Alimemazine ………………. 5 mg
(As alimemazine tartrate)
Film coated tablet.
Product description: A dark pink, film-coated tablet, imprinted with on one side, scored on the other side, undamaged edges.
Box of 2 blisters x 25 film coated tablets.
Box of 10 blisters x 10 film coated tablets.
ANTIHISTAMINES FOR SYSTEMIC USE, ATC code: R06AD01.
Alimemazine is an aliphatic side-chain phenothiazine.
Alimemazine has properties:
- neuroleptics and sedatives at the usual doses,
- H1 antihistamines,
- antidopaminergics,
- central and peripheral anticholinergics (atropine),
- adrenolytics (risk of orthostatic hypotension).
These activities cause adverse effects and are exacerbated in overdose and in polypharmacy subjects who are at increased risk of drug interactions.
Pharmacokinetic data with alimemazine are insufficient.
The central nervous effects of alimemazine testify to the passage of blood-brain barrier of alimemazine.
Patients, particularly vehicle operators and machine users should be warned about drowsiness during the early days of treatment.
This symptom is accentuated by the intake of alcoholic beverages or drugs containing alcohol.
Start treatment at night.
Pregnancy
Given the available data, it is preferable as a precaution to avoid using alimemazine during pregnancy.
Indeed, animal data are insufficient to conclude and clinical data are reassuring, but limited.
In treated at the end of pregnancy, take into account the anticholinergic and sedative properties of this molecule for monitoring the newborn.
Breastfeeding
It is not known whether alimemazine passes into breast milk. Given the possibilities of sedation or paradoxical excitement of the newborn, and even more risks of sleep apnea associated with phenothiazines, this drug is not recommended during breastfeeding.
Combination with medicines known to prolong the QT interval
Caution is required when alimemazine is prescribed in combination with QT-prolonging drugs, such as antiarrhythmics (e.g., quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), tricyclic antidepressants (amitriptyline), tetracyclic antidepressants (maprotiline), some antihistamines, antipsychotics, certain antimalarials (quinine and mefloquine), and drugs causing electrolyte disturbances (hypokalemia, hypomagnesemia), bradycardia. Risk of increased QT interval.
Combinations not recommended
+ ALCOHOL
Alcohol enhances the sedative effect of antihistamines. impaired alertness can make driving vehicles and using machines dangerous.
Avoid taking alcoholic beverages and other drugs containing alcohol.
+ LITHIUM
Risk of neuropsychological signs suggestive of neuroleptic malignant syndrome or lithium intoxication.
Regular clinical and biological monitoring, especially at the beginning of the association.
+ TOPICAL GASTROINTESTINAL TRACT, ANTIACIDS AND ADSORBENTS
Decreased absorption of alimemazine. Topical drugs or antacid, adsorbents should be taken away from alimemazine (more than 2 hours, if possible).
Combinations to take into account
+ OTHER SEDATIVE DRUGS, HYPNOTICS, CENTRAL NERVOUS SYSTEM DEPRESSANTS (certain sedative antidepressants: amitriptyline, doxepine, mianserine, mirtazapine, trimipramine barbiturates, benzodiazepines and zolpidem or zopiclone, other anxiolytics, central antihypertensives, hypnotics, morphine derivatives (analgesics, antitussives, substitution treatments), other sedative antihistamines, neuroleptics, baclofen, thalidomide).
Increase of the central depression. Impaired alertness can make driving and using machines dangerous.
+ ATROPINE AND OTHER ANTI-CHOLINERGIC SUBSTANCES (imipramine antidepressants, anticholinergic antiparkinson drugs, atropine antispasmodics, disopyramide, phenothiazine neuroleptics, atropine H1 antihistamines, clozapine)
Addition of anticholinergic adverse effects such as urinary retention, constipation, dry mouth.
+ DAPOXETINE
Risk of aggravation of adverse effects, particularly vertigo or syncope.
