Etopiryna pro

Package leaflet: information for the patient

Etopiryna PRO, 500 mg, enteric-coated tablets
Acidum acetylsalicylicum
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, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3 days, consult your doctor.

Table of contents

1. What Etopiryna PRO is and what it is 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 pack and other information

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

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

• Mild to moderate pain of various origins, including: headache, toothache, muscle pain, joint pain;
• Symptoms associated with cold and flu accompanied by fever;
• Conditions requiring long-term, high-dose acetylsalicylic acid therapy, such as rheumatoid arthritis (only on prescription).

2. Important information before using Etopiryna PRO

When not to use Etopiryna PRO:

• if the patient is allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6); allergy to acetylsalicylic acid occurs in 0.3% of the population, including 20% of patients with bronchial asthma or chronic urticaria. Symptoms of hypersensitivity (urticaria, or even shock) may occur within 3 hours after taking acetylsalicylic acid;

• if the patient is allergic to other non-steroidal anti-inflammatory drugs (NSAIDs), with symptoms such as bronchospasm, rhinitis, or shock;

• if the patient has bronchial asthma, chronic respiratory diseases, hay fever, or nasal mucosal swelling, as patients with these conditions may react to non-steroidal anti-inflammatory drugs with asthma attacks, limited skin and mucosal swelling (angioedema), or urticaria more frequently than other patients;

• if the patient has active peptic ulcer disease of the stomach and/or duodenum, or inflammatory conditions or gastrointestinal bleeding (this may lead to gastrointestinal bleeding or activation of peptic ulcer disease);

• if the patient has severe liver, kidney, or heart failure;

• if the patient has blood clotting disorders (e.g. haemophilia, thrombocytopenia), or is being treated with anticoagulant drugs (e.g. coumarin derivatives, heparin);

• if the patient has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder);

• if the patient is simultaneously receiving methotrexate at doses of 15 mg per week or higher, due to harmful effects on bone marrow;

• in children and adolescents under 16 years of age;

• if the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions
Before starting treatment with Etopiryna PRO, consult a doctor or pharmacist if:

• the patient has impaired kidney function or chronic kidney failure;
• the patient has juvenile rheumatoid arthritis and/or systemic lupus erythematosus, or liver dysfunction, as this increases salicylate toxicity. In such patients, liver function should be monitored;
• the female patient has uterine bleeding, excessive menstrual bleeding, or uses an intrauterine contraceptive device;
• the patient has hypertension or heart failure;
• the patient is taking methotrexate at doses less than 15 mg per week, due to increased risk of methotrexate toxicity to bone marrow. Concurrent use with methotrexate at doses greater than 15 mg per week is contraindicated;
• the patient is taking oral antidiabetic sulfonylureas, due to the risk of enhanced hypoglycaemic effect (reducing blood glucose concentration), or if the patient is taking drugs for gout or has reduced uric acid excretion;
• the female patient is in the first or second trimester of pregnancy.

Serious allergic reactions, including chest pain and even myocardial infarction (Kounis syndrome), have occurred during treatment with acetylsalicylic acid (see section 4). Seek immediate medical attention if chest pain occurs along with allergic symptoms (such as skin rash, shortness of breath).
Etopiryna PRO should be discontinued 5 to 7 days before any planned surgical procedure due to the risk of prolonged bleeding time, both during and after surgery.
When acetylsalicylic acid is administered to children, there is a risk of Reye's syndrome.
Reye's syndrome is a very rare condition affecting the brain and liver, which may be fatal.
Taking the medicine at the lowest effective dose for the shortest necessary duration reduces the risk of adverse effects.
Long-term use of the medicine may be harmful and should therefore be under medical supervision.
Prolonged use of analgesics, especially those containing multiple active substances, may lead to severe kidney dysfunction and kidney failure.
Acetylsalicylic acid may impair fertility in women (see section: Pregnancy, breastfeeding and effects on fertility).

Etopiryna PRO and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Medicines contraindicated for concomitant use with acetylsalicylic acid:

• methotrexate at doses of 15 mg per week or higher, due to toxic effects on bone marrow.

Use Etopiryna PRO with caution together with:

• angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, captopril), as acetylsalicylic acid reduces the antihypertensive effect of these drugs;
• acetazolamide, as acetylsalicylic acid may increase the harmful effects of acetazolamide;
• anticoagulants (heparin and warfarin), as there is an increased risk of bleeding;
• valproic acid, as acetylsalicylic acid enhances the toxic effects of valproic acid, and valproic acid enhances the antiplatelet (preventing platelet aggregation) effect of acetylsalicylic acid;
• diuretics, as acetylsalicylic acid may reduce the effectiveness of these drugs and increase the ototoxicity (hearing-damaging effect) of furosemide;
• methotrexate at doses less than 15 mg per week, as acetylsalicylic acid intensifies its harmful effects on bone marrow;
• other non-steroidal anti-inflammatory drugs (e.g. ibuprofen), as there is an increased risk of gastrointestinal adverse effects;
• systemic glucocorticoids (except hydrocortisone used as replacement therapy in Addison's disease), as they increase the risk of peptic ulcer disease and gastrointestinal bleeding, reduce plasma salicylate concentrations during treatment, and increase the risk of salicylate overdose after treatment cessation;
• antidiabetic drugs, as acetylsalicylic acid enhances the hypoglycaemic effect (reducing blood glucose concentration) of these drugs;
• drugs increasing uric acid excretion (e.g. probenecid, sulfinpyrazone), as salicylates reduce the effectiveness of these drugs. Concomitant use of acetylsalicylic acid with these drugs is not recommended;
• drugs that neutralize gastric juice, as increasing gastric pH may damage the tablet coating;
• digoxin, as acetylsalicylic acid may enhance the effect of this drug;
• selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine, as the risk of upper gastrointestinal bleeding increases;
• ibuprofen, as it may inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation;
• thrombolytic drugs (clot-dissolving agents), such as streptokinase and alteplase, as acetylsalicylic acid may enhance the effect of these drugs.

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

Etopiryna PRO with food, drink and alcohol
Tablets should be taken with a large amount of liquid.
Alcohol should not be consumed during treatment with acetylsalicylic acid due to increased risk of gastrointestinal mucosal damage.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Etopiryna PRO should not be taken during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. Use during the last 3 months of pregnancy is contraindicated.

Pregnancy
If the patient continues or starts treatment with Etopiryna PRO during pregnancy as advised by a doctor, she should follow the doctor's instructions and not exceed the recommended dose.

Pregnancy – third trimester
Acetylsalicylic acid should not be used at doses exceeding 100 mg per day during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Etopiryna PRO may cause kidney and heart disorders in the unborn child. It may also affect bleeding tendency in both the mother and her child and may delay or prolong labour.
If the patient takes acetylsalicylic acid at low doses (up to 100 mg per day inclusive), strict obstetric monitoring according to the doctor's recommendations is required.

Pregnancy – first and second trimester
Etopiryna PRO should not be taken during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest effective dose for the shortest possible duration should be used. Use of Etopiryna PRO for longer than a few days starting from the 20th week of pregnancy may cause kidney dysfunction in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
Use of this medicine during breastfeeding is contraindicated.

Effect on fertility
This medicine belongs to a group of medicines that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
The medicine does not impair psychophysical performance.

Etopiryna PRO contains carmine red, lac (E 124) and sodium
The medicine may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Etopiryna PRO

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine should be taken orally, during or after a meal. Tablets should be swallowed whole with a large amount of fluid.

For pain relief and fever reduction, the usual dose is:
Adults: 1 to 2 tablets (corresponding to 500 mg to 1000 mg acetylsalicylic acid) as a single dose. If necessary, the dose may be repeated 2 or 3 times daily.
Do not take more than 5 tablets per day (corresponding to 3000 mg acetylsalicylic acid per day).

Adolescents over 16 years of age, only on medical advice: 1 to 2 tablets per day (corresponding to 500 mg to 1000 mg acetylsalicylic acid per day).

Use the lowest effective dose.
Self-medication for symptomatic treatment without medical advice should not last longer than 3 days.

In rheumatic diseases, only on medical advice, the following doses are usually used:
in rheumatic fever: 2 tablets (1000 mg acetylsalicylic acid) 4 times daily.
in rheumatoid arthritis: 1 tablet (500 mg acetylsalicylic acid) 3 or 4 times daily.

Use of Etopiryna PRO in patients with impaired liver and/or kidney function
In patients with impaired liver and/or kidney function, there is an increased risk of adverse effects; therefore, dose adjustment may be necessary depending on the severity of liver and/or kidney impairment.
This medicine is contraindicated in cases of severe liver and/or kidney failure.

Use of Etopiryna PRO in elderly patients
In elderly patients (over 65 years of age), the medicine should be used at lower doses and with longer intervals due to increased risk of adverse effects.

Taking more than the recommended dose of Etopiryna PRO
If more than the recommended dose has been taken, consult your doctor or pharmacist immediately.
After an overdose of acetylsalicylic acid, symptoms such as nausea, vomiting, rapid breathing, and tinnitus may occur.

Other symptoms observed include: hearing loss, visual disturbances, headache, restlessness, drowsiness and coma, convulsions, and hyperthermia (body temperature above normal). In severe poisoning, acid-base and water-electrolyte imbalances occur (metabolic acidosis and dehydration).

Mild to moderate toxicity symptoms occur after acetylsalicylic acid doses of 150–300 mg/kg body weight. Severe poisoning symptoms occur after ingestion of 300–500 mg/kg body weight. A potentially lethal dose of acetylsalicylic acid is greater than 500 mg/kg body weight.
Fatalities due to acetylsalicylic acid poisoning have been reported following a single oral dose of 10–30 g in adults.

