Aspirin Complex Hot

Leaflet attached to the packaging: information for the user

Aspirin Complex Hot

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 advised 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 a doctor.

Table of contents of the leaflet

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

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

Aspirin Complex Hot contains the active substances: acetylsalicylic acid and pseudoephedrine hydrochloride. This medicine has analgesic, anti-inflammatory, antipyretic, and decongestant properties. Aspirin Complex Hot is used for the symptomatic treatment of nasal congestion and (or) sinusitis (rhinosinusitis) 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 containing only one of the active substances. If there is no improvement after 3 days or if the patient feels worse, they should contact a doctor. Aspirin Complex Hot is intended for use in adults and adolescents from 16 years of age.

2. Important information before taking Aspirin Complex Hot

When not to take Aspirin Complex Hot:

• if the patient is allergic (hypersensitive) to acetylsalicylic acid, pseudoephedrine, 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 a stomach ulcer
• 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 monoamine oxidase inhibitors (MAOIs) for depression or Parkinson's disease (or has taken them in the last 2 weeks)
• if the patient has glaucoma with closed-angle glaucoma
• if the patient has urinary retention

Warnings and precautions

Before taking Aspirin Complex Hot, the patient should talk to their doctor or pharmacist:

• if the patient has an allergy (hypersensitivity) to other painkillers, anti-rheumatic, or anti-inflammatory medicines
• if the patient has allergies (e.g., 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 thinners or anticoagulants
• if the patient is going to have surgery (including minor procedures such as tooth extraction), as acetylsalicylic acid, even in small doses, increases the risk of bleeding
• if the patient has impaired liver function
• if the patient has impaired kidney function and cardiovascular system (e.g., when the heart does not pump blood strongly enough, reduced blood volume, major surgery, blood infection, or significant bleeding)
• if the patient has a tendency to gout. Acetylsalicylic acid, even in small doses, 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 disorder affecting red blood cells), as acetylsalicylic acid in higher doses can lead to hemolysis (red blood cell breakdown)
• if the patient is taking several painkillers regularly (especially in combination with different types of painkillers) - this can lead to permanent kidney damage
• if the patient has hyperthyroidism, mild to moderate hypertension, diabetes, heart disease, increased eye pressure, or enlarged prostate (prostate hypertrophy) or is hypersensitive to certain ingredients of cough and cold medicines (e.g., phenylephrine and ephedrine, sympathomimetic substances)
• if the patient has renal tubular acidosis, which means the kidneys cannot properly remove acid from the body. This can increase the risk of side effects due to higher pseudoephedrine levels in the blood
• If the patient experiences fever with generalized skin rash and pustular eruption, they should discontinue Aspirin Complex Hot and consult a doctor or seek medical attention immediately. See section 4.
• During treatment with Aspirin Complex Hot, sudden abdominal pain or rectal bleeding may occur due to inflammatory bowel disease (ischemic colitis). If such gastrointestinal symptoms occur, the patient should discontinue Aspirin Complex Hot and seek medical attention immediately. See section 4.
• During treatment with Aspirin Complex Hot, reduced blood flow to the optic nerve may occur. In case of sudden vision loss, the patient should discontinue Aspirin Complex Hot and consult a doctor immediately. See section 4.
• After taking pseudoephedrine-containing medicines, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported. PRES and RCVS are rare conditions that can be associated with reduced blood flow to the brain. If symptoms occur that may be indicative of PRES or RCVS, the patient should discontinue Aspirin Complex Hot immediately and seek medical attention (symptoms, see section 4 "Possible side effects").

Doping

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

Elderly

Elderly patients may be particularly sensitive to 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.

Aspirin Complex Hot with other medicines

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

• methotrexate used to treat severe arthritis, cancer, or psoriasis. Aspirin Complex Hot 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 lower than 15 mg per week.
• monoamine oxidase inhibitors used to treat depression or Parkinson's disease. Aspirin Complex Hot should not be taken if the patient has taken these medicines in the last 2 weeks.
• blood thinners or anticoagulants
• 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 Hot with food, drink, and alcohol

The medicine can be taken independently of meals. However, before taking the granules, they should be poured into a glass of water and mixed well. During treatment with 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 Hot should not be taken during pregnancy and breastfeeding, due to the lack of data on the safety of the combined use of both active substances. 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 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 a doctor or pharmacist before taking this medicine. This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may have a negative effect on female fertility. This effect is temporary and disappears after the end of therapy.

