TRICLONAM ELIXIR

Israel - English - Ministry of Health

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Active ingredient:
TRICLOFOS SODIUM
Available from:
CTS CHEMICAL INDUSTRIES LTD
ATC code:
N05CM07
Pharmaceutical form:
ELIXIR
Composition:
TRICLOFOS SODIUM 500 MG / 5 ML
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
CTS CHEMICAL INDUSTRIES LTD
Therapeutic group:
TRICLOFOS
Therapeutic area:
TRICLOFOS
Therapeutic indications:
Insomnia, daytime sedation and pre-medication in EEC.
Authorization number:
047 92 23600 00
Authorization date:
2020-04-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

17-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

19-07-2020

يئاجف لكشب ة

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يئاودلا ةعرجلا

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لق وأ ءاودلا لوانت نع تف

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حصلا ةرازو عقومل ة

يسيئرلا ةحفصلا قيرط نع وأ ،ة

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جوي https://sideeffects.health.gov.il/ :طبارلا ىلإ لوخدلا

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ضيأ ءاودلا يوتحي ،لا

عفلا ب

كرملا ىلإ ةفاضلإاب

Sucrose, Ethanol 95%, Sodium Hydroxide, Orange

Oil 926, Lemon Oil NO, Vanillaroma 200, Saccharin

Sodium, Nipastat, Disodium Edetate, Hydrochloride

acid 37%, Sodium Carbonate anhydrous, Sunset

Yellow, Purified Water

يربنعلا نو

للاب ة

يجاجز ةني

نق :ة

وبعلا ىوتحم وه امو ءاودلا ودبي فيك

PATIENT LEAFLET IN ACCORDANCE

WITH THE PHARMACISTS’ REGULATIONS

)PREPARATIONS( – 1986

The medicine is dispensed with a doctor's

prescription only

Triclonam Elixir

The active ingredient and its concentration:

Triclofos Sodium 500 mg/5 ml

Inactive ingredients and allergens in the

preparation - see section 6 “Additional information”

and the “Important information about some

ingredients of the medicine” section.

Read the entire leaflet carefully before using the

medicine.

This leaflet contains concise information

about the medicine. If you have any other

questions, refer to the doctor or the pharmacist.

This medicine has been prescribed for you. Do not

pass it on to others. It may harm them even if it

seems to you that their medical condition is similar.

1. What is the medicine intended for?

This preparation is intended for the treatment of

insomnia, for sedation in states of tension and

anxiety and prior to various medical examinations.

Therapeutic class: Hypnotic medicines to induce

sleep.

2. Before using the medicine

Do not use this medicine if:

You are sensitive to the active ingredient

or to any of the additional components the

medicine contains.

You have acute intermittent porphyria

)Triclonam aggravates symptoms of

porphyria(.

Special warnings regarding the use of the

medicine

Before treatment with Triclonam, inform the

doctor if:

You have liver or kidney impairment )may

cause the medicine to accumulate in the blood,

which may result in side effects(.

You are suffering from weakness )the

preparation may cause respiratory

depression(.

You are suffering from impaired respiratory

function )the preparation may cause

respiratory depression(.

You are suffering from impaired function of the

heart or from arrhythmias )the preparation may

aggravate the symptoms due to its effect on

heart function(.

The treatment is intended for the elderly )see

“The elderly” section(.

The treatment is intended for children )see

“Children” section(.

Prolonged use may lead to dependence.

Carefully evaluate the necessity of the treatment

and avoid prolonged and long-term use )see

“Side effects” section(.

The preparation may cause respiratory

depression. See ”Tests and follow-up” section.

Tests and follow-up

During the treatment period and particularly in

children, you may be required by the doctor to

monitor your respiration rate, heart rate, oxygen

saturation level in the blood etc.

The elderly

The preparation may cause respiratory depression.

Use with care; for example, start treatment with the

lowest dose.

