Aspirin Complex Zatoki

Leaflet attached to the packaging: information for the user

Aspirin Complex Zatoki

500 mg + 30 mg, granules for oral suspension

Acetylsalicylic acid +Pseudoephedrine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform 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 is Aspirin Complex Zatoki and what is it used for
• 2. Important information before taking Aspirin Complex Zatoki
• 3. How to take Aspirin Complex Zatoki
• 4. Possible side effects
• 5. How to store Aspirin Complex Zatoki
• 6. Contents of the packaging and other information

1. What is Aspirin Complex Zatoki and what is it used for

Aspirin Complex Zatoki contains the active substances: acetylsalicylic acid and pseudoephedrine hydrochloride. This medicine has analgesic, anti-inflammatory, antipyretic, and decongestant properties. Aspirin Complex Zatoki is used for the symptomatic treatment of nasal congestion and (or) sinusitis (rhinitis, sinusitis) and pain and fever associated with colds and (or) flu-like symptoms. If the patient has only one of these symptoms, it may be more appropriate to use a medicine that contains only one of the active substances.

2. Important information before taking Aspirin Complex Zatoki

When not to take Aspirin Complex Zatoki

• if the patient is allergic to acetylsalicylic acid, pseudoephedrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has had asthma caused by the administration of salicylates or substances with similar action (i.e., non-steroidal anti-inflammatory drugs)
• if the patient has stomach ulcers
• if the patient has an increased tendency to bleeding
• if the patient has liver failure
• if the patient has severe, acute (sudden) or chronic (long-term) kidney disease or kidney failure
• if the patient has severe heart failure
• if the patient has severe coronary artery disease
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension
• if the patient is taking methotrexate at a dose of 15 mg per week or higher
• if the patient is pregnant
• if the patient is breastfeeding
• if the patient is taking antidepressant medicines from the group of monoamine oxidase inhibitors (MAOIs) or has taken these medicines within the last two weeks
• if the patient has glaucoma with closed-angle glaucoma
• if the patient has urinary retention

Warnings and precautions

Before starting to take Aspirin Complex Zatoki, the patient should discuss it with their doctor or pharmacist:

• if the patient has been diagnosed with an allergy (hypersensitivity) to other painkillers, anti-rheumatic, or anti-inflammatory medicines
• if the patient has allergies (e.g., allergies with accompanying rash, itching, hives), asthma, hay fever, nasal polyps, or chronic respiratory diseases
• if the patient has had stomach ulcers or gastrointestinal bleeding in the past
• if the patient is taking blood-thinning medicines or anticoagulants
• if the patient is to undergo surgery (including minor procedures, such as tooth extraction), as acetylsalicylic acid, even in low doses, increases the risk of bleeding
• in patients with impaired liver function
• in patients with impaired kidney function and circulatory system (e.g., when the heart does not pump enough blood to other parts of the body, in case of reduced blood volume, in case of major surgery, in case of blood infection or massive bleeding)
• in patients prone to gout; in small doses, acetylsalicylic acid reduces the excretion of uric acid, which can cause a gout attack
• if the patient has a deficiency of G6PD (glucose-6-phosphate dehydrogenase) (a hereditary disease affecting red blood cells), as increased levels of acetylsalicylic acid can lead to hemolysis (i.e., red blood cell breakdown)
• if the patient is taking several painkillers at the same time (especially a combination of different painkillers), as this can lead to permanent kidney damage
• if the patient has hyperthyroidism, mild to moderate hypertension, diabetes, heart disease, increased eye pressure, or prostatic hyperplasia (prostate enlargement) or is hypersensitive to certain substances contained in cough and cold medicines, such as phenylephrine and ephedrine (sympathomimetic substances)
• if the patient has renal tubular acidosis, which means that the kidneys cannot properly remove acid from the body. This can increase the risk of side effects due to higher levels of pseudoephedrine in the blood. If the patient experiences fever with generalized redness and pustular rash, they should stop taking Aspirin Complex Zatoki and contact their doctor or seek medical attention immediately. See section 4.
• if the patient experiences sudden abdominal pain or rectal bleeding due to inflammatory bowel disease (ischemic colitis). If such gastrointestinal symptoms occur, the patient should stop taking Aspirin Complex Zatoki and seek medical attention immediately. See section 4.
• if the patient experiences a decrease in blood flow to the optic nerve. In case of sudden vision loss, the patient should stop taking Aspirin Complex Zatoki and contact their doctor or seek medical attention immediately. See section 4.
• if the patient experiences posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) after taking pseudoephedrine-containing medicines. PRES and RCVS are rare conditions that can be associated with reduced blood flow to the brain. If symptoms occur that may be symptoms of PRES or RCVS, the patient should stop taking Aspirin Complex Zatoki and seek medical attention immediately (symptoms, see section 4 "Possible side effects").

