HYPNODORM

Israel - English - Ministry of Health

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Active ingredient:
FLUNITRAZEPAM
Available from:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
ATC code:
N05CD03
Pharmaceutical form:
TABLETS
Composition:
FLUNITRAZEPAM 2 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
Therapeutic group:
FLUNITRAZEPAM
Therapeutic area:
FLUNITRAZEPAM
Therapeutic indications:
Insomnia of various etiology.
Authorization number:
032 33 22417 00
Authorization date:
2013-06-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

26-10-2016

This leaflet format has been

determined by the Ministry of

Health and the content thereof has

been checked and approved

PATIENT PACKAGE INSERT

IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS

(PREPARATIONS) - 1986

This medicine is dispensed with a

doctor’s prescription only

HyPNODORM

®

Tablets

COMPOSITION

Each tablet contains:

Flunitrazepam 2 mg.

For a list of the inactive ingredients,

see section 6 in this leaflet.

Read this leaflet carefully in its

entirety before using this medicine.

This leaflet contains concise information

about the medicine. If you have further

questions, refer to the doctor or

pharmacist.

This medicine has been prescribed

for the treatment of your ailment. Do

not pass it on to others. It may harm

them even if it seems to you that their

medical condition is similar.

Introduction

This

medicine

belongs

benzodiazepine group, which has

special characteristics that demand

great caution when used. Medicines

from this group impair the quality of

sleep, suppress deep refreshing sleep

and therefore cause ineffective and

superficial sleep.

Close medical monitoring is

very important when taking this

medicine. Therefore, when you

are taking this medicine, be sure

to refer to a doctor after 7-10 days

of treatment, as the treatment is

intended for a short period of time

only.

Prolonged use of this medicine may

lead to a diminution in the efficacy

of the medication. Such use may

also cause severe dependence, in

which the patient will find it difficult

to discontinue the intake of this

medicine. Sometimes, prolonged

use of this medicine may cause

changes in behavior patterns

as well as bring on troublesome

thoughts.

Uncontrolled discontinuation of

treatment may be accompanied

by withdrawal symptoms such as:

tension, nervousness, confusion,

trembling, recurrence of insomnia,

abdominal pain, nausea, vomiting,

sweating, seizures.

Elderly: Be careful to lean on

something when standing up

from a lying or sitting position, as

this medicine impairs alertness

and sometimes body movement

coordination; therefore falling is a

concern.

1. WHAT

IS

THE

MEDICINE

INTENDED FOR?

This medicine is intended to treat

insomnia.

Therapeutic group:

Benzodiazepine group.

2. BEFORE USING THE MEDICINE

Do not use this medicine:

During the first trimester of

pregnancy or while breastfeeding

If you have a known sensitivity to

flunitrazepam or to any of the other

medicine’s ingredients or to other

medicines from the benzodiazepine

group

I n

p a t i e n t s

s u ff e r i n g

from

psychiatric

problems,

from

respiratory depression, from severe

pulmonary insufficiency, from acute

angle-closure glaucoma, from

myasthenia gravis (severe muscle

weakness), from severe liver failure

or from sleep apnea syndrome

(paused breathing during sleep)

Do not use in children

Special warnings regarding use of

the medicine:

The medicine contains lactose and

may cause an allergic reaction in

people sensitive to lactose.

If you are sensitive to any type of

food or medicine, inform the doctor

before taking the medicine.

Use of this medicine may impair

alertness, cause drowsiness and/or

dizziness and therefore caution

is required when driving a car,

operating dangerous machinery

and when engaging any activity

which requires alertness.

P ro l o n g e d

u s e

c a u s e

dependence! (See introduction

above).

Inform the doctor if you are about

to undergo laboratory or diagnostic

tests (e.g., EEG), as this medicine

may affect the test results.

Inform every doctor, including

the dentist, that you are using

this medicine, especially before

undergoing a surgical procedure.

Before treatment with Hypnodorm

®

tell the doctor:

If you are suffering, or have suffered

in the past from impaired function

- the respiratory system (e.g.,

asthma)

- the liver

- the kidney

- low blood pressure

- blood disorders

- glaucoma (increased intraocular

pressure)

- depression

- schizophrenia

- psychosis

- epilepsy

- from severe muscle weakness

If you have suffered in the past from

dependence on medicines, drugs or

alcohol

If you are taking, or have recently

taken, other medicines, including

non-prescription medicines and

nutritional supplements, tell the

doctor or pharmacist. Especially

inform the doctor or pharmacist if you

are taking:

Medicines which affect the central

nervous system (e.g., sedatives,

antiallergics, surgical anesthetics,

muscle relaxants, narcotic painkillers,

hypnotics, for Parkinson's [e.g.,

levodopa], for epilepsy, for mental

illnesses)

Antidepressants

Anticholinergics

Cisapride (for reflux)

Cimetidine (for gastric ulcer)

Oral contraceptives

Disulfiram (for alcohol dependence)

Digoxin (for the heart)

R i f a m p i n

i s o n i a z i d

( f o r

tuberculosis)

Use of the medicine and alcohol

consumption

Do not drink wines or other beverages

containing alcohol during the course of

treatment with this medicine.

Use of the medicine and smoking

Do not smoke during the course of

treatment with the medicine.

If you smoke, inform the doctor before

commencing treatment with this

medicine.

Pregnancy and breastfeeding

Consult a doctor before using this

medicine if you are pregnant or trying

to become pregnant.

Do not use this medicine during the

first trimester of pregnancy or while

breastfeeding.

Driving and use of machines

Use of this medicine may impair

alertness and cause drowsiness

and/or

dizziness

therefore

caution is required when driving a

car, operating dangerous machinery

and when engaging any activity which

requires alertness.

3. HOW SHOULD yOU USE THE

MEDICINE?

Always use according to the doctor's

instructions.

Check with the doctor or pharmacist

if you are unsure.

The dosage and treatment regimen will

be determined by the doctor only.

Do not exceed the recommended dose

under any circumstances.

Do not take more than one tablet

before going to sleep.

Directions for use of the medicine:

Swallow the tablet with a glass of

water before going to sleep.

Do not hold the tablet in your mouth

beyond the time necessary to swallow

Tests and follow up

Upon prolonged treatment with this

medicine, blood, urine and liver

function tests should be performed.

If you took an overdose, or if a child

has accidentally swallowed the

medicine, refer immediately to a doctor

or proceed to a hospital emergency

room and bring the package of the

medicine with you.

If you forgot to take this medicine

before going to sleep, do not take

the dose late at night or early in the

morning, as it may affect your alertness

during the day. Never take two doses

together.

Adhere to the treatment regimen as

recommended by the doctor.

