Etopirina Pro

Leaflet attached to the packaging: patient information

Etopiryna PRO, 500 mg, enteric-coated tablets

Acetylsalicylic acid

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 this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Etopiryna PRO and what is it used for

Etopiryna PRO contains acetylsalicylic acid, which has analgesic, anti-inflammatory, and antipyretic effects.
The enteric-coated tablet dissolves only in the small intestine, reducing the irritating effect of acetylsalicylic acid on the gastric mucosa.

Indications:

• Pain of various origins with mild and moderate severity, including: headaches, toothaches, muscle pains, joint pains;
• Conditions accompanying colds and flu with fever;
• Diseases requiring long-term use of acetylsalicylic acid in high doses, such as rheumatoid arthritis (only on a doctor's prescription).

2. Important information before taking Etopiryna PRO

When not to take Etopiryna PRO:

and gastrointestinal bleeding (may cause gastrointestinal bleeding or exacerbation of ulcer disease);

• in children and adolescents under 16 years of age;

Warnings and precautions

Before starting treatment with Etopiryna PRO, the patient should discuss it with their doctor or pharmacist if:

• the patient has kidney function disorders or chronic kidney failure;
• the patient has juvenile rheumatoid arthritis and/or systemic lupus erythematosus or liver failure, as the toxicity of salicylates increases. In these patients, liver function should be monitored;
• the patient has menstrual bleeding, excessive menstrual bleeding, or uses an intrauterine contraceptive device;
• the patient has hypertension, heart failure;
• the patient is taking methotrexate in doses less than 15 mg per week, due to the increased toxic effect of methotrexate on the bone marrow. Concurrent use with methotrexate in doses higher than 15 mg per week is contraindicated;
• the patient is taking oral antidiabetic drugs from the sulfonylurea group, due to the risk of increased hypoglycemic effect (reducing blood glucose levels) and if the patient is taking medications for gout or has reduced uric acid excretion;
• the patient is pregnant or planning to become pregnant.

Etopiryna PRO should be discontinued 5 to 7 days before a planned surgical procedure, due to the risk of prolonged bleeding time, both during and after the procedure.
When administering acetylsalicylic acid to children, there is a risk of developing Reye's syndrome.
Reye's syndrome is a very rare disease that affects the brain and liver and can be fatal.
Taking the medicine in the smallest effective dose for the shortest possible time necessary to relieve symptoms reduces the risk of side effects.
Long-term use of the medicine may be harmful, so it should be under medical supervision.
Long-term use of painkillers, especially those containing multiple active substances, can lead to severe kidney dysfunction and kidney failure.
Acetylsalicylic acid may impair female fertility (see section: Pregnancy, breastfeeding, and fertility).

Etopiryna PRO and 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.
Medicines contraindicated for concurrent use with acetylsalicylic acid:

• Methotrexate in doses of 15 mg per week or higher, due to its toxic effect on the bone marrow.

Caution should be exercised when using Etopiryna PRO with:

• Angiotensin-converting enzyme inhibitors (e.g., enalapril, captopril), as acetylsalicylic acid reduces the antihypertensive effect of these medicines;
• Acetazolamide, as acetylsalicylic acid may increase the harmful effect of acetazolamide;

Acetazolamide;

• Anticoagulant medications (heparin and warfarin), as there is an increased risk of bleeding;
• Valproic acid, as acetylsalicylic acid increases the toxic effect of valproic acid, and valproic acid increases the anti-aggregatory effect (preventing platelet aggregation) of acetylsalicylic acid;
• Diuretics, as acetylsalicylic acid may reduce the effectiveness of these medicines and increase the ototoxicity (hearing damage) of furosemide;
• Methotrexate in doses less than 15 mg per week, as acetylsalicylic acid increases its harmful effect on the bone marrow;
• Non-steroidal anti-inflammatory drugs (e.g., ibuprofen), as there is an increased risk of gastrointestinal side effects;
• Systemic glucocorticosteroids (except for hydrocortisone used as replacement therapy in Addison's disease), as they increase the risk of gastric ulcer and gastrointestinal bleeding, and reduce salicylate levels in the blood during treatment, and after its completion, increase the risk of salicylate overdose;
• Antidiabetic medications, as acetylsalicylic acid increases the hypoglycemic effect (reducing blood glucose levels) of these medicines;
• Medications increasing uric acid excretion (e.g., probenecid, sulfinpyrazone), as salicylates weaken the effect of these medicines. Acetylsalicylic acid should not be used concurrently with these medicines;
• Antacids, as they can increase the pH of gastric juice and damage the tablet coating;
• Digoxin, as acetylsalicylic acid may increase its effect;
• Selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine), as the risk of bleeding from the upper gastrointestinal tract increases;
• Ibuprofen, as it may inhibit the effect of acetylsalicylic acid taken in low doses on platelet aggregation;
• Thrombolytic medications (e.g., streptokinase and alteplase), as acetylsalicylic acid may increase their effect.

