Instructions for Helpex Anticold tablets blister pack No. 100
Composition
active ingredients: paracetamol, caffeine, phenylephrine hydrochloride, chlorpheniramine maleate;
1 tablet contains paracetamol 500 mg, caffeine 30 mg, phenylephrine hydrochloride 10 mg, chlorpheniramine maleate 2 mg;
Excipients: corn starch, microcrystalline cellulose, calcium hydrogen phosphate, methylparaben (E 218), propylparaben (E 216), povidone, magnesium stearate, talc, sodium starch glycolate (type A), sunset yellow FCF dye (E 110).
Dosage form
Pills.
Main physicochemical properties:
tablets of orange or light orange color with speckles, oblong oval shape, with a score, with imprints of "M" and "H" on the side where the score is, without a shell.
Pharmacotherapeutic group
Analgesics and antipyretics. Anilides. Paracetamol, combinations without psycholeptics.
ATX code N02B E51.
Pharmacological properties
Pharmacodynamics
Combined drug for the treatment of flu and colds. Has antipyretic, analgesic, antiallergic and weak anti-inflammatory properties. Eliminates symptoms of nasal congestion, runny nose, tearing, sneezing, headache, improves general well-being.
Paracetamol acts as an antipyretic, analgesic, and anti-inflammatory agent. The analgesic and antipyretic effects of paracetamol are associated with the drug's effect on the thermoregulatory center and its ability to inhibit prostaglandin synthesis.
Phenylephrine hydrochloride acts as a vasoconstrictor, reducing swelling of the nasal mucosa and paranasal sinuses.
Chlorpheniramine maleate has an antiallergic effect, relieves tearing and itching in the nose.
Caffeine has a stimulating effect on the central nervous system, mainly on the cerebral cortex, respiratory and vasomotor centers, increases mental and physical performance, reduces drowsiness, fatigue, and weakens the effect of drugs that depress the central nervous system.
Indication
Treatment of symptoms that occur during acute respiratory viral infections, influenza (to reduce elevated body temperature, reduce runny nose, relieve swelling of the nasal mucosa, eliminate body aches, eliminate headaches).
Contraindication
Hypersensitivity to any component of the drug, other xanthine derivatives (theophylline, theobromine). Severe cardiovascular diseases, including uncompensated heart failure, conduction disorders, arrhythmias, severe atherosclerosis, tendency to vasospasm, severe ischemic heart disease; severe arterial hypertension. Severe liver and kidney dysfunction, prostatic adenoma with difficulty urinating, bladder neck obstruction. Stenosing gastric and duodenal ulcer, pyloroduodenal obstruction; acute pancreatitis. Blood diseases (including severe anemia, leukopenia), hyperthyroidism, diabetes mellitus, bronchial asthma, angle-closure glaucoma, glucose-6-phosphate dehydrogenase deficiency, alcoholism, increased excitability, sleep disorders, congenital hyperbilirubinemia, pheochromocytoma, epilepsy. Elderly age. Concomitant use with tricyclic antidepressants, ß-blockers; with MAO inhibitors and within 2 weeks after their discontinuation. Patients at risk of respiratory failure.
Interaction with other medicinal products and other types of interactions
Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol. When used simultaneously with paracetamol, the following types of interactions may be observed: the elimination of antibiotics from the body may be slowed down; tetracycline increases the risk of anemia and methemoglobinemia caused by paracetamol; antacids and food reduce the absorption of paracetamol. With simultaneous long-term use, the anticoagulant effect of coumarins (for example, warfarin) is enhanced. Barbiturates reduce the antipyretic activity of paracetamol. Anticonvulsants (phenytoin, barbiturates, carbamazepine), which stimulate microsomal liver enzymes and isoniazid, may increase the hepatotoxicity of paracetamol. When used simultaneously with hepatotoxic drugs, the toxic effect of drugs on the liver increases. Paracetamol reduces the effectiveness of diuretics.
The use of phenylephrine hydrochloride with indomethacin and bromocriptine can cause severe arterial hypertension; with sympathomimetic amines, digoxin and cardiac glycosides - increases the risk of arrhythmias and myocardial infarction.
May reduce the effectiveness of ß-blockers and other antihypertensive drugs (reserpine, methyldopa) with an increased risk of arterial hypertension and adverse cardiovascular reactions.
