Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Aspirin Pro (Aspirin 500 mg coated tablets), 500 mg, coated tablets
Acetylsalicylic acid
Aspirin Pro and Aspirin 500 mg überzogene Tabletten are different trade names of the same
medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

Keep this leaflet for possible future reference.
If advice or additional information is needed, please consult a pharmacist.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. See section 4.
If there is no improvement after 3 days (in case of fever) or 3–4 days (in case of pain), or if the patient feels worse, consult a doctor.

Table of contents

What Aspirin Pro is and what it is used for
Important information before taking Aspirin Pro
How to take Aspirin Pro
Possible side effects
How to store Aspirin Pro
Contents of the pack and other information

1. What Aspirin Pro is and what it is used for

Aspirin Pro contains acetylsalicylic acid. Acetylsalicylic acid is an analgesic and antipyretic medicine.
Aspirin Pro is used for symptomatic treatment of fever and/or mild to moderate pain such as headache, flu-related discomfort, toothache, muscle pain.
Aspirin Pro is intended for use in adults and adolescents aged 12 years and older (with body weight of 40 kg or more). Please consult a doctor or pharmacist about other formulations of acetylsalicylic acid intended for patients with body weight below 40 kg.
If there is no improvement after 3 days (in case of fever) or 3–4 days (in case of pain), or if the patient feels worse, consult a doctor.

2. Information before using Aspirin Pro

When not to use Aspirin Pro:

if the patient is allergic to acetylsalicylic acid, other salicylates, or any of the other ingredients of this medicine (listed in section 6);
if the patient has ever experienced asthma attacks or an allergic reaction (e.g. urticaria, angioedema, severe rhinitis, shock) after taking acetylsalicylic acid or substances with similar action, particularly nonsteroidal anti-inflammatory drugs;
if the patient has gastric or duodenal ulcer disease;
if the patient has a bleeding tendency or an increased risk of bleeding;
if the patient has severe renal, hepatic, or cardiac insufficiency;
if the patient is being treated with methotrexate at doses greater than 20 mg per week;
if the patient is being treated with oral anticoagulant drugs (blood thinners and antithrombotic agents);
if the patient is in the second half of pregnancy (beyond 24 weeks of amenorrhea).

If there are any doubts regarding the use of this medicine, consult a
physician or pharmacist.
Warnings and precautions
Before starting treatment with Aspirin Pro, discuss with your doctor or pharmacist:

if the patient is being treated with other medicines containing acetylsalicylic acid – to avoid the risk of overdose;
if headaches persist despite prolonged use of high doses of acetylsalicylic acid, do not increase the dose but consult a physician or pharmacist;
if the patient regularly uses painkillers, especially several painkillers simultaneously, as this may impair kidney function;
if the patient suffers from a genetic red blood cell disorder due to deficiency of the enzyme glucose-6-phosphate dehydrogenase, as higher doses of acetylsalicylic acid may trigger hemolysis (destruction of red blood cells);
if the patient has a history of peptic ulcer disease, gastrointestinal bleeding, or gastric mucosal inflammation;
if the patient has impaired kidney or liver function;
if the patient has impaired kidney function or cardiovascular circulation disorders;
if the patient suffers from asthma: in some patients, asthma attacks may be associated with allergic reactions to nonsteroidal anti-inflammatory drugs or acetylsalicylic acid. In such cases, use of this medicine is not recommended;
in case of heavy menstrual bleeding;
if gastrointestinal bleeding occurs during treatment (bloody vomiting, blood in stool, black stool), discontinue treatment immediately and contact a physician or emergency services;
if the patient is concurrently taking anticoagulant drugs (blood thinners and antithrombotic agents);
acetylsalicylic acid increases the risk of bleeding even at low doses and even if taken several days earlier. Inform the physician, surgeon, anesthesiologist, or dentist about taking this medicine, even if a minor surgical procedure is planned;
acetylsalicylic acid alters blood uric acid levels. This should be considered if the patient is taking medication for gout;
use of this medicine is not recommended during breastfeeding.

Children
Reye's syndrome (a rare but very serious condition involving neurological and liver damage) has been observed in children with viral infections who were given acetylsalicylic acid. Therefore:

in case of viral infections such as influenza or varicella, do not administer acetylsalicylic acid to a child without prior consultation with a physician;
if symptoms such as dizziness, fainting, behavioral disturbances, or vomiting occur in a child taking acetylsalicylic acid, contact a physician immediately.

