisis),
• guanethidine, mecamylamine, or reserpine (medicines used in hypertension treatment) - may reduce their antihypertensive effect.

Also, some other medicines may be affected by or affect treatment with Acatar Zatoki Tabs. Therefore, before taking Acatar Zatoki Tabs with other medicines, the patient should always consult their doctor or pharmacist.

Acatar Zatoki Tabs with food or alcohol

Food does not significantly affect the absorption of the medicine.
If the patient consumes alcohol while taking this medicine, there is a greater likelihood of side effects.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Taking Acatar Zatoki Tabs during pregnancy and breastfeeding is contraindicated.
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Ibuprofen may cause fertility problems in women, as it inhibits the synthesis of prostaglandins - hormones involved in reproductive processes. This effect is temporary and disappears after the end of therapy. It is unlikely that occasional use of Acatar Zatoki Tabs will reduce the chance of becoming pregnant, but if a woman has problems becoming pregnant, she should consult her doctor before taking the medicine.

Driving and using machines

While taking the medicine, the patient should be cautious when driving a car and operating machinery. Ibuprofen may rarely cause dizziness and fatigue.

The medicine contains tartrazine (E 102) and sucrose

Tartrazine (E 102) may cause allergic reactions.
One tablet contains 31.66 mg of sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
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 Tabs

The medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Take orally.
Recommended dose
Adults and children over 12 years: 2 tablets 3 times a day (every 8 hours). There should be at least a 4-hour interval between doses. Do not take more than 6 tablets per day.
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).
If it is necessary to take the medicine for more than 3 days or if the patient's condition worsens, they should contact their doctor.

Use in children

The medicine should not be given to children under 12 years of age.

Taking a higher dose of Acatar Zatoki Tabs than recommended

If the patient has taken a higher dose of Acatar Zatoki Tabs 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 risk to their health and advice on what actions to take.
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 problems may occur. In rare cases, after significant overdose, excessive stimulation, coma, and rarely: low blood pressure and loss of consciousness may occur. Severe poisonings may be characterized by metabolic disorders (acidosis), decreased blood coagulability, acute kidney or liver failure. Asthma may also worsen.
If the overdose occurred no more than an hour ago, it is recommended to induce vomiting (or gastric lavage) or administer activated charcoal. Specialized treatment may be necessary to maintain vital functions.
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In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Acatar Zatoki Tabs can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects while taking Acatar Zatoki Tabs, they should stop taking the medicine and contact their doctor immediately.

Serious side effectsoccur very rarely (less than 1 in 10,000 patients taking the medicine)

• Worsening of inflammatory conditions associated with infection (e.g., occurrence of necrotizing fasciitis) related to the use of non-steroidal anti-inflammatory drugs.

The doctor will decide whether the use of anti-infective medicines (e.g., antibiotics) is necessary.

• Symptoms of aseptic meningitis, such as stiffness of the neck, headache, nausea, vomiting, fever, or changes in consciousness, mainly in patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease).
• Disorders of blood cell production: the first symptoms are fever, sore throat, superficial mucosal lesions, flu-like symptoms, fatigue, bleeding (e.g., bruising, petechiae, purpura, nosebleeds). Do not treat these symptoms with pain-relieving or antipyretic medicines!
• Severe generalized hypersensitivity reactions. This may include facial swelling, tongue swelling, internal swelling of the larynx with reduced airway patency, respiratory failure, increased heart rate, decreased blood pressure, up to life-threatening shock. Immediate medical attention may be necessary.
• Palpitations, heart failure, myocardial infarction. If acute chest pain occurs, the patient should stop taking the medicine and contact their doctor immediately.
• Esophageal inflammation, pancreatitis, formation of stricture-like narrowing of the intestine.

If the patient experiences: acute abdominal pain, black stools, or bloody vomiting, they should stop taking the medicine and contact their doctor immediately.

• Decreased urine output and formation of edema, especially in patients with hypertension or kidney failure, nephrotic syndrome, interstitial nephritis with possible acute kidney failure. These may be the first symptoms of kidney damage or failure.

Other side effects that may occur during treatment with Acatar Zatoki Tabs

Common side effects (occurring in 1 to 10 patients in 100 taking the medicine)

• Heartburn, stomach pain, nausea, vomiting, bloating with gas, diarrhea, constipation, digestive disorders, loss of appetite, minor gastrointestinal bleeding, which may rarely lead to anemia.

Uncommon side effects (occurring in 1 to 10 patients in 1,000 taking the medicine)

• Hypersensitivity reactions with skin rash and itching, also asthma attacks (possible occurrence in combination with decreased blood pressure).
• Headache, dizziness, insomnia, agitation, irritability, and fatigue.
• Visual disturbances.
• Gastrointestinal ulcers, with possible bleeding and perforation, oral mucosal ulcers, worsening of colitis and Crohn's disease, gastritis.

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

• Hypersensitivity reactions, from itching and rash to anaphylactic shock and bronchospasm.
• Increased blood pressure, increased heart rate, arrhythmias, palpitations, pallor.
• Tinnitus.
• Necrosis of renal papillae, increased uric acid levels in the blood.

Very rare side effects (occurring in less than 1 patient in 10,000 taking the medicine)

• Psychotic reactions, depression, anxiety, restlessness, tremors, nervousness, insomnia, irritability, dizziness, and headache, hallucinations.
• Hypertension.
• Liver function disorders, especially during long-term use, liver failure, acute hepatitis.
• Severe skin reactions: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis; in rare cases, during chickenpox, severe skin infections and soft tissue complications may occur.

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

• Urinary retention.
• Red scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking Acatar Zatoki Tabs and seek medical attention immediately. See also section 2.
• Skin becomes sensitive to light.

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).
In case of occasional use of the medicine, side effects are rare.
In elderly patients, there is an increased risk of side effects related to the use of ibuprofen compared to younger patients. The frequency and severity of side effects can be reduced by using the smallest therapeutic dose for the shortest possible duration.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should consult their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
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Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Acatar Zatoki Tabs

Store the medicine at a temperature below 25°C.
Keep the medicine in its original packaging to protect it from light.
Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the carton and blister packaging (month/year). The expiry date is indicated by EXP - expiry date, LOT - batch number.

6. Contents of the pack and other information

What Acatar Zatoki Tabs contains

The active substances of the medicine are ibuprofen and phenylephrine hydrochloride. One chewable tablet contains 200 mg of ibuprofen and 6.1 mg of phenylephrine hydrochloride.
The other ingredients are calcium hydrogen phosphate dihydrate, sodium croscarmellose, powdered cellulose, talc, simethicone, colloidal silica, anhydrous, sucrose, calcium carbonate, Macrogol 6000, Povidone K90, Macrogol 4000, Green Spruce Food Colourant 83270-DO (sodium sulfate (E 514), tartrazine (E 102), brilliant blue (E 133)), titanium dioxide (E 171), shellac, cocoa oil.

What Acatar Zatoki Tabs looks like and what the pack contains

The tablets are round, biconvex, and green in color.
Packaging:6, 12, 16, 24 chewable tablets in PVC/PVDC/Aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
Ziębicka 40, 50-507 Wrocław
For more detailed information, please contact:
USP Zdrowie Sp. z o.o.
Poleczki 35
02-822 Warsaw
phone: +48 (22) 543 60 00
Date of last revision of the leaflet: March 2022
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