Rhinathiol® used as adjunctive therapy of respiratory tract disorders characterized by excessive, viscous mucus.

One 5 mlmeasuring spoon contains 100mg of carbocisteine.
Children 6 years to 12 years: 300 mg per day, in 3 divided doses, i.e. one 5 mlmeasuring spoon three times per day.
Treatmentduration
Treatment duration should be short and not exceed 8 to 10 days.

In patients with thick and purulent sputum, fever or chronic bronchial and pulmonary disease, the clinical situation should be reassessed.
Productive cough, which is a fundamental bronchopulmonarydefensemechanism, should not be suppressed.
Combining drugs that affect bronchial secretions with antitussives and/or substances that dry up
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secretions (atropine-like agents) is irrational.
Mucolytic agents may induce severe bronchial congestion in infants. Their bronchialmucus drainage
capacities are limited due to the physiological characteristics of their bronchial tree. Mucolytics should therefore not be used in infants (see Sections 4.3 and 4.8).
Treatment should be re-evaluated if symptoms or the disease persist or worsen.
Thismedicinal product contains sucrose. It should therefore not be used in patients with fructose intolerance, glucose and galactosemalabsorption syndrome or sucrase/isomaltase deficiency.
Special precautions for use
Caution should be exercised in subjects with peptic ulcers.
Thismedicinal product contains 3.5 g of sucrose per measuring spoon; this must be taken into account in the daily allowance in patients on a low-sugar diet or with diabetes.
Thismedicinal product contains sodium. It contains 13 mg of sodium per 5mlmeasuring spoon of syrup. This should be taken into account in patients on a strict low-sodium diet.
Thismedicinal product contains sodium methyl paraben (E219) and an azo dye (cochineal red A (E124)); they can cause allergic reactions (possibly delayed).

Notapplicable.

Although tests in mammalian species have revealed no teratogenic effects, Rhinathiol® is not recommended during the first trimester of pregnancy..
Lactation
Effects not known.

Notapplicable.

• Risk of severe bronchial congestion in infants (see Sections 4.3 and 4.4).
• Allergic skin reactions such as pruritus, erythematous eruption, urticaria and angioedema.
• A few cases of fixed drug eruption have been reported.
• Possible gastrointestinal intolerance reactions (gastric pain, nausea, diarrhea). It these occur, the dose should be reduced.

To report any side effect(s):
Saudi Arabia
National Pharmacovigilance & Drug Safety Centre (NPC):
Fax: +966-11-205-7662
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Sanofi - Pharmacovigilance: KSA_Pharmacovigilance@sanofi.com

Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of Rhinathiol® overdosage.

Carbocisteine (5-carboxymethyl L-cysteine) has been shown in normal and bronchitic animal models to affect the nature and amount of mucus glycoprotein which is secreted by the respiratory tract. An increase in the acid:neutral glycoprotein ratio of the mucus and a transformation of serous cells to mucus cells is known to be the initial response to irritation and will normally be followed by hypersecretion. The administration of Carbocisteine to animals exposed to irritants indicates that the glycoprotein that is secreted remains normal; administration after exposure indicates that return to the normal state is accelerated. Studies in humans have demonstrated that Carbocisteine reduces goblet cell hyperplasia. Carbocisteine can therefore be demonstrated to have a role in the management of disorders characterised by abnormal mucus.

Orally administered carbocisteine is rapidly absorbed; peak plasma concentrations are reached within two hours. Bioavailability is low (less than 10%of the administered dose), probably as a result of intraluminalmetabolism
and a marked hepatic first-pass effect. Elimination half-life is approximately 2 hours.
Carbocisteine and its metabolites are eliminated primarily in the urine.

Notapplicable.

Sucrose, sodium methyl paraben (E219), vanillin, cochineal red A (E124), raspberry flavor, cherry flavor, sodium hydroxide, purified water.

Notapplicable.

Store below25°C.

125ml (glass) bottle with (polypropylene) child-resistant cap and 5 ml (polystyrene) measuring spoon.

Noparticular instructions.