Etopirina Kontrol

Leaflet attached to the packaging: patient information

ETOPIRYNA KONTROL, 300 mg + 50 mg, tablets

Acetylsalicylic acid + 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 or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Etopiryna Kontrol is a combination medicine that combines the analgesic, anti-inflammatory, and antipyretic effects of acetylsalicylic acid and caffeine, which enhances the analgesic effect of acetylsalicylic acid.
The medicine is recommended for use in the following indications:

• mild or moderate pain, e.g., headache, muscle and joint pain, and others.
• fever in the course of a cold, viral infections, and other diseases.

2. Important information before taking Etopiryna Kontrol

When not to take Etopiryna Kontrol:

• if the patient is hypersensitive to acetylsalicylic acid, caffeine, or any of the other ingredients of this 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. Symptoms of hypersensitivity (urticaria, even anaphylaxis) may occur within 3 hours of taking acetylsalicylic acid;
• if the patient is hypersensitive to other non-steroidal anti-inflammatory drugs, with symptoms such as bronchospasm, allergic rhinitis, anaphylaxis;
• if the patient has asthma, chronic respiratory diseases, hay fever, or nasal mucosa edema, as patients with these diseases may react to non-steroidal anti-inflammatory drugs with asthma attacks, limited skin and mucous membrane edema (angioedema), or urticaria more frequently than other patients;
• if the patient has active gastric or duodenal ulcer disease and gastrointestinal bleeding (may lead to gastrointestinal bleeding or exacerbation of ulcer disease);
• if the patient has severe liver, kidney, or heart failure, severe kidney damage;
• if the patient has blood coagulation disorders (e.g., hemophilia, thrombocytopenia) and is being treated with anticoagulant medications (e.g., coumarin derivatives, heparin);

if the patient has a glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease);

• if the patient has been diagnosed with gout or has had it in the past;
• if the patient is taking methotrexate at doses of 15 mg per week or higher (see "Etopiryna Kontrol and other medicines");
• in children and adolescents under 16 years of age, unless a doctor recommends otherwise;
• during the last trimester of pregnancy and during breastfeeding.

Warnings and precautions

Before starting treatment with Etopiryna Kontrol, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when taking Etopiryna Kontrol:

• in patients with kidney function disorders and chronic kidney failure;
• if the patient is taking oral antidiabetic drugs from the sulfonylurea group, methotrexate at doses less than 15 mg per week, or anti-gout drugs (see "Etopiryna Kontrol and other medicines");
• in patients with juvenile rheumatoid arthritis and systemic lupus erythematosus, as well as liver failure, as the toxicity of salicylates increases; in these patients, liver function should be monitored;
• in cases of menstrual bleeding, excessive menstrual bleeding, use of an intrauterine contraceptive device, hypertension, heart failure;
• in patients with hypoprothrombinemia (blood coagulation factor deficiency), vitamin K deficiency, thrombocytopenia (reduced platelet count), and those treated with anticoagulant medications;
• before planned surgery. Due to the risk of prolonged bleeding time, both during and after surgery, the medicine should be discontinued 5 to 7 days before the planned surgery;
• in elderly patients, as they may more frequently experience gastric mucosa irritation and gastrointestinal bleeding, and may also have changes in drug metabolism.
• in patients who are psychomotorically excited or suffer from insomnia.

Taking the medicine in the smallest effective dose for the shortest necessary period reduces the risk of side effects.
Long-term use of the medicine may be harmful and should be under medical supervision.
During long-term treatment with high doses of acetylsalicylic acid, iron deficiency anemia or kidney damage may occur; therefore, kidney function and hematocrit should be periodically monitored.
In the course of certain viral diseases, especially in the case of influenza A or B virus infection or chickenpox, mainly in children and adolescents, there is a risk of developing Reye's syndrome - a rare but life-threatening disease. Persistent vomiting during infection may indicate the onset of Reye's syndrome, which requires immediate medical attention.
The risk of developing Reye's syndrome during viral infections may increase if acetylsalicylic acid is administered simultaneously, although a causal relationship has not been proven.
Therefore, in children and adolescents under 16 years of age, products containing acetylsalicylic acid should not be used (unless a doctor recommends otherwise).
Products containing acetylsalicylic acid should not be used in women during the first and second trimesters of pregnancy, unless absolutely necessary (see below).
The medicine may cause fertility disorders in women (see below).
During treatment with this medicine, excessive caffeine consumption (e.g., coffee, tea, and canned drinks) should be avoided.