Driving and using machines

During treatment with Aspirin Complex Hot, the patient's ability to react to stimuli may be impaired. The patient should avoid driving if this applies to them. The risk of this type of side effect may be increased by concurrent alcohol consumption. This should be taken into account in situations that require increased attention.

Aspirin Complex Hot contains sucrose

This medicine contains 2 g of sucrose (sugar) per sachet (equivalent to 0.17 bread units). Patients with diabetes should take this into account. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking Aspirin Complex Hot.

3. How to take Aspirin Complex Hot

This 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 a 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 maximum daily dose should not be exceeded.

Method of administration

Pour the contents of one or two sachets of Aspirin Complex Hot into a glass of hot, but not boiling, water and stir well. The suspension should be cooled to a suitable temperature for drinking. The entire contents of the glass should be drunk immediately after preparation. Note: The granules do not dissolve completely.

Duration of treatment

The medicine should not be taken for more than 3 days without consulting a doctor.

Taking a higher dose of Aspirin Complex Hot than recommended

In case of suspected overdose, the patient should contact a doctor immediately. Symptoms of overdose are: headache, dizziness, seizures, vomiting, tinnitus, accelerated heart rate, chest pain, agitation, or shortness of breath. In case of any further doubts about the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Aspirin Complex Hot 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 caused by acetylsalicylic acid are:

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

• Allergic reactions (including difficulty breathing, rash with possible blood pressure drop), 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.
• Impaired kidney function, 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 a doctor immediately:

• Increased risk of bleeding, e.g., bleeding from the mouth, vagina, or anus.
• Gastrointestinal 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 caused by pseudoephedrine are:

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

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

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

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

• increased blood pressure (not applicable to patients with controlled hypertension)
• heart-related side effects (e.g., accelerated or irregular heart rate)
• insomnia, rarely hallucinations, and other symptoms of central nervous system stimulation
• urinary retention, especially in patients with prostate hypertrophy
• skin symptoms such as rash, hives, itching
• 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 Aspirin Complex Hot. See section 2. If such symptoms occur, the patient should discontinue Aspirin Complex Hot and consult a doctor or seek medical attention immediately.
• ischemic colitis (inflammatory bowel disease caused by insufficient blood flow)
• reduced blood flow to the optic nerve (ischemic optic neuropathy)

Mild side effects:

• sudden facial flushing
• 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 Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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, it is possible to gather more information on the safety of the medicine.

5. How to store Aspirin Complex Hot

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. This medicine does not require special storage conditions. 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 Aspirin Complex Hot contains

• The active substances of the medicine are: acetylsalicylic acid (500 mg) and pseudoephedrine hydrochloride (30 mg).
• The other ingredients are: sucrose, hypromellose, sucralose, vanilla flavor, and peppermint-menthol-eucalyptus flavor (containing menthol and cineole).

What Aspirin Complex Hot looks like and contents of the pack

The medicine is in the form of white to yellowish granules for oral suspension. Aspirin Complex Hot is available in packs of 10 or 20 sachets. Not all pack sizes may be marketed.

Marketing authorization holder

Bayer Sp. z o.o. Al. Jerozolimskie 158 02-326 Warsaw

Manufacturer

Bayer Bitterfeld GmbH Ortsteil 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 the medicinal product is registered in other Member States, it may not be available on the market. Germany Aspirin Complex Heissgetränk 500 mg / 30 mg Granulat zur Herstellung einer Suspension zum Einnehmen Austria Aspirin Complex Heissgetränk 500 mg / 30 mg Granulat zur Herstellung einer Suspension zum Einnehmen Bulgaria Аспирин Комплекс Горещ Евкалипт 500 mg / 30 mg Гранули за перорална суспензия Hungary Aspirin Complex Forró Ital 500 mg / 30 mg granulátum belsőleges szuszpenzióhoz Poland Aspirin Complex Hot Romania Aspirin Complex Hot Drink 500 mg / 30 mg Granule pentru suspensie orală Date of last revision of the leaflet:07.2024