Even if there is an improvement in your

health, do not discontinue treatment

with this medicine without first

consulting the doctor or pharmacist.

Discontinuation of treatment with

the medicine

When discontinuing treatment with

this medicine, isolated incidents of

withdrawal symptoms may occur,

especially after prolonged use.

Withdrawal symptoms can also occur

after a controlled discontinuation,

as instructed by the doctor. These

reactions usually appear only after a

few days after the end of treatment.

Therefore, if you experience withdrawal

symptoms, such as those listed above

(see the "Introduction" section in this

leaflet), or any new symptom, consult

a doctor.

How can you contribute to the

success of this treatment?

Do not take medicines in the dark!

Check the label and the dose each time

you take medicine. Wear glasses if you

need them.

If you have any further questions

regarding use of this medicine, consult

a doctor or pharmacist.

4. SIDE EFFECTS:

with

medicine,

Hypnodorm

may cause side effects in

some users. Do not be alarmed when

reading the list of side effects. You may

not experience any of them.

The most common side effects are:

Drowsiness, fatigue and muscle

weakness.

Other side effects:

B e i n g

l e s s

a l e r t ,

d i z z i n e s s ,

unsteadiness

when

walking,

drowsiness during the day, fatigue,

headache, confusion, slurred speech,

vision disturbances

Gastrointestinal problems, dry

mouth

Decreased blood pressure, tremor

Changes in sexual function

Sweating

The effects listed above usually

decrease after the period of adaptation

to the medicine. If these effects are

bothersome, consult a doctor.

Discontinue treatment with the

medicine and refer to a doctor

immediately if the following side

effects occur:

Increased heart rate, chest pain,

that sometimes radiates to the

neck, shoulders and down the left

arm, which can be a sign of a heart

attack.

Sudden onset of allergic reactions,

manifested by swelling of the face,

lips, tongue or throat, with breathing

or swallowing difficulties (rare), other

reactions, including sudden swelling

of the hands, feet, skin rash or

itching.

Breathing problems (respiratory

depression), where the early signs

can include uneven breathing and

breathing difficulty.

Urgent need to empty the bladder

and difficulty in doing so.

Change in mood and regular behavior

patterns such as: nervousness,

tension, excitability, restlessness,

appearance of nightmares and

hallucinations,

severe

sleep

disturbances, violent behavior,

irregular, troublesome, thoughts,

confusion, forgetfulness, psychosis,

muscle weakness.

If any of the side effects worsen or

if you experience a side effect not

mentioned in this leaflet, consult the

doctor immediately.

5. HOW SHOULD THE MEDICINE BE

STORED?

Avoid poisoning! This medicine and

any other medicine must be kept in a

safe place out of the reach and sight

of children and/or infants in order

to avoid poisoning. Do not induce

vomiting without explicit instruction

from the doctor.

Do not use the medicine after the

expiry date (exp. date) that appears

on the package. The expiry date refers

to the last day of that month.

Store below 25°C.

Do not dispose of medicines via

wastewater or household waste. Ask

the pharmacist how to dispose of

unused medicines. These measures

will help protect the environment.

6. FURTHER INFORMATION

In addition to the active ingredient, the

medicine also contains:

Microcrystalline cellulose, lactose

(monohydrate and spray dried), talc,

magnesium stearate.

What does the medicine look like

and what are the contents of the

package:

Description of the tablet:

The tablet is round and white, with

a score line on one side and "TEVA"

imprinted on the other side.

Manufacturer and address:

Teva Pharmaceutical Industries, Ltd.,

P.O.B. 3190, Petah-Tiqva.

Registration number of the medicine

in the National Drug Registry of the

Ministry of Health:

032.33.22417.00

This leaflet was checked and approved

by the Ministry of Health in 05.2013.

Sent to QA 01.12.2013

BP OK 15.12.2013

HYPNODORM 1 6 2013, RH

"

ע עבקנ הז ןולע טמרופ

"

רשואו קדבנ ונכותו תואירבה דרשמ י

."

רשואמ ןולע

יאמ

2013

“This leaflet format has been determined by the Ministry of Health and the content thereof has been

checked and approved.” Date of approval: May 2013

HYPNODORM

TABLETS

Composition

Each tablet contains:

Active Ingredient

Flunitrazepam

2 mg

Other Ingredients

Microcrystalline cellulose, lactose, talc, magnesium stearate

Lactrose content: 63.8 mg per tablet.

Action

Hypnodorm contains flunitrazepam, a benzodiazepine hypnotic.

Hypnodorm induces sleep within 15-20 minutes, which lasts for 6-8 hours.

Hypnodorm enjoys a wide therapeutic margin, is well tolerated and during prolonged use,

tolerance has practically not been observed.

Indications

Insomnia of various etiology.

Contraindications

Known hypersensitivity to benzodiazepines or to any other ingredient of the preparation.

First trimester of pregnancy and in breastfeeding.

Acute pulmonary insufficiency; respiratory depression, chronic psychoses, phobic or

obsessional states.

Acute narrow-angle glaucoma because of atropine-like side effects. Benzodiazepines may

be used in patients with open-angle glaucoma who are receiving appropriate therapy).

Myasthenia gravis.

Severe hepatic insufficiency

Sleep apnea syndrome.

Use in children.

Warnings

(See also Precautions)

Effect on Ability to Drive and/or Operate Machinery

Complex behaviours such as “sleep -driving” (i.e.driving while not fully awake after

taking a sedative-hypnotic, with amnesia for the event) have been reported with

sedative hypnotics. These events can occur in sedative-hypnotic naive as well as in

sedative-hypnotic

experienced

persons.

These

events

occur

normal

therapeutic doses, and the risk appears to be increased when sedative-hypnotics are

combined with alcohol or other CNS depressants or used at doses exceeding the

maximum recommended dose. Due to the risk to the patient and the community,

discontinuation of sedative-hypnotics should be strongly considered for patients who

report a “sleep -driving” episode. Other complex behaviours (e.g.preparing and eating

food, making phone calls, or having sex) have been reported in patients who are not

fully awake after taking a sedative-hypnotic .As with “sleep -driving”, patients usually

do not remember these events.

HYPNODORM 1 6 2013, RH

with

patients

taking

CNS-depressant

medications,

patients

receiving

flunitrazepam

should

warned

operate

dangerous

machinery or motor

vehicles until it is known that they do not become drowsy or dizzy from flunitrazepam

therapy. Abilities may be impaired on the day following Patients should be advised

that their tolerance for alcohol and other CNS depressants will be diminished and that

these medications should either be eliminated or given in reduced dosage in the

presence of flunitrazepam.

Due to the slight accumulation of flunitrazepam in the plasma, a 2 mg dose of

flunitrazepam should not be administered on a daily basis to patients involved in

activities requiring concentration during the early part of the day.

Severe allergic reactions

Rare cases of angioedema involving the tongue, glottis or larynx have been reported

in patients after taking the first or subsequent doses of sedative-hypnotics. Some

patients have had additional symptoms such as dyspnea, throat closing, or nausea

and vomiting that suggest anaphylaxis. Some patients have required medical therapy

in the emergency department. If angioedema involves the tongue, glottis or larynx,

airway obstruction may occur and be fatal.

Withdrawal Reactions

Following the prolonged use of flunitrazepam at therapeutic doses, withdrawal from

the medication should be gradual. An individualized withdrawal timetable needs to be

planned for each patient in whom dependence is known or suspected. Periods from

4 weeks to 4 months have been suggested. As with other benzodiazepines, when

treatment is suddenly withdrawn, a temporary increase of sleep disturbance can occur

after use of flunitrazepam.

Tolerance

In general, benzodiazepines should be prescribed for short periods only (e.g.2 to

4 weeks). Continuous long-term use of flunitrazepam is not recommended. There is

evidence that tolerance/some loss of efficacy develops to the sedative/hypnotic

effects

benzodiazepines.

After

little

week

therapy,

withdrawal

symptoms can appear following the cessation of recommended doses (e.g.rebound

insomnia following cessation of a hypnotic benzodiazepine).

Hypotension

Although

hypotension

occurred

only

rarely,

flunitrazepam

should

administered with caution to patients in whom a drop in blood pressure might lead to

cardiac or cerebral complications. This is particularly important in elderly patients.

Memory Impairment

Transient amnesia or memory impairment has been reported in association with the

use of benzodiazepines. On rare occasions, especially when flunitrazepam was taken

with alcohol or CNS active drugs, patients developed unusual or disturbed behaviour

of which they had no recollection.

Myasthenia gravis

Flunitrazepam could increase the muscle weakness in myasthenia gravis and is

therefore contraindicated in this condition.

Glaucoma

See Contraindications

HYPNODORM 1 6 2013, RH

Impaired renal/liver function and Blood Dyscrasias

Patients

with

impaired

renal

hepatic

function

should

benzodiazepine

medication with caution and dosage reduction may be advisable. In rare instances,

some patients taking benzodiazepines have developed blood dyscrasias, and some

have had elevations of liver enzymes. As with other benzodiazepines, periodic blood

counts and liver function tests are recommended.

Depression, Psychosis and Schizophrenia

(see also Contraindications)

Flunitrazepam is not recommended as primary therapy in patients with depression

and/or psychosis. In such conditions, psychiatric assessment and supervision are

necessary

benzodiazepines

indicated.

Benzodiazepines

increase

depression in some patients, and may contribute to deterioration in severely disturbed

schizophrenics with confusion and withdrawal. Suicidal tendencies may be present or

uncovered and protective measures may be required.

Paradoxical Reactions

Flunitrazepam should be discontinued if paradoxical reactions such as acute rage,

stimulation or excitement occur. These reactions are more common in the elderly.

Reactions

like

paradoxical

aggressive

outbursts,

excitement,

confusion,

restlessness,

agitation,

irritability,

aggressiveness,

delusion,

rages,

nightmares,

hallucination,

psychoses,

inappropriate

behaviour,

uncovering

suicidal

tendencies and other adverse behavioural effects are known to occur when using

benzodiazepines.

Extreme

caution

should

therefore

used

prescribing

benzodiazepines to patients with personality disorders. Should this occur, use of the

drug should be discontinued. These reactions may be quite severe and are more

likely to occur in the elderly.

Concomitant use of alcohol and/or CNS depressants

The concomitant use of flunitrazepam with alcohol and/or CNS depressants should be

avoided. Such concomitant use has the potential to increase the clinical effects of

flunitrazepam, possibly including severe sedation and clinically relevant respiratory

and/or cardiovascular depression.

Geriatric or debilitated patients

Such

patients

particularly

susceptible

sedative

effects

benzodiazepines and associated giddiness, ataxia and confusion, which may increase

the possibility of a fall. Also, due to the myorelaxant effect of benzodiazepines, there

is a risk of falls and consequently of hip fractures, particularly in the elderly when they

get up at night.

Impaired respiratory function

Caution in the use of flunitrazepam is recommended in patients with respiratory

depression. In patients with chronic obstructive pulmonary disease, benzodiazepines

can cause increased arterial carbon dioxide tension and decreased arterial oxygen

tension.

Epilepsy

Abrupt withdrawal of benzodiazepines in patients with convulsive disorders may be

associated with a temporary increase in the frequency and/or severity of seizures.

HYPNODORM 1 6 2013, RH

Abuse

Caution must be exercised in administering flunitrazepam to individuals known to be

addiction prone or those whose history suggests they may increase the dosage on

their own initiative. It is desirable to limit repeat prescription without adequate medical

supervision.

Dependence

The use of benzodiazepines may lead to dependence, as defined by the presence of

a withdrawal syndrome on discontinuation of the drug. The risk of dependence

increases with dose and duration of treatment; it is also greater in patients with a

medical history of alcohol and/or drug abuse.

Tolerance, as defined by a need to increase the dose in order to achieve the same

therapeutic effect, seldom occurs in patients receiving the recommended doses under

medical

supervision.

Tolerance

sedation

occur

with

benzodiazepines,

especially in those with drug seeking behavior.

Regular monitoring of such patients is essential; routine repeat prescriptions should

be avoided and treatment should be withdrawn gradually. Once physical dependence

has developed, abrupt termination of treatment will be accompanied by withdrawal

symptoms.

Withdrawal symptoms similar in character to those noted with barbiturates and

alcohol have occurred following abrupt discontinuation of benzodiazepines. These

symptoms can range from headache, tension, muscle pain, depression, nervousness,

mood

changes,

diarrhea,

rebound

insomnia,

restlessness,

irritability,

insomnia,

extreme anxiety, dysphoria, palpitations, panic attacks, vertigo, myoclonus, akinesia,

hypersensitivity to light, sound and touch, abnormal body sensations (e.g. feelings of

motion,

metallic

taste),

hyperacusis,

numbness

tingling

extremities,

hypersensitivity to light, noise and physical contact and hallucinations or epileptic

seizures, depersonalisation, derealization, delusional beliefs, hyperreflexia and loss of

short term memory, to a major syndrome which may include convulsions, tremor,

abdominal

muscle

cramps,

confusional

states,

delirium,

hallucinations,

hyperthermia, psychosis, vomiting and sweating. Such manifestations of withdrawal,

especially the more serious ones, are more common in those patients who have

received excessive doses over a prolonged period.

However,

withdrawal

symptoms

have

also

been

reported

following

abrupt

discontinuation

benzodiazepines

taken

continuously

therapeutic

levels.

Accordingly, flunitrazepam should be terminated by tapering the dose to minimise

occurrence of withdrawal symptoms. Patients should be advised to consult with their

physician before either increasing the dose or abruptly discontinuing the medication.

Rebound phenomena have been described in the context of benzodiazepine use.

Rebound insomnia and anxiety mean an increase in the severity of these symptoms

beyond

pre-treatment

levels

following

cessation

benzodiazepines.

Rebound

phenomena

general

possibly

reflect

re-emergence

pre-existing

symptoms

combined with withdrawal symptoms described earlier; It may be accompanied by

other

reactions

including

mood

changes,

anxiety

sleep

disturbances

restlessness. Some patients prescribed benzodiazepines with very short half-lives (in

the order of 2 to 4 hours) may experience relatively mild rebound symptoms in

between their regular doses. Withdrawal/rebound symptoms may follow high doses

taken for relatively short periods.

Abuse of flunitrazepam had been reported.

HYPNODORM 1 6 2013, RH

It is important to warn against changing to a benzodiazepine with a short duration of

action when benzodiazepines with a long half-life are used, as withdrawal symptoms

may develop.

Duration of treatment

duration

treatment

should

short

possible

(see

Dosage

Administration) should not exceed four weeks for insomnia, including tapering off

process. Extension beyond these periods should not take place without re-evaluation

of the situation.

It may be useful to inform the patient when treatment is started that it will be of limited

duration and to explain precisely how the dosage will be progressively decreased.

Moreover it is important that the patient should be aware of the possibility of rebound

phenomena, thereby minimising anxiety over such symptoms should they occur while

the medicinal product is being discontinued.

There are indications that, in the case of benzodiazepines with a short duration of

action, withdrawal phenomena can become manifest within the dosage interval,

especially when the dosage is high. When benzodiazepines with a long duration of

action are being used it is important to warn against changing to a benzodiazepine

with a short duration of action, as withdrawal symptoms may develop.

Other warnings

Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency

as they may precipitate encephalopathy.

Benzodiazepines are not recommended for the primary treatment of psychotic illness.

Benzodiazepines should not be used alone to treat depression or anxiety associated

with depression, (suicide may be precipitated in such patients).

This drug should be used with extreme caution in patients with a history of alcohol or

drug abuse.

In cases of loss or bereavement, psychological adjustment may be inhibited by

benzodiazepines.

Use in Pregnancy

Benzodiazepines have the potential to cause fetal harm when administered to pregnant

women. If this drug is used during pregnancy or the patient becomes pregnant while taking

this drug, she should be informed of the potential hazard to the fetus.

Benzodiazepines are assumed to be capable of causing an increased risk of congenital

abnormalities when administered to pregnant women during the first trimester. Since use of

these drugs is rarely a matter of urgency, their use during the first trimester of pregnancy

should almost always be avoided (see Contraindications).

The possibility that women of child-bearing potential may be pregnant when therapy is

instituted should be considered. Patients should be advised that if they become pregnant

during therapy or intend to become pregnant, they should refer to their physician about the

desirability of discontinuing the drug.

Administration of benzodiazepines in the last trimester of pregnancy or during labour has

been reported to produce irregularities in the foetal heart rate, and hypotonia, poor sucking,

hypothermia and moderate respiratory depression in the neonate.

Infants born to mothers who took benzodiazepines chronically during the latter stages of

pregnancy

have

developed

physical

dependence

some

risk

developing withdrawal symptoms in the postnatal period.

HYPNODORM 1 6 2013, RH

Use in Breastfeeding

Benzodiazepines are excreted in breast milk. Since neonates metabolize this drug more

slowly than adults, and accumulation of the drug and its metabolites to toxic levels is

possible,

should

administered

nursing

mothers

(see

Contraindications).

Flunitrazepam has been detected in breast milk.

Adverse Reactions

Adverse reactions with different benzodiazepines vary in type and frequency. Some are

dose-related, while others involve individual patient sensitivity. Although not all of the

following adverse reactions have been attributed specifically to each benzodiazepine drug,

the potential for their occurrence exists. This should be borne in mind when drugs of this

class are administered.

Side

effects

most

commonly

reported

have

been

drowsiness,

fatigue

ataxia,

especially in elderly or debilitated patients.

Infrequently reported side effects are as follows:

Central Nervous System

Sedation and sleepiness, hangover, tiredness, drowsiness during the day, ataxia, tremor,

amnesia, excitation, daytime sedation, disorientation, hallucinations, agitation, anxiety,

depression, lethargy, apathy, hypoactivity, lightheadedness, disorientation, restlessness,

confusion, delirium, headache, slurred speech, dysarthria, syncope, vertigo, dizziness,

nervousness, vivid dreams, psychomotor retardation.

Occasionally, prolonged use with this medicine may cause behavioral changes and

paranoid symptoms.

Gastrointestinal

Constipation, diarrhea, dry mouth, nausea, vomiting, increased salivation, hiccups.

Genitourinary

Incontinence,

dysuria,

enuresis,

changes

libido,

urinary

retention,

menstrual

irregularities.

Cardiovascular

Bradycardia,

tachycardia,

hypertension,

hypotension,

palpitations,

cardiac

failure

including cardiac arrest .

Ophthalmological

Visual disturbances, diplopia.

Dermatological

Urticaria, pruritus, skin rash, dermatitis, sweating, angioedema.

Musculoskeletal and Connective Tissue Disorders

Muscle weakness. This phenomenon occurs predominantly at the start of therapy and

usually disappears with prolonged administration.

Immune System Disorders:

Hypersensitivity reactions, including rash, angioedema and hypotension, may occur.

Respiratory Disorders

Respiratory depression.

HYPNODORM 1 6 2013, RH

Other

Hepatic

dysfunction

(including

hepatitis

jaundice),

blood

dyscrasias

including

agranulocytosis, anemia, thrombocytopenia, eosinophilia.

More frequent adverse reactions indicative of possible withdrawal synptoms following

abrupt discontinuation, and necessitating medical attention (if they occur within 2-3 days

with short to intermediate half-life benzodiazepines, and 10-20 days with long half-life

benzodiazepines) include: irritability, nervousness, and trouble in sleeping.

Other adverse reactions: falling, asthenia, collapse, unsteadiness, muscle weakness.

Injury, Poisoning and Procedural Complications: An increased risk for falls and fractures

has been reported in elderly benzodiazepine users

Postmarketing experience

Paradoxical reactions

Restlessness, irritability, nightmares, inappropriate behaviour, delusions,

aggressiveness and psychoses.

Special senses

Double vision.

Urogenital system

Changes in libido.

Central nervous system

Pre-existing depression may be unmasked during benzodiazepine use.

Precautions

In elderly or debilitated patients and in children, the initial dose should be low and dosage

increments made gradually, in accordance with the response of the patient, to preclude

ataxia or excessive sedation.

Although hypotension has rarely occurred, administer with caution to patients in whom a

drop in blood pressure might lead to cardiac complications.

Caution should be exercised in patients with chronic pulmonary insufficiency, and in

patients with impaired renal or hepatic function.

Flunitrazepam clearance is increased in cigarette smokers, probably due to enzyme

induction.

Patients who experience drowsiness during treatment should be warned that their ability to

perform potentially-hazardous tasks requiring mental alertness or physical coordination ,

such as driving a vehicle or operating machinery, may be impaired.

Because of a possible muscular relaxant effect, caution should be exercised when

administering this drug in patients with myasthenia gravis.

Liver and kidney function tests and blood counts should be performed regularly during

long-term therapy.

This

product

contains

lactose.

Patients

with

rare

hereditary

problems

galactose

intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not

take this medicine.

Drug Interactions

Flunitrazepam/Estrogen-Containing

Oral

Contraceptives/Cimetidine/Disulfiram:

Concurrent

administration of estrogen-containing oral contraceptives, disulfiram or cimetidine with

flunitrazepam, which is metabolized primarily by nitro-reduction, may result in inhibition of

hepatic metabolism of the benzodiazepine leading to delayed elimination and increased

plasma concentrations of the benzodiazepine. Dosage reduction of fllunitrazepam may be

required in some patients.

HYPNODORM 1 6 2013, RH

Benzodiazepines/Centrally-Acting Drugs/Alcohol:

Benzodiazepines may have a potentiating

effect

centrally-acting

drugs

such

barbiturates,

neuroleptics,

tranquilizers,

antidepressants, nonselective MAO inhibitors, phenothiazines and other antipsychotics,

hypnotics, antiepileptics, sedatives, analgesics (including narcotic analgesics), skeletal

muscle relaxants, antihistamines, and anesthetics. When these drugs are administered

concomitantly with benzodiazepines, their dosage should be reduced.

In case of narcotic analgesics, enhancement of euphoria may also occur, leading to an

increase in psychological dependence.

Benzodiazepines may also intensify the response to alcohol. Patients should be advised to

avoid drinking alcoholic beverages while under treatment with this drug.

Benzodiazepines/Anticholinergics

:

The anticholinergic effects of other drugs, including

atropine and similar drugs, antihistamines and antidepressants may be potentiated.

Benzodiazepines/Anticonvulsants:

Interactions have been reported between some

benzodiazepines and anticonvulsants, with changes in the serum concentration of the

benzodiazepine or anticonvulsant. It is recommended that patients be observed for

altered

responses

when

benzodiazepines

anticonvulsants

prescribed

together, and that serum level monitoring of the anticonvulsant be performed more

frequently.

Benzodiazepines/Cisapride:

Cisapride may lead to a temporary increase in the serum

levels, and thus sedative effects, of orally administered benzodiazepines due to faster

absorption.

Benzodiazepines/Anticoagulants/Antidiabetics:

There appears to be no interaction

with coumarin anticoagulants or oral diabetic agents.

Benzodiazepines/Levodopa:

Rare

reports

indicate

that

patients

treated

with

levodopa

experienced

diminished

control

parkinsonian

symptoms

when

chlordiazepoxide

diazepam was added to their therapeutic regimen, For this reason, benzodiazepines should

be administered with caution to patients receiving levodopa.

Benzodiazepines/Digoxin

: Limited evidence suggests that some benzodiazepines, namely

diazepam and alprazolam, may reduce the renal excretion of digoxin, resulting in an

increased plasma half-life of the cardiac glycoside and possibe digoxin toxicity.

Although the exact mechanism for the effect of benzodiazepines on the renal excretion of

digoxin has not been clearly elucidated, serum digoxin concentrations should be monitored

and patients should be carefully observed for signs and/or symptoms of digoxin toxicity

during concomitant therapy. Dosage reduction of digoxin may be necessary in some

patients receiving concomitant therapy.

Benzodiazepines/Rifampin/Isoniazid:

Concurrent

enhance

elimination

diazepam,

resulting

decreased

plasma

concentrations;

dosage

adjustment

benzodiazepine

necessary.

Data

whether

this

effect

applies

other

benzodiazepines are not available.

Known Inhibitors of Hepatic Enzymes: e.g. cimetidine, have been shown to reduce the

clearance of benzodiazepines and may potentiate their action, and known inducers of

hepatic enzymes, e.g. rifampicin, may increase the clearance of benzodiazepines

Diagnostic Interference

: Minor EEG changes, usually low voltage fast activity, of no

known clinical significance, have been reported with benzodiazepine administration.

Information for Patients

(see also Dosage and Administration)

Treatment is usually intended for short periods only. Patients should be instructed to

consult their physician after 2-4 weeks of the treatment.

Since benzodiazepines may produce psychologic and physical dependence, patients

should be advised to consult their physician before increasing the dose of, or abruptly

discontinuing, benzodiazepine therapy.

HYPNODORM 1 6 2013, RH

Patients should be advised to exercise caution if drowsiness, dizziness, lightheadedness,

or clumsiness or unsteadiness occurs, especially in the elderly, who are more sensitive to

the CNS effects of benzodiazepines.

Dosage and Administration

Treatment

should

short

possible

should

started

with

lowest

recommended dose. The maximum dose should not be exceeded. Generally the duration of

treatment varies from a few days to two weeks with a maximum of four weeks, including the

tapering off process. Patients who have taken benzodiazepines for a prolonged time may

require

longer

period

during

which

doses

reduced.

Specialist

help

appropriate. Little is known regarding the efficacy or safety of benzodiazepines in long-term

use.

In certain cases, extension beyond the maximum treatment period may be necessary; if

so, it should not take place without re-evaluation of the patient's status. Long-term chronic

use is not recommended.

The product should be taken just before going to bed.

The dosage should be carefully adapted to the age and the general condition of the

patient and to the nosological classification of the sleep disturbance.

Adults: Half a tablet at bedtime. In severe insomnia, 1 tablet at bedtime.

Elderly Patients: One quarter of a tablet at bedtime. In severe insomnia, half a tablet at

bedtime.

Overdosage

Manifestations

Overdosage of benzodiazepines is usually manifested by degrees of central nervous

system depression ranging from drowsiness to coma. In mild cases, symptoms

include drowsiness, mental confusion and lethargy. In more serious cases, symptoms

may include ataxia, hypotonia, hypotension, respiratory depression, coma and very

rarely death. Coma may be more protracted and cyclical, particularly in elderly

patients. Benzodiazepine respiratory depressant effects are more serious in patients

with respiratory disease.

Benzodiazepines increase the effects of other central nervous system depressants,

including

alcohol.

When

combined

with

other

depressants,

effects

overdosage are likely to be severe and may prove fatal.

Treatment

managing

overdosage

possibility

multiple

drug

involvement

considered.

The patient’s vital signs should be monitored and supportive measures should be

instituted as indicated by the patient’s clinical state. In particular, patients may require

symptomatic treatment for cardiorespiratory effects or central nervous system effects.

If the patient is conscious, vomiting should be induced either mechanically or with emetics.

Also,

activated

charcoal

administered

orally

(within

hours)

increase

clearance, as well as decrease absorption of the benzodiazepine

If the patient is unconscious, immediate gastric lavage utilizing a cuffed endotracheal tube,

to prevent aspiration and pulmonary complications, should be employed.

General supportive measures should be employed along with intravenous fluids. An

adequate airway should be maintained.

Hypotension may be combated by the administration of noradrenaline or metaraminol

If excitation occurs, barbiturates should not be used.

Hemoperfusion and hemodialysis are of limited value.

HYPNODORM 1 6 2013, RH

If CNS depression is severe the use of Flumazenil injection (Anexate), a specific

benzodiazepine-receptor antagonist, should be considered for the complete or partial

reversal of the sedative effects of benzodiazepines, and may be used in situations

when an overdose with a benzodiazepine is known or suspected.

The following should be kept in mind when flumazenil is used in the treatment of

benzodiazepine overdosage:

Flumazenil should only be administered under closely monitored conditions. In

view of the short half life (about 1 hour) and duration of action of flumazenil, and

the possible need for repeat doses, the patient should be closely monitored until all

possible central benzodiazepine effects (e.g., resedation) have subsided.

Particular caution is necessary when using flumazenil in cases of multiple drug

overdosage, since the toxic effects (cardiac arrhythmias and/or convulsions) of

other psychotropic drugs, especially cyclic antidepressants, may increase as the

effects of benzodiazepines subside. Flumazenil is contraindicated in patients who

are showing signs of serious cyclic antidepressant overdose.

Warning: The benzodiazepine receptor antagonist flumazenil is not indicated in

patients with epilepsy who have been treated with benzodiazepines. Antagonism of

the benzodiazepine effect in such patients may provoke seizures.

Prior to the administration of flumazenil, the complete package insert of the product

should be consulted, and necessary measures should be instituted to secure airway,

ventilation, and intravenous access.

Flumazenil is intended as an adjunct to, not a substitute for, proper management of

benzodiazepine overdosage. Patients treated with flumazenil should be monitored for

resedation,

respiratory

depression,

other

residual

benzodiazepine

effects,

appropriate period after treatment. Awareness is required regarding a risk of seizure in

association with flumazenil treatment, particularly in long-term benzodiazepine users

and in cyclic antidepressant overdose.

Storage

Store below 25

Drug Registration Number:

032 33 22417 00.

Manufacturer

Teva Pharmaceutical Industries Ltd

P.O.Box 3190, Petach Tikva 49131

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

)תוחיטב )תוחיטב

ןולעב ןולעב

ל

ל

אפור אפור

ךיראת

________

May 29, 2013

___

םש

רישכת

__תילגנאב

HYPNODORM TABLETS

,

רפסמ

____םושיר

032

33

22417

00

םש

לעב

םושירה

Teva Pharmaceutical Industries Ltd, P.O.Box 3190, Petach Tikva 49131

םיטרפ

לע

םי/יונישה

םי/שקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח

Warnings

Tolerance

In general, benzodiazepines should be

prescribed for short periods only (e.g.2 to

4 weeks). Continuous long-term use of

flunitrazepam is not recommended. There

is evidence that tolerance develops to the

sedative effects of benzodiazepines. After

little

week

therapy,

withdrawal

symptoms

appear

following the cessation of recommended

doses (e.g.rebound insomnia following

cessation of a hypnotic benzodiazepine).

Paradoxical Reactions

Flunitrazepam should be discontinued if

paradoxical reactions such as acute rage,

stimulation or excitement occur. These

reactions are more common in the elderly

Geriatric or debilitated patients

Such patients may be particularly

susceptible to the sedative effects of

benzodiazepines and associated giddiness,

ataxia and confusion, which may increase

the possibility of a fall

Dependence

The use of benzodiazepines may lead to

dependence, as defined by the presence of

a withdrawal syndrome on discontinuation

of the drugTolerance, as defined by a need

to increase the dose in order to achieve the

same therapeutic effect, seldom occurs in

patients receiving the recommended doses

under medical supervision. Tolerance to

sedation may occur with benzodiazepines,

especially in those with drug seeking

behavior.

Tolerance

In general, benzodiazepines should be prescribed for short

periods only (e.g.2 to 4 weeks). Continuous long-term use of

flunitrazepam is not recommended. There is evidence that

tolerance/some loss of efficacy develops to the sedative/hypnotic

effects of benzodiazepines. After as little as one week of therapy,

withdrawal symptoms can appear following the cessation of

recommended doses (e.g.rebound insomnia following cessation

of a hypnotic benzodiazepine).

Paradoxical Reactions

Flunitrazepam should be discontinued if paradoxical reactions

such as acute rage, stimulation or excitement occur. These

reactions are more common in the elderly.

Reactions like paradoxical aggressive outbursts, excitement,

confusion, restlessness, agitation, irritability, aggressiveness,

delusion,

rages,

nightmares,

hallucination,

psychoses,

inappropriate behaviour, the uncovering of suicidal tendencies

and other adverse behavioural effects are known to occur when

using benzodiazepines. Extreme caution should therefore be used

in prescribing benzodiazepines to patients with personality

disorders. Should this occur, use of the drug should be

discontinued. These reactions may be quite severe and are more

likely to occur in the elderly.

Concomitant use of alcohol and/or CNS depressants

The concomitant use of flunitrazepam with alcohol and/or CNS

depressants should be avoided. Such concomitant use has the

potential to increase the clinical effects of flunitrazepam, possibly

including severe sedation and clinically relevant respiratory

and/or cardiovascular depression.

Geriatric or debilitated patients

Such patients may be particularly susceptible to the sedative

effects of benzodiazepines and associated giddiness, ataxia and

confusion, which may increase the possibility of a fall. Also, due

to the myorelaxant effect of benzodiazepines, there is a risk of

falls and consequently of hip fractures, particularly in the elderly

when they get up at night.

Dependence

The use of benzodiazepines may lead to dependence, as defined

by the presence of a withdrawal syndrome on discontinuation of

the drug. The risk of dependence increases with dose and

duration of treatment; it is also greater in patients with a medical

history of alcohol and/or drug abuse.

Tolerance, as defined by a need to increase the dose in order to

achieve the same therapeutic effect, seldom occurs in patients

Withdrawal

symptoms

similar

character to those noted with barbiturates

alcohol

have

occurred

following

abrupt discontinuation of benzodiazepines.

These symptoms can range from headache,

tension,

muscle

pain,

restlessness,

irritability, insomnia, anxiety, dysphoria,

palpitations,

panic

attacks,

vertigo,

myoclonus, akinesia, hypersensitivity to

light, sound and touch, abnormal body

sensations

(e.g.

feelings

motion,

metallic taste), numbness and tingling of

extremities,

depersonalisation,

derealization,

delusional

beliefs,

hyperreflexia and loss of short term

memory, to a major syndrome which may

include convulsions, tremor, abdominal

and muscle cramps, confusional states,

delirium,

hallucinations,

hyperthermia,

psychosis, vomiting and sweating. Such

manifestations of withdrawal, especially

the more serious ones, are more common

in those patients who have received

excessive doses over a prolonged period.

Rebound

phenomena

have

been

described in the context of benzodiazepine

use. Rebound insomnia and anxiety mean

an increase in the severity of these

symptoms beyond pre-treatment levels

following cessation of benzodiazepines.

Rebound phenomena in general possibly

reflect

re-emergence

pre-existing

symptoms

combined

with

withdrawal

symptoms described earlier; Some patients

prescribed

benzodiazepines

with

very

short half-lives (in the order of 2 to 4

hours) may experience relatively mild

rebound

symptoms

between

their

regular

doses.

Withdrawal/rebound

symptoms may follow high doses taken for

relatively short periods.

receiving the recommended doses under medical supervision.

Tolerance

sedation

occur

with

benzodiazepines,

especially in those with drug seeking behavior.

Regular monitoring of such patients is essential; routine repeat

prescriptions should be avoided and treatment should be

withdrawn gradually. Once physical dependence has developed,

abrupt termination of treatment will be accompanied by

withdrawal symptoms.

Withdrawal symptoms similar in character to those noted with

barbiturates

alcohol

have

occurred

following

abrupt

discontinuation of benzodiazepines. These symptoms can range

from headache, tension, muscle pain, depression, nervousness,

mood

changes,

diarrhea,

rebound

insomnia,

restlessness,

irritability, insomnia, extreme anxiety, dysphoria, palpitations,

panic attacks, vertigo, myoclonus, akinesia, hypersensitivity to

light, sound and touch, abnormal body sensations (e.g. feelings of

motion, metallic taste), hyperacusis, numbness and tingling of the

extremities, hypersensitivity to light, noise and physical contact

and hallucinations or epileptic seizures,

depersonalisation,

derealization, delusional beliefs, hyperreflexia and loss of short

term memory, to a major syndrome which may include

convulsions, tremor, abdominal and muscle cramps, confusional

states,

delirium,

hallucinations,

hyperthermia,

psychosis,

vomiting and sweating. Such manifestations of withdrawal,

especially the more serious ones, are more common in those

patients who have received excessive doses over a prolonged

period.

Rebound phenomena have been described in the context of

benzodiazepine use. Rebound insomnia and anxiety mean an

increase in the severity of these symptoms beyond pre-treatment

levels

following

cessation

benzodiazepines.

Rebound

phenomena in general possibly reflect re-emergence of pre-

existing

symptoms

combined

with

withdrawal

symptoms

described earlier; It may be accompanied by other reactions

including mood changes, anxiety or sleep disturbances and

restlessness.

Some patients prescribed benzodiazepines with

very short half-lives (in the order of 2 to 4 hours) may experience

relatively mild rebound symptoms in between their regular doses.

Withdrawal/rebound symptoms may follow high doses taken for

relatively short periods.

Abuse of flunitrazepam had been reported.

Duration of treatment

The duration of treatment should be as short as possible (see

Dosage and Administration) depending on the indication, but

should not exceed four weeks for insomnia and eight to twelve

weeks in case of anxiety, including tapering off process.

Extension beyond these periods should not take place without re-

evaluation of the situation.

It may be useful to inform the patient when treatment is started

that it will be of limited duration and to explain precisely how the

dosage will be progressively decreased. Moreover it is important

that the patient should be aware of the possibility of rebound

phenomena, thereby minimising anxiety over such symptoms

should they occur while the medicinal product is being

discontinued.

There are indications that, in the case of benzodiazepines with a

short duration of action, withdrawal phenomena can become

manifest within the dosage interval, especially when the dosage

is high. When benzodiazepines with a long duration of action are

being used it is important to warn against changing to a

benzodiazepine with a short duration of action, as withdrawal

symptoms may develop.

Other warnings

Benzodiazepines are not indicated to treat patients with severe

hepatic insufficiency as they may precipitate encephalopathy.

Benzodiazepines are not recommended for the primary treatment

of psychotic illness.

Benzodiazepines should not be used alone to treat depression or

anxiety associated with depression, (suicide may be precipitated

in such patients).

This drug should be used with extreme caution in patients with a

history of alcohol or drug abuse.

In cases of loss or bereavement, psychological adjustment may

be inhibited by benzodiazepines.

Use in Pregnancy

Administration of benzodiazepines in the last trimester of

pregnancy or during labour has been reported to produce

irregularities in the foetal heart rate, and hypotonia, poor sucking,

hypothermia and moderate respiratory depression in the neonate.

Infants born to mothers who took benzodiazepines chronically

during the latter stages of pregnancy may have developed

physical dependence and may be at some risk of developing

withdrawal symptoms in the postnatal period.

Use in Breastfeeding

Flunitrazepam has been detected in breast milk.

Contraindications

Known

hypersensitivity

benzodiazepines or to any other ingredient

of the preparation.

First

trimester

pregnancy

breastfeeding.

Acute pulmonary insufficiency; psychoses

Acute narrow-angle glaucoma because of

atropine-like side effects. Benzodiazepines

may be used in patients with open-angle

glaucoma who are receiving appropriate

therapy).

Myasthenia gravis.

evere hepatic insufficiency

Sleep apnea syndrome.

Known hypersensitivity to benzodiazepines or to any other

ingredient of the preparation.

First trimester of pregnancy and in breastfeeding.

Acute pulmonary insufficiency; respiratory depression, chronic

psychoses, phobic or obsessional states.