Children

Use with care; for example, start treatment with the

lowest dose. Children treated with the medicine

should be monitored for fear of side effects )see

“Side effects in children” subsection(.

Drug-drug interactions

If you are taking or have recently taken

other medicines, including non-prescription

medicines and food supplements, tell the doctor

or the pharmacist, especially if you are taking:

Chloral hydrate )for fear of an overdose, as

both preparations break down to the same

metabolite(.

Medicines affecting the central nervous system

)phenothiazine derivatives, barbituric acid

derivatives(. Triclonam may enhance depression

of the nervous system caused by these

medicines.

Monoamine oxidase inhibitors. Triclonam may

enhance depression of the nervous system

caused by these medicines.

Alcohol. Triclonam may enhance the effects of

alcohol.

Anticoagulant agents of the coumarin group.

Triclonam may enhance the effects of these

medicines.

Use of the medicine and alcohol consumption

Do not drink wine or alcoholic beverages during

treatment with this medicine.

Pregnancy, breastfeeding and fertility

Use of the preparation is not recommended for

women who are pregnant or might be pregnant

)safety of use during pregnancy is unknown(.

Driving and operating machinery

Use of this medicine may impair alertness and

therefore caution should be exercised when driving

a car, operating dangerous machinery and in any

activity which requires alertness. Children should be

cautioned against riding a bicycle or playing near a

road etc.

Important information about some ingredients

of the medicine

The preparation contains about 2.7 grams of

sucrose in every 5 ml. If you have been told by

the doctor that you have an intolerance to certain

sugars, consult your doctor before taking this

medicine. This should be taken into consideration in

diabetic patients. May harm your teeth.

The preparation contains ethanol in

concentration of 4.8%. Each 5 ml contain about

0.3 ml ethanol. The ethanol content in the

package is 6 ml. The preparation contains 240

mg of ethanol 95% )alcohol( in every 5 ml, which

is equivalent to 6 ml of beer and 2.5 ml of wine.

This is harmful for people with alcoholism. This

should be taken into consideration in pregnant and

breastfeeding women, children and patients at risk,

such as patients with liver disease or epilepsy.

The preparation contains about 50 mg of sodium in

every 5 ml, which is equivalent to about 2.5% of the

maximum recommended daily intake in adults.

The preparation contains Sunset Yellow. This may

cause allergic reactions.

3. How should you use the medicine?

Always use the preparation according to the

doctor's instructions.

Check with the doctor or pharmacist if you are

uncertain about the dosage and how to use the

preparation.

The dosage and treatment regimen will be

determined by the doctor only. The generally

accepted dosage is:

Sleep induction:

Adults and children over the age of 12 years: 10 ml.

In certain cases a higher dosage may be required -

up to 20 ml per day.

Children 6-12 years old: 5-10 ml per day.

Children 1-5 years old: 2.5-5 ml per day.

Infants up to 1 year old: 1-2.5 ml per day.

For sedation:

Adults and children over the age of 12 years: 5 ml

twice per day.

Children 6-12 years old: 5 ml per day.

Children 1-5 years old: 2.5 ml per day.

Infants up to 1 year old: 1 ml per day.

Do not exceed the recommended dose.

With liquid medicines, use the measuring spoon,

syringe or dropper intended for measuring the

proper amount of medicine. If a spoon or any

other measuring device was not provided with

the package, consult a pharmacist. Do not use a

household teaspoon to measure the amount of

medicine. Household teaspoons vary in size and it

is likely you will not receive the correct amount of

medicine.

Child-proof safety caps have significantly reduced

the number of poisoning incidents caused by

medicines each year. However, if you find it difficult

to open the package, you can refer to a pharmacist

to ask to have the safety mechanism removed and

to turn the cap into a regular, easy-to-open cap.

If you accidentally take a higher dosage, you

may suffer from respiratory arrest, slowing of heart

rate and a drop in blood pressure. If you took an

overdose or if a child swallowed this medicine by

mistake, go to the doctor or the emergency room of

the hospital immediately and take the package of

the medicine with you.

