Symptomatic treatment of irritating, unproductive cough, particularly when occurring predominantly at night.
Note: combination of an antitussive and an expectorant is not justified.

Oral use.
For use in adults and children over 2 years of age only.
Symptomatic treatment should be brief (a few days) and limited to episodes of coughing.
Adults
3 to 4 tablespoons of 15 ml per day.
Children
Use the measuring spoon supplied with the syrup:
24 to 30 months: 3 to 4 x 5 ml measuring spoons per day,
30 months to 12 years: 4 to 6 x 5 ml measuring spoons per day,
12 to 15 years: 6 to 9 x 5 ml measuring spoons per day.
This medicinal product should preferably be taken in the evening due to the marked sedative effect of promethazine.

Special warnings
Productive coughs are a fundamental bronchopulmonary defense mechanism and should not be suppressed.
It is irrational to combine an expectorant or mucolytic agent with this antitussive.
Before prescribing an antitussive, it is advisable to ensure that the underlying causes of the cough, which require specific treatment, have been investigated.
If the cough does not respond to antitussive treatment administered at the normal dosage, the dose must not be increased, but the clinical situation should be re-evaluated instead.
Mucolytic agents may induce severe bronchial congestion in infants. Their bronchial mucus 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.
This medicinal product contains sucrose. It is not recommended for use in patients with fructose intolerance, glucose or galactose malabsorption syndrome or sucrase-isomaltase deficiency.
WARNING: THIS MEDICINAL PRODUCT CONTAINS ALCOHOL:
The alcohol content of the syrup is 3.09%, i.e.
122 mg of alcohol per measuring spoon (5 ml)
366 mg of alcohol per tablespoon (15 ml)
This medicinal product contains 3.09% v/v ethanol (alcohol); i.e. up to 366 mg per tablespoon of syrup or 1.46 g ethanol per maximum daily dose, which is equivalent to a maximum of 37 ml of beer or 15 ml of wine per day. Use of this medicinal product is dangerous in alcoholics and the alcohol content should be taken into account in pregnant or breast-feeding women, in children or high-risk populations such as patients with hepatic insufficiency or epilepsy.
Precautions for use
Related to carbocisteine:
Caution is recommended in patients with peptic ulcers.
Related to promethazine:
Phenothiazines have been considered hypothetical risk factors in the occurrence of sudden infant death syndrome (SIDS). Use in children at risk of apnea, aged under one year, is not therefore recommended.
Monitoring (clinical and, if necessary, ECG monitoring) must be increased in epileptic patients due to the possible lowering of the seizure threshold.
Promethazine hydrochloride must be used with caution:
• in elderly subjects with:
o increased susceptibility to postural hypotension, dizziness and sedation,
o chronic constipation (risk of paralytic ileus),
o possible benign prostatic hypertrophy,
• in patients with certain cardiovascular diseases, due to the tachycardia-inducing and hypotensive effects of phenothiazines,
• in patients with severe hepatic and/or renal insufficiency (due to the risk of accumulation).
The possibility of bronchial asthma or gastroesophageal reflux should be eliminated before prescribing promethazine as an antitussive in children.

Consumption of alcoholic beverages or medicinal products containing alcohol (see Section 4.5) is highly inadvisable during treatment.
Exposure to sun should preferably be avoided during treatment due to the photosensitizing effects of phenothiazines.
Related to the excipients:
This medicinal product contains 3 g of sucrose per measuring spoon and 9 g per tablespoon; this must be taken into account in the daily allowance in patients following a low-carbohydrate diet or in diabetic patients.
This medicinal product contains sodium. It contains 13 mg of sodium per 5 ml of syrup. This should be taken into account in patients on a strict low-sodium diet.
This medicinal product contains methyl paraben (E218) and can cause allergic reactions (possibly delayed).

The interactions stated below are related to promethazine.
Inadvisable combinations
+ Alcohol
Alcohol enhances the sedative effect of antihistamines. Impaired alertness may make driving or using machines dangerous.
Alcoholic beverages or medicinal products containing alcohol should be avoided.
+ Sultopride
Increased risk of ventricular arrhythmias, particularly torsades de pointes, as a result of cumulative electrophysiological effects.
Combinations to be taken into account
+ Other central nervous system depressants (sedative antidepressants, barbiturates, clonidine and related substances, hypnotic agents, morphine derivatives (analgesics and antitussives), methadone, neuroleptics, anxiolytics)
Increased central depression. Impaired alertness may make driving or using machine dangerous.
+ Atropine and other atropine-like drugs (imipramine antidepressants, anticholinergic antiparkinsonians, atropine antispasmodics, disopyramide, phenothiazine neuroleptics)
Additive atropine-induced adverse effects such as urinary retention, constipation, dry mouth.