Acute narrow-angle glaucoma because of atropine-like side

effects. Benzodiazepines may be used in patients with open-angle

glaucoma who are receiving appropriate therapy).

Myasthenia gravis.

evere hepatic insufficiency

Sleep apnea syndrome.

Use in children.

Adverse events

Cardiovascular

Bradycardia,

tachycardia,

hypertension,

hypotension,

palpitations, cardiac failure including cardiac arrest .

Musculoskeletal and Connective Tissue Disorders

Muscle weakness. This phenomenon occurs predominantly at the

start

therapy

usually

disappears

with

prolonged

administration.

Injury, Poisoning and Procedural Complications: An increased

risk for falls and fractures has been reported in elderly

benzodiazepine users

Immune System Disorders:

Hypersensitivity

reactions,

including

rash,

angioedema

hypotension, may occur.

Respiratory Disorders

Respiratory depression.

Precautions

This product contains lactose. Patients with rare hereditary

problems of galactose intolerance, the Lapp lactase deficiency or

glucose-galactose malabsorption should not take this medicine.

Drug Interactions

Known Inhibitors of Hepatic Enzymes: e.g. cimetidine, have

been shown to reduce the clearance of benzodiazepines and may

potentiate their action, and known inducers of hepatic enzymes,

e.g. rifampicin, may increase the clearance of benzodiazepines

Dosage

and

Administration

N.B.: Treatment should be as short as possible and should be

started with the lowest recommended dose. The maximum dose

should not be exceeded. Generally the duration of treatment

varies from a few days to two weeks with a maximum of four

weeks, including the tapering off process. Patients who have

taken benzodiazepines for a prolonged time may require a longer

period during which doses are reduced. Specialist help may be

appropriate. Little is known regarding the efficacy or safety of

benzodiazepines in long-term use.

In certain cases, extension beyond the maximum treatment

period may be necessary; if so, it should not take place without

re-evaluation of the patient's status. Long-term chronic use is not

recommended.

The product should be taken just before going to bed.

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

)תוחיטב )תוחיטב

ןולעב ןולעב

ןכרצל ןכרצל

ךיראת

___________

29-05-2013

____________

םש

רישכת

תילגנאב

רפסמו

םושירה

22417

___________

ypnodorm tablets

םש

לעב

םושירה

עבט

תוישעת

תויטבצמרפ

מ"עב

תורמחהה

תושקובמה

קרפ ןולעב טסקט

יחכונ טסקט

שדח

ןיא יתמ שמתשהל

?

רישכתב

ךניה רשאכ הפורתב ישמתשת לא וא ןוירהה לש ןושארה שילשב .הקינמ

העודי םא וז הפורתב שמתשהל ןיא דחאל ,םפזארטינולפל תושיגר תופורתל וא רישכתה יביכרממ .םיניפזאידוזנבה תחפשממ תורחא

םילוחב רישכתב שמתשהל ןיא יאמ ,תוירטאיכיספ תויעבמ םילבוסה המוקואלג ,הרומח תיתאיר הקיפס סיברג הינטסאימ ,הפירח תיווז תרצ תקיפס יא ,)הרומח םירירש תשלוח( -מ וא הרומח דבכ

Sleep apnea

syndrome

ךלהמב המישנ תקספה( )הניש

שילשב

ןושארה

לש

ןוירהה

וא

ןמזב

הקנה

םא

העודי

תושיגר

םפזארטינולפל

Flunitrazepam

וא ,

דחאל

יביכרממ הפורתה

םירחאה

וא

תופורתל

תורחא תחפשממ

םיניפזאידוזנבה

םילוחב

םילבוסה

תויעבמ

,תוירטאיכיספ יוכידמ

המישנ יאמ ,

הקיפס

תיתאיר

,הרומח המוקואלגמ

תרצ

תיווז

הינטסאיממ ,הפירח סיברג

תשלוח(

םירירש

יאמ ,)הרומח תקיפס

דבכ

הרומח

וא

Sleep apnea

syndrome

תקספה(

המישנ

ךלהמב

)הניש

ןיא

שמתשהל

םידליב ןוירה

:

הקנהו לא

ךניה רשאכ הפורתב ישמתשת לא .הקינמ וא ןוירהה לש ןושארה שילשב שי

ץעוויהל

אפורב

ינפל

שומישה

הפורתב

םא

ךניה ןוירהב

וא

הסנמ

סנכהל

.ןוירהל ןיא

שמתשהל

הפורתב

שילשב

ןושארה

לש

ןוירהה וא

ןמזב

.הקנה דציכ שמתשת

:

הפורתב ןמזל רבעמ הפב הילבטה תא קיזחהל ןיא התעילבל שורדה שי

עולבל

תא

הילבטה

םע

סוכ

םימ

ינפל

הנישה

שורדה ןמזל רבעמ הפב הילבטה תא קיזחהל ןיא התעילבל תועפות

:

יאוול ,הפורתה לש היוצרה תוליעפל ףסונב עיפוהל תולולע הב שומישה ןמזב ,תרוחרחס ,שוטשיט :ןוגכ יאוול תועפשה תוביצי רסוח ,שאר באכ ,תופייע ,םויב םונמנ ,הכילהב שבוי ,לוכיע תכרעמב תויעב ,לובלב ,םדה ץחלב הדירי ,רורב אל רוביד ,הפב ,דער ,ינימה דוקפתב יוניש ,הייארב תוערפה .העזה רחאל ללכ ךרדב תותחופ ולא תועפות םא .רישכתל תולגתסהה תפוקת ץעוויהל שי ,תודירטמ ולאה תועפותה .אפורב ומכ

לכב

שומישה ,הפורת

םרודונפיהב

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םא .רישכתל

תועפותה תדחוימ תוסחייתה תובייחמה תועפות םייוניש ,תוליגר יתלב תוינדרוט תובשחמ ,החירפ ,םיליגרה תוגהנתהה יסופדב ,םירירש תשלוח ,בל בצק תרבגה ,טקש יא ,תושגרתהו חתמ ,תונבצע הניש תוערפה ,לובלב ,המילא תוגהנתה ,תויזה ,החכש ,הליל יטויס ,תורומח ,םייתפשה ,םינפה תוחפנתה ,הזוכיספ וא המישנ יישק םע( ןורגה וא ןושלה י/הנפו לופיטה י/קספה :)רידנ( )העילב !דימ אפורל תועפות ה/שיגרמ ךניה ובש הרקמ לכב לח םא וא ,הז ןולעב ונייוצ אלש יאוול ץעייתהל ךילע ,תיללכה ךתשגרהב יוניש אפורה םע

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אפורה

.דימ

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