Aspirin Pro and other medicines
Inform your physician or pharmacist about all medicines currently used, recently used, or planned to be used.
In the following text, the following definitions are used:
Acetylsalicylic acid may be used in treatment of rheumatic disorders at high doses (defined as "anti-inflammatory doses"), defined as: 1 g or more per single dose and (or) 3 g or more per day.
Acetylsalicylic acid may be used in treatment of pain and fever at doses defined as: 500 mg or more per single dose and (or) no more than 3 g per day.
When not to use Aspirin Pro:

if the patient is taking methotrexate at doses greater than 20 mg per week. In this case, avoid using acetylsalicylic acid at high (anti-inflammatory) doses as well as for treatment of pain and fever.
if the patient is taking oral anticoagulant drugs and has ever had gastric ulcer disease. In this case, avoid using acetylsalicylic acid at high (anti-inflammatory) doses as well as for treatment of pain and fever. Consult your physician or pharmacist before starting concomitant use of acetylsalicylic acid with any of the following medicines:
oral anticoagulants, when acetylsalicylic acid is used for treatment of pain and fever, even if there are no gastric or duodenal ulcers;
nonsteroidal anti-inflammatory drugs, when acetylsalicylic acid is used at high (anti-inflammatory) doses as well as for treatment of pain and fever;
heparins at therapeutic doses or in elderly patients (≥65 years), when acetylsalicylic acid is used at high (anti-inflammatory) doses, particularly in treatment of rheumatic disorders or for treatment of pain and fever;
thrombolytic agents;
clopidogrel;
ticlopidine;
drugs increasing urinary excretion of uric acid used in treatment of gout (e.g.: benzbromarone, probenecid);
glucocorticoids (except for replacement therapy with hydrocortisone), when acetylsalicylic acid is used at high (anti-inflammatory) doses;
pemetrexed in patients with mild or moderate renal impairment;
anagrelide;
drugs used to remove excess fluid from the body (diuretics);
angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists;
methotrexate at doses of 20 mg or less per week;
drugs acting locally on the gastrointestinal tract, such as antacids and activated charcoal;
deferasirox;
selective serotonin reuptake inhibitors (e.g.: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

To avoid potential interactions with other medicines, inform your physician or pharmacist
about all other medicines being taken.
Aspirin Pro and alcohol
Do not take Aspirin Pro with alcohol.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a physician or pharmacist before using this or any other medicine.
Pregnancy
Do not take Aspirin Pro during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medicine may cause kidney and heart function disorders in the unborn child. It may also affect the tendency of both mother and child to bleed and may delay or prolong labor. Do not use Aspirin Pro during the first six months of pregnancy unless absolutely necessary and prescribed by a physician. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible duration. If Aspirin Pro is taken for longer than a few days after the 20th week of pregnancy, it may cause kidney function disorders in the unborn child, leading to reduced amniotic fluid volume surrounding the fetus (oligohydramnios), or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment is necessary, the physician may recommend additional monitoring.
Breastfeeding
This medicine may pass into breast milk. As a precaution, it is not recommended to take Aspirin Pro during breastfeeding.
Fertility
This medicine belongs to a group of medicines that may adversely affect female fertility. This effect is reversible and resolves after discontinuation of therapy.
Driving and operating machinery
Acetylsalicylic acid has no effect on the ability to drive or operate machinery.
Aspirin Pro contains sodium
This medicine contains 71.7 mg of sodium (the main component of table salt) in each coated tablet.
This corresponds to 3.6% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Aspirin Pro

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
For oral use only.
Use in adults and adolescents (individuals aged 16 years and older)

The recommended single dose is 1 tablet; if necessary, this dose may be repeated after at least 4 hours. In cases of more severe fever or pain, the recommended single dose is 2 tablets; if necessary, this dose may be repeated after at least 4 hours.
The total daily dose should not exceed 6 tablets. Use in elderly patients (aged 65 years and older)
The recommended single dose is 1 tablet; if necessary, this dose may be repeated after at least 4 hours.
The total daily dose should not exceed 4 tablets. Use in adolescents aged 12–15 years (individuals with body weight 40–50 kg)
The dose depends on the patient's body weight; the indicated age is only approximate.
The recommended single dose is 1 tablet; if necessary, this dose may be repeated after at least 4 hours.
The total daily dose should not exceed 6 tablets. Use in special patient groups
Patients with impaired liver or kidney function or circulatory problems (e.g. heart failure or serious bleeding episodes): Medical advice from a doctor or pharmacist should be sought.
Children under 12 years of age (with body weight below 40 kg): This medicine should not be used unless prescribed by a doctor.

