Etopiryna kontrol

Patient Information Leaflet

ETOPIRYNA KONTROL, 300 mg + 50 mg, tablets
Acidum acetylsalicylicum + Coffeinum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact 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, consult your doctor.

Leaflet Contents

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

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

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

• Mild to moderate pain, e.g., headache, muscle and joint pain, and others.
• Fever associated with colds, viral infections, and other illnesses.

2. Important information before using Etopiryna Kontrol

When not to use Etopiryna Kontrol:

• if the patient is allergic 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 bronchial asthma or chronic urticaria. Symptoms of hypersensitivity (urticaria, and 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, allergic rhinitis, or shock;
• if the patient has bronchial asthma, chronic respiratory diseases, hay fever, or nasal mucosal edema, as patients with these conditions may react to non-steroidal anti-inflammatory drugs with asthma attacks, limited skin and mucosal edema (angioedema), or urticaria more frequently than other patients;
• if the patient has active gastric or duodenal ulcer disease and/or gastrointestinal inflammation or bleeding (gastrointestinal bleeding or exacerbation of ulcer disease may occur);
• if the patient has severe liver, kidney, or heart failure, or severe kidney damage;
• if the patient has blood clotting disorders (e.g. hemophilia, thrombocytopenia), or if the patient is being treated simultaneously with anticoagulants (e.g. coumarin derivatives, heparin);
• if the patient has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disease);
• if the patient has gout or a history of gout;
• if the patient is concurrently receiving methotrexate at doses of 15 mg weekly or higher (see "Etopiryna Kontrol and other medicines");
• in children and adolescents under 16 years of age, unless otherwise directed by a physician;
• during the third trimester of pregnancy and during breastfeeding.

Warnings and precautions
Before starting treatment with Etopiryna Kontrol, consult your doctor or pharmacist.
Exercise particular caution when using Etopiryna Kontrol:

• in patients with impaired kidney function or chronic renal failure;
• if the patient is taking oral antidiabetic sulfonylureas, methotrexate in doses less than 15 mg per week, or medications for gout (see "Etopiryna Kontrol and other medicines");
• in patients with juvenile rheumatoid arthritis and/or systemic lupus erythematosus, as well as in those with liver dysfunction, since the toxicity of salicylates increases; liver function should be monitored in these patients;
• in cases of uterine bleeding, excessive menstrual bleeding, use of intrauterine contraceptive devices, arterial hypertension, or heart failure;
• in patients with hypoprothrombinemia (deficiency of blood clotting factor), vitamin K deficiency, thrombocytopenia (reduced platelet count leading to increased risk of bleeding and bruising), or those treated with anticoagulant drugs;
• before planned surgical procedures. Due to the risk of prolonged bleeding time during and after surgery, the medicine should be discontinued 5 to 7 days before the scheduled surgical procedure;
• in elderly patients, as they may more frequently experience gastric mucosal irritation and gastrointestinal bleeding, and the metabolism of the drug may change rapidly;
• in patients with psychomotor agitation or insomnia.

Using the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.
Long-term use of the medicine may be harmful and should therefore be under medical supervision.
Prolonged treatment with high doses of acetylsalicylic acid may lead to iron-deficiency anemia or adverse effects on the kidneys; kidney function and hematocrit should be monitored periodically.
During certain viral infections, particularly influenza A, influenza B, or varicella (chickenpox), especially in children and adolescents, there is a risk of Reye's syndrome—a rare but life-threatening condition. Persistent vomiting during infection may indicate the onset of Reye's syndrome, requiring immediate medical attention.
The risk of Reye's syndrome during viral infections may increase if acetylsalicylic acid is administered concurrently, although a causal relationship has not been proven.
For these reasons, products containing acetylsalicylic acid should not be used in children and adolescents under 16 years of age (unless otherwise directed by a physician).
Products containing acetylsalicylic acid should not be used in women during the first and second trimesters of pregnancy unless absolutely necessary (see below).
This medicine may affect fertility in women (see below).
While taking this medicine, avoid excessive intake of caffeine (e.g. coffee, tea, and canned beverages).

Etopiryna Kontrol and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Exercise caution when using Etopiryna Kontrol with:

• angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, captopril), as acetylsalicylic acid reduces their antihypertensive effect;
• acetazolamide, as acetylsalicylic acid may increase acetazolamide toxicity;
• anticoagulants (heparin and warfarin), due to increased risk of bleeding;
• valproic acid, as acetylsalicylic acid enhances its toxic effects, and valproic acid enhances the antiplatelet (anti-aggregation) effect of acetylsalicylic acid;
• beta-blockers, as acetylsalicylic acid may reduce their blood pressure-lowering effect;
• diuretics, as acetylsalicylic acid may reduce their effectiveness and enhance the ototoxicity (ear-damaging effect) of furosemide;
• methotrexate in doses less than 15 mg per week (concomitant use with methotrexate at doses greater than 15 mg per week is contraindicated), as acetylsalicylic acid enhances its toxic effects on bone marrow;
• other non-steroidal anti-inflammatory drugs (e.g. ibuprofen), due to 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 their hypoglycemic (blood glucose-lowering) effect;
• uricosuric agents (e.g. probenecid, sulfinpyrazone), as salicylates reduce their effectiveness. Concomitant use of acetylsalicylic acid with these drugs is not recommended;
• digoxin, as acetylsalicylic acid may enhance its effects;
• thrombolytic agents (clot-dissolving drugs) such as streptokinase and alteplase, as acetylsalicylic acid may enhance their effects;
• selective serotonin reuptake inhibitors (SSRIs), due to increased risk of upper gastrointestinal bleeding resulting from synergistic effects;
• ibuprofen, as it may inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation;
• oral contraceptives, cimetidine, and disulfiram, as they slow down caffeine metabolism;
• barbiturates, as they accelerate caffeine metabolism;
• stimulant drugs and ergotamine, as the medicine may enhance their effects.

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

Etopiryna Kontrol with food, drink, and alcohol
Take the medicine during meals, drinking plenty of water.
Do not consume alcohol during treatment, due to increased risk of gastrointestinal mucosal damage.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The medicine is contraindicated during the third trimester of pregnancy.
If the patient continues or starts treatment with Etopiryna Kontrol during pregnancy as advised by a physician, she should follow the physician's instructions and not exceed the recommended dose.

Pregnancy – third trimester
Do not use acetylsalicylic acid in doses exceeding 100 mg per day during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Etopiryna Kontrol may lead to kidney and heart disorders in the unborn child. It may also affect the bleeding tendency in both the mother and the child and may delay or prolong labor.

If the patient takes acetylsalicylic acid in low doses (up to 100 mg daily), strict obstetric monitoring as advised by the physician is required.

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

Breastfeeding
The medicine is contraindicated during breastfeeding.

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
There is no data available on the effect of the medicine on psychomotor performance.

3. How to use Etopiryna Kontrol

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
For adults and adolescents over 16 years of age: 1 to 2 tablets; the single dose may be repeated up to 3 times daily, no more frequently than every 4 hours.
Use the lowest effective dose.
Do not exceed 6 tablets per day.
In elderly patients, increase the interval between doses of acetylsalicylic acid (see "Warnings and precautions" in section 2).
Children and adolescents under 16 years of age
Do not use in children and adolescents under 16 years of age unless otherwise advised by a doctor.
Method of administration
The medicine should be taken orally, preferably during a meal, with plenty of water.
Do not use this medicine for longer than 3 days without consulting a doctor.
Use of a higher than recommended dose of Etopiryna Kontrol
Symptoms of acetylsalicylic acid overdose:
The first signs of acetylsalicylic acid poisoning include nausea, vomiting, tinnitus (ringing in the ears), and rapid breathing.
Other symptoms observed include hearing loss, visual disturbances, headache, motor restlessness, drowsiness and coma, convulsions, and hyperthermia (elevated body temperature). In severe cases, serious acid-base and water-electrolyte imbalances occur (metabolic acidosis and dehydration).
Mild to moderate toxic symptoms occur after acetylsalicylic acid doses of 150–300 mg/kg body weight. Severe poisoning symptoms occur at doses of 300–500 mg/kg body weight.
A potentially lethal dose of acetylsalicylic acid is greater than 500 mg/kg body weight.
Death due to acetylsalicylic acid poisoning has been reported in adults after a single dose of 10 to 30 g. There has also been a reported case of survival after ingestion of 130 g of acetylsalicylic acid.
Symptoms of caffeine overdose:
In case of caffeine overdose, symptoms may include insomnia, fatigue, muscle tremors, delirium, tachycardia, extrasystoles, and convulsions.
If a higher than recommended dose of the medicine has been taken, contact a doctor or pharmacist immediately.
Induce vomiting to reduce drug absorption. This is effective within 3–4 hours after taking the medicine, and in cases of very large overdoses, may be effective up to 10 hours. Activated charcoal may be administered 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 cool environment and applying cold compresses. Patients with breathing difficulties should be provided with fresh air.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Following the use of acetylsalicylic acid, the following undesirable effects may occur:

Blood and lymphatic system disorders
Thrombocytopenia, anemia due to gastrointestinal microbleeding, hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency, leukopenia, agranulocytosis, eosinopenia, increased risk of bleeding, prolonged bleeding time, prolonged prothrombin time, iron deficiency anemia confirmed by laboratory findings and clinical symptoms, hemolysis.

Immune system disorders
Hypersensitivity reactions (rash, urticaria, itching), allergic edema and angioedema, bronchospasm, anaphylactic reactions, anaphylactic shock confirmed by laboratory findings and clinical symptoms.
Hypersensitivity to acetylsalicylic acid occurs in 0.3% of the population and in 20% of patients with bronchial asthma or chronic urticaria. Hypersensitivity symptoms (urticaria, and even shock) may occur within 3 hours after 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.
Ringing and buzzing in the ears are the first signs of salicylate poisoning.

Cardiac disorders
Heart failure, edema, cardiopulmonary insufficiency.

Vascular disorders
Hypertension, hemorrhages, perioperative bleeding, hematomas, intramuscular hemorrhages.

Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary edema (mainly occurring in chronic or acute poisoning), epistaxis, aspirin-induced asthma syndrome, nasal mucosal inflammation, nasal mucosal hyperemia.

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 taking acetylsalicylic acid long-term.

Hepatobiliary 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
Various types of skin rashes, rarely blisters or purpura.

Renal and urinary disorders
Proteinuria, presence of leukocytes and erythrocytes in urine, nephropathy with necrosis of renal papillae, interstitial nephritis, hemorrhages from the genitourinary system, impaired kidney function, acute renal failure.
In case of overdose: significant reduction in creatinine clearance or acute tubular necrosis with impaired kidney function.

General disorders and administration site conditions
Fever.

Adverse reactions caused by caffeine may include:
Headache, insomnia, difficulty concentrating, hand tremors, gastrointestinal disorders (diarrhea, nausea, vomiting).
Caffeine may cause dependence.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Etopiryna Kontrol

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging.
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 packaging and other information

What Etopiryna Kontrol contains

• The active substances in the medicine are: acetylsalicylic acid and caffeine. Each tablet contains 300 mg of acetylsalicylic acid and 50 mg of caffeine.
• Other components of the medicine are: pregelatinized starch and microcrystalline cellulose.

What Etopiryna Kontrol looks like and contents of the pack
Etopiryna Kontrol is a white, round, biconvex tablet with a diameter of 11 mm.
The pack contains 10 tablets.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01