+ BLOOD PRESSURE LOWERING DRUGS
Increased risk of hypotension, particularly orthostatic.
+ OTHER DRUGS THAT LOWERING EPILEPTOGENIC THRESHOLD (antidepressants (imipramines, selective serotonin reuptake inhibitors), neuroleptics (phenothiazines and butyrophenones), mefloquine, chloroquine, fluoroquinolones, bupropion, tramadol)
Increased risk of convulsions.
+ BETA-BLOCKING IN CARDIAC INSUFFICIENCY
Vasodilator effect and risk of hypotension, particularly orthostatic (additive effect).
+ ORLISTAT
Risk of treatment failure in concomitant treatment with Orlistat.
The pharmacological characteristics of alimemazine are those of phenothiazines which cause undesirable effects. The intensity and frequency of occurrence of adverse effects are increased in the elderly and children.
Heart conditions: Palpitations; Bradycardia, tachycardia; Rhythm disorders; QT interval prolongation (which could potentially lead to torsades de pointes)
Vascular disorders: Orthostatic hypotension.
Gastrointestinal disorders: Constipation, decreased intestinal peristalsis with possibility of ischemic colitis and intestinal necrosis.
Blood and lymphatic system disorders: Leukopenia, neutropenia, rare agranulocytosis; Thrombocytopenia; Hemolytic anemia.
Hepatobiliary disorders: Cholestatic jaundice, predominantly cholestatic hepatitis.
Eye disorders: Accommodation disturbances; Mydriasis; Hypotonic iris syndrome; Acute glaucoma; Brownish deposits in the anterior segments of the eye due to accumulation of the product, generally without impact on vision.
Reproductive system and breast disorders: Hyperprolactinemia: amenorrhea, galactorrhea, gynecomastia; Disorders of ejaculation and erection.
Skin and subcutaneous tissue disorders: Photosensitization; Allergic skin reactions: erythema, eczema, pruritus, purpura, possibly giant urticaria.
Renal and urinary disorders: Urinary retention.
Respiratory, thoracic and mediastinal disorders: Hyperviscosity of bronchial secretions.
Immune system disorders: Systemic allergic reactions, anaphylactic shock, more rarely angioedema.
Psychiatric conditions: Indifference, anxious reactions, mood disorders; Confusional state (more common in the elderly); Hallucinations; Excitement, nervousness, insomnia.
Nervous system disorders: Balance problems, dizziness; Impaired memory or concentration; Sedation or drowsiness, more marked at the beginning of treatment; Motor incoordination, tremors (more common in the elderly); Rare cases of seizures, mainly in case of a history of epilepsy or in the presence of other risk factors, such as combination with other drugs lowering epileptogenic threshold or intake of alcohol; Neuroleptic malignant syndrome; Thermoregulation disorder (which can be a warning of a neuroleptic malignant syndrome); Early dyskinesias (spasmodic torticollis, oculogyric crises, trismus); Tardive dyskinesia, occurring mainly during prolonged treatment. These tardive dyskinesias sometimes occur when the neuroleptic is stopped and disappear when it is reintroduced or the dosage is increased. Antiparkinsonians have no effect or can cause aggravation; Extrapyramidal syndrome: akinetic, with or without hypertonia; Akathisia; Restless legs syndrome.
General disorders and administration site conditions: Dryness of mucous membranes.
Metabolism and nutrition disorders: Hyperglycemia, impaired glucose tolerance, impaired glycoregulation (including hypoglycaemia); Weight gain, increased appetite.
Please inform your doctor of all undesirable effects upon drug administration.
Signs and symptoms of an alimemazine overdose result from an exacerbation of its pharmacological effects. They include respiratory depression, blood pressure disorders, convulsions (particularly in children), impaired consciousness, coma. Cases of QT interval prolongation have been reported during overdose with alimemazine.
Symptomatic treatment and appropriate resuscitation measures should be instituted in hospitals.
Store in dry places, not exceeding 30oC, protect from light.