Follow the treatment as recommended by the

doctor.

If you stop taking the medicine or reduce

your dosage suddenly after prolonged use, you

may experience withdrawal symptoms, such

as seizures, hallucinations, tremor, anxiety etc.

When discontinuing treatment, the dosage should

be reduced gradually. Before discontinuing the

treatment you should discuss the consequences

with your doctor.

Do not take medicines in the dark! Check the

label and the dose every time you take the

medicine. Wear glasses if you need them.

If you have any other questions regarding

use of the medicine, consult the doctor or the

pharmacist.

4. Side effects:

As with any medicine, using Triclonam 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.

Stop using this medicine and refer to a doctor

immediately if:

You experience anaphylactic shock: itch, edema,

respiratory distress, a drop in blood pressure,

cyanosis or a hypersensitivity reaction: rash,

erythema, blisters, itch, fever.

You experience respiratory arrest or respiratory

depression which may lead to cardiac arrest.

Changes in white blood cells count )eosinophilia,

leukopenia( have occurred.

Severe side effects )with unknown frequency(:

Dependence.

Additional side effects )with unknown

frequency(:

Slowing of heart rate.

Liver enzymes elevation.

Nausea, vomiting, flatulence, abdominal pain.

Headache, dizziness, fainting sensation, ataxia,

neurological disturbance, depression, speech

disturbances, late wake up.

Edema, reduced urine output, appearance of

ketones in the urine.

Side effects in children:

Respiratory arrest, respiratory depression which

may lead to cardiac arrest.

Seizures )clonic or partial(.

If a side effect occurs, if one of the side effects

worsens, or if you suffer from a side effect not

mentioned in this leaflet, consult your doctor.

Side effects may be reported to the Ministry of

Health by clicking on the link "report side effects

due to medicinal treatment" found on the Ministry

of Health website homepage )www.health.gov.il(,

which will direct you to the online form for reporting

side effects, or by clicking on the following link:

https://sideeffects.health.gov.il/

5. How to store the medicine?

Avoid poisoning! This medicine and any other

medicine must be kept in a closed place out of

the reach and sight of children and/or infants to

avoid poisoning. Do not induce vomiting without an

explicit instruction from the doctor.

Do not use the medicine after the expiry date )Exp(

appearing on the package. The expiry date refers to

the last day of that month.

Storage

Store at a temperature lower than 25°C.

The preparation may be used for up to 110 days

following first opening.

6. Additional information

In addition to the active ingredient, the medicine

also contains:

Sucrose, Ethanol 95%, Sodium Hydroxide, Orange

Oil 926, Lemon Oil NO, Vanillaroma 200, Saccharin

Sodium, Nipastat, Disodium Edetate, Hydrochloride

acid 37%, Sodium Carbonate anhydrous, Sunset

Yellow, Purified Water

What does the medicine look like and what are

the contents of the package: an amber-colored

glass bottle, containing 100 ml of a slightly viscous

orange liquid.

Manufacturer and license holder: CTS Chemical

Industries Ltd., Kiryat Malachi, Israel, p.o. box 385

The format of this leaflet was determined by the

Ministry of Health and its content was checked and

approved by the Ministry of Health on April 2010,

and has been updated in accordance with the

Ministry of Health instructions on June 2020.

Registration number of the medicine in the national

drug registry of the Ministry of Health:

047-92-23600-00.

LFL 222 06/20

SUMMARY OF PRODUCT CHARACTERISTICS

TRICLONAM ELIXIR

TRICLOFOS SODIUM 500 MG / 5 ML

Treatment Matters

1. Therapeutic indications

Insomnia, daytime sedation and pre-medication in EEC.

2. Dosage and Administration

For insomnia:

Adults and children over 12 years: 10 ml daily, in certain cases a higher dosage

may be required - up to 20 ml daily.

