One tablet contains active ingredients: cinnarizine 20 mg, dimensionhydrinate 40 mg
Indications for use
Symptomatic treatment of dizziness of various origins.
Adults: one tablet 3 times a day, take after meals with a small amount of liquid without chewing.
In general, the duration of use of the drug should not exceed 4 weeks. Longer treatment should be decided by the doctor.
Children and adolescents under the age of 18 years: in children and adolescents under 18 years of age, it is not recommended to use Arlevert®, since there are no data on the use of Arlevert® in this age group.
Elderly patients: the same dose is used as for adults.
With kidney dysfunction:
In patients with mild to moderate renal impairment, Arlevert® should be used with caution. In patients with creatinine clearance <25 ml / min (severe renal impairment), Arlevert® should not be used.
If liver function is impaired:
In patients with impaired liver function, studies of the efficacy and safety of Arlevert® have not been conducted. If the liver function is severely impaired, Arlevert® should not be used.
The most common side effects include confusion (including drowsiness, fatigue, fatigue, dullness), which was reported in about 8% of participants in clinical trials, and dry mouth, which was noted in about 5% of participants. Usually these reactions are mild and stop within a few days, even with continued treatment. Data on the frequency of side effects that occurred during the use of the drug Arlevert® in clinical trials and in subsequent spontaneous reports are given below:
Often> 1/100, <1/10
– drowsiness, headache
– dry mouth, abdominal pain
Sometimes> 1/1000, <1/100
– paresthesia, amnesia, tinnitus, tremors, nervousness, convulsions
– dyspepsia, nausea, diarrhea
– sweating, rash
Rarely> 1/10000, <1/1000
– allergic reactions (for example, skin reactions)
– visual impairment
Difficulty starting to urinate
Very rare <1/10000
– leukopenia, thrombocytopenia, aplastic anemia
In addition, the following adverse reactions are associated with the use of dimensionhydrinate and cinnarizine:
Dimenhydrinate: paradoxical excitability (especially in children), aggravation of the existing angle-closure glaucoma, reversible agranulocytosis.
Cinnarizine: constipation, weight gain, chest tightness, cholestatic jaundice, extrapyramidal disorders, skin reactions like lupus erythematosus, lichen planus.
– severe renal dysfunction (creatinine clearance £ 25 ml / min)
– severe liver dysfunction
– hypersensitivity to active substances, diphenhydramine or other antihistamines of a similar structure, or to any of the auxiliary components of the drug
– patients with angle-closure glaucoma, convulsions, suspected increased intracranial pressure, as well as patients suffering from alcoholism and urinary retention caused by disorders of the urethra and prostate.
The anticholinergic and sedative efficacy of Arlevert® may be enhanced by the use of monoamine oxidase inhibitors. The effect of the drug Arlevert® can be enhanced by procarbazine.
Like other antihistamines, Arlevert® can enhance the sedative efficacy of drugs that depress the central nervous system, in particular alcohol, barbiturates, narcotic analgesics and tranquilizers. Patients should be warned not to consume alcoholic beverages during treatment with Arlevert®. Arlevert® can also enhance the effects of antihypertensive drugs, ephedrine and anticholinergics, in particular atropine and tricyclic antidepressants.
Arlevert® can mask the manifestations of the ototoxic effect of antibiotics-aminoglycosides and the skin reaction to allergic skin tests.
Avoid the simultaneous use of Arlevert® with drugs that prolong the QT interval on the ECG (for example, antiarrhythmics of classes Ia and III).
There is not enough information on the possible pharmacokinetic interaction of cinnarizine and diphenhydramine with other drugs. Diphenhydramine inhibits the metabolic processes mediated by the cytochrome IID6 isoenzyme, therefore, caution is advised when using Arlevert® in combination with substrates of this enzyme (especially those with a narrow therapeutic range).
Arlevert® does not significantly lower blood pressure, but it should be used with caution in patients with low blood pressure.
To minimize irritation of the gastric mucosa, Arlevert® should be used after meals.
Arlevert® should be used with caution in patients with diseases or conditions that may be aggravated by the use of anticholinergics, for example, in patients with increased intraocular pressure, obstruction of the pylorus of the stomach and duodenum, prostate hypertrophy, arterial hypertension, thyrotoxicosis, or severe coronary artery disease.
Arlevert® should be used with caution in patients with Parkinson’s disease.
Application during pregnancy and lactation
The safety level of Arlevert® in pregnant women has not been established. To assess the effect of the drug on pregnancy, embryo and fetal development, and postnatal development, animal tests alone are not enough. The risk of a teratotogenic effect of each of the components separately (dimensionhydrinate / diphenhydramine and cinnarizine) is small. In animal tests, no teratotogenic effect was found.
Dimenhydrinate may have a stimulating effect on the muscles of the uterus and shorten the duration of labor. For this reason, Arlevert® should not be used during pregnancy.
Dimenhydrinate and cinnarizine pass into mother’s milk. For this reason, Arlevert® should not be used in women who are breastfeeding.
Features of the effect of the drug on the ability to drive a vehicle and potentially dangerous mechanisms
Arlevert® may cause drowsiness, especially during the initial phase of treatment. In such cases, patients should not drive vehicles or service machinery.
Symptoms: drowsiness, dizziness and ataxia combined with anticholinergic manifestations such as dry mouth, facial flushing, dilated pupils, tachycardia, fever, headache and urinary retention. Complications such as convulsions, hallucinations, agitation, respiratory depression, arterial hypertension, tremors and coma can also occur (especially in the case of severe overdose).
Treatment: in case of respiratory depression or acute circulatory failure, the patient should be prescribed supportive therapy. It is recommended to flush the stomach with isotonic sodium chloride solution. Body temperature should be closely monitored, as intoxication with antihistamines can cause fever (especially in children).
For cramping pains, short-acting barbiturates can be prescribed, but they should be used with caution. In the case of a pronounced anticholinergic effect on the central nervous system, a test with physostigmine should be performed, and then physostigmine should be prescribed by slow intravenous infusion (or, if necessary, by intramuscular injection) at a dose of 0.03 mg / kg body weight (the maximum dose for adults is 2 mg; the maximum dose for children is 0.5 mg).
Dimenhydrinate can be removed from the blood by hemodialysis, but this method of treatment for overdose is considered unacceptable. It is possible to remove the required amount of the drug from the blood by means of hemoperfusion using activated carbon. There are no data on the removal of cinnarizine by hemodialysis.
Store at a temperature not exceeding 25 ºC.
Keep out of the reach of children!
Shelf life 3 years
Do not use after the expiration date!