Aspirin Pro

Leaflet attached to the packaging: information for the user

ASPIRIN PRO

500 mg, coated tablets
Acetylsalicylic acid

You should carefully read the contents of the leaflet 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days (in the case of fever) or 3-4 days (in the case of pain) there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Aspirin Pro contains acetylsalicylic acid. Acetylsalicylic acid is a pain reliever and antipyretic.
Aspirin Pro is used for the symptomatic treatment of fever and/or pain of mild or moderate intensity, such as headache, flu-like symptoms, toothache, muscle pain.

Aspirin Pro is intended for use in adults and adolescents – persons aged

12 years and older (with a body weight of 40 kg or more).You should ask your doctor or pharmacist about other forms of acetylsalicylic acid intended for patients with a body weight below 40 kg.
If after 3 days (in the case of fever) or 3–4 days (in the case of pain) there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Aspirin Pro

When not to take 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 had asthma attacks or allergic reactions (e.g., hives, angioedema, severe rhinitis, anaphylactic shock) caused by taking acetylsalicylic acid or substances with similar effects, especially non-steroidal anti-inflammatory drugs;
• if the patient has stomach or duodenal ulcer disease;
• if the patient has a bleeding disorder or is at increased risk of bleeding;
• if the patient has severe kidney, liver, or heart failure;
• if the patient is being treated with methotrexate at doses greater than 20 mg per week;
• if the patient is being treated with oral anticoagulants (blood thinners);
• if the patient is in the fifth month of pregnancy (more than 24 weeks of amenorrhea).

In case of any doubts related to the use of this medicine, you should consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Aspirin Pro, you should discuss it with your doctor or pharmacist:

• if the patient is being treated with other products containing acetylsalicylic acid - to avoid the risk of overdose;
• if, despite taking large doses of acetylsalicylic acid for a long time, headaches persist, you should not increase the dose but consult a doctor or pharmacist;
• if the patient regularly takes painkillers, especially several painkillers at the same time, as this may lead to worsening of kidney function;
• if the patient has a genetic disorder of red blood cells involving a deficiency of the enzyme - glucose-6-phosphate dehydrogenase, as administration of higher doses of acetylsalicylic acid may cause hemolysis (destruction of red blood cells);
• if the patient has a history of stomach ulcers, gastrointestinal bleeding, or stomach lining inflammation;
• if the patient has kidney or liver function disorders;
• if the patient has kidney function disorders or cardiovascular disorders;
• if the patient has asthma: in some patients, the occurrence of asthma attacks may be related to allergic reactions to non-steroidal anti-inflammatory drugs or acetylsalicylic acid. In such cases, it is not recommended to use this medicine.
• in case of heavy menstrual bleeding;
• if gastrointestinal bleeding occurs during treatment (vomiting blood, blood in stool, black stool discoloration), treatment should be discontinued and medical help should be sought immediately;
• if the patient is taking blood thinners (anticoagulants) at the same time;
• acetylsalicylic acid increases the risk of bleeding even at low doses and even if it was taken several days earlier. You should inform your doctor, surgeon, or anesthesiologist or dentist if a minor surgical procedure is planned;
• acetylsalicylic acid modifies the amount of uric acid in the blood. This should be taken into account if the patient is taking medicines for gout;
• it is not recommended to take this medicine during breastfeeding.

Children

In children with viral diseases who were given acetylsalicylic acid, Reye's syndrome (a rare but very serious disorder related to damage to the nervous system and liver) has been observed. Therefore:

• in case of viral diseases, such as flu or chickenpox, acetylsalicylic acid should not be given to a child without prior consultation with a doctor;
• if symptoms such as dizziness or fainting, behavioral disorders, or vomiting occur in a child taking acetylsalicylic acid, a doctor should be notified immediately.

Aspirin Pro and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In the following text, the following definitions are used:
Acetylsalicylic acid can be used in treatment of rheumatic diseases in high
doses (defined as "anti-inflammatory" doses), defined as: 1 g or more in a single dose and (or) 3 g or more per day.
Acetylsalicylic acid can be used in treatment of pain and fever in dosesdefined as: 500 mg or more in a single dose and (or) no more than 3 g per day.
When not to take Aspirin Pro:

• if the patient is taking methotrexate at doses greater than 20 mg per week. In this case, it is recommended to avoid taking acetylsalicylic acid in large (anti-inflammatory) doses, as well as in the treatment of pain and fever.
• if the patient is taking oral anticoagulants and has ever had stomach ulcers. In this case, it is recommended to avoid taking acetylsalicylic acid in large (anti-inflammatory) doses, as well as in the treatment of pain and fever.

You should talk to your doctor or pharmacist before starting treatment with acetylsalicylic acid at the same time as any of the following medicines:

• oral anticoagulants, when acetylsalicylic acid is used to treat pain and fever, even if there are no stomach or duodenal ulcers;
• non-steroidal anti-inflammatory drugs, when acetylsalicylic acid is used in large (anti-inflammatory) doses, as well as in the treatment of pain and fever;
• heparin in therapeutic doses or in elderly patients (≥ 65 years), when acetylsalicylic acid is used in high (anti-inflammatory) doses, especially in the treatment of rheumatic disorders, or in the treatment of pain and fever;
• thrombolytic agents;
• clopidogrel;
• ticlopidine;
• medicines that increase uric acid excretion in the urine, used to treat gout (e.g., benzobromarone, probenecid);
• glucocorticosteroids (except for replacement therapy with hydrocortisone), when acetylsalicylic acid is used in large (anti-inflammatory) doses;
• pemetrexed in patients with mild or moderate kidney function disorders;
• anagrelide;
• medicines used to remove excess water from the body (diuretics);
• angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists;
• methotrexate used at a dose of 20 mg or less per week;
• medicines that act locally on the gastrointestinal tract, such as antacids and activated charcoal;
• deferazirox;
• selective serotonin reuptake inhibitors (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline). To avoid potential interactions with other medicines, you should tell your doctor or pharmacist about all other medicines you are taking.