Children 6-12 years: 5-10 ml daily.

Children 1-5 years: 2.5-5 ml daily.

Infants up to 1 year: 1-2.5 ml daily.

As a sedative:

Adults and children over 12 years: 5 ml twice daily.

Children 6-12 years: 5 ml daily.

Children 1-5 years: 2.5 ml daily.

Infants up to 1 year: 1 ml daily.

3. Clinical Results

(1) Clinical Data Package

None

(2) Clinical Effects

Clinical results judging by sleeping effects were 84.3% (321/381).

(3) Clinical Pharmacological Test

No applicable data

(4) Exploratory Test

No applicable data

(5) Verification Test

1) Randomized Parallel Dosage Response Study

No applicable data

2) Comparative Test

The following results were obtained comparing chloral hydrate (22mg/kg) and

triclofos sodium (33mg/kg) in 71 children aged 4 to 14 years old who require

sedation during EEG. EEG was used for the sleep start monitor.

Triclofos Sodium syrup (37 subjects)

Chloral hydrate (34 subjects)

Dosage*

Average 1 g (480 mg to 1960 mg)

Average: 680 mg (300mg to 1,510mg)

Sleep introduction time

37.3 ± 12.1 minutes

36.6 ± 14.4 minutes

Ineffective cases

6 cases

4 cases

Taste

Aversion

2 cases (5%)

9 cases (27%)

Good

14 cases (33%)

11 cases (32%)

Very good

21 cases (51%)

14 cases (41%)

Adverse reactions

16 types in 9 people (24%)

16 types in 9 people (26%)

*: Dosage is expressed in the amount of the active ingredient.

Triclofos Sodium Syrup active ingredient: Triclofos sodium

Chloral hydrate active ingredient

3) Safety Test

No applicable data

4) Testing by patient/condition

No applicable data

(6) Therapeutic Use

1) Treatment outcome study and research of specific uses (special survey)/Clinical

studies after manufacturing and sales (post-marketing clinical results)

No applicable uses

2) Approval conditions of details for execution or overview of the executed testing

None

Pharmacology Matters

1. Pharmacologically-related Chemical Compound or Compound Group

Chloral hydrate

2. Pharmacological Action

(1) Site and mechanism of action

Site of action:

Reticular of brainstem

Mechanism of action:

Inside the body, it becomes the metabolite trichloroethanol,

in the same way chloral hydrate does, and exhibits sedation

and hypnotic activity. There is less gastrointestinal irritation

than with chloral hydrate.

(2) Study results that support drug efficacy

See Treatment Matters I-2. Pharmacological Action (3) Onset time/duration of action

(3) Onset time/duration of action

Onset time of action

Within 60 minutes

Fell asleep within 30 minutes of administration:

381/1075 cases (35.4%)

within 45 minutes:

818/1075 cases (76.1%)

within 60 minutes:

1011/1075 cases (94.0%)

Duration of action:

Action lasted 2 to 3 hours in the highest amount of cases

Out of 295 pediatric cases, sleep duration was 2 to 3 hours in 41.7% (123), 5 to 6

hours in 14.2% (42) and at least 2 hours in 68.8% (203) of cases.

Out of 143 adult cases, sleep duration was at least 2 hours in 62.9% (90) of cases.

