Similar drugsTo uncover Dosage form: & nbspPills Composition:Composition per one tabletActive substances:Paracetamol 500.00 mgAscorbic acid 30.00 mgCaffeine 25.00 mgTerpin hydrate 20.00 mgPhenylephrine hydrochloride 5.00 mgExcipients: corn starch - 103.5 mg, pregelatinized starch - 30.0 mg, talc - 12.47 mg, stearic acid - 6.24 mg, povidone - 4.0 mg, potassium sorbate - 0.8 mg, sodium lauryl sulfate - 0 , 8 mg, dye solar sunset yellow (E110) - 0.4 mg. Description:Two-layer capsule capsules, one layer of orange, another layer of white. The orange layer can contain white inclusions. The white layer can contain orange inclusions. On one side of the tablet is marked Coldrex in the form of embossing. Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic remedy + psychostimulant + alpha-adrenomimetic + expectorant + vitamin) ATX: & nbspParacetamol in combination with other drugs, excluding psycholeptics Pharmacodynamics:Tablets "Coldrex®" combined preparation. Paracetamol has analgesic and antipyretic effect, phenylephrine reduces edema of the mucous membranes of the cavity and sinuses of the nose, resulting in easier breathing, terpinhydrate enhances the secretion of the bronchial glands, promotes the evacuation of mucus from the respiratory tract, caffeine has a tonic acting effect, ascorbic acid (vitamin C) replenishes the need for vitamin C for "colds" and flu. Indications:Coldrex® tablets eliminate cold and flu symptoms such as fever, headache, chills, joint and muscle pain, nasal congestion, pain in the sinuses of the nose and in the throat. Contraindications:The drug should not be taken with increased sensitivity to the components included in the preparation, in the genetic absence of glucose-6-phosphate dehydrogenase, with diseases of the blood system, with severe violations of the liver or kidney function, thyrotoxicosis, diabetes, hypertension, alcoholism, simultaneously with MAO inhibitors and within 14 days after their cancellation (see section "Interaction with other medicinal products"); during pregnancy and lactation, as well as in childhood (up to 12 years). Carefully:With angle-closure glaucoma, prostatic hyperplasia; congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), pheochromocytoma, vasospastic diseases (Raynaud's syndrome), diseases of the cardiovascular system. Dosing and Administration:Inside.Adults and children over 12 years of age: single dose - 2 tablets.Repeated use of the drug is possible not earlier than 4 hours and no more than 4 times / day. The maximum daily dose should not exceed 8 tablets. The duration of the course of treatment without consulting a doctor is no more than 7 days.Do not exceed the indicated dose.Do not take concomitantly with other paracetamol-containing drugs, sympathomimetics (such as decongestants, appetite suppressants, amphetamine-like psychostimulants), with other agents to relieve the symptoms of "colds" and flu.It is necessary to avoid excessive consumption of caffeine (tea, coffee and other drinks containing caffeine), as this can contribute to the development of undesirable side effects (see section "Side effect").If symptoms persist while taking the drug, you should consult a doctor. Side effects:Side effects are classified according to organ systems and frequency. The frequency of side effects is defined as follows: very often (greater than or equal to 1/10), often (greater than or equal to 1/100 and less than 1/10), sometimes (greater than or equal to 1/1000 and less than 1/100), rarely greater than or equal to 1/10 000 and less than 1/1000) and very rarely (greater than or equal to 1/100 000 and less than 1/10 000).In recommended doses, the drug is usually well tolerated. With prolonged use with excess of the recommended dose, hepatotoxic and nephrotoxic effects can be observed. Excessive consumption of caffeine (tea, coffee) during the administration of the drug "Coldrex®" can enhance the manifestation of side effects caused by caffeine, such as insomnia, irritability, nervous tension, headache, palpitations, digestive system disorders.From the hematopoiesis: Very rarely: thrombocytopenia.Allergic reactions:Very rarely: anaphylaxis, skin rash, hives, allergic dermatitis, angioedema, Stevens-Johnson syndrome.From the respiratory system:Very rarely: bronchospasm in patients susceptible to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).From the digestive system:Very rarely: nausea, vomiting, impaired liver function.From the central nervous system:Very rarely: irritability, nervous tension, dizziness, headache, insomnia.From the sense organs:Very rarely: mydriasis, an acute attack of glaucoma in most cases in patients with closed-angle glaucoma.From the cardiovascular system:Very rarely: tachycardia, palpitations.From the urinary system:Very rarely: dysuria, urinary retention in patients with obstruction of the bladder outlet with prostatic hypertrophy.In case of any undesired reactions, consult a physician. Overdose:If you suspect an overdose, even if you feel