Coffepirine Headache Tablets x 12 tablets

Coffepirine 12 tablets

Headache tablets

Coffepirine Description

The drug Coffepirine Headache Tablets is used in the treatment of pain of various origins of low and moderate intensity (such as headache, rheumatic pain, muscle pain, neuralgia, toothache).

Composition - what ingredients are contained in the drug Coffepirine

1 tablet contains 450 mg of acetylsalicylic acid and 50 mg of caffeine.

Dosage - that is, how to use the drug Coffepirine

Adults and adolescents over 12 years: usually use 1 tablet, if necessary, 2-6x/day, not more often than every 4 h, up to 6 tablets per day (equivalent to 2700 mg ASA and 300 mg caffeine). The drug product should not be used without consulting a doctor for more than 3 days in adults and for 1 day in adolescents over 12 years. Use with caution in adolescents over 12 years of age due to caffeine content. Children and adolescents under 12 years: do not use.

Notes

Do not use on an empty stomach. Tables should be swallowed with plenty of liquid.

Action

ASA belongs to the group of acidic non-steroidal anti-inflammatory drugs with analgesic, antipyretic and anti-inflammatory properties. It has also been shown to have anti-aggregation properties. Caffeine belongs to the group of xanthines, which in therapeutic doses act as adenosine receptor antagonists. As a result, the inhibitory effect of adenosine on the central nervous system is reduced.

Indications

Pain of various origins of low to moderate intensity (e.g. headache, rheumatic pain, muscular pain, neuralgia, toothache).

Coffepirine Contraindications

Hypersensitivity to the active substance or to any of the excipients and salicylates. Pregnancy and lactation period, gastric and/or duodenal ulcer disease, gastrointestinal bleeding, hemorrhagic diathesis, gout, severe renal or hepatic impairment. In children under 12 years of age. In patients with a history of bronchial asthma attacks induced by the administration of salicylates or substances with similar effects, especially non-steroidal anti-inflammatory drugs. Concurrently with methotrexate at doses of 15 mg per week or more. The drug product (as well as others containing ASA) should not be used on the day the patient receives a dose of methotrexate. In severe heart failure. The medicinal product should not be used for pain control after coronary bypass surgery.

Side effects of Coffepirine drug

The incidence of side effects of the medicinal product depends on the dose of the medicinal product, the condition and sensitivity of the patient and the accompanying treatment. Blood and lymphatic system disorders: (unknown) increased risk of bleeding, prolongation of bleeding time, prothrombin time, thrombocytopenia. Immune system disorders: (unknown) hypersensitivity reactions, including urticaria, skin reactions, anaphylactic reactions, bronchial asthma, angioedema. Nervous system disorders: (unknown) dizziness, tinnitus; (unknown) caffeine contained in the drug product may cause insomnia, motor restlessness. Long-term intake of a medicinal product containing ASA may cause headache, which intensifies during subsequent doses. Cardiac disorders: caffeine may cause cardiac arrhythmias; (unknown) occurrence of edema, hypertension and heart failure. Clinical studies and epidemiological data suggest that taking some NSAIDs (especially long-term in high doses) may be associated with a small increase in the risk of arterial blockages (e.g., heart attack or stroke). Gastrointestinal disorders: (unknown) abdominal pain, heartburn, nausea, vomiting; gastrointestinal bleeding: overt (fusiform vomiting, tarry stools) or latent, which may cause iron deficiency anemia; gastric and duodenal ulcer disease, perforations. Liver and biliary tract disorders: (rarely) liver dysfunction (increased aminotransferases) has been observed. Renal and urinary tract disorders: in rare cases, renal papillary necrosis and interstitial nephritis have been reported after long-term use of high doses of ASA.

Notes and warnings regarding the drug Coffepirine

This is a medication. For safety, use it according to the package insert. Do not exceed the maximum dose of the drug. If in doubt, consult your doctor or pharmacist.

Special warnings / Precautions

The drug product should be used with caution: in case of hypersensitivity to non-steroidal anti-inflammatory and anti-rheumatic drugs or other allergenic substances; during concomitant use of anticoagulants; in patients with a history of peptic ulcer disease or gastrointestinal bleeding; in patients with glucose-6-phosphate dehydrogenase deficiency; in patients with hyperthyroidism; in patients with hypertension; in patients with epilepsy. Use with caution in patients with allergic diseases (bronchial asthma, hay fever, with nasal mucosal polyps), before surgical procedures, in hepatic and renal impairment, when using an intrauterine contraceptive IUD, or when menstrual bleeding is heavy. There is evidence that drugs that inhibit cyclooxygenase (prostaglandin synthesis) can cause fertility disorders in women by affecting ovulation. This effect is transient and disappears after discontinuation of therapy. Taking the medicinal product at the lowest effective dose for the shortest period necessary to relieve symptoms reduces the risk of side effects. Cardiovascular and cerebrovascular effects: clinical and epidemiological data suggest that taking some NSAIDs (especially long-term in high doses) is associated with a small increase in the risk of arterial blockages (e.g., heart attack or stroke). The available data are insufficient to rule out such a risk when the drug is taken in daily doses of no more than 6 tabl (2.7 g ASA). Children and adolescents with symptoms of viral infection, occurring with or without fever, should not take ASA without first consulting a doctor. For viral infections, especially those such as influenza A and B and chickenpox, there is a risk of Reye's syndrome, a rare but life-threatening condition that requires immediate medical intervention. The risk may increase if, during the course of these diseases, acetylsalicylic acid is administered (however, a causal relationship has not been proven). Persistent vomiting occurring during viral illnesses may be a symptom of Reye's syndrome. The drug has no or negligible effect on the ability to drive and operate machinery.

Interactions

Concomitant use with methotrexate at doses of 15 mg per week or higher is contraindicated. Methotrexate in doses less than 15 mg per week - exacerbation of the toxic effect of methotrexate on the bone marrow. Concomitant use with tyclopidine increases the risk of bleeding. If there is a need for concomitant administration of products containing ASA and tyclopidine, the bleeding time should be monitored. The effectiveness of drugs that increase uric acid excretion, diuretics, e.g. spironolactone and furosemide, blood pressure-lowering drugs may be reduced when used concomitantly with ASA. ASA increases the ototoxicity of furosemide. During the general use of glucocorticosteroids, the concentration of salicylates in the blood is reduced. After steroid withdrawal, there is a risk of salicylate overdose. The dose of salicylates should be determined separately during the period of concomitant administration with steroid preparations and again after their withdrawal. Concomitant use of the product with fluoroquinolone derivatives (e.g. ciprofloxacin), may cause caffeine to accumulate in the body. Cimetidine and disulfiram, as well as oral contraceptives, slow the metabolism of caffeine. Barbiturates accelerate caffeine metabolism. Caffeine can potentiate the effects of isoprenaline. ASA intensifies the hypoglycemic effect of oral antidiabetic drugs of the sulfonylurea group. ASA intensifies the effects of all drugs that reduce blood clotting, including coumarin derivatives. ASA exacerbates the effects of some antibiotics. Concomitant use of ASA and other non-steroidal anti-inflammatory drugs increases the risk of gastrointestinal mucosal damage, and kidney damage. Drinking alcohol during treatment increases mucosal irritation and the danger of gastrointestinal bleeding. Caffeine weakens the effect of sedatives and sleeping pills. Caffeine intensifies the effects of drugs that cause tachycardia, e.g. sympathicomimetics, thyroxine. Experimental data indicate that ibuprofen may inhibit the effect of low-dose ASA on platelet aggregation when given concurrently. However, the limitations of the studies and the uncertainty relating to extrapolation of ex vivo studies to clinical cases mean that there are no clear conclusions for regular or occasional use of ibuprofen.

Pregnancy and lactation

The medicinal product is contraindicated for use during pregnancy. The medicinal product is contraindicated during breastfeeding. There is evidence that drugs that inhibit cyclooxygenase (prostaglandin synthesis) can cause fertility disorders in women by affecting ovulation. This effect is transient and disappears after therapy is discontinued.

Overdose

Symptoms of overdose usually occur after 2 h. Overdose may be followed by hand tremor, diarrhea, drowsiness, tinnitus, headache and dizziness, disorientation, accelerated breathing, acid-base disturbances and metabolic acidosis, vomiting and abdominal pain, elevated body temperature, decreased prothrombin, convulsions. In cases of severe overdose, hyperventilation, respiratory distress, fever, metabolic acidosis, coma may occur. Symptoms of caffeine overdose are disorders of the central nervous system, i.e. restlessness, agitation, racing thoughts, insomnia, convulsions, palpitations, abdominal pain, diarrhea, nausea and vomiting. Management after an overdose The patient should be immediately transported to the hospital. Management depends on the size of the dose taken, the stage and clinical signs. Measures should be taken to reduce the absorption of the active substance: gastric lavage, administration of activated charcoal and control of acid-base balance (it is necessary to control the following blood parameters: pH, _pC02, bicarbonate concentration, potassium concentration). If normal renal function is preserved, alkaline diuresis can be used until the urine pH is in the range of 7.5-8; in the case of plasma salicylate concentrations above 500 mg/dL (3.6 mmol/1) in adults or 300 mg/dL (2.2 mmol/1) in children, forced alkaline diuresis should be considered. Intravenous infusions containing _NaHC03, KCl and diuretics should be used. In cases of symptoms of central nervous system agitation, 1,4-benzodiazepine derivatives are administered. In cases of severe intoxication, hemodialysis or peritoneal dialysis may be used. Fluids should be supplemented and general symptomatic management should be carried out.

Responsible Entity
MARCMED Sp.z o.o.