Etopirina

Leaflet attached to the packaging: patient information

ETOPIRINA

(300 mg + 100 mg + 50 mg), tablets
Acetylsalicylic acid + Ethenzamide + Caffeine

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.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• 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 a few days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Etopirina and what is it used for

Etopirina is a medicine used to treat headaches and moderate pain, especially of inflammatory origin.

2. Important information before taking Etopirina

When not to take Etopirina

• if the patient is allergic to acetylsalicylic acid, ethenzamide, caffeine, or any other component of the medicine (listed in section 6). Hypersensitivity to acetylsalicylic acid occurs in 0.3% of the population, including 20% of patients with asthma or chronic urticaria. Hypersensitivity symptoms (urticaria, even anaphylaxis) may occur within 3 hours of taking acetylsalicylic acid;
• if the patient is allergic to other non-steroidal anti-inflammatory drugs, with symptoms such as bronchospasm, nasal mucosa inflammation, anaphylaxis;
• if the patient has asthma, chronic respiratory diseases, hay fever, or nasal mucosa edema, as these patients may react to non-steroidal anti-inflammatory drugs with asthma attacks, skin and mucous membrane edema (angioedema), or urticaria more frequently than other patients;
• if the patient has active gastric or duodenal ulcers, as well as inflammatory or bleeding conditions of the gastrointestinal tract (gastrointestinal bleeding or ulcer exacerbation may occur);
• if the patient has severe liver, kidney, or heart failure;
• if the patient has blood coagulation disorders (e.g., hemophilia, thrombocytopenia) or is being treated with anticoagulant agents (e.g., coumarin derivatives, heparin);
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (a rare hereditary disease);
• if the patient is taking methotrexate in doses of 15 mg per week or higher, due to the harmful effect on the bone marrow;
• in children and adolescents under 16 years of age, especially during viral infections, due to the risk of Reye's syndrome, a rare but severe disease that causes liver and brain damage;
• during the last trimester of pregnancy and during breastfeeding.

Warnings and precautions

Before starting to take Etopirina, the patient should discuss it with their doctor in the following situations:

• if the patient is taking oral antidiabetic drugs from the sulfonylurea group, due to the risk of enhanced hypoglycemic effect (reduced blood glucose levels), or if the patient is taking anti-gout drugs;
• in patients with renal function disorders and chronic renal failure;
• in patients with juvenile rheumatoid arthritis and systemic lupus erythematosus, as well as liver failure, as the toxicity of salicylates increases in these patients, and liver function should be monitored;
• in cases of menstrual bleeding, excessive menstrual bleeding, use of an intrauterine contraceptive device, hypertension, heart failure;
• in patients who are psychomotorically excited and suffer from insomnia;
• when 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;
• 5 to 7 days before a planned surgical procedure, the medicine should be discontinued, due to the risk of prolonged bleeding during and after the procedure.

Etopirina 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 that should not be taken with Etopirina include:
• anticoagulant agents (heparin, coumarin derivatives);
• methotrexate in doses of 15 mg per week or higher.

Caution should be exercised when taking Etopirina with:

• angiotensin-converting enzyme inhibitors (e.g., enalapril, captopril), as Etopirina may reduce the antihypertensive effect of these medicines;
• acetazolamide, as Etopirina may increase the toxicity of acetazolamide;
• valproic acid, as acetylsalicylic acid enhances the toxic effect of valproic acid, and valproic acid enhances the anti-aggregatory effect (preventing platelet aggregation) of acetylsalicylic acid;
• diuretics, as Etopirina 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 enhances its toxic effect on the bone marrow;
• non-steroidal anti-inflammatory drugs (e.g., ibuprofen), as there is an increased risk of adverse effects on the gastrointestinal tract;
• 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 the salicylate levels in the blood during treatment, and increase the risk of salicylate overdose after treatment;
• antidiabetic drugs, as Etopirina may enhance the hypoglycemic effect (reduced blood glucose levels) of these medicines;
• medicines that increase uric acid excretion (e.g., probenecid, sulfinpyrazone), as salicylates reduce the effect of these medicines. Acetylsalicylic acid should not be taken with these medicines;

Acetylsalicylic acid should not be taken with:

• digoxin, as Etopirina may enhance its effect;
• thrombolytic agents (dissolving blood clots), such as streptokinase and alteplase, as Etopirina may enhance their effect;
• barbiturates (e.g., phenobarbital);
• oral contraceptives;
• cimetidine and disulfiram;
• ergotamine and analeptics (e.g., nikethamide), as Etopirina may enhance their effect;
• omeprazole and ascorbic acid (vitamin C) do not affect the absorption of acetylsalicylic acid.

Taking Etopirina with food, drink, and alcohol

The medicine should be taken after a meal, with a large amount of water.

During treatment, alcohol should not be consumed, due to the increased risk of gastrointestinal mucosa damage.

Taking Etopirina in patients with liver and kidney function disorders

In patients with liver and kidney function disorders, there is a risk of increased adverse effects of the medicine, so dose adjustment may be necessary depending on the severity of liver and kidney failure.

The medicine is contraindicated in cases of severe liver and kidney failure.

Taking Etopirina in elderly patients

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

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.

Pregnancy

The medicine may be taken during the first and second trimesters of pregnancy only if the doctor considers it absolutely necessary.

The medicine is contraindicated during the last trimester of pregnancy.

If the patient continues or starts treatment with Etopirina during pregnancy according to the doctor's instructions, they should take the medicine as directed and not exceed the recommended dose.

