RITOFF HOT [Multicomponent preparation] 20 g Granules for solution preparation

  instructions for the medical use of the medicinal product

RITOFF HOT

Tradename

Ritoff Hot, Ритофф Хот

International non-proprietary name or generic name

Paracetamol is found with drugs other than psycholeptics.

Composition

One 20 g sachet contains:

active substance: paracetamol 600 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg, ascorbic acid 100 mg, guaifenesin 100 mg;

excipients: sugar, starch, sodium starch glycolate, sodium carbonate, stevia, essence.

Dosage form

Granules for the preparation of the solution.

Pharmacotherapeutic group

Means for eliminating the symptoms of acute respiratory infections and “colds” (non-narcotic analgesic agent + vasoconstrictor + H1-histamine receptor blocker + vitamin + expectorant).

Pharmacological properties

Pharmacodynamics

Combined drug, the action of which is due to its constituent components.

Paracetamol is a non-narcotic analgesic that acts on the centers of pain and thermoregulation. It has an analgesic and antipyretic effect. Reduces headache and muscle pain, fever phenomena, soothes sore throat.

Phenylephrine hydrochloride - has a vasoconstrictive effect, facilitates breathing through the nose and helps to cleanse the nasal passages and paranasal sinuses.

Pheniramine maleate - a blocker of histamine H1 receptors, reduces rhinorrhea and lacrimation, eliminates spastic phenomena, swelling and hyperemia of the mucous membrane of the nasal cavity, nasopharynx and paranasal sinuses.

Ascorbic acid - is involved in the regulation of redox processes, carbohydrate metabolism, increases the body's resistance to infections.

Guaifenesin - has an expectorant effect. By increasing the volume of sputum and reducing its viscosity, it contributes to its evacuation from the respiratory tract.

Pharmacokinetics

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Cmax in plasma is achieved within 10-60 minutes after ingestion. Distributed in most tissues of the body. Penetrates through the placental barrier, excreted in breast milk. At therapeutic concentrations, plasma protein binding is negligible, but increases with increasing concentration. It undergoes primary metabolism in the liver. It is excreted mainly in the urine in the form of glucuronides and sulfates. T1 / 2 is from 1 to 3 hours.

Phenylephrine hydrochloride is absorbed from the gastrointestinal tract. It is metabolized during the "first pass" through the intestinal wall and in the liver, therefore, when administered orally, phenylephrine hydrochloride is characterized by limited bioavailability. Cmax in plasma is achieved in the range from 45 minutes to 2 hours. It is excreted by the kidneys almost completely in the form of sulfate compounds. T1 / 2 is 2-3 hours.

Pheniramine maleate is well absorbed from the gastrointestinal tract. Cmax in plasma is reached after about 1-2.5 hours. T1 / 2 pheniramine - 16-19 hours. 70-83% of the dose is excreted from the body in the urine as metabolites or unchanged.

Ascorbic acid is rapidly and completely absorbed from the gastrointestinal tract. Plasma protein binding - 25%. Excreted as metabolites in the urine. Ascorbic acid, taken in excessive amounts, is rapidly excreted unchanged in the urine.

Rapidly absorbed from the gastrointestinal tract (25-30 minutes after ingestion). Penetrates into tissues containing acidic mucopolysaccharides. Metabolized in the liver. T1 / 2 - 1 hour. Excreted with sputum through the lungs and kidneys in the form of inactive metabolites.

Guaifenesin is rapidly absorbed from the gastrointestinal tract (25-30 minutes after ingestion). Penetrates into tissues containing acidic mucopolysaccharides. Metabolized in the liver. T1 / 2 - 1 hour. Excreted with sputum through the lungs and kidneys in the form of inactive metabolites.

Indications for use

Symptomatic treatment of "cold" diseases, acute respiratory viral infections, influenza, accompanied by high fever, chills and fever, headache, runny nose, pain in the sinuses and throat, nasal congestion, sneezing, muscle and joint pain, cough with difficult sputum discharge.

Contraindications

• severe cardiovascular diseases;

• arterial hypertension;

• simultaneous use of tricyclic antidepressants, beta-blockers, MAO inhibitors (including up to 14 days after their cancellation);

• simultaneous use of tricyclic antidepressants, MAO inhibitors, beta-blockers;

• pronounced violations of liver function;

• the expressed disturbances of function of kidneys;

• erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase);

• portal hypertension;

• acute pancreatitis;

• diseases of the urethra and prostate gland with urination disorders;

• diabetes;

• bronchial asthma;

• angle-closure glaucoma;

• congenital hyperbilirubinemia;

• alcoholism;

• hyperthyroidism,

• pheochromocytoma;

• pregnancy and breastfeeding period;

• children's age up to 15 years;

• hypersensitivity to individual components of the drug.

