Aspirin complex hot

Package leaflet: Information for the user

Aspirin Complex Hot
500 mg + 30 mg, effervescent granules for oral suspension
Acetylsalicylic acid + Pseudoephedrine hydrochloride
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

Aspirin Complex Hot contains the active substances: acetylsalicylic acid and pseudoephedrine hydrochloride. This medicine has analgesic, anti-inflammatory, antipyretic, and decongestant properties that reduce nasal mucosal hyperaemia and oedema.
Aspirin Complex Hot is used for the symptomatic treatment of nasal and/or sinus congestion (rhinosinusitis) and for pain and fever associated with the common cold and/or influenza-like symptoms.
If the patient suffers from only one of these symptoms, a medicine containing only one of the active substances mentioned may be more appropriate.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.
Aspirin Complex Hot is intended for use in adults and adolescents from the age of 16 years.

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 to any of the other components of this medicine (listed in section 6)
• if the patient has previously experienced asthma triggered by salicylates or substances with similar action (i.e. non-steroidal anti-inflammatory drugs)
• if the patient has gastric ulcer disease
• if the patient has an increased tendency to bleed
• if the patient has liver failure
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or renal 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 concurrently 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 concurrently taking antidepressant medicines from the group of monoamine oxidase inhibitors (MAO inhibitors) (or has taken them within the last two weeks)
• if the patient has closed-angle glaucoma
• if the patient has urinary retention

Warnings and precautions
Before starting to take Aspirin Complex Hot, consult a doctor or pharmacist:

• if the patient has a known allergy (hypersensitivity) to other painkillers, anti-rheumatic or anti-inflammatory medicines
• if the patient suffers from allergies (e.g. with rash, itching, urticaria), asthma, hay fever, nasal mucosa swelling (nasal polyps), or chronic lung diseases
• if the patient has previously had gastric ulcer disease or gastrointestinal bleeding
• if the patient is concurrently taking blood-thinning and anticoagulant medicines (antithrombotic agents)
• if the patient is scheduled for surgery (including minor procedures such as tooth extraction), because acetylsalicylic acid, even at low doses, increases the risk of bleeding
• if the patient has impaired liver function
• if the patient has impaired kidney or cardiovascular function (e.g. when the heart pumps blood inadequately, reduced circulating blood volume, major surgical procedures, blood infection, or significant hemorrhagic event)
• if the patient is prone to gout attacks. Acetylsalicylic acid at low doses reduces uric acid excretion, which may trigger an acute gout attack
• if the patient has G6PD deficiency (glucose-6-phosphate dehydrogenase deficiency) (an inherited disorder affecting red blood cells), because higher doses of acetylsalicylic acid may cause hemolysis (breakdown of red blood cells)
• if the patient is systematically taking multiple painkillers simultaneously (especially combinations of different types of painkillers) – this may lead to permanent kidney damage
• if the patient has hyperthyroidism, mild to moderate hypertension, diabetes, heart disease, elevated intraocular pressure, prostate enlargement (benign prostatic hyperplasia), or hypersensitivity to certain ingredients in cough and cold medicines, such as phenylephrine and ephedrine (sympathomimetic agents)
• if the patient has renal tubular acidosis, meaning the kidneys cannot properly eliminate acid from the body. This may increase the risk of adverse effects due to higher blood levels of pseudoephedrine
• If fever occurs with generalized skin redness and blistering rash, discontinue taking Aspirin Complex Hot and contact a doctor or seek immediate medical help. See section 4.
• During treatment with Aspirin Complex Hot, sudden abdominal pain or rectal bleeding due to inflammation of the large intestine (ischemic colitis) may occur. If such gastrointestinal symptoms occur, discontinue use of Aspirin Complex Hot and immediately consult a doctor or seek medical help. See section 4.
• During treatment with Aspirin Complex Hot, reduced blood flow to the optic nerve may occur. In case of sudden vision loss, discontinue use of Aspirin Complex Hot and immediately contact your doctor or seek medical help. See section 4.
• Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine. PRES and RCVS are rare conditions that may involve reduced blood flow to the brain. If symptoms suggestive of PRES or RCVS occur, immediately discontinue use of Aspirin Complex Hot and seek immediate medical help (symptoms, see section 4 “Possible side effects”).

Doping
Athletes should be aware that this medicine may lead to a positive result in anti-doping tests.
Elderly patients
Elderly individuals may be particularly sensitive to pseudoephedrine, and insomnia or perception of things that do not exist (hallucinations) may occur.
Children and adolescents
There is a potential association between the use of acetylsalicylic acid in children and adolescents and the occurrence of Reye’s syndrome. This is a very rare condition that may be fatal. For this reason, acetylsalicylic acid should not be used in children and adolescents under 16 years of age, unless advised by a doctor.
Aspirin Complex Hot and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use, especially when taking medicines containing:

• methotrexate used in the treatment of severe arthritis, cancer, and psoriasis. Do not use Aspirin Complex Hot if the patient is concurrently taking methotrexate at a dose of 15 mg per week or higher. Medical monitoring is recommended if the patient is taking methotrexate at doses lower than 15 mg per week.
• monoamine oxidase inhibitors (MAO inhibitors) used in the treatment of depression or Parkinson’s disease. Do not use Aspirin Complex Hot if the patient has taken the above-mentioned medicines within the last 2 weeks.
• substances preventing blood clotting or dissolving clots
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain, inflammation, or rheumatism
• selective serotonin reuptake inhibitors (SSRIs) used in the treatment of depression
• other substances used in the treatment of depression
• digoxin used in heart failure or irregular heartbeat
• substances lowering blood glucose levels
• substances used to remove excess fluid from the body (diuretics)
• glucocorticoids administered orally or by injection/infusion – except hydrocortisone used in replacement therapy. Glucocorticoids may be used to reduce skin inflammation 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 those ending in “lol”
• valproic acid used in the treatment of epilepsy
• benzbromarone or probenecid used in the treatment of gout
• oral salbutamol tablets used to dilate airways. This does not exclude the use of inhalers at doses prescribed by a doctor
• phenylephrine and ephedrine or other sympathomimetic agents contained in nasal drops or sprays