Omeprazole and ascorbic acid (vitamin C) do not affect the absorption of acetylsalicylic acid.

Etopiryna PRO with food, drinks, and alcohol

Tablets should be taken with a large amount of liquid.
During treatment with acetylsalicylic acid, the patient should not drink alcohol, due to the increased risk of gastric mucosa damage.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Etopiryna PRO should not be taken during the first 6 months of pregnancy, unless it is absolutely necessary and prescribed by a doctor, and its use is contraindicated in the last 3 months of pregnancy.
Pregnancy
If the patient continues or starts treatment with Etopiryna PRO during pregnancy according to the doctor's recommendations, they should take Etopiryna PRO as directed and not take a higher dose than recommended.
Pregnancy - last trimester
Acetylsalicylic acid should not be taken in doses higher than 100 mg per day in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Etopiryna PRO may cause kidney and heart disorders in the unborn child. This may affect the patient's and their child's tendency to bleed and cause delayed or prolonged labor.
If the patient takes acetylsalicylic acid in low doses (up to 100 mg per day), close obstetric monitoring is necessary according to the doctor's recommendations.
Pregnancy - first and second trimester
Etopiryna PRO should not be taken during the first 6 months of pregnancy, unless it is absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose of the medicine should be used for the shortest possible time. Etopiryna PRO taken for a period longer than a few days, starting from the 20th week of pregnancy, may cause kidney disorders in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct in the child's heart. If longer treatment is necessary, the doctor may recommend additional monitoring.
Breastfeeding
Using the medicine during breastfeeding is contraindicated.
Fertility
This medicine belongs to a group of medicines that may adversely affect female fertility. This effect is temporary and disappears after the end of treatment.

Driving and using machines

The medicine does not affect psychophysical abilities.

Etopiryna PRO contains crosposphorone, lake (E 124), and sodium

The medicine may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Etopiryna PRO

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
The medicine should be taken during or after a meal. Tablets should be swallowed whole, with a large amount of liquid.
For analgesic and antipyretic purposes, the following are usually taken:
Adults: 500 mg to 1000 mg (1 to 2 tablets) at a time. If necessary, the dose can be repeated 2 or 3 times a day.
No more than 3000 mg should be taken per day.
Adolescents over 16 years of age, only on a doctor's prescription: 500 mg to 1000 mg (1 to 2 tablets) per day.
The smallest effective doses should be used.
Symptomatic treatment without medical advice should not be used for more than 3 days.
In rheumatic diseases, only on a doctor's prescription, the following are usually taken:
in rheumatic fever: 1000 mg (2 tablets) 4 times a day;
in rheumatoid arthritis: 500 mg (1 tablet) 3 or 4 times a day.

Using the medicine in patients with liver and/or kidney function disorders

In patients with liver and/or kidney function disorders, there is a risk of increased side effects of the medicine, so dose adjustment may be necessary depending on the severity of liver and/or kidney failure.
The medicine is contraindicated in cases of severe liver and/or kidney failure.

Using the medicine in elderly patients

In elderly patients (over 65 years of age), the medicine should be taken in smaller doses and at longer intervals, due to the increased risk of side effects.

Taking a higher dose of Etopiryna PRO than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
After an overdose of acetylsalicylic acid, the following may occur: nausea, vomiting, rapid breathing, tinnitus.
Other symptoms have also been observed, such as: hearing loss, vision disturbances, headaches, restlessness, drowsiness, and coma, seizures, hyperthermia (body temperature above normal values). In severe poisonings, there are disorders of acid-base and water-electrolyte balance (metabolic acidosis and dehydration).
Mild or moderate toxicity symptoms occur after taking acetylsalicylic acid in doses of 150-300 mg/kg body weight. Severe poisoning symptoms occur after taking doses of 300-500 mg/kg body weight. A potentially fatal dose of acetylsalicylic acid is higher than 500 mg/kg body weight.
Death from acetylsalicylic acid poisoning has been observed after taking a single dose of 10-30 g by adults.