well, you should stop using the drug and immediately seek medical help.Symptoms (due to paracetamol): pallor of the skin, decreased appetite, nausea, vomiting; hepatic insufficiency, hepatonecrosis (the severity of necrosis, due to intoxication directly depends on the degree of overdose). Toxic effect in adults is possible after taking more than 10-15 g of paracetamol: an increase in the activity of "liver" transaminases, a clinical picture of liver damage manifests itself after 1-6 days. Rarely, liver failure develops at a lightning speed and can be complicated by renal insufficiency (tubular necrosis).Treatment: gastric lavage followed by the use of activated charcoal, administration of SH-group donors and glutathione-methionine synthesis precursors 8-9 hours after an overdose and N-acetylcysteine after 12 hours.Symptoms (due to caffeine): epigastric pain, vomiting, frequent urination, tachycardia, arrhythmia, CNS stimulation (insomnia, anxiety, excitability, anxiety, increased neural reflex excitability, tremors and convulsions). However, it should be borne in mind that the appearance of clinically significant symptoms of caffeine overdose when taking this drug is always associated with severe liver damage caused by an overdose of paracetamol. Treatment: symptomatic, specific antidote is absent. Symptoms (due to phenylephrine): irritability, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, increased excitability, reflex bradycardia. In severe cases of overdose, it is possible to develop hallucinations, confusion, convulsions, arrhythmias.Treatment: symptomatic therapy, with severe arterial hypertension, the use of alpha-blockers, such as phentolamine. Symptoms (due to ascorbic acid): high doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and gastrointestinal disturbances, such as nausea, discomfort in the stomach. Manifestations of an overdose can be categorized as those caused by severe liver damage, as a result of an overdose of paracetamol.Treatment: symptomatic, forced diuresis.Symptoms (due to terpinhydrate): disorders of the gastrointestinal tract, such as nausea, vomiting, pain in the stomach.Treatment: symptomatic. Interaction:The drug should not be taken simultaneously with tricyclic antidepressants, beta-blockers and other antihypertensive drugs, as well as with sympathomimetics, as the risk of developing hypertension and other cardiovascular disorders increases. Do not take concomitantly with MAO inhibitors and within 14 days after their withdrawal, as the risk of developing hypertension increases.With simultaneous admission with digoxin and cardiac glycosides, there may be an increased risk of heart rhythm disturbances or heart attack.The anticoagulant effect of warfarin and other coumarins can be enhanced with the simultaneous continued regular daily use of paracetamol, with an increased risk of bleeding. Irregular intake of single doses does not have a significant effect.The risk of hepatotoxic action increases with the simultaneous use of barbiturates, diphenin, carbamazepine, rifampicin, zidovudine and other inducers of microsomal liver enzymes. Consult your doctor if you are taking metoclopramide, domperidone (used to treat nausea and vomiting) or colestramine (used to lower blood cholesterol), because metoclopramide and domperidone increase the rate of absorption of paracetamol, and colestramine reduces. Special instructions:Before taking Coldrex®, consult your doctor: - if you are taking other medicines containing paracetamol, as well as other non-narcotic analgesics, NSAIDs (metamizol, acetylsalicylic acid, ibuprofen etc.);- if you accept metoclopramide, domperidone (used to treat nausea and vomiting) or colestramine (used to lower blood cholesterol).TO AVOID THE TOXIC LESION OF THE LIVER PARACETAMOL DO NOT CONSTITUTE WITH THE RECEPTION OF ALCOHOLIC BEVERAGES, AND ALSO TO TAKE PERSONS STRONG TO THE CHRONIC CONSUMPTION OF ALCOHOL.In case of dizziness when taking the drug, you should refrain from carrying out potentially dangerous activities requiring special attention and quick reactions (driving and other vehicles, working with moving mechanisms, etc.). Form release / dosage:Pills. Packaging:For 6 or 12 tablets in blisters (pvc / aluminum foil).1 or 2 blisters (6 or 12 tablets each), along with instructions for use, are placed in a cardboard box. Storage conditions:Store in a dark place at a temperature of no higher than 25 ° C.Keep out of the reach of children. Shelf life:4 years.Do not use after the expiration date printed on the package. Terms of leave from pharmacies:Without recipe Registration number:П N015713 / 01 Date of registration:24.06.2009 / 18.03.2013 The owner of the registration certificate: GlaxoSmithClean Consumer Helscher GlaxoSmithClean Consumer Helscher United Kingdom Manufacturer: & nbspGlaxoSmithKline Dungarvan, Ltd. Ireland Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom Information update date: & nbsp19.03.2016 Illustrated instructions × Illustrated instructions Instructions