Doping

Athletes should be aware that this medicine may cause a positive result in doping tests.

Elderly

Elderly patients may be particularly sensitive to the effects of pseudoephedrine and may experience insomnia or hallucinations.

Children and adolescents

There is a potential link between the use of acetylsalicylic acid in children and adolescents and the occurrence of Reye's syndrome. This is a very rare disease that can be fatal. Therefore, acetylsalicylic acid should not be used in children and adolescents under 16 years of age, unless advised by a doctor.

Other medicines and Aspirin Complex Zatoki

The patient should tell their doctor or pharmacist about all medicines they are currently taking and have recently taken, as well as any medicines they plan to take, especially if they are taking medicines containing:

• methotrexate used to treat severe arthritis, cancer, or psoriasis. Aspirin Complex Zatoki should not be taken if the patient is taking methotrexate at a dose of 15 mg per week or higher. Medical supervision is recommended if the patient is taking methotrexate at doses less than 15 mg per week.
• monoamine oxidase inhibitors used to treat depression or Parkinson's disease. Aspirin Complex Zatoki should not be taken if the patient has taken these medicines within the last two weeks.
• substances that prevent blood clotting or dissolve clots
• non-steroidal anti-inflammatory drugs used to treat pain, inflammation, or rheumatism
• selective serotonin reuptake inhibitors (SSRIs) used to treat depression
• other substances used to treat depression
• digoxin used to treat heart failure or irregular heartbeats
• substances that lower blood sugar levels
• substances used to remove excess water from the body
• glucocorticoids taken orally or administered by injection or infusion - except for hydrocortisone used as replacement therapy. Glucocorticoids may be used to reduce inflammation of the skin or in asthma
• ACE inhibitors, i.e., substances whose names end in "-pril", mainly used to treat hypertension
• other substances used to treat hypertension, such as guanethidine, methyldopa, or substances whose names end in "-lol"
• valproic acid used to treat epilepsy
• benzbromarone or probenecid used to treat gout
• salbutamol in tablet form, used to dilate airways. This does not exclude the use of an inhaler in doses determined by a doctor
• phenylephrine and ephedrine or other sympathomimetic substances that are part of nasal drops or sprays.

Aspirin Complex Zatoki with food, drink, and alcohol

The medicine can be taken regardless of meals. It is essential to pour the granules into water and mix well before taking. During the use of acetylsalicylic acid, the patient should avoid alcohol, as its consumption may increase the risk of stomach and intestinal bleeding.

Pregnancy, breastfeeding, and fertility

Aspirin Complex Zatoki should not be used during pregnancy and breastfeeding, due to the lack of data on the safety of using both active substances in combination. Additionally, acetylsalicylic acid:

• may cause kidney and heart problems in the unborn child if taken from the 20th week of pregnancy
• may harm the unborn child or cause complications during delivery if taken during the last trimester of pregnancy
• may affect the patient's and child's tendency to bleed and may cause delayed or prolonged delivery if taken before or during delivery.

If the patient is pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. This medicine belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which may adversely affect fertility in women. This effect is temporary and disappears after the medicine is stopped.

Driving and using machines

During the use of Aspirin Complex Zatoki, the patient's ability to react may be impaired. The patient should avoid driving if this applies to them. The risk of such an effect may be increased by concurrent alcohol consumption. This should be taken into account in situations where increased attention is required.

Aspirin Complex Zatoki contains sucrose

This medicine contains 2 g of sucrose (sugar) in each sachet (which corresponds to 0.17 carbohydrate exchange, WW). Patients with diabetes should take this into account. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Aspirin Complex Zatoki contains benzyl alcohol

This medicine contains 3.78 mg of benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions. Patients with liver or kidney disease should consult their doctor before taking this medicine, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

3. How to take Aspirin Complex Zatoki

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The recommended dose for adults and adolescents from 16 years of age:

• single dose: 1-2 sachets. The single dose can be repeated after 4 hours.
• maximum daily dose: 6 sachets

The patient should not exceed the maximum daily dose.

Method of administration

Pour the contents of one or two sachets of Aspirin Complex Zatoki into a glass of water and mix well. The resulting suspension has an orange flavor. The patient should drink the entire contents of the glass immediately. Note: The granules do not dissolve completely.

Duration of use

The patient should not take this medicine for more than 3 days without consulting their doctor.

Taking a higher dose of Aspirin Complex Zatoki than recommended

In case of suspected overdose, the patient should contact their doctor immediately. Symptoms of overdose include: headache, dizziness, seizures, vomiting, tinnitus, rapid heartbeat, chest pain, agitation, or shortness of breath. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Aspirin Complex Zatoki can cause side effects, although not everybody gets them. The frequency of side effects cannot be estimated from the available data - frequency not known.