Treating an overdose

The patient should be taken to the hospital emergency department. There is no specific antidote.
Procedure in case of acetylsalicylic acid poisoning:

• Induce vomiting and rinse the stomach (to reduce drug absorption).
• This procedure is effective within 3-4 hours after taking the medicine, and in case of poisoning with a very large dose of the medicine, even up to 10 hours;
• Administer activated charcoal in the form of a water suspension (in a dose of 50-100 g in adults and 30-60 g in children) to reduce acetylsalicylic acid absorption;
• In case of hyperthermia, lower the body temperature by maintaining a low ambient temperature and using cool compresses;
• Continuously monitor water-electrolyte balance and correct disorders;
• To accelerate the excretion of acetylsalicylic acid by the kidneys and to treat acidosis, administer sodium bicarbonate intravenously;
• In patients with normal kidney function, alkaline diuresis can be used until the urine pH is between 7.5 and 8. In severe poisonings, hemodialysis or peritoneal dialysis can be used. Dialysis effectively removes acetylsalicylic acid from the body and helps to correct acid-base and water-electrolyte balance disorders;
• In cases of prolonged prothrombin time, administer vitamin K;
• Do not use medications that depress the central nervous system, such as barbiturates, due to the risk of respiratory depression;
• Patients with respiratory disorders should be given oxygen. If necessary, perform endotracheal intubation and use substitute breathing;
• In case of shock, use standard anti-shock treatment;
• Fluids should be supplemented, and general symptomatic treatment should be provided.

Missing a dose of Etopiryna PRO

In case of missing a dose, the patient should take the next dose at the scheduled time. They should not take a double dose to make up for the missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After taking acetylsalicylic acid, the following side effects may occur with unknown frequency (frequency cannot be estimated from available data).

Blood and lymphatic system disorders

Decreased platelet count, anemia due to microbleeding from the gastrointestinal tract, hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), decreased white blood cell count, neutrophils, eosinophils, increased risk of bleeding, prolonged bleeding time, prolonged blood coagulation time, iron deficiency anemia with laboratory and clinical symptoms, hemolysis (red blood cell breakdown).

Immune system disorders

Hypersensitivity, drug hypersensitivity, bronchospasm, allergic edema, and angioedema, anaphylactic reactions, anaphylactic shock with demonstrated laboratory tests and clinical symptoms.

Nervous system disorders

Tinnitus (usually as a symptom of overdose), hearing disorders, dizziness, cerebral and intracranial bleeding.
Long-term use of acetylsalicylic acid may cause headaches that can worsen after taking subsequent doses.

Cardiac disorders

Heart failure.

Vascular disorders

Hypertension, bleeding, surgical bleeding, hematomas, muscle bleeding.

Respiratory, thoracic, and mediastinal disorders

Nasal bleeding, analgesic asthma, nasal mucosal inflammation, nasal congestion.

Gastrointestinal disorders

Indigestion, heartburn, feeling of fullness in the upper abdomen, nausea, vomiting, loss of appetite, abdominal pain, gastrointestinal bleeding, gastric mucosa damage, exacerbation of ulcer disease, perforations, gum bleeding, gastrointestinal inflammation.
Gastric ulcer occurs in 15% of patients taking acetylsalicylic acid long-term.

Hepatobiliary disorders

Focal liver cell necrosis, liver tenderness, and enlargement, especially in patients with juvenile rheumatoid arthritis, systemic lupus erythematosus, rheumatic fever, or a history of liver disease, transient increase in serum aminotransferase activity, alkaline phosphatase, and bilirubin levels.

Skin and subcutaneous tissue disorders

Rash, urticaria, itching.

Renal and urinary disorders

Proteinuria, leukocyturia, erythrocyturia, renal papillary necrosis, interstitial nephritis, urinary tract bleeding, renal dysfunction, acute kidney failure.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Etopiryna PRO

The medicine should be stored out of sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Etopiryna PRO contains

• The active substance of the medicine is acetylsalicylic acid. Each enteric-coated tablet contains 500 mg of acetylsalicylic acid.
• Other ingredients are: corn starch; modified corn starch; hypromellose; methacrylic acid copolymer; talc; titanium dioxide (E 171); triethyl citrate; crosposphorone, lake (E 124); anhydrous colloidal silica; sodium bicarbonate; sodium lauryl sulfate.

What Etopiryna PRO looks like and contents of the pack

Pink, round, biconvex tablets.
The packaging contains 6, 10, 12, or 20 enteric-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. 22 364 61 01

Date of last revision of the leaflet: