Immediate symptomatic treatment to relieve the symptoms of influenza and colds such as: rhinitis (runny nose), headache (among others caused by a reduction in the patency of the paranasal sinuses as a result of nasal edema and restriction of its patency), fever, arthralgia muscle.
Composition:
1 hard capsules contain 500 mg of Paracetamol and 6.1 mg of phenylephrine hydrochloride.
Action:
The preparation combines the action of individual ingredients. Paracetamol has analgesic and antipyretic effects. It inhibits the activity of arachidonic acid cyclooxygenase. The effect of this action is to reduce the sensitivity to such mediators as kinins and serotonin, resulting in an increase in the pain threshold. The reduction in the concentration of prostaglandins in the hypothalamus is responsible for the antipyretic effect. Paracetamol is quickly and almost completely absorbed from the gastrointestinal tract. After oral administration it reaches Cmax after about 1 hour. The main route of elimination is its biotransformation in the liver. The main metabolite of paracetamol in adults is glucuronide and in children - sulphate. In addition to sulphate and glucuronide, an indirect metabolite, N-acetyl-p-benzoquinone, is formed with the participation of the cytochrome P-450 oxidative system. This hepatotoxic metabolite is immediately bound to hepatic glutathione and then excreted in combination with cysteine or mercaptopurine. T0,5 paracetamol is 2-4 h. Phenylephrine is a postsynaptic stimulator of α-adrenergic receptors. It has a decongestant effect on peripheral vessels, reducing swelling of mucous membranes. The digestive tract is absorbed only to a small extent, the bioavailability is 40%. T0,5 is 2-3 hours. Cmax in the serum reaches after 1-2 h. Phenylephrine is metabolised mainly in the liver by combining with sulfuric or glucuronic acid, or by oxidative deamination and subsequent coupling with sulfuric acid. Metabolites are then excreted in the urine.
Contraindications:
Hypersensitivity to active substances or other medicines with a similar effect or to any of the excipients of the drug. Severe hepatic or renal failure. Cardiovascular disorders. Heart arythmia. Hypertension. Diabetes. Pheomophyte tumor of the adrenal glands. Glaucoma with closed angle of perception. Hyperthyroidism. Hyperplasia of the prostate gland. Congenital deficiency of glucose-6-phosphate dehydrogenase and methemoglobin reductase. The use of MAO inhibitors and within 14 days of discontinuation of their use. The use of tricyclic antidepressants or zidovudine. Pregnancy or breastfeeding. Children under 12 years old.
Precautions:
Caution should be exercised in patients with: hepatic or renal failure (liver enzyme and kidney function should be monitored), obliterative vascular disease, Reynaud's syndrome, stable coronary heart disease, respiratory failure, bronchial asthma, patients taking β-adrenergic receptor antagonists who are taking anticoagulants (it is advisable to adjust their dose based on the blood coagulation markers). The use of the drug by people with liver failure, overuse alcohol and starved poses the risk of toxic liver damage. Because of the risk of overdose, check that other medicines do not contain paracetamol.
Pregnancy and lactation:
Do not use during pregnancy and breast-feeding.
Side effects:
Side effects of paracetamol - rare: anemia, bone marrow suppression, thrombocytopenia, agranulocytosis, leukopenia, neutropenia, edema, acute and chronic pancreatitis, haemorrhage, abdominal pain, diarrhea, nausea, vomiting, liver failure, liver necrosis, jaundice, pruritus, rash, sweating, purpura, angioneurotic edema, urticaria, nephropathy and tubulopathy; in addition, isolated cases of epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, laryngeal edema, anaphylactic shock and dizziness have been observed.Side effects of phenylephrine - often: nausea, vomiting, digestive disorders, anorexia; rarely: allergic skin reactions (pruritus, urticaria), allergic and hypersensitivity reactions up to the symptoms of anaphylactic shock and bronchospasm, elevation of blood pressure, tachycardia, arrhythmia, palpitations, pallor of the coatings; very rare: anxiety, anxiety, tremors, nervousness, insomnia, irritability, dizziness and headaches, hallucinations; frequency unknown: urinary retention.
Dosage:
Orally. Adults and adolescents over 12 years: 1-2 capsules 3-4 times a day. Do not use more than 8 capsules a day.