Aspirin Complex Hot with food, drink, and alcohol
This medicine can be taken regardless of meals. However, before taking the medicine, the granules must be poured into a glass of water and thoroughly mixed. During treatment with acetylsalicylic acid, alcohol should be avoided, as its consumption may increase the risk of gastrointestinal bleeding.
Pregnancy, breastfeeding, and effect on fertility
Aspirin Complex Hot should not be used during pregnancy or breastfeeding due to lack of safety data on the combined use of both active substances. Additionally, consider that acetylsalicylic acid:

• may cause kidney and heart problems in the unborn child if taken from week 20 of pregnancy
• may harm the unborn child or cause delivery complications if taken during the third trimester of pregnancy
• may affect the bleeding tendency of both mother and child and may delay or prolong labor if taken before or during delivery

If the patient is pregnant or planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of therapy.
Driving and operating machinery
During treatment with Aspirin Complex Hot, reduced reaction ability may occur. Driving should be avoided if this affects the patient. The risk of such effects may increase if alcohol is consumed concurrently. This should be considered in situations requiring high concentration.
Aspirin Complex Hot contains sucrose
This medicine contains 2 g of sucrose (sugar) per sachet (equivalent to 0.17 carbohydrate exchange units). This should be taken into account by patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient 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 this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose for adults and adolescents from the age of 16:

• Single dose: 1–2 sachets. The single dose may be repeated after 4 hours.
• Maximum daily dose: 6 sachets. Do not exceed the maximum daily dose.

Instructions for use
Pour the contents of one or two sachets of Aspirin Complex Hot into a glass of hot, but not boiling, water and stir thoroughly. Allow the suspension to cool to a suitably low temperature that enables drinking. The entire contents of the glass should be consumed immediately after preparation.
Note: The granules do not dissolve completely.
Duration of use
Do not use this medicine for longer than 3 days without consulting a doctor.
Overdose of Aspirin Complex Hot
In case of suspected overdose, contact a doctor immediately.
Symptoms of overdose include: headache, dizziness, seizures, vomiting, tinnitus (ringing in the ears), increased heart rate, chest pain, restlessness, or shortness of breath.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of occurrence cannot be determined from the available data – frequency unknown.

Possible adverse reactions caused by acetylsalicylic acid include:
If any of the following very serious adverse reactions occur, seek immediate medical advice or go to the nearest hospital:

• Allergic reactions (including difficulty in breathing, rash, possibly with a drop in blood pressure), especially in patients suffering from bronchial asthma.
• Respiratory disease aggravated by aspirin (symptoms of existing respiratory disease worsen under the influence of the medicine).
• Gastric ulcers, which in isolated cases may lead to perforation.
• Constrictive enteropathy of the intestines (particularly during long-term use).
• Gastrointestinal bleeding, which in isolated cases may lead to iron-deficiency anemia. Black stools or vomiting blood are signs of gastrointestinal bleeding.
• Impaired kidney function, kidney failure.
• Hemolysis (breakdown of red blood cells) in severe cases of G6PD deficiency (glucose-6-phosphate dehydrogenase deficiency).

If any of the following serious adverse reactions occur, contact your doctor immediately:

• Increased risk of bleeding, e.g. bleeding from the mouth, vagina or rectum.
• Gastrointestinal discomfort such as abdominal pain, indigestion, and inflammation of the stomach lining.
• Temporary impairment of liver function with increased activity of liver enzymes known as transaminases.
• Dizziness
• Tinnitus (ringing in the ears)

Mild adverse reactions:

• Nausea, vomiting, diarrhoea.

Possible adverse reactions caused by pseudoephedrine include:

• Severe conditions affecting blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Immediately discontinue use of Aspirin Complex Hot and seek immediate medical help if symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:

• Sudden, severe headache,
• Nausea,
• Vomiting,
• Confusion,
• Seizures,
• Visual disturbances.

If any of these serious adverse reactions occur, contact your doctor immediately:

• Increased blood pressure (does not apply to individuals with controlled arterial hypertension).
• Adverse effects on the heart (e.g. rapid or irregular heartbeat).
• Insomnia, rarely hallucinations and other symptoms of central nervous system stimulation.
• Urinary retention, especially in patients with benign prostatic hyperplasia (enlarged prostate).
• Skin reactions such as rash, urticaria, 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, discontinue use of Aspirin Complex Hot and contact your doctor or seek immediate medical help.
• Colitis of the large intestine caused by insufficient blood supply (ischemic colitis).
• Reduced blood flow to the optic nerve (ischemic optic neuropathy).

Mild adverse reactions:

• Sudden flushing of the face
• Dry mouth

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Aspirin Complex Hot

Keep this medicine 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 stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices will help protect the environment.

6. Contents of the pack and other information

What Aspirin Complex Hot contains

• The active substances are: acetylsalicylic acid (500 mg) and pseudoephedrine hydrochloride (30 mg).
• Other ingredients are: sucrose, hypromellose, sucralose, vanilla flavour, and menthol-eucalyptus-mint flavour (containing menthol and cineole).

What Aspirin Complex Hot looks like and contents of the pack
Aspirin Complex Hot is in the form of granules for oral suspension, white to slightly yellowish in colour.
The medicine is available in packs containing 10 or 20 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the European Economic Area under the following names:
Although the medicinal product is registered in other Member States, it may not be marketed in all countries.
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