Treatment of overdose
The patient should be taken immediately to a hospital emergency department. There is no specific antidote. Management of acetylsalicylic acid poisoning includes:

• Induce vomiting and perform gastric lavage (to reduce drug absorption). This procedure is effective within 3–4 hours after ingestion, and in cases of very large overdoses, it may be effective up to 10 hours;
• Administer activated charcoal as an aqueous suspension (50–100 g in adults and 30–60 g in children) to reduce absorption of acetylsalicylic acid;
• In case of hyperthermia, reduce body temperature by maintaining a low ambient temperature and applying cold compresses;
• Continuously monitor water-electrolyte balance and correct any disturbances;
• To accelerate renal excretion of acetylsalicylic acid and treat acidosis, administer intravenous sodium bicarbonate;
• In patients with normal kidney function, alkaline diuresis may be used until urine pH reaches 7.5–8. In severe poisoning, hemodialysis or peritoneal dialysis may be performed. Dialysis effectively removes acetylsalicylic acid from the body and helps correct acid-base and water-electrolyte imbalances;
• In cases of prolonged prothrombin time, administer vitamin K;
• Do not use drugs that depress the central nervous system, such as barbiturates, due to the risk of respiratory depression;
• Administer oxygen to patients with respiratory disturbances. If necessary, perform endotracheal intubation and apply artificial ventilation;
• In cases of shock, apply standard anti-shock measures;
• Replenish fluids and provide general symptomatic treatment.

Missed dose of Etopiryna PRO
If a dose is missed, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur after administration of acetylsalicylic acid,
with unknown frequency (frequency cannot be estimated from available data).
Blood and lymphatic system disorders
Reduced platelet count, anaemia due to gastrointestinal microbleeding,
haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase deficiency
(a rare inherited disease), reduced white blood cell count, neutrophils,
eosinophils, increased risk of bleeding, prolonged bleeding time, prolonged blood
clotting time, iron deficiency anaemia with laboratory and clinical manifestations,
haemolysis (breakdown of red blood cells).
Immune system disorders
Hypersensitivity, drug hypersensitivity, bronchospasm, allergic oedema and angioedema,
anaphylactic reactions, anaphylactic shock with confirmed laboratory findings
and clinical symptoms.
Nervous system disorders
Tinnitus (usually as a symptom of overdose), hearing disturbances, dizziness,
cerebral and intracranial haemorrhage.
Long-term use of medicines containing acetylsalicylic acid may cause headaches,
which may worsen after taking further doses.
Cardiac disorders
Heart failure, acute myocardial ischaemia (painful heart disease caused by
lack of blood supply to the heart), with or without myocardial infarction (heart attack),
occurring as part of an allergic reaction (Kounis syndrome).
Vascular disorders
Hypertension, haemorrhage, surgical bleeding, haematoma, muscular bleeding.
Respiratory, thoracic and mediastinal disorders
Epistaxis (nosebleeds), analgesic-induced asthma, nasal mucosal inflammation, nasal mucosal congestion.
Gastrointestinal disorders
Dyspepsia, heartburn, feeling of fullness in the epigastrium, nausea, vomiting, loss of appetite, abdominal pain, gastrointestinal bleeding, gastric mucosal damage, exacerbation of peptic ulcer disease, perforations, gingival bleeding, inflammatory conditions of the gastrointestinal tract.
Gastric ulceration occurs in 15% of patients on long-term acetylsalicylic acid therapy.
Hepatic and biliary disorders
Focal necrosis of liver cells, tenderness and enlargement of the liver, particularly
in patients with juvenile rheumatoid arthritis, systemic lupus erythematosus, rheumatic fever or history of liver disease, transient increases in serum aminotransferase activity, alkaline phosphatase and bilirubin concentration.
Skin and subcutaneous tissue disorders
Rash, urticaria, pruritus.
Renal and urinary disorders
Proteinuria, presence of leukocytes and erythrocytes in urine, renal papillary necrosis, interstitial nephritis, urogenital haemorrhage, renal dysfunction, acute renal failure.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Etopiryna PRO

Keep this medicine 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 stated month.
Medicines must 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 Etopiryna PRO contains

• The active substance is acetylsalicylic acid. Each enteric-coated tablet contains 500 mg of acetylsalicylic acid (Acidum acetylsalicylicum).
• The other ingredients are: maize starch; modified maize starch; hypromellose; methacrylic acid copolymer; talc; titanium dioxide (E 171); triethyl citrate; carmine red, lake (E 124); colloidal anhydrous silica; sodium hydrogen carbonate; sodium lauryl sulfate.

What Etopiryna PRO looks like and contents of the pack
Pink, round, biconvex enteric-coated tablets.
The pack contains 6, 10, 12 or 20 enteric-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01