Pharmacokinetic Matters

1. Change in Blood Concentration and Method of Measurement

(1) Blood concentration effective in treatment

No applicable data

(2) Time to reach peak blood concentration

About 1 hour

(3) Blood concentration confirmed in clinical trials

Blood concentration of trichloroethanol when a 22.5 mg/kg dose was administered orally to a

healthy adult (n=7) reached a peak of 8.2 ± 0.6μg/mL one hour after administration, with a

half-life (T1/2β) of 8.2 hours. 4)

(4) Toxicity Zone

No applicable data

(5) Effects of diet and concomitant drugs

No applicable data

(6) Pharmacokinetic variability factors found by population analysis

No applicable data

2. Pharmacokinetic Parameters

(1) Analysis method

No applicable data

(2) Absorption rate constant

No applicable data

(3) Bioavailability

No applicable data

(4) Elimination rate constant

No applicable data

(5) Clearance

No applicable data

(6) Distribution volume

No applicable data

(7) Blood plasma protein coupling

3. Absorption

Absorption site: Stomach

4. Distribution

(1) Permeability of blood-brain barrier

High (permeates)

(2) Permeability of blood-placental barrier

High (permeates)

(3) Transferability to breastmilk

No applicable data

(4) Transferability to cerebrospinal fluid

No applicable data

(5) Penetrability to other tissue

No applicable data

5. Metabolism

(1) Metabolic site and metabolic pathway

Trichloroethanol is metabolized by trichloro acetic acid in red blood cells, liver and other

tissue.

Biological half-life is 4 to 12 hours.

(2) Molecular species of enzymes involved in metabolism (CYP450, etc.)

No applicable data

(3) Initial permeation effects and ratio, if any

No applicable data

(4) Metabolite action and ratio, if any

No applicable data

(5) Kinetic parameters of metabolites

No applicable data

6. Excretion

(1) Excretion site and route

There are excretions in the urine and excretions in bile in the form of trichloroethanol,

glucuronic acid conjugate and trichloro acetic acid.

(2) Excretion rate

At 24 hours after administration, 17 to 40% is excreted in the urine comprising 4.6% (0.5 to

19%) of the dosage (15mg/kg) as an unaltered substance, combined with glucuronic acid

conjugate.

(3) Excretion speed

Trichloro acetic acid excretion is slower with 10% or less during the first two hours, 25% or

less during the next 6 hours and reaching 38% at 24 hours (excretion is slow and there are

still traces in the blood even three days after administration).

7. Transporter Information

No applicable data

8. Extraction Ratio by Dialysis, etc.

No applicable data

Safety Matters (precautions in use)

1. Warnings and Reasons

None

2. Contraindications and Reasons (including contraindications in principle)

Contraindications (do not administer to the following patients)

(1) Hypersensitivity to the active substance, to chloral hydrate [TRICLONAM is converted to

trichloroethanol in the body the same way as chloral hydrate] or to any of the excipients listed in

section Pharmaceutical Particulars.

(2) Patients with acute intermittent porphyria [TRICLONAM exacerbates the symptoms of porphyria]

3. Precautions Related to Indications or Effects and Reasons

None

4. Precautions and Related to Dosage and Administration and Reasons

None

5. Careful Administration Warnings and Reasons

Careful administration (extra care should be taken when administering to the following

patients)

(1) Patients with hepatic disorder or renal disorder [TRICLONAM is hydrolyzed in the liver,

converting it to trichloroethanol, then excreted by the kidneys, leading to risk in exacerbating

adverse reactions in patients due to maintained and increased blood concentration]

(2) Children (see 11. Pediatric Use, etc.)

(3) Weak patients [may cause respiratory depression]

(4) Patients with reduced respiratory function [may cause respiratory depression]

(5) Patients with serious heart disease or arrhythmia [may exacerbated symptoms due to inhibited

cardiac function]

(6) Elderly patients (See 9. Use in Elderly)

6. Important Precautions, Reasons and Measures

Important precautions

(1) Monitor patients carefully due to risk of respiratory depression. Especially in children, careful

attention must be given to respiratory rate, heart rate, percutaneous arterial blood oxygen

saturation, etc., through monitoring. (See 5. Careful Administration Warnings and Reasons, 8.

Adverse Reactions (2) Serious Adverse reactions and Initial Symptoms, 11. Pediatric Use, etc.)

(2) As chloral hydrate is converted into the in vivo metabolite trichloroethanol, in the same way as

TRICLONAM, combined use may cause overdosage. (See 13. Overdosage)

(3) Patients administered TRICLONAM must be warned not to engage in operating dangerous

machinery, such as motor vehicles.

(4) Since prolonged administration may cause drug dependency, avoid long-term use through

random, continued administration. Take careful consideration of therapeutic necessity when

continuing administration. (See 8. Adverse reactions (2) Serious Adverse reactions and Initial

Symptoms)

7. Drug Interactions

(1) Contraindications for coadministration and reasons

None

(2) Precautions for coadministration and reasons

[Precautions for Co-administration] (TRICLONAM should be administered with care when co-

administered with the following drugs)

Drug name, etc.

Clinical symptoms and

procedures

Mechanism and risk factors

Central nervous system

depressants

Phenothiazine derivative

Barbiturates

Monoamine oxidase inhibitors

TRICLONAM may exacerbate

these effects, so take careful

care if administration is

unavoidable.

There is a possibility of

enhanced central nervous

system depressant action.

Alcohol

It competitively prohibits

alcohol dehydrogenase,

increasing blood concentration

of alcohol.

Coumarin-based

anticoagulants

Warfarin, etc.

There is a possibility of

exacerbating these effects, so

in case of coadministration,

carefully administer drug while

measuring prothrombin levels

more frequently than usual.

Trichloro acetic acid, a major

metabolite, isolates and

replaces warfarin from the

blood plasma protein coupling

site and increases free-type

warfarin concentration.

8. Adverse Reactions

(1) Summary of adverse reactions

There has been no research, such as a treatment outcome study, to determine the incidence

of occurrence of adverse reactions.

(2) Serious of adverse reactions and initial symptoms

Serious adverse reactions

1) Respiratory arrest, respiratory depression (incidence unknown): Respiratory

arrest and respiratory depression may occur, and there are also reports of

symptoms resulting in cardiopulmonary arrest, so respiratory conditions must be

monitored carefully and appropriate measures taken in case of abnormality.

2) Shock, anaphylaxis, (incidence unknown): Shock and anaphylaxis may occur,

so patient must be monitored carefully and in case pruritus, edema, respiratory

distress, decreased blood pressure, cyanosis, etc. occur, discontinue administration

and take appropriate measures.

3) Dependence (incidence unknown): Since prolonged administration may cause

drug dependency, monitor patient carefully and take careful care in dosage and

duration of administration. Furthermore, sudden dosage reduction or discontinuation

after prolonged use may cause withdrawal symptoms such as convulsive seizure,

delirium, tremors, anxiety, etc. In case of discontinuing administration, carefully

reduce dosage gradually.

(3) Other adverse reactions

Other adverse reactions

In case any of the following adverse reactions occur, take appropriate measures based on

symptoms.

Frequency unknown

Hypersensitivity

Note)

Rash, erythema, blister, fixed drug

eruption, pruritus, fever

Circulatory system

Bradycardia

Liver

Increase in AST (GOT) and ALT (GPT)

Blood

Note)

Eosinophilia, leukopenia

Digestive system

Nausea/vomiting, flatulence,

stomachache

Neuropsychiatric

Headache, dizziness, lightheadedness,

ataxia, erethism, depression, dysarthria,

delayed awakening

Other

Edema, decreased urine volume,

ketonuria

Note) In these cases, discontinue administration.

(4) List of adverse event frequency and abnormalities in clinical laboratory values by

category

The incidence of adverse reactions in combination with tablets* was 202 cases (6.33%) out

of 3,189 cases.