Etopiryna Kontrol 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.
Caution should be exercised when taking Etopiryna Kontrol 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 toxicity of acetazolamide;
• anticoagulant medications (heparin and warfarin), as there is an increased risk of bleeding;
• valproic acid, as acetylsalicylic acid enhances the toxic effect of valproic acid, and valproic acid enhances the anti-aggregatory effect of acetylsalicylic acid;
• beta-adrenolytics, as acetylsalicylic acid may reduce the blood pressure-lowering effect of these medicines;
• diuretics, as acetylsalicylic acid may reduce the effectiveness of these medicines and increase the ototoxicity of furosemide;
• methotrexate at doses less than 15 mg per week (use with methotrexate at doses greater than 15 mg per week is contraindicated), 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 gastrointestinal side effects;
• systemic glucocorticosteroids (except for hydrocortisone used as replacement therapy in Addison's disease), as they increase the risk of gastric ulcer disease and gastrointestinal bleeding, and reduce the salicylate concentration in serum during treatment, and increase the risk of salicylate overdose after treatment;
• antidiabetic drugs, as acetylsalicylic acid enhances the hypoglycemic effect of these drugs;
• medicines that increase uric acid excretion (e.g., probenecid, sulfinpyrazone), as salicylates weaken the effect of these medicines. Salicylates should not be used simultaneously with these medicines;
• digoxin, as acetylsalicylic acid may enhance its effect;
• thrombolytic drugs (e.g., streptokinase and alteplase), as acetylsalicylic acid may enhance their effect;
• selective serotonin reuptake inhibitors (SSRIs) - due to the increased risk of gastrointestinal bleeding;
• ibuprofen, as it may inhibit the effect of acetylsalicylic acid taken in small doses on platelet aggregation;
• oral contraceptives, cimetidine, and disulfiram, as they slow down caffeine metabolism;
• barbiturates, as they accelerate caffeine metabolism;
• stimulants and ergotamine, as the medicine may enhance their effect.

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

Etopiryna Kontrol with food, drink, and alcohol

The medicine should be taken during a meal, drinking plenty of water.
During treatment, alcohol should not be consumed, due to the increased risk of gastric mucosa damage.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The medicine is contraindicated in the last trimester of pregnancy.
If the patient continues or starts treatment with Etopiryna Kontrol during pregnancy according to the doctor's recommendations, they should take the medicine as recommended and not exceed the recommended dose.
Pregnancy - last trimester
Acetylsalicylic acid should not be used in a dose greater than 100 mg per day in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Taking Etopiryna Kontrol 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 recommendations.
Pregnancy - first and second trimester
Due to the content of acetylsalicylic acid, the medicine should not be taken during the first 6 months of pregnancy, unless absolutely necessary and recommended 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. 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 amniotic fluid levels or narrowing of the arterial duct 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 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

There is no data on the effect of the medicine on psychophysical abilities.

3. How to take Etopiryna Kontrol

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.
In adults and adolescents over 16 years of age: 1 to 2 tablets, if necessary, the single dose can be repeated 3 times a day, but not more often than every 4 hours.
The smallest effective dose of the medicine should be used.
No more than 6 tablets should be taken per day.
In elderly patients, the intervals between consecutive doses of acetylsalicylic acid should be increased (see "Warnings and precautions" in section 2).
Children and adolescents under 16 years of age
The medicine should not be used in children and adolescents under 16 years of age, unless a doctor recommends otherwise.
Method of administration
The medicine should be taken orally, preferably during a meal, drinking plenty of water.
The medicine should not be used for more than 3 days without consulting a doctor.

Using a higher than recommended dose of Etopiryna Kontrol

Symptoms of acetylsalicylic acid overdose:
The first symptoms of acetylsalicylic acid poisoning are nausea, vomiting, tinnitus, and rapid breathing.
Other symptoms, such as hearing loss, vision disorders, headaches, psychomotor agitation, drowsiness, and coma, seizures, hyperthermia, have also been observed. In severe poisonings, serious acid-base and water-electrolyte disorders (metabolic acidosis and dehydration) occur.
Mild or moderate toxic symptoms occur after taking acetylsalicylic acid in a dose of 150-300 mg/kg body weight. Severe symptoms of poisoning occur after a dose of 300-500 mg/kg body weight.
A potentially fatal dose of acetylsalicylic acid is greater than 500 mg/kg body weight.
Death due to acetylsalicylic acid poisoning has been observed after taking a single dose of 10-30 g by adults. A case of a patient who survived after taking 130 g of acetylsalicylic acid has also been reported.
Symptoms of caffeine overdose:
In case of caffeine overdose, the following symptoms are observed: insomnia, fatigue, muscle tremors, hallucinations, tachycardia, extra beats, seizures.
In case of taking a higher than recommended dose of the medicine, the patient should immediately contact their doctor or pharmacist.
Vomiting can be induced to reduce the 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. Activated charcoal can be administered 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 environmental temperature and using cool compresses. Patients with respiratory disorders should be provided with fresh air.

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:
Blood and lymphatic system disorders
Thrombocytopenia, anemia due to microbleeding from the gastrointestinal tract, hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency, leukopenia, agranulocytosis, eosinophilia, increased risk of bleeding, prolonged bleeding time, prolonged prothrombin time, iron deficiency anemia confirmed by laboratory tests and clinical symptoms, hemolysis.
Immune system disorders
Hypersensitivity reactions (rash, urticaria, itching), allergic edema, and angioedema, bronchospasm, anaphylactic reactions, anaphylactic shock confirmed by laboratory tests and clinical symptoms.
Hypersensitivity to acetylsalicylic acid occurs in 0.3% of the population and in 20% of patients with asthma or chronic urticaria. Symptoms of hypersensitivity (urticaria, even anaphylaxis) may occur within 3 hours of taking the medicine.
Nervous system disorders
Cerebral and intracranial hemorrhage, dizziness.
Long-term use of medicines containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Eye disorders
Visual disturbances.
Ear and labyrinth disorders
Tinnitus, reversible hearing loss.
Tinnitus and ringing in the ears are the first symptoms of salicylate poisoning.
Cardiac disorders
Heart failure, edema, cardiopulmonary failure.
Vascular disorders
Hypertension, bleeding, perioperative bleeding, hematomas, muscle bleeding.
Respiratory, thoracic, and mediastinal disorders
Non-cardiogenic pulmonary edema (mainly in chronic or acute poisoning).
nosebleeds, aspirin-induced asthma, rhinitis, nasal mucosa congestion.
Gastrointestinal disorders
Nausea, heartburn, feeling of fullness in the upper abdomen, nausea, vomiting, loss of appetite, abdominal pain, gastrointestinal bleeding, gastric mucosa damage, exacerbation of ulcer disease, perforation, 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 liver disease in their medical history, transient increase in serum aminotransferase activity, alkaline phosphatase, and bilirubin concentration.
Skin and subcutaneous tissue disorders
Various skin rashes, rarely blisters or purpura.
Renal and urinary disorders
Proteinuria, presence of leukocytes and erythrocytes in urine, nephropathy with renal papillary necrosis, interstitial nephritis, urinary tract bleeding, kidney function disorders, acute kidney failure.
In case of overdose: significant decrease in creatinine clearance or acute renal tubular necrosis with kidney function disorders.
General disorders and administration site conditions
Fever.
Side effects caused by caffeine may include:
Headache, insomnia, inability to concentrate, hand tremors, gastrointestinal disorders (diarrhea, nausea, vomiting).
Caffeine may cause dependence.

Reporting side effects

If any 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 Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Etopiryna Kontrol

The medicine should be stored out of sight and reach of children.
Do not store above 25°C. Store in the original packaging.
Do not use the medicine after the expiration date stated on the packaging.
The expiration date refers to the last day of the specified 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 does Etopiryna Kontrol contain

• The active substances of the medicine are acetylsalicylic acid and caffeine. Each tablet contains 300 mg of acetylsalicylic acid and 50 mg of caffeine.
• The other ingredients of the medicine are cornstarch and microcrystalline cellulose.

What Etopiryna Kontrol looks like and what the packaging contains

Etopiryna Kontrol is a white, round, biconvex tablet, 11 mm in diameter.
The packaging contains 10 tablets.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of the last update of the leaflet: