Symptomatic treatment of irritating, non-productive cough, occurring predominantly at night.

Posology
FOR ADULTS AND CHILDREN OVER 2 YEARS OF AGE ONLY.
In adults: 10 ml per dose, 4 times daily.
Pediatric population
In children: the daily dose is based on the child’s bodyweight (1 ml of syrup per kg of bodyweight and per day), i.e. as an indication:
• Child weighing 13 to 20 kg (i.e. 2 to 6 years of age): 5 ml per dose, 2 to 3 times daily.
• Child weighing 20 to 30 kg (i.e. 6 to 10 years of age): 10 ml per dose, 2 to 3 times daily.
• Child weighing 30 to 40 kg (i.e. 10 to 12 years of age): 10 ml per dose, 3 to 4 times daily.
• Child weighing over 40 kg (i.e. 12 years of age): 10 ml per dose, 4 times daily. Doses should be repeated if necessary. A minimum interval of 4 hours should be allowed between doses.
Method of administration
Oral use. Use the measuring cup.
Doses should preferably be given in the evening due to the sedative effect of oxomemazine, especially at the start of treatment.

This medicine is contraindicated in the following situations: • hypersensitivity to any of the ingredients, and especially to antihistamines, • because of the active substance oxomemazine: o in infants (under 2 years of age) (see section 4.4), o in patients with a history of agranulocytosis, o in patients with a risk of urinary retention related to urethro-prostate disorders, o in patients with a risk of acute closed-angle glaucoma, • in combination with cabergoline and quinagolide (see section 4.5).

Special warnings:
Productive cough, which is a fundamental part of the bronchopulmonary defense mechanism, should be left untreated.
Concomitant use of an expectorant or a mucolytic with this antitussive agent is not logical.
Before prescribing an antitussive treatment, the cough should be investigated for causes that require a specific treatment.
If the cough does not respond to antitussive treatment at normal doses, the dose must not be increased; the clinical situation should instead be re-evaluated.
Precautions for use:
RELATED TO OXOMEMAZINE:
As phenothiazines have been considered as possible risk factors in the occurrence of sudden infant death syndrome, oxomemazine must not be used in children under 2 years of age.
Monitoring (clinical and possibly EEG) should be increased in epileptic patients, as this medicine may lower the seizure threshold.
Oxomemazine should be used with caution:
• In elderly subjects with the following:
o greater sensitivity to postural hypotension, dizziness and sedation,
o chronic constipation (risk of paralytic ileus),
o possible prostate hypertrophy.
• In patients with certain cardiovascular conditions due to the tachycardia-inducing and hypertensive effects of phenothiazines.
• In patients with severe hepatic and/or renal insufficiency (due to the risk of accumulation).
Bronchial asthma and gastroesophageal reflux should be ruled out before administering oxomemazine as an antitussive treatment in children.
Use of alcoholic beverages or medicinal products containing alcohol (see section 4.5) is strongly discouraged for the duration of treatment.
Sun exposure should preferably be avoided during treatment due to the photosensitizing effect of phenothiazines.
Caution must be exercised when using H1-antihistamines due to the risk of sedation. Combined use with other sedative medicinal products is not recommended (see section 4.5).
This medicinal product contains sucrose. It is therefore not recommended in patients with fructose intolerance, glucose and galactose malabsorption syndrome or sucrase/isomaltase deficiency.
This medicinal product contains 3.7 g of sucrose per 5 ml dose, and 7.3 g of sucrose per 10 ml dose; this should be taken into account in the daily allowance of patients on a low-sugar diet or with diabetes.
This medicinal product contains sodium. This medicinal product contains 8.25 mg of sodium per 5 ml of syrup and 16.50 mg of sodium per 10 ml of syrup; this should be taken into account in patients on a strict low-salt diet.

Seizure threshold-lowering drugs
Concomitant use of seizure-inducing drugs or seizure threshold-lowering drugs should be carefully considered due to the severity of the risk for the patient. These drugs include most antidepressants (imipramine agents, selective serotonin reuptake inhibitors), neuroleptics (phenothiazines and butyrophenones), mefloquine, chloroquine, bupropion and tramadol.
Atropine-like drugs
The fact that atropine-like substances can have additive adverse effects and more easily lead to urinary retention, acute attacks of glaucoma, constipation, dry mouth, etc. must be taken into account.

Various atropine-like substances include imipramine antidepressants, most atropine-like H1- antihistamines, anticholinergic antiparkinsonian agents, atropine-like antispasmodics, disopyramide, phenothiazine neuroleptics and clozapine.
Sedative drugs
The fact that many medicinal products or substances can have additive depressant effects on the central nervous system and contribute to a decrease in alertness must be taken into account. These drugs include morphine derivatives (analgesics, antitussives and replacement therapies), neuroleptics, barbiturates, benzodiazepines, non-benzodiazepine anxiolytics (such as meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative H1- antihistamines, centrally-acting antihypertensives, baclofen and thalidomide.
Contraindicated combinations
• Non-antiparkinsonian dopamine agonists (cabergoline, quinagolide): Reciprocal antagonism of the dopamine agonist and neuroleptics.
Inadvisable combinations
• Other sedative agents: Potentiation of the sedative effect of H1-antihistamines.
• Consumption of alcohol: Alcohol potentiates the sedative effects of these substances. Impaired alertness can make it dangerous to drive or operate machinery. Alcoholic beverages and medicinal products containing alcohol should be avoided.
Combinations requiring precautions for use
• Topical gastrointestinal agents, antacids and charcoal: Decreased gastrointestinal absorption of phenothiazine neuroleptics. Phenothiazine neuroleptics should not be administered concomitantly with topical gastrointestinal agents (an interval of more than 2 hours should be allowed if possible).
Combinations to be taken into account
• Antihypertensive agents: The risk of hypotension, particularly postural hypotension, is increased.
• Beta-blockers (except for esmolol and sotalol): Vasodilator effect and risk of hypotension, particularly postural hypotension (additive effect).
• Beta-blockers used in heart failure (bisoprolol, carvedilol, metoprolol, nebivolol): Vasodilator effect and risk of hypotension, particularly postural hypotension (additive effect).
• Nitrates, nitrites and related drugs: The risk of hypotension, particularly postural hypotension, is increased.