Method of administration:
To open the blister pack, peel back the foil at any point.
Tablets should be taken with a large amount of water.
Duration of use:
This medicine should not be taken for longer than 3 days (in case of fever) or 3–4 days (in case of pain), unless otherwise advised by a doctor.
Taking more Aspirin Pro than recommended

During treatment, tinnitus, sensation of hearing loss, headache, or dizziness may occur – these are typical signs of overdose.
If overdose is suspected, treatment should be stopped immediately and a doctor should be contacted without delay.
Missed dose of Aspirin Pro

Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Frequency of occurrence: unknown – frequency cannot be estimated from the available data.
Possible adverse reactions associated with acetylsalicylic acid use:
All of the following adverse reactions are very serious and may require urgent medical attention or hospitalization. If any of the symptoms listed below occur, contact a doctor immediately or go to the nearest hospital:

bleeding (nosebleeds, gum bleeding, red spots under the skin, etc.);
allergic reactions such as skin rash, asthma attack, or facial swelling accompanied by difficulty breathing;
headache, dizziness, feeling of hearing loss, tinnitus (ringing in the ears), which usually indicate overdose;
intracranial bleeding;
abdominal pain;
gastrointestinal bleeding – see section “Warnings and precautions” – occurs more frequently after high doses;
increased liver enzyme activity, usually reversible after discontinuation of treatment, liver function disorders (mainly affecting liver cells);
urticaria, skin reactions;
Reye's syndrome (disturbances in consciousness or unusual behavior or vomiting) in a child with a viral illness taking acetylsalicylic acid (see section 2. Important information before taking Aspirin Pro);
kidney function disorders, kidney damage;
intestinal stenosing enteropathy (especially during long-term use).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse.
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
Reporting adverse reactions enables the collection of additional information on the safety of medicine use.

5. How to store Aspirin Pro

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Do not use this medicine if visible signs of deterioration are observed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aspirin Pro contains
The active substance is acetylsalicylic acid.
Each coated tablet contains 500 mg of acetylsalicylic acid.
Other ingredients are: colloidal anhydrous silica, sodium carbonate.
Coating: Carnauba wax, hypromellose, zinc stearate.

What Aspirin Pro looks like and contents of the pack
This medicine is in the form of white or almost white, round, biconvex coated tablets with a diameter of 12 mm, embossed with the letters “BA 500” on one side and the “Bayer cross” symbol on the other.
The pack contains 4, 8, 12, 20, 24, 40, 60 or 80 coated tablets in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Germany, the country of export:
Bayer Vital GmbH
Kaiser-Wilhelm-Allee 70, 51373 Leverkusen, Germany

Manufacturer:
Bayer Bitterfeld GmbH
Salegaster Chaussee 1, 06803 Bitterfeld-Wolfen, Germany

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

German Marketing Authorisation Number (country of export): 86750.00.00
Parallel Import Authorisation Number: 187/20

This medicinal product is authorised for sale in the European Economic Area under the following names:
France Asproflash 500 mg coated tablet
Austria Aspirin Express 500 mg coated tablet
Belgium Aspirine Fasttabs 500 mg coated tablet
Czech Republic Aspirin 500 mg coated tablets
Germany Aspirin 500 mg coated tablets
Hungary Aspirin Ultra 500 mg bevont tabletta
Luxembourg Aspirine Fasttabs 500 mg coated tablet
Poland Aspirin Pro
Portugal Aspirina Xpress 500 mg coated tablet
Romania Aspirin 500 mg dragee
Slovenia Aspirin 500 mg obložene tablete
Cyprus Aspirin Express 500 mg επικαλυμμένα δισκία
Greece Aspirin Express 500 mg επικαλυμμένα δισκία