Instructions for Resleep (Doxylamine) pills 15 mg
English product name
Reslip
Release form:
Coated tablets
Description:
The tablets, which are covered with a film shell of white or almost colour, are double-convex and have an elongated shape with rounded ends,
with risk; on the cross section, the inner layer is white or almost white.
1 tab.
Doxylamine succinate 15 mg
Auxiliary substances: lactose monohydrate - 50 mg, silicon dioxide colloidal (aerosyl) - 0.5 mg, cellulose microcrystalline - 27.7 mg, sodium croskarmellose - 5 mg, povidone - 0.8 mg, magnesium stearate - 1 mg.
Film sheath composition: Hypromellose (hydroxypropyl methylcellulose) - 1.8 mg, macrogol 6000 (polyethylene glycol 6000) - 0.6 mg, titanium dioxide - 0.6 mg.
ATC codes
R06AA09 Doxylamine
Clinical-pharmacological groups / Group affiliation
Sleeping drug Resleep
Active substance
Doxylamine succinate
Pharmacotherapy group:
Histamine H1 receptor antagonist
Storage Conditions
The drug Resleep should be stored in a place inaccessible to children at a temperature not higher than 25 ° C.
Best before date
Shelf life is 3 years. Do not apply after the expiry date indicated on the package.
Pharmacological effect:
Histamine H1 receptor blocker from the ethanol group.
Has sedative, sleeping effects.
Reduces falling asleep time, improves sleep duration and quality, does not change sleep phases.
the drug has an anti-allergic effect. It has m-choline-blocking activity.
The degree of sedation is comparable to barbiturates. Activity duration - six - eight hours
Duration of action - 6-8 hours.
Testimony:
transient sleep disturbances.
Method of use, course and dosage:
The preparation is used internally, for 15-30 minutes before sleep. The tablets are washed down with a small amount of liquid.
The recommended dose is 1/2-1 tabb/day. If the treatment is ineffective, the dose may be increased to 2 tabs on the doctor's recommendation.
Duration of treatment - from 2 to 5 days; If insomnia persists, the patient should see a doctor.
Due to evidence of increased blood plasma concentration and decreased plasma clearance of Doxylamine, reduced dose is recommended for patients with renal and liver failure.
Histamine H1 receptor blockers should be cautiously prescribed for patients over 65 years of age due to possible dizziness and delayed reactions with a risk of falls (e.g. during night-time waking after sleeping pills). In view of evidence of increased blood plasma concentration, decreased plasma clearance and increased T1/2, a reduced dose is recommended.
Overdose:
Symptoms: daytime drowsiness, arousal, midriasis, accommodation disorders, dry mouth, facial and neck skin hyperemia, hyperthermia, sinus tachycardia, disorder of consciousness, hallucinations, decreased mood, anxiety, violation of movement coordination, tremors, atetosis, convulsions (epileptic syndrome), coma.
Involuntary movements are sometimes a harbinger of seizures, which can indicate a severe poisoning. Even in the absence of cramps, severe poisoning can cause the development of rhabdomyolysis, which is often accompanied by acute renal failure. In such cases standard therapy with constant control of CFC activity is shown.
If symptoms of poisoning occur, the patient should immediately consult a doctor.
Treatment: symptomatic (m-cholinomimetics and other means), activated carbon is indicated as first aid (50 g for adults and 1 g/kg for children).
Drug interaction:
When the preparation Reslip® with sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), barbiturates, benzodiazepines, clonidine, morphine derivatives (analgesics, anti-cough preparations), neuroleptics, anxiolytics, histamine H1 receptor blockers with sedative effect, antihypertensive central action drugs Resleep, thalidomide, baclofen, pizotifen is used simultaneously the oppressive action on the CNS.
When used simultaneously with m-cholinocentating agents (atropine, imipramine antidepressants, antiparkinsonian drugs, atropine spasmolytics, disopiramide, phenothiazine neuroleptics), the risk of side effects such as delayed urine, constipation, dry mouth increases.
Since ethanol enhances the sedative effect of most histamine H1 receptor antagonists, including Reslip®, it is necessary to avoid simultaneous use of this drug Resleep with alcoholic beverages and ethanol-containing drugs Resleep.
Use in pregnancy and breastfeeding
Based on the results of adequate and well-controlled studies, can be used in pregnant women throughout pregnancy.
In the case of late pregnancy, atropine-like and sedative should be taken into account when monitoring the condition of the newborn.
It is not known whether Doxylamine penetrates breast milk. Due to the possibility of developing a sedative and stimulating effect in the child should not be breastfed when using the drug Doxylamine.
Side Effect:
On the digestive side: constipation, dry mouth.
On the cardiovascular side: the feeling of a heartbeat.
From the viewpoint of: visual impairments and accommodation, blurred vision.
From the nervous system: Daytime sleepiness (in this case the dose of the drug Doxylamine should be reduced), confusion, hallucinations.
From the urinary system: urine delay.
On the laboratory side: increase in CFC activity.
From the side of the musculoskeletal system: rabdomyolysis.
Contraindications for use:
angle-closure glaucoma or family history of angle-closure glaucoma;
diseases of the urethra and prostate gland, accompanied by a violation of urine;
lactose intolerance, lactase deficiency, glucose-galactic malabsorption;
children and adolescents under the age of 15;
hypersensitivity to other components of doksylamine drug or other antihistamines.
With caution: patients with a history of apnea (due to the fact that it can aggravate the syndrome of night apnea); patients older than 65 years (due to possible dizziness and delayed reactions with a risk of falls (for example, during night wakefulness after taking sleeping pills), as well as a possible increase in T1 / 2); patients with renal and hepatic insufficiency (T1/2 may increase)
Special Instructions:
It should be taken into account that insomnia can be caused by a number of reasons, when it is not necessary to prescribe this drug Resleep.
The drug Resleep has sedative effects, suppresses cognitive abilities and slows psychomotor reactions. The first generation of histamine H1 receptor blockers may have m-cholinocclusive, antialpha-adrenergic, and antiserotonin effects, which may cause dry mouth, constipation, urine retention, accommodation and visual impairment.
Like all sleeping pills or sedatives, doxylamine can exacerbate night apnea syndrome by increasing the number and duration of apnea attacks.
Use in children
The use of the preparation in childhood and adolescence up to fifteen years is contraindicated.
Nosology (ICD codes)
F51.2
Sleep and wake disorders of inorganic etiology
