ATX code: N02BE51
INSTRUCTIONS FOR USE
SALDO
BALANCE
Trade name of the drug: Saldon
Active ingredients (INN): paracetamol, chlorpheniramine maleate, phenylephrine hydrochloride, caffeine.
Dosage form: tablets
Composition:
Each tablet contains:
Active substances:
Paracetamol 500 mg
Caffeine 30 mg
Phenylephrine hydrochloride 5 mg
Chlorpheniramine maleate 2 mg
Excipients: corn starch, povidone, sodium metabisulfite, purified talc, magnesium stearate, sodium starch glycolate, aerosil, purified water, dye: Ponceau 4R.
Description : pink, round, uncoated, tablet with a dividing line on one side.
Pharmacotherapeutic group: means to eliminate symptoms of acute respiratory infections and colds.
Code ATH: N02BE51
Pharmacological properties
A combined drug whose effect is determined by the properties of its constituent components.
Paracetamol
Has an analgesic and antipyretic effect. The mechanism of action is associated primarily with the ability to inhibit the synthesis of prostaglandins in the central nervous system and, to a lesser extent, the effect on thermoregulation in the hypothalamus.
Chlorpheniramine maleate
Histamine H1 receptor blocker . Has an antiallergic effect, reduces exudation. Constricts nasal vessels, eliminates swelling and hyperemia of the mucous membrane of the nasal cavity, nasopharynx and paranasal sinuses.
Phenylephrine a hydrochloride
It is a stimulator of vascular α-adrenergic receptors and has little effect on cardiac receptors. Causes constriction of arterioles and an increase in systemic blood pressure (with possible reflex bradycardia). Promotes pupil dilation (without affecting accommodation) and can lower intraocular pressure in open-angle forms of glaucoma.
Caffeine
Stimulates the psychomotor centers of the brain, has an analeptic effect, enhances the effect of analgesics, reduces headaches (including migraines), eliminates drowsiness and fatigue, increases physical and mental performance.
Pharmacokinetics
Paracetamol
Rapidly absorbed from the gastrointestinal tract, mainly in the small intestine, mainly by passive transport. The half-life (T 1/2 ) is 1-4 hours. Metabolized in the liver. It is excreted mainly by the kidneys.
Chlorpheniramine maleate
After oral administration, the maximum concentration (C m ax ) in the blood plasma is reached after 1-2.5 hours. T 1/2 in the final phase is 16-19 hours. Excreted in urine (70-83%) in the form of unchanged metabolites.
Phenylephrine hydrochloride
After oral administration, it is poorly absorbed from the gastrointestinal tract. Metabolized with the participation of MAO in the intestinal wall and “first pass” through the liver. Bioavailability is low.
Caffeine
Well absorbed in the intestines, T1 /2 in plasma is 5-10 hours. It is excreted by the kidneys mainly in the form of metabolites.
Indications for use
Symptomatic treatment of infectious and inflammatory diseases (ARVI, rhinitis, colds, flu), accompanied by fever, headache and muscle pain, runny nose, nasal congestion and sneezing.
Directions for use and doses
Inside.
Adults: 1 tablet 3-4 times a day.
Children: from 2 to 6 years: 1/4 tablet 3-4 times a day.
from 6 to 12 years: 1/2 tablet 3-4 times a day.
The course of treatment should not exceed 7 days.
If there is no relief of symptoms within 3 days after starting to take the drug, you should consult a doctor.
Side effects
The drug is usually well tolerated. However, sometimes it is possible:
From the nervous system: dizziness, sleep disturbance, increased excitability.
From the cardiovascular system: increased blood pressure, tachycardia, arrhythmia, bradycardia.
From the digestive system: nausea, vomiting, pain in the epigastric region, constipation, dry mouth, hepatotoxic effect.
Contraindications
Drug interactions
Paracetamol, when used simultaneously, reduces the effectiveness of uricosuric drugs and enhances the effects of MAO inhibitors, sedatives, and ethanol. Antidepressants, antiparkinsonian, antipsychotic drugs, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation, and corticosteroids increase the risk of developing glaucoma.
When used simultaneously with inducers of microsomal liver enzymes, drugs that have a hepatotoxic effect, there is a risk of increasing the hepatotoxic effect of paracetamol, with anticoagulants – a slight or moderate increase in prothrombin time, with diazepam – a decrease in the excretion of diazepam, with metoclopromide – increased absorption of paracetamol and an increase in its concentration in blood plasma.
Phenylephrine reduces the hypotensive effect of guanethidine. Guanethidine enhances the alpha-adrenergic stimulating effect, and tricyclic antidepressants enhance the sympathomimetic effects of phenylephrine.
Caffeine reduces the effect of sleeping pills and anesthetics and increases the effect of non-narcotic analgesics.
special instructions
With long-term use, it is necessary to monitor the functions of the liver, kidneys, and the state of the hematopoietic system (due to the presence of paracetamol in the drug).
Prescribe with caution to elderly people.
During treatment, blood pressure and ECG should be monitored.
Stimulators of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of paracetamol, which makes it possible to develop severe intoxications with small overdoses.
Impact on the ability to drive a car and operate complex machinery
While taking the drug, you should refrain from driving vehicles and operating other potentially dangerous mechanisms that require speed of psychomotor reactions and concentration.
The drug should not be used after the expiration date and should be stored out of the reach of children.
Overdose
Symptoms: The condition of a patient who has taken an excessively high dose of paracetamol may be satisfactory during the first 3 days and only after that signs of liver damage appear. Changes that develop in liver cells as a result of overdose cause damage and accumulation of toxic metabolic intermediates.
Treatment: gastric lavage, use of saline laxatives. In case of severe damage to the central nervous system, mechanical ventilation and oxygen supply, as well as the administration of naloxone, may be necessary to control the condition. Antidotes for paracetamol are acetylcysteine or methionine, which exhibit a hepatoprotective effect.
Release form
Pills. 50×4 or 25×4 tablets in blister packs.
Food conditions
Store in a dry and dark place at a temperature not exceeding 25˚C.
Best before date
3 years.
Conditions for dispensing from pharmacies
No prescription.
Manufacturer
Avison Pharmaceutical Pvt. Ltd., India
Coral Laboratories Limited
Plot № . 27-28, Pharmacity, Selaqui,
Dehradun, Uttarakhand – 248197, India