Insomnia
Insomnia can have various causes that do not necessarily require medication.
The cause of insomnia should if possible be identified and any underlying factors treated.
Persistence of insomnia after 5 days of this treatment may indicate an underlying pathology and the treatment should be re-evaluated.
Neuroleptic malignant syndrome
Cases of neuroleptic malignant syndrome have been reported with alimemazine. Neuroleptic malignant syndrome is characterized by hyperthermia, muscle rigidity, autonomic nervous system instability, impaired consciousness, and increased blood creatine phosphokinase (CPK). Additional signs may include myoglobinuria (a symptom of rhabdomyolysis) and acute renal failure. Any signs suggestive of neuroleptic malignant syndrome should immediately discontinue treatment with alimemazine. In case of unexplained hyperthermia, it is imperative to suspend treatment with alimemazine because this sign may be one of the elements of the neuroleptic malignant syndrome. Signs of autonomic dysfunction, such as pallor, excessive sweating, and arterial instability, may be early warning signs preceding the onset of hyperthermia. Although the neuroleptic malignant syndrome may have an idiosyncratic origin, certain risk factors seem to predispose, such as dehydration or organic brain damage.
Agranulocytosis
Cases of agranulocytosis have been reported with alimemazine. The occurrence of fever, angina or other infection should lead to a medical examination and control of the blood count. Alimemazine treatment should be immediately discontinued in case of neutropenia or granulopenia.
Patients with epilepsy or at risk of seizures
Phenothiazines lower the seizure threshold. Caution is required and monitoring should be reinforced in epileptic patients or at risk for convulsions.
Elderly patients
Alimemazine is not recommended in elderly patients who, because of their greater sensitivity, are at increased risk of orthostatic hypotension, dizziness, falls, sedation, extrapyramidal effects, and respiratory depression.
Due to the anticholinergic properties of alimemazine, caution is also required in the elderly with chronic constipation (risk of paralytic ileus), prostatic hypertrophy (risk of urinary retention) or treatment with anticholinesterases (risk of confusional state).
If alimemazine is used anyway, the dosage should be reduced.
Decreased intestinal peristalsis
Cases of intestinal obstruction have been reported in patients treated with neuroleptic anticholinergics. Rare cases of ischemic colitis and intestinal necrosis, sometimes fatal, have also been reported. The majority of these patients were treated concomitantly with one or more drugs inducing a decrease in intestinal motility (particularly drugs with anticholinergic properties). The appearance of abdominal pain with vomiting and/or diarrhea during treatment should attract attention. Constipation must be recognized and actively treated. The occurrence of an ileus/intestinal obstruction syndrome requires emergency management.
Depressant effects of the central nervous system
Alimemazine has a central depressant effect that can aggravate a pre-existing sleep apnea syndrome (increase in the number and duration of apnea).
The sedative action of alimemazine may be potentiated by the administration of any other central nervous system depressant (especially alcohol). Use of alcoholic beverages and medicines containing alcohol is strongly discouraged during the course of treatment.
Polypharmacy subjects
Caution is required in polypharmacy subjects because of the potential for drug interactions and potentiation of adverse effects.
Combination with acetylcholinesterase inhibitors should be avoided. Acetylcholinesterase inhibitors may interfere with anticholinergic activity.
Cardiovascular disorders
Alimemazine should be used with caution in subjects with cardiovascular disorders because of the tachycardic and hypotensive effects of phenothiazines.
Cases of prolonged QT interval have been reported with alimemazine most often in combination with other drugs that may prolong QT interval. Caution is required in patients with a personal or family history of prolonged QT interval and concomitant use of QT-prolonging drugs.
Photosensitization
Given the photosensitizing effect of phenothiazines, it is recommended not to be exposed to the sun during treatment.
Hepatic or renal insufficiency
The elimination of alimemazine is decreased in case of severe hepatic and/or renal insufficiency. It is best not to administer alimemazine in patients with renal or hepatic impairment due to the risk of accumulation. If a treatment is started anyway, the doses should be decreased.