Aspirin Pro with alcohol

Do not take Aspirin Pro with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this or any other medicine.
Pregnancy
Do not take Aspirin Pro during the last 3 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 patient's and child's tendency to bleed and cause delayed or prolonged labor. Do not take Aspirin Pro during the first 6 months of pregnancy, unless it is absolutely necessary and has been prescribed by a doctor. If you require treatment during this period or are trying to conceive, you should use the smallest dose for the shortest possible time. If Aspirin Pro is taken for more than a few days from the 20th week of pregnancy, it may cause kidney function disorders in the unborn child, leading to a decrease in the amount of amniotic fluid surrounding the fetus (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is necessary for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
This medicine may pass into breast milk. As a precaution, do not take Aspirin Pro while breastfeeding.
Fertility
The product belongs to a group of medicines that may adversely affect female fertility. This effect is temporary and disappears after the end of therapy.

Driving and using machines

Acetylsalicylic acid does not affect the ability to drive and use machines.

Aspirin Pro contains sodium.

The medicine contains 71.7 mg of sodium (the main component of common salt) in each coated tablet.
This corresponds to 3.6% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Aspirin Pro

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubts, you should consult a doctor or pharmacist.

Recommended dose

For oral use only.

Use in adults and adolescents (persons aged 16 years and older)

• The recommended single dose is 1 tablet; if necessary, the dose can be repeated after at least 4 hours. In case of more severe fever or pain, the recommended single dose is 2 tablets; if necessary, the dose can be repeated after at least 4 hours.
• The total daily dose should not exceed 6 tablets.

Use in elderly patients(65 years and older)

• The recommended single dose is 1 tablet; if necessary, the dose can be repeated after at least 4 hours.
• The total daily dose should not exceed 4 tablets.

Use in adolescents aged 12-15 years (with a body weight of 40-50 kg)

• The dose is dependent on the patient's body weight;the indicated age is only a guideline.
• The recommended single dose is 1 tablet; if necessary, the dose can be repeated after at least 4 hours.
• The total daily dose should not exceed 6 tablets.

Use in special patient groups

• Patients with liver or kidney function disorders or circulation problems (e.g., heart failure or severe bleeding incidents): You should consult a doctor or pharmacist.
• Children under 12 years of age (with a body weight below 40 kg): Do not use the medicine unless prescribed by a doctor.

Method of administration

To open the blister, tear the foil from the center of any edge.
Tablets should be taken with a large amount of water.

Duration of treatment

Do not take this medicine for more than 3 days (in the case of fever) or 3-4 days (in the case of pain), unless your doctor recommends otherwise.

Taking a higher dose of Aspirin Pro than recommended

During treatment, tinnitus, hearing loss, headaches, dizziness - these are typical signs of overdose.
In case of suspected overdose, treatment should be discontinued and medical help should be sought immediately.

Missing a dose of Aspirin Pro

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency of occurrence: unknown - the frequency of occurrence cannot be estimated from the available data.

Possible side effects related to taking acetylsalicylic acid:

All the following side effects are very serious and may require urgent medical attention or hospitalization. If you notice any of the following symptoms, you should contact your doctor or go to the nearest hospital immediately:

• bleeding (nosebleeds, bleeding gums, red spots under the skin, etc.);
• allergic reactions, such as skin rashes, asthma attacks, or facial swelling, which may be accompanied by difficulty breathing;
• headache, dizziness, hearing loss, tinnitus (ringing in the ears), which usually indicate an overdose;
• bleeding into the brain;
• abdominal pain;
• gastrointestinal bleeding, see section "Warnings and precautions" - occurs more frequently after taking large doses;
• elevated liver enzyme activity, usually reversible after discontinuation of treatment, liver function disorders (mainly affecting liver cells);
• hives, skin reactions;
• Reye's syndrome (disorders of consciousness or unusual behavior or vomiting) in a child with a viral disease taking acetylsalicylic acid (see section 2. Important information before taking Aspirin Pro);
• kidney function disorders, kidney damage;
• enteropathy (narrowing of the intestine), especially during long-term use.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, 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, you can help provide more information on the safety of this medicine.

5. How to store Aspirin Pro

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date stated on the blister pack after: EXP. The expiration date refers to the last day of the month stated.
Do not store above 30°C.
Do not use this medicine if you notice visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Aspirin Pro contains

The active substance of the medicine is acetylsalicylic acid.
Each coated tablet contains 500 mg of acetylsalicylic acid.
The other ingredients of the medicine are:
Colloidal anhydrous silica, sodium carbonate
Tablet coating: carnauba wax, hypromellose, zinc stearate.

What Aspirin Pro looks like and what the pack contains

The medicine is in the form of white or almost white, round, biconvex, coated tablets with a diameter of 12 mm, with the inscription "BA 500" on one side and the "Bayer cross" symbol on the other side.
The packaging contains 4, 8, 12, 20, 24, 40, 60, or 80 coated tablets in a cardboard box.
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
Tel.: +48 22 572 35 00
Fax: +48 22 572 35 55
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:

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 coated tablet
Luxembourg
Aspirine Fasttabs 500 mg coated tablet
Poland
Aspirin Pro
Portugal
Aspirina Xpress 500 mg coated tablet
Romania
Aspirin 500 mg coated tablets
Slovenia
Aspirin 500 mg coated tablets
Cyprus
Aspirin Express 500 mg coated tablets
Greece
Aspirin Express 500 mg coated tablets

Date of last revision of the leaflet: 08/2023