Pregnancy
+ Malformative effect (1st trimestrer):
Animal studies:
• have not demonstrated any teratogenic effect of carbocisteine.
• have not made it possible to establish any reliable teratogenicity data for promethazine.
In humans:
• No data is available for carbocisteine.
• To date, the use of promethazine in a limited number of pregnancies does not appear to have demonstrated any specific teratogenic or fetotoxic effects.
However, additional studies are required in order to assess the consequences of exposure during pregnancy.
+ Fetotoxicity (2nd and 3rd trimesters):
In newborns whose mothers received long-term treatment with high doses of an anticholinergic antihistamine such as promethazine, gastrointestinal signs related to the atropine-like properties of phenothiazines have been described in rare cases (abdominal distension, meconium ileus, delayed meconium excretion, difficulty starting feeding, tachycardia, neurological disorders, etc.).

In view of these data, use of this medicinal product should be avoided as a precaution during the first trimester of pregnancy, and should only be prescribed thereafter if necessary, limited to occasional use in the 3rd trimester.
If this medicinal product is administered at the end of pregnancy, monitoring of neurological and gastrointestinal function in the newborn appears to be warranted.
Lactation
Since antihistamines are excreted into breast-milk, although in small quantities, and owing to the marked sedative properties of promethazine, this medicinal product should be avoided in breast-feeding women.

Patients who drive or use machines should be warned of the risk of drowsiness associated with this medicinal product, particularly at the start of treatment.
This is exacerbated by alcoholic beverages or medicinal products containing alcohol

Related to carbocisteine:
• Risk of severe bronchial congestion particularly in infants and in some patients incapable of effective expectoration (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).
If these occur, the dose should be reduced.
Related to promethazine:
The pharmacological characteristics of promethazine cause adverse effects of varying severity and may or may not be related to the dose (see Section 5.1).
Autonomic nervous system effects:
• sedation or drowsiness, more pronounced at the start of treatment,
• anticholinergic effects such as dryness of the mucous membranes, constipation, accommodation disorders, mydriasis, heart palpitations, risk of urinary retention,
• postural hypotension,
• balance disorders, dizziness, impaired memory or concentration,
• lack of motor coordination, tremor (more common in the elderly),
• confusion, hallucination,
• more rarely, excitatory effects: agitation, nervousness, insomnia.
Sensitization reactions:
• erythema, eczema, pruritus, purpura, urticaria, possibly giant urticaria,
• asthma attack,
• edema, more rarely angioedema,
• anaphylactic shock,
• photosensitization.
Hematological effects:
• leukopenia, neutropenia, agranulocytosis in exceptional cases,
• thrombocytopenia,
• hemolytic anemia.

Signs of overdose with promethazine
• Seizures (especially in children), consciousness disorders, coma.

• Symptomatic treatment should be initiated in a specialized setting.

Antihistamines for systemic use
(R: Respiratory System)
Promethazine
An H1-antihistamine of the phenothiazine group with an aliphatic side chain, characterized by:
• a marked sedative effect at usual doses, as a result of central histaminergic and adrenolytic activity,
• an anticholinergic effect causing peripheral adverse effects,
• a peripheral adrenolytic effect, possibly affecting hemodynamics (risk of postural hypotension).
All antihistamines are opposed to the effects of histamine, particularly on the skin, bronchi, intestine and blood vessels, through more or less reversible competitive antagonism.
Most have an antitussive effect, which is mild in itself but potentiates the effects of central morphine antitussives as well as those of other bronchodilators such as sympathomimetic amines with which they are often combined.

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 intraluminal metabolism and a marked hepatic first-pass effect.
Elimination half-life is approximately 2 hours.
Carbocisteine and its metabolites are eliminated primarily in the urine.
Promethazine bioavailability is 13 to 40%.
Peak plasma concentrations are reached within 1.5 to 3 hours.
The volume of distribution is high due to the liposolubility of the drug (approximately 15 l/kg).
Promethazine is 75-80% bound to plasma proteins.
The elimination half-life is 10 to 15 hours.
Metabolism consists of sulfoxidation followed by demethylation.
Renal clearance accounts for less than 1% of total clearance, and approximately 1% of administered promethazine is excreted unchanged in the urine. The metabolites recovered in the urine, particularly sulfoxide, account for approximately 20% of the dose.
Pathophysiological changes:
Risk of accumulation of antihistamines in patients with renal or hepatic insufficiency.

Not applicable.

Sucrose, methyl paraben (E218), caramel color powder (E150), cocoa flavor*, vanillin, alcohol, sodium hydroxide, purified water.
*Qualitative composition of the cocoa flavor: tincture of vanilla; alcohol extract of cocoa with addition of vanillin; acetic, butyric, caproic, isobutyric, valeric acid esters; ethyl, butyl, amyl, hexyl alcohol esters; ethyl alcohol and propylene glycol as solvents.

Not applicable.

This medicinal product does not require any special storage conditions

125 ml or 200 ml type III brown glass bottles sealed with an aluminum cap and a 5 ml polystyrene measuring spoon.

No special requirements.