Pregnancy - last trimester

Acetylsalicylic acid should not be taken in doses higher than 100 mg per day during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Taking Etopirina 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 small doses (up to 100 mg per day), close obstetric monitoring is necessary according to the doctor's instructions.

Pregnancy - first and second trimesters

Due to the content of acetylsalicylic acid, the medicine should not be taken during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by the doctor. If treatment is necessary during this period or during attempts to conceive, the smallest effective dose of the medicine should be taken for the shortest possible time. Taking acetylsalicylic acid 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 levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If longer treatment is necessary, the doctor may recommend additional monitoring.

Breastfeeding

The medicine is contraindicated during breastfeeding.

Fertility

This medicine belongs to the group of non-steroidal anti-inflammatory drugs, which may have a negative effect on fertility in women. This effect is temporary and disappears after the end of treatment.

Driving and operating machines

The medicine does not affect psychophysical abilities and does not affect the ability to drive vehicles and operate machines.

Etopirina contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Etopirina

This medicine should always be taken exactly as described in the 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 orally, preferably after a meal, with a large amount of water.

The patient should take the smallest effective dose for the shortest possible time to reduce the risk of adverse effects.

The medicine should not be taken for longer than a few days.

Usually, the following dosing is recommended:

Taking Etopirina in adults and adolescents over 16 years

1 to 2 tablets at a time or as needed, every 8 hours.

Do not take more than 6 tablets per day.

Taking Etopirina in children and adolescents under 16 years

The medicine is contraindicated in children and adolescents under 16 years (see section "When not to take Etopirina").

Taking a higher dose of Etopirina than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor, and in case of severe poisoning, the patient should be taken to the hospital immediately.

Overdose in elderly patients and small children (taking higher doses than recommended or accidental poisoning) requires special attention, as it may lead to death in these patient groups.

After an overdose of acetylsalicylic acid, the following symptoms may occur: nausea, vomiting, rapid breathing, tinnitus.

Other symptoms, such as hearing loss, vision disorders, headaches, psychomotor agitation, drowsiness, and coma, seizures, hyperthermia (body temperature above normal values), have also been observed.

In severe poisonings, there are disorders of acid-base balance and water-electrolyte balance (metabolic acidosis and dehydration).

Symptoms of caffeine overdose are: insomnia, fatigue, muscle tremors, hallucinations, tachycardia (rapid heart rate), extra beats, seizures.

Mild or moderate toxicity occurs after taking acetylsalicylic acid in doses of 150-300 mg/kg body weight (bw). Severe poisoning occurs after taking doses of 300-500 mg/kg bw. A potentially fatal dose of acetylsalicylic acid is higher than 500 mg/kg bw.

Treatment of overdose:

There is no specific antidote for acetylsalicylic acid. The patient should be taken to the hospital.

Procedure in case of poisoning

• Induce vomiting and rinse the stomach (to reduce absorption of the medicine). 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 the absorption of acetylsalicylic acid.
• In case of hyperthermia, the body temperature should be lowered by maintaining a low ambient temperature and using cold compresses.

In severe poisonings, forced alkaline diuresis (increased urine excretion under the influence of appropriate medicines), peritoneal dialysis, or hemodialysis may be necessary.

Missing a dose of Etopirina

In case of missing a dose, the patient should take the next dose at the scheduled time. A double dose should not be taken to make up for the missed dose.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Etopirina can cause side effects, although not everybody gets them.

Blood and lymphatic system disorders

thrombocytopenia (reduced platelet count), anemia due to microbleeding from the gastrointestinal tract, hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency, leukopenia (reduced white blood cell count), agranulocytosis (absence of granulocytes), eosinopenia (reduced eosinophil count), increased risk of bleeding, prolonged bleeding time, and (or) prolonged prothrombin time.

Immune system disorders

hypersensitivity reactions: rash, urticaria, angioedema (swelling of the face, tongue, and trachea, causing breathing difficulties), bronchospasm. If these occur, the patient should immediately inform their doctor.

Nervous system disorders

tinnitus (usually as a symptom of overdose), hearing disorders, dizziness.

Cardiac disorders

heart failure.

Vascular disorders

hypertension.

Gastrointestinal disorders

dyspepsia, heartburn, feeling of fullness in the upper abdomen, nausea, vomiting, loss of appetite, abdominal pain, gastrointestinal bleeding, gastric mucosa damage, ulcer exacerbation, perforations.

Gastric ulcer occurs in 15% of patients taking acetylsalicylic acid for a long time.

Hepatobiliary disorders

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

Renal and urinary disorders

proteinuria, presence of leukocytes and erythrocytes in the urine, renal papillary necrosis, interstitial nephritis.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 to gather more information on the safety of the medicine.

5. How to store Etopirina

Do not store above 25°C. Store in the original packaging to protect from light and moisture.

The medicine should be stored out of 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 month.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Etopirina contains

• The active substances of the medicine are acetylsalicylic acid, ethenzamide, and caffeine. Each tablet contains 300 mg of acetylsalicylic acid, 100 mg of ethenzamide, and 50 mg of caffeine.
• Other ingredients are: potato starch and lactose monohydrate.

What Etopirina looks like and what the packaging contains

White, oblong, biconvex tablets.

The packaging contains 2, 6, 10, 30, or 50 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

Zakłady Farmaceutyczne POLPHARMA S.A.

Production Plant in Nowa Dęba

ul. Metalowca 2, 39-460 Nowa Dęba

Date of last update of the leaflet: