Etopiryna headache tablets are a drug used to treat headaches and moderate pain, especially of inflammatory origin.

Symptoms

Headaches and other pains of moderate intensity, especially of inflammatory origin.

Active substance: Acidum acetylsalicylicum, Coffeinum, Ethenzamidum

Composition

1 tablet contains 300 mg of acetylsalicylic acid (Acidum acetylsalicylicum), 100 mg of etenzamide (Ethenzamidum), 50 mg of caffeine (Coffeinum).

Excipient: lactose monohydrate 75 mg.

For the full list of excipients, see section 6.1.

Dosage

The drug should be taken orally, preferably after a meal, with plenty of water.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms in order to reduce the risk of side effects.

The drug should not be used for more than a few days.

The following dosage is usually recommended:

• Use in children and adolescents under 16 years of age
  The drug is contraindicated in children and adolescents under 16 years of age.
• Use in adults and children over 16 years of age
  1 to 2 tablets at a time, or if necessary, the same dose every 8 hours.

Do not take more than 6 tablets a day.

Contraindications

When not to use Etopiryna headache tablets

• if you are allergic to acetylsalicylic acid, etenzamide, caffeine or any of the other ingredients of this medicine
• if the patient is allergic to other non-steroidal anti-inflammatory drugs with symptoms such as: bronchospasm, rhinitis, shock;
• if you suffer from bronchial asthma, chronic respiratory diseases, hay fever or swelling of the nasal mucosa, as patients with these conditions may react to non-steroidal anti-inflammatory drugs with asthma attacks, limited swelling of the skin and mucosa (angioedema) or hives more often than other patients;
• if you have active gastric and/or duodenal ulcers and inflammation or bleeding from the gastrointestinal tract (gastrointestinal bleeding or ulcer reactivation may occur);
• if you have severe liver, kidney or heart failure;
• if you have blood clotting disorders (e.g. haemophilia, thrombocytopenia) or if you are being treated with anticoagulants (e.g. coumarin derivatives, heparin) at the same time;
• if you have glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease);
• if you are concomitantly receiving methotrexate in doses of 15 mg per week or more, due to the damaging effect on the bone marrow;
• in children and adolescents under 16 years of age, especially in the course of viral infections, due to the risk of Reye’s syndrome, a rare but serious disease that causes damage to the liver and brain;
• in the last trimester of pregnancy and during breastfeeding.

Storage method
Below 25°C
Manufacturer
POLPHARMA

Warnings

Talk to your doctor before taking Etopiryna headache tablets in the following situations:

• if you are taking oral antidiabetic drugs of the sulphonylurea group, because of the risk of increased hypoglycaemic (blood glucose lowering) effect, or if you are taking anti-gout medicines;
• in patients with impaired renal function and chronic renal failure;
• in patients with juvenile rheumatoid arthritis and/or systemic lupus and with hepatic insufficiency, as the toxicity of salicylates increases, liver function should be monitored in these patients;
• in the case of uterine hemorrhage, excessive menstrual bleeding, use of an intrauterine device, hypertension, heart failure;
• in patients with psychomotor agitation and insomnia;
• when used with methotrexate at doses lower than 15 mg per week, due to increased toxicity of methotrexate on the bone marrow. Concomitant use with methotrexate in doses higher than 15 mg per week is contraindicated;
• 5 to 7 days before the planned surgery, the drug should be discontinued due to the risk of prolonged bleeding time both during and after the surgery.

Pregnancy and breastfeeding
The drug can be used in the first and second trimester of pregnancy only if, in the opinion of the doctor, it is absolutely necessary.

The drug is contraindicated in the last trimester of pregnancy.

The drug is contraindicated during breastfeeding.

This drug belongs to the group of non-steroidal anti-inflammatory drugs that may impair fertility in women. This is a transient effect that disappears after the end of treatment.

Interactions with other drugs
The use of Etopiryna headache tablets is contraindicated with:

• anticoagulants (heparin, coumarin derivatives);
• methotrexate in doses of 15 mg per week or more.

Caution should be exercised when taking Etopiryna headache tablets with:

• angiotensin converting enzyme inhibitors (e.g. enalapril, captopril), as Etopiryna headache tablets may reduce the antihypertensive effect of these drugs;
• acetazolamide, as Etopyrin headache tablets may increase the toxicity of acetazolamide;
• valproic acid, because acetylsalicylic acid intensifies the toxic effect of valproic acid, and valproic acid intensifies the anti-aggregating effect (preventing platelets from sticking together) of acetylsalicylic acid;
• diuretics, as Etopiryna headache tablets may reduce the effectiveness of these drugs and increase the ototoxicity (damage to hearing) of furosemide;
• methotrexate in doses less than 15 mg per week, as acetylsalicylic acid intensifies 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 glucocorticoids (with the exception of hydrocortisone used as replacement therapy in Addison’s disease), as they increase the risk of ulcers and gastrointestinal bleeding and reduce the plasma concentration of salicylates during treatment, and after its completion they increase the risk of overdose of salicylates;
• antidiabetic drugs, because Etopiryna headache tablets may increase the hypoglycaemic effect (lowering blood glucose) of these drugs;
• drugs that increase the excretion of uric acid (e.g. probenecid, sulfinpyrazone), as salicylates weaken the effect of these drugs. Do not use acetylsalicylic acid concomitantly with these drugs;
• digoxin, as Etopyrin headache tablets may increase the effect of this drug;
• thrombolytics (thrombus-dissolving drugs) such as streptokinase and alteplase, as Etopyrina headache tablets may increase the effects of these drugs;
• barbituranami (np. fenobarbital);
• oral contraceptives;
• cymethydyne and disulfiram;
• ergotamine and analeptics (e.g. niketamide), as Etopiryna headache tablets may intensify the effects of these drugs;
• omeprazole and ascorbic acid (vitamin C) do not affect the absorption of acetylsalicylic acid.

Side effects

The following side effects may occur after using the product:

Gastrointestinal disorders: indigestion, heartburn, epigastric fullness, nausea, vomiting, anorexia, abdominal pain, gastrointestinal bleeding, damage to the gastric mucosa, ulceration, perforation.

Gastric ulceration occurs in 15% of patients on long-term aspirin therapy.

Hepatobiliary disorders: focal hepatocellular necrosis, liver tenderness and enlargement, especially in patients with juvenile rheumatoid arthritis, systemic lupus erythematosus, rheumatic fever or a history of liver disease, transient increases in serum transaminases, alkaline phosphatase and bilirubin.

Nervous system disorders: tinnitus (usually as a symptom of overdose), hearing impairment, dizziness.

Renal and urinary disorders: proteinuria, leukocytes and erythrocytes in the urine, renal papillary necrosis, interstitial nephritis.

Cardiac disorders: heart failure.

Vascular disorders: hypertension.

Blood and lymphatic system disorders: thrombocytopenia, anemia due to gastrointestinal microbleeding, haemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency, leucopenia, agranulocytosis, eosinopenia, increased risk of bleeding, prolonged bleeding time, prolonged prothrombin time.

Immune system disorders:

Hypersensitivity reactions: rash, urticaria, angioedema, bronchospasm, shock.