Excipients
Wheat starch
This medicine contains only very low levels of gluten. It is very unlikely to cause problems if you have coeliac disease. If you have a wheat allergy you should not take this medicine.
Lactose monohydrate
Patients with rare hereditary problems of galactose intolerance, glucose-galactose malabsorption, Lapp lactase, or sucrase-isomaltase insufficiency should not take this medicine.
Cough and pruritus in adults and children aged > 6 years
Cough of various etiologies may occur in: acute or chronic conditions of upper respiratory tract, persistent cough, bronchial irritation, whooping cough.
Pruritus regardless of site or etiology may occur in: neurodermatitis, eczema, urticaria, pruritus ani, dermatitis herpetiformis, insect bites, contact dermatitis; pruritus due to non-dermatological conditions: chicken pox, measles, Hodgkin’s disease, obstructive jaundice, diabetes, zona.
Insomnia in adults and children aged > 6 years
Adults: treatment of occasional or transient insomnia.
Children aged over 6 years and weighed more than 20 kg: short-term and second-line treatment of insomnia related to a state of hyperarousal (increased vigilance related to anxiety at bedtime), after failure of behavioral measures alone.
Related to anticholinergic effects:
• Personal or family history of acute glaucoma due to iridocorneal angle closure.
• Urethroprostatic disorders at risk of urinary retention.
Others:
• Hypersensitivity to the active substance or any of the excipients mentioned in the list of excipients section (presence of wheat starch).
• Children aged under 6 years are contraindicated because of the risk of choking.
• History of agranulocytosis with other phenothiazines.
• History of neuroleptic malignant syndrome.
• Parkinson's disease or Parkinson's syndrome.
This medicine is generally not recommended:
• During pregnancy.
• If breastfeeding.
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE.
METHOD OF ADMINISTRATION: For oral use.
POSOLOGY
The dosage may vary for each patient. In all cases, the lowest effective dose should be used and the dose should be individually adjusted according to the severity of symptoms and patient response.
Treatment of cough and pruritus
Adults: 2.5 - 5 mg twice daily after meals plus 5 mg at bedtime. In predominantly nocturnal conditions, a single dose of 5 to 10 mg at bedtime.
Children (from 6 to 12 years): 2.5 - 5 mg at bedtime. If necessary, an additional dose of 2.5 mg twice daily after meals may be given. The daily dose should rarely exceed 15 mg.
Use of higher dosage in hospitalized adult patients.
Daily doses up to 80 mg (in divided doses) may be occasionally used in case of severe pruritus resistant to the usual doses.
Because pronounced drowsiness is expected to occur, these dosages should be given only to hospitalized adult patients.
Do not exceed the recommended dose.
Treatment of insomnia
Take once per day, 15 to 30 minutes before bedtime.
Adult: 5 to 10 mg (or 1 to 2 tablets), particularly a maximum dose of 20 mg (or 4 tablets).
Children aged older than 6 years and weighed more than 20 kg: 0.25 to 0.50 mg alimemazine per kg body weight, i.e.:
- Children weighed 40 to 50 kg (approximately 10 to 15 years): 1 to 2 tablets
- Children weighed from 20 to 40 kg (over 6 to 10 years of age): 1 tablet.
Do not exceed the maximum recommended dose.
Treatment should be as short as possible (2 to 5 days). If insomnia persists beyond this period, treatment should be re-evaluated.
Special populations
Elderly patients
The dosage should be reduced in elderly patients.
Patients with renal or hepatic impairment
The dosage should be reduced. However, in the absence of data in patients with renal or hepatic impairment, it is preferable not to use alimemazine in patients with renal or hepatic impairment.
Pediatric population
Children aged under 6 years are contraindicated because of the risk of choking. Other dosage forms should be advised for children.
Or as directed by the physician.
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