Possible side effects of acetylsalicylic acid:

In case of any of the following very serious side effects, the patient should contact their doctor or go to the nearest hospital immediately:

• allergic reactions (including difficulty breathing, rash with possible drop in blood pressure), especially in patients with asthma
• aspirin-induced respiratory disease (symptoms of existing respiratory disease worsen under the influence of the medicine)
• stomach ulcers, which in individual cases can lead to perforation
• enteropathy with narrowing of the intestines (especially during long-term use)
• gastrointestinal bleeding, which in individual cases can lead to iron deficiency anemia. The occurrence of black stools or vomiting blood are symptoms of gastrointestinal bleeding
• kidney function disorders, kidney failure
• hemolysis (red blood cell breakdown) in cases of severe G6PD deficiency (glucose-6-phosphate dehydrogenase deficiency)

In case of any of the following serious side effects, the patient should contact their doctor immediately:

• increased risk of bleeding, e.g., bleeding from the mouth, vagina, or rectum
• gastrointestinal disorders or intestinal disorders, such as abdominal pain, indigestion, and gastritis
• temporary liver function impairment with increased activity of liver enzymes called transaminases
• dizziness
• tinnitus (ringing in the ears)

Mild side effects:

• nausea, vomiting, diarrhea

Possible side effects of pseudoephedrine:

• severe vascular disorders affecting the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

The patient should stop taking Aspirin Complex Zatoki and seek medical attention immediately if they experience symptoms indicating PRES or RCVS, including:

• severe headache with sudden onset
• nausea
• vomiting
• confusion
• seizures
• changes in vision

In case of any of the following serious side effects, the patient should contact their doctor immediately:

• increased blood pressure (not applicable to patients with controlled hypertension)
• heart-related side effects (e.g., rapid or irregular heartbeat)
• insomnia, rarely hallucinations, and other symptoms of central nervous system stimulation
• urinary retention, especially in patients with prostatic hyperplasia (prostate enlargement)
• skin symptoms such as rash, hives, itching
• sudden fever, redness of the skin, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP). See section 2. If such symptoms occur, the patient should stop taking Aspirin Complex Zatoki and contact their doctor or seek medical attention immediately.
• ischemic colitis (inflammatory bowel disease caused by insufficient blood flow)
• decreased blood flow to the optic nerve (ischemic optic neuropathy)

Mild side effects:

• sudden redness of the face
• dry mouth

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: (22) 49 21 301, fax: (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 Aspirin Complex Zatoki

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 sachets. The expiry date refers to the last day of the month. Do not store above 30°C. 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 packaging and other information

What Aspirin Complex Zatoki contains

The active substances of the medicine are acetylsalicylic acid (500 mg) and pseudoephedrine hydrochloride (30 mg). The other ingredients of the medicine are: citric acid, sucrose, hypromellose, saccharin, orange flavor (containing benzyl alcohol, acetic acid, alpha-tocopherol, modified starch, and maltodextrin).

What Aspirin Complex Zatoki looks like and contents of the pack

Aspirin Complex Zatoki is a granule for oral suspension with a color ranging from white to yellowish. The medicine is available in packs containing 10 or 20 sachets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Bayer Sp. z o.o., Al. Jerozolimskie 158, 02-326 Warsaw. Manufacturer: Bayer Bitterfeld GmbH, OT Greppin, Salegaster Chaussee 1, 06803 Bitterfeld-Wolfen, Germany.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Although this product is authorized in other Member States, it may not be available in all of them. Germany: ASPIRIN COMPLEX 500 mg / 30 mg Granulat zur Herstellung einer Suspension zum Einnehmen. Austria: Aspirin Complex Granulat zur Herstellung einer Suspension zum Einnehmen. Bulgaria: Аспирин Комплекс 500 mg / 30 mg Гранули за перорална суспензия. Croatia: Aspirin Complex 500 mg/30 mg granule za oralnu suspenziju. Hungary: Aspirin Complex 500 mg / 30 mg granulátum belsőleges szuszpenzióhoz. Italy: “Aspirina influenza e naso chiuso” 500mg/30mg granulato per sospensione orale. Poland: Aspirin Complex Zatoki 500 mg / 30 mg Granulat do sporządzania zawiesiny doustnej. Portugal: Aspirina Complex 500 mg/30 mg granulado para suspensão oral. Romania: ASPIRIN COMPLEX 500 mg/30 mg granule pentru suspensie orală. Slovenia: Aspirin Complex 500 mg/30 mg zrnca za peroralno suspenzijo.