Method of administration and dosage

Inside. The contents of 1 sachet are dissolved in a glass (200 ml) of boiled hot water and taken immediately after preparation.

Adults are prescribed 1 sachet every 4-6 hours. Do not take more than 4 sachets in 24 hours. Do not take the drug more often than after 4 hours.

Children over 12 years of age are prescribed 1 sachet every 6 hours. Do not take more than 3 sachets in 24 hours.

The patient should be warned that the drug is not recommended to be used for more than 5 days as an anesthetic and 3 days as an antipyretic.

If the symptoms persist during the indicated period of time, the patient should consult a doctor.

Special instructions and precautions

Before using the drug, consult a doctor.

For patients taking metoclopramide, domperidone, cholestyramine, anticoagulants (warfarin), the doctor determines the need to prescribe Ritoff Hot individually.

should not be used simultaneously with other drugs containing paracetamol.

To avoid an overdose of paracetamol, make sure that the total daily dose of paracetamol contained in all drugs taken by the patient does not exceed 4 g.

In order to avoid toxic damage to the liver, the drug should not be combined with the use of alcoholic beverages, and should not be taken by persons prone to chronic alcohol consumption.

The drug can distort the results of various laboratory tests (blood and urine levels of glucose, bilirubin, liver transaminase activity and LDH).

Possibility of pink discoloration of urine

In the evening, the drug should be taken a few hours before bedtime.

If the disease is caused by a bacterial infection, simultaneous antibiotic treatment is recommended.

The drug should be used with caution in patients over the age of 70 years.

Influence on the ability to drive vehicles and mechanisms

Given the possibility of developing such undesirable effects as drowsiness and dizziness, it is recommended to refrain from driving and operating mechanisms during the period of drug treatment.

Interaction with other medicinal products

The simultaneous administration of drugs that suppress the cough center (including codeine) makes it difficult to expectorate liquefied sputum.

Reduces the effectiveness of diuretic drugs.

Halothane increases the risk of ventricular arrhythmia.

The risk of developing a hepatotoxic effect increases with the simultaneous use of barbiturates, diphenin, carbamazepine, rifampicin, zidovudine and other inducers of microsomal liver enzymes.

Enhances the effects of MAO inhibitors, sedatives, ethanol.

Antidepressants, antiparkinsonian drugs, antipsychotics, phenothiazine derivatives - increase the risk of urinary retention, dry mouth, constipation.

Glucocorticosteroids increase the risk of developing glaucoma.

Reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenostimulating activity of phenylephrine.

Ethanol enhances the sedative effect of antihistamines and contributes to the development of acute pancreatitis, so it should be avoided during the treatment period.

Reception simultaneously with salicylates increases the risk of nephrotoxicity.

With simultaneous use with chloramphenicol (levomycetin), the toxicity of the latter increases.

Side effect

From the digestive system: nausea, vomiting, dry mouth, abdominal pain, diarrhea.

From the nervous system: dizziness, headache, drowsiness, confusion, hallucinations, irritability, nervousness, insomnia, coordination dysfunction, tremor.

From the side of the cardiovascular system: palpitations, orthostatic hypotension, increased blood pressure.

On the part of the organ of vision: disturbance of accommodation, increased intraocular pressure.

From the urinary system: violation of urination.

From the hemopoietic system: anemia, leukopenia, agranulocytosis, thrombocytopenia.

Allergic reactions: erythema, skin rash, urticaria, itching, angioedema, anaphylactic shock.

If any of the side effects listed in the instructions get worse, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: nausea, vomiting, discomfort in the abdominal cavity and (or) abdominal pain, diarrhea, flatulence, irritability, convulsions, impaired consciousness, coma.

Treatment: gastric lavage, followed by the appointment of activated charcoal; symptomatic and supportive therapy.

Storage conditions

Store in a cool and dry place at a temperature not exceeding 25°C.

Keep out of the reach of children!

Shelf life

3 years. Do not use after the expiry date stated on the package.

Vacation conditions

Released by prescription.

Release form

20 g granules in 1 sachet. 10 sachets with instructions for use in a cardboard box.