Rauwolfia alkaloids reduce the therapeutic effect of phenylephrine hydrochloride.
α-blockers (phentolamine), phenothiazines, furosemide, and other diuretics prevent vasoconstriction.
Chlorpheniramine maleate enhances the anticholinergic effect of atropine, antispasmodics, central nervous system depressants (tranquilizers, barbiturates), and antiparkinsonian drugs.
Concomitant use with hypnotics, barbiturates, sedatives, neuroleptics, tranquilizers, anesthetics, narcotic analgesics enhances the effect of chlorpheniramine maleate.
Maprotiline (a tetracyclic antidepressant) and other anticholinergic drugs: the anticholinergic effect of these drugs or antihistamines such as chlorpheniramine may be enhanced.
Caffeine enhances the effect (improves bioavailability) of analgesics-antipyretics, potentiates the action of xanthine derivatives, ɑ- and ß-adrenomimetics, and psychostimulants.
Caffeine increases the likelihood of liver damage from hepatotoxic drugs.
Cimetidine, hormonal contraceptives, and isoniazid enhance the effects of caffeine.
Caffeine reduces the effect of opioid analgesics, anxiolytics, hypnotics and sedatives, is an antagonist of anesthetics and other drugs that depress the central nervous system, a competitive antagonist of adenosine drugs, ATP. With simultaneous use of caffeine with ergotamine, the absorption of ergotamine in the digestive tract improves, with thyroid-stimulating drugs - the thyroid effect increases. Caffeine reduces the concentration of lithium in the blood.
Ototoxic and photosensitizing drugs may increase side effects when used simultaneously.
Application features
Do not exceed the specified dose.
Concomitant use with other medicines containing paracetamol should be avoided.
If symptoms persist, consult a doctor. If the headache becomes persistent, you should consult a doctor.
This medicine is not recommended to be used simultaneously with sedatives, hypnotics, alcohol. The risk of overdose increases in alcoholic liver disease.
When using the drug, you should avoid excessive consumption of coffee, strong tea, other tonic drinks and medications containing caffeine. This may cause sleep problems, tremors, tension, irritability, and palpitations.
3 should be used with caution in compensated heart failure, patients at risk of seizures, patients with chronic obstructive airway diseases, persistent or chronic cough resulting from smoking or emphysema, when the cough is accompanied by excessive sputum secretion, patients with congenitally prolonged QT interval or in cases of prolonged use of drugs that can prolong the QT interval.
The drug may affect the results of laboratory tests for blood glucose.
The use of the drug may cause a positive analytical result in doping control.
Before using the drug, you should consult a doctor if you are using warfarin or similar drugs that have an anticoagulant effect and in patients with impaired kidney and liver function.
Use during pregnancy or breastfeeding
Do not apply.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment, you should avoid driving vehicles, working with mechanisms and other dangerous activities.
Method of administration and doses
Adults and children over 12 years of age should take 1 tablet up to 4 times a day. The interval between doses should be at least 4 hours. The duration of treatment should not exceed 5 days.
The drug should be taken orally 1 hour after meals, with plenty of water.
Children
The drug is used to treat children over 12 years of age.
Overdose
In case of paracetamol overdose, symptoms develop in the first 24 hours - pallor, nausea, vomiting, anorexia and abdominal pain. The activity of hepatic transaminases increases, the concentration of bilirubin increases and the level of prothrombin decreases. In case of overdose, increased sweating, psychomotor agitation or depression of the central nervous system, dizziness, sleep disturbances, drowsiness, heart rhythm disturbances, tachycardia, extrasystole, tremor, hyperreflexia, convulsions, pancreatitis may be observed. In isolated cases, acute renal failure with acute tubular necrosis, manifested by pain in the lumbar region, hematuria, proteinuria, nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis) has been reported.
The use of 10 g or more of paracetamol by adults and more than 150 mg of paracetamol per kg of body weight by children can lead to hepatocellular necrosis with the development of encephalopathy with impaired consciousness, hepatic coma and death.
The first clinical and biochemical signs of liver damage may appear 12-48 hours after overdose. Glucose metabolism disorders and metabolic acidosis may occur. With prolonged use of high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia are possible.