Whether a drug contains oxomemazine is a determining factor when defining therapeutic options for pregnant and breast-feeding women. Pregnancy
Teratogenicity:
There are no reliable data on teratogenesis in animals.
No sufficiently relevant data are currently available to evaluate a possible teratogenic or fetotoxic effect of oxomemazine when administered during pregnancy.
Fetotoxicity:
Rare cases of gastrointestinal signs related to the atropine properties of the drugs have been described in neonates whose mothers had received long-term treatment with high-dose anticholinergic agents (abdominal distension, meconium ileus, delayed meconium excretion, difficulty initiating feeding, tachycardia, neurological disorders, etc.).
Based on these data, use of this medicinal product is not recommended during the first trimester of pregnancy. Thereafter, it should only be prescribed when necessary, for limited use only in the 3rd trimester.
If this medicinal product is administered at the end of pregnancy, monitoring of the neurological and gastrointestinal functions of the neonate appears to be warranted.

Lactation
It is not known whether oxomemazine is excreted in human breast milk. Due to the possibility of sedation or paradoxical excitation in the neonate, and especially the risk of sleep apnea reported with phenothiazines, administration of this medicinal product is not recommended during breast-feeding.

Patients, particularly those who drive vehicles or use machines, should be aware of the risks of drowsiness that can occur following use of this medicinal product, particularly at the beginning of treatment. This effect is accentuated by the use of alcoholic beverages and medicinal products containing alcohol.

The pharmacological characteristics of oxomemazine cause adverse effects of unequal intensity that are dose-dependent or non dose-dependent (see Pharmacodynamic properties).
Effects on the autonomic nervous system:
•sedation or drowsiness, more marked at the beginning of treatment;
•anticholinergic effects such as dry mucosa, constipation, accommodation disorders, mydriasis, heartpalpitations, risk of urinary retention;
•postural hypotension;
•balance disorders, dizziness, loss of memory or diminished concentration (more common in elderlysubjects);
•lack of motor coordination, tremor;
•mental confusion, hallucinations;
•more rarely, excitation-related effects, such as agitation, nervousness and insomnia.
Hypersensitivity reactions:
•erythema, eczema, pruritus, purpura, urticaria, which may be giant urticaria,
•edema, more rarely angioedema,
•anaphylactic shock,
•photosensitization.
Blood disorders:
•leukopenia, neutropenia and very rare cases of agranulocytosis,
•thrombocytopenia,
•hemolytic anemia.
This medicinal product contains glycerol. There is therefore a risk of gastrointestinal disorders and diarrhea.

To report any side effect(s):
•  Saudi Arabia:
-  The National Pharmacovigilance and Drug Safety Centre (NPC)
•  SFDA call center : 19999
•  E-mail: npc.drug@sfda.gov.sa
•  Website: https://ade.sfda.gov.sa/
• Sanofi- Pharmacovigilance: KSA_Pharmacovigilance@sanofi.com

Other GCC States:
- Please contact the relevant competent authority.

 

Signs of an oxomemazine overdose: seizures (especially in children), consciousness disorders, coma.
Symptomatic treatment should be instituted in a specialized setting.

Pharmacotherapeutic group: ANTIHISTAMINES FOR SYSTEMIC USE, ATC code: R06AD08 (R: Respiratory system).
Oxomemazine: H1-antihistamine of the phenothiazine group with an aliphatic side chain, characterized by:
• a distinct sedative effect at usual doses, of central adrenolytic and histaminergic origin,
• an anticholinergic effect that can cause peripheral adverse effects,
• a peripheral adrenolytic effect that may have an impact on hemodynamics (risk of postural hypotension).
Antihistamines have the common property of inhibiting, through more or less reversible competitive antagonism, the effects of histamine, particularly on the skin, the bronchi, the intestines and blood vessels.

Pharmacokinetic data on oxomemazine are insufficient.
The following general information about all antihistamines, and particularly phenothiazines, applies:
• Bioavailability is generally moderate.
• Metabolism may potentially be intense, with the formation of numerous metabolites, which accounts for the very low percentage of parent drug found unchanged in the urine.
• The half-life varies but is often prolonged, enabling a single daily dose to be used.
• The volume of distribution is high due to the liposolubility of these active substances. Pathophysiological variation: risk of accumulation of antihistamines in patients with kidney or liver failure.
 

Not applicable

Sodium benzoate, glycerol, citric acid monohydrate, sodium citrate, caramel compound flavor (caramel, fenugreek resinoid, methyl cyclopentenolone hydrate, maltol, butyric acid, piperonal, diacetyl, ethyl vanillin, vanillin, propylene glycol, distilled water), caramel (E150), sucrose solution, purified water.

Not applicable.
 

3 years. Store for a maximum of 6 months after opening the bottle.

Store at a temperature no higher than 25°C.
Store in original immediate packaging, protected from light.
For storage conditions for the medicinal product after initial opening, see section
 

150 ml in (amber glass, type III) bottles with a (polypropylene) measuring cup and (aluminum) cap. 200 ml in (amber glass, type III) bottles with a (polypropylene) measuring cup and (aluminum) cap. 250 ml in (amber glass, type III) bottles with a (polypropylene) measuring cup and (aluminum) cap. Not all pack sizes may be marketed.

No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.