Active substanceDimenhydrinateDimenhydrinate
Dosage form: & nbspTabletki.
Composition:

1 tablet contains:

active substance: dimenhydrinate - 50 mg;

Excipients: lactose monohydrate - 112.86 mg; cellulose microcrystalline - 57,50 mg, magnesium stearate - 1,150 mg; povidone K30 - 4.247 mg; crospovidone - 4,247 mg.

Description:

Tablets are white, round in shape, flat, with chamfers and risk on one side.

Pharmacotherapeutic group:H1-histamine receptor blocker
ATX: & nbsp

R.06.A.X   Other antihistamines for systemic use

Pharmacodynamics:

It blocks histamine H1receptors and M-cholinergic receptors of the central nervous system. Oppresses the vestibular apparatus of the inner ear, acting primarily on the otoliths, in high doses - on the semicircular canals. Has antiemetic, anorexic, sedative, moderate antiallergic effect, eliminates dizziness.

Pharmacokinetics:PAfter ingestion, the drug is well absorbed, distributed to organs and tissues. The drug appears after 15-30 minutes and persists for 3-6 hours.Virtually completely eliminated from the body with urine within 24 hours. Small amounts are excreted in breast milk.
Indications:

- Disease of motion (seasickness, car sickness, air sickness);

- prevention and treatment of symptoms of vestibular and labyrinthine disorders (dizziness, nausea, vomiting), except for symptoms caused by antitumor therapy;

- Ménière's disease.

Contraindications:

Hypersensitivity to the components of the drug, epilepsy, acute exudative and vesicular dermatoses, children under 3 years, pregnancy, lactation.

Carefully:

Convulsive syndrome, zakratougolnaya glaucoma, prostatic hyperplasia, bronchial asthma, cardiovascular diseases, hyperthyroidism, stenosing peptic ulcer, pyloroduodenal obstruction and obstruction of the neck of the bladder.

Pregnancy and lactation:

Contraindicated (I trimester of pregnancy). Perhaps with extreme caution (II-III trimester) if the expected effect of therapy exceeds the potential risk to the fetus.

For the duration of treatment, breastfeeding should be discontinued.

Dosing and Administration:

Inside, before meals:

- motion sickness (seasickness, car sickness, air sickness):

children from 3 to 6 years old - 1/4 -1/2 tablets 2-3 times a day; children from 7 to 12 years old - 1/2-1 tablet 2-3 times a day; Children over 12 years and adults - 1-2 tablets 2-3 times a day;

- prevention and treatment of symptoms of vestibular and labyrinth disorders (dizziness, nausea, vomiting), with the exception of symptoms caused by antitumor therapy:

children from 3 to 6 years old - 1 / 4-1 / 2 tablets 2-3 times a day; children from 7 to 12 years old - 1 / 2-1 tablet 2-3 times at day; Children over 12 years and adults - 1-2 tablets 2-3 times a day;

- Ménière's disease:

children from 3 to 12 years old - 1 / 2-1 tablet 2-3 times a day; dChildren over 12 years of age and adults - 1-2 tablets 2-3 times a day.

The maximum daily intake for adults should not exceed 7 tablets.

To prevent kinetosis, 1-2 tablets should be taken 30 minutes before the trip.

The duration of the drug and the possibility of repeating the course of treatment - in consultation with the doctor.

Side effects:

Parameters of incidence of side effects: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10000, <1 / 1000), very rarely (<1/10000), unspecified frequency.

Violation of the blood and lymphatic system:

Rarely: hemolytic anemia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia or pancytopenia.

Immune system disorders:

Rarely: anaphylactic shock.

Disorders of the psyche:

Often: mood changes, anxiety, stiffness of movements.

Infrequently: insomnia.

Violation of the nervous system:

Often: drowsiness.

Infrequently: impaired sense of balance, weakened concentration and memory impairment (more often in elderly patients), tremor, lack of coordination, confusion, hallucinations.

Rarely: headache, sleep disturbance, dizziness, orthostatic hypotension.

Rarely: paradoxical stimulation of the central nervous system (especially in children).

Impaired vision:

Rarely: glaucoma, vision problems (pupil dilated, blurred vision or bifurcation).

Violation of the hearing organ and labyrinthine disturbances:

Rarely: tinnitus.

Heart Disease:

Rarely: heart palpitations, tachycardia and hypotension.

Disturbance from the respiratory system, organs of the thorax and mediastinum:

Often: nasal congestion.

Disturbance of the gastrointestinal tract:

Often: dry mouth, constipation, diarrhea, nausea, abdominal pain.

Disorders from the liver and bile ducts:

Unspecified frequency: abnormal liver function (cholestatic jaundice).

Disturbance from the skin and subcutaneous tissues:

Rarely: a rash, an erythema.

Violation of the kidneys and urinary tract:

Often: violation of urination (urine retention due to anticholinergic action).

General disorders and disorders at the site of administration:

Rarely: Edema (less often - Quincke's edema).

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

Symptoms of overdose: dry mouth, nose and throat, redness of the face, slowed and shortness of breath, confusion, in children - convulsions, hallucinations. If these symptoms appear, you should immediately call your doctor.

Treatment: lavage of the stomach with a suspension of activated carbon (20-30 g), the appointment of salt laxative (10-15 grams of sodium sulfate), symptomatic therapy, with cramps in children - phenobarbital (5-6 mg / kg), diazepam.

Interaction:

Strengthens the effects of atropine, tricyclic antidepressants, catecholamines, barbiturates, alcohol, sedatives and hypnotics, neuroleptics, weakens the action of corticosteroids, anticoagulants.

Decreases the reaction to apomorphine.

Reduces the depressive effect of acetylcholine on the heart muscle.

The combination with bismuth preparations, scopolamine, analgesics and psychotropic agents increases the likelihood of a visual impairment.

Incompatible with ototoxic antibiotics (streptomycin, neomycin, biomycin, amikacin, kanamycin), t. can mask the symptoms of ototoxicity and contribute to the development of irreversible hearing loss.

Effect on the ability to drive transp. cf. and fur:

Given the side effects, caution should be exercised when engaging in potentially hazardous activities requiring increased attention and speed of psychomotor reactions (including motor vehicle management).

Form release / dosage:Tablets, 50 mg.
Packaging:

For 5 or 10 tablets in PVC / Al blister.

One blister, along with instructions for use, is placed in a cardboard box.

Storage conditions:

At a temperature not higher than 25 ° C, out of the reach of children.

Shelf life:

5 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe
Registration number:П N016084 / 01
Date of registration:17.11.2009 / 14.06.2016
Expiration Date:Unlimited
The owner of the registration certificate:Yadran Galensky Laboratories a.o.Yadran Galensky Laboratories a.o. Croatia
Manufacturer: & nbsp
Representation: & nbspYadran Galen Laboratory as.Yadran Galen Laboratory as.Croatia
Information update date: & nbsp21.11.2016
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