Symptoms of overdose due to the action of phenylephrine and chlorpheniramine maleate: headache, hyperhidrosis, drowsiness, insomnia, behavioral changes, restlessness, irritability, tremor, convulsions, hyperreflexia, dizziness, nausea, vomiting, tachycardia, arrhythmias, extrasystole.
In case of overdose with chlorpheniramine maleate, the state may vary from depressed to excited (restlessness and convulsions). Atropine-like symptoms may be observed, including mydriasis, photophobia, dryness of the skin and mucous membranes, fever, intestinal atony; depression of the central nervous system is accompanied by respiratory disorders and disorders of the cardiovascular system.
In case of caffeine overdose, the following symptoms are observed: dehydration, hyperthermia, tinnitus, epigastric pain, increased frequency of diuresis, extrasystole, tachycardia, rapid breathing, arrhythmia, effects on the central nervous system (dizziness, insomnia, excitement, irritability, psychomotor agitation, state of affect, anxiety, tremor, vomiting, seizures, convulsions, agitation, restlessness, delirium, increased tactile or pain sensitivity).
Treatment of overdose: In case of suspected overdose, the patient should be taken to hospital. Intravenous acetylcysteine is administered within 24 hours after paracetamol ingestion, with the maximum effect being achieved within the first 8 hours after ingestion. Oral methionine may be administered within the first 8 hours after overdose.
Adverse reactions
Immune system disorders: hypersensitivity reactions, including pruritus, rash (erythematous, urticaria), anaphylactic shock, angioedema, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis.
From the side of the central nervous system: psychomotor agitation and disorientation, anxiety, behavioral changes, feelings of fear, anxiety, irritability, sleep disturbances, insomnia, drowsiness, dizziness, confusion, hallucinations, depressive states, tremor, tingling and heaviness in the limbs, tinnitus, headache, in some cases - coma, convulsions, dyskinesia.
Respiratory system: bronchospasm in patients sensitive to aspirin and other NSAIDs.
On the part of the organs of vision: impaired vision and accommodation, mydriasis, increased intraocular pressure, dry eyes.
Gastrointestinal: decreased appetite, nausea, vomiting, dry mouth, hypersalivation, heartburn, discomfort and pain in the epigastrium, exacerbation of peptic ulcer, flatulence, diarrhea, constipation.
On the part of the hepatobiliary system: impaired liver function, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (when using high doses), hepatotoxicity.
On the part of the endocrine system: hypoglycemia, up to hypoglycemic coma.
From the blood and lymphatic system: anemia, including hemolytic anemia, bruising or bleeding; sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain).
With prolonged use in high doses - aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia.
On the part of the kidneys and urinary system: when using high doses - nephrotoxicity (including papillary necrosis), urination disorders, urinary retention and difficulty urinating, dysuria, interstitial nephritis, increased creatinine clearance, increased sodium and calcium excretion, aseptic pyuria, renal colic.
Cardiovascular system: arterial hypertension, tachycardia or reflex bradycardia, arrhythmia, shortness of breath, heart pain.
Others: general weakness, increased sweating, hypoglycemia, which may progress to hypoglycemic coma, nasal congestion, possible false increase in blood uric acid, determined by the Bittner method; slight increase in 5-hydroxyindoleacetic acid
(5-NIAA), vanillylmandelic acid (VMA) and catecholamines in urine.
The excipients methylparaben (E 218) and propylparaben (E 216) may cause allergic reactions (possibly delayed) and in some cases bronchospasm.
Expiration date
4 years.
Storage conditions
Store out of the reach of children in the original packaging at a temperature not exceeding 25 °C.
Packaging
4 or 10 tablets in a blister, 1 blister in a cardboard box with instructions for medical use; 20 packs of 4 tablets in a group cardboard box (No. 80), 10 packs of 10 tablets in a group cardboard box (No. 100).
Vacation category
Without a prescription.
Producer
Valles Pharmaceuticals Pvt. Ltd.
Location of the manufacturer and its business address
India, Bhatian, Nalagarh, Distr. Solan, Ech. Pi.
Applicant
Movie Health GmbH.
Applicant's location
35 Egerischstrasse, Baar, 6340, Switzerland.