Cases

Incidence (%)

Cases

Incidence (%)

Headache

0.34

Lack of restraint

0.03

Vomiting

0.09

Elation

0.03

Nausea

0.16

Hyperactivity

0.03

Abdominal pain

0.03

Fear

0.03

Gastric irritation

0.38

Nightmares

0.03

Stomach discomfort

0.03

Nervousness

0.03

Reflux

0.06

Insomnia

0.03

Heartburn

0.06

Incoordination

0.03

Flatulence

0.09

Ataxia

0.09

Mental desensitization

0.03

Sluggish movement

0.03

Fatigue/drowsiness

1.00

Hangover-like feeling

0.09

Dizziness, light-

headedness

0.44

Residual action

0.28

Aftertaste

0.03

* triclofos sodium tablets were taken off the market in 1975

(5) Incidence of adverse reactions by background, including underlying disease,

complications, severity and whether or not surgery was performed

No applicable data

(6) Precautions and study methods for drug allergy

1) Patients with a history of hypersensitivity to the components of TRICLONAM or chloral

hydrate.

2) Shock and anaphylaxis may occur as major adverse reactions, so patient must be

monitored carefully and in case pruritus, edema, respiratory distress, decreased blood

pressure, cyanosis, etc. occur, discontinue administration and take appropriate measures.

3) Rash, erythema, blister, fixed drug eruption, pruritus or fever may occur. If such

symptoms occur, discontinue administration.

Reporting of suspected adverse reactions:

Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows

continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the National

Regulation by using an online form:

https://sideeffects.health.gov.il/

9. Use in the Elderly

TRICLONAM may cause respiratory depression in elderly patients. Since adverse reactions are

likely to occur in general, administer drug carefully, for example by starting with minimal dosage.

10. Use during Pregnancy, Delivery or Lactation, etc.

Preferably, TRICLONAM should not be administered to pregnant women or woman who may be

pregnant. [Safety in administration during pregnancy has not been established]

11. Pediatric Use, etc.

(1) In general, children have a higher drug sensitivity than adults, so administer drug carefully, for

example by starting with minimal dosage (there have been many reports of respiratory arrest,

respiratory depression and convulsions children with low birth weight, newborns, and infants)

(2) There are reports of respiratory arrest and respiratory depression occurring, leading to heart

failure, so drug must be administered carefully and patient must be monitored closely. (See 6.

Important Precautions, Reasons and Measures)

(3) Convulsions (clonic convulsions, partial attacks, etc.) may occur, so administer carefully.

12. Effects in clinical test results

No applicable data

13. Overdose

Signs and symptoms:

Respiratory arrest, bradycardia and decreased blood pressure were found.

(See 6. Important Precautions, Reasons and Measures)

Treatment:

In the event of overdose, monitor respiration, pulse, blood pressure,

percutaneous arterial blood oxygen saturation, and take appropriate

measures, such as securing the airway. There have been reports that

hemodialysis and blood perfusion are effective.

Acute overdose: Similar to symptoms of acute barbiturates poisoning. In addition, effects as a

stimulant appear. The first symptom is vomiting followed by stomach necrosis that progresses to

stenosis. There have been reports of cardiac arrhythmias. Jaundice leads to liver disorder. Renal

disorder is accompanied by Alb urine.

Chronic oral ingestion at high dose: Gastritis, skin rash, teleangiectasia, hypotension, reduced

myocardial function, renal disorder.

Sudden discontinuation of drug causes withdrawal symptoms such as tremors and delirium.

Treatment: Administer palliatives such as liquid paraffin, in order to relieve stomach and esophageal

irritation. Administer lidocaine hydrochloride (xylocaine) to manage heart arrhythmia. Forced diuresis

or dialysis are effective for severe toxicity.

14. Precautions in Application

None

15. Other Precautions

None

16. Excipients

This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance,

glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicinal product contains 50 mg sodium per 5ml, equivalent to 2.5% of the WHO recommended

maximum daily intake of 2 g sodium for an adult.

Matters Related to Non-clinical Studies

1. Pharmacological Studies

(1) Pharmacological studies (see Pharmacology Matters)

(2) Secondary pharmacology studies

No applicable data

(3) Safety pharmacology studies

No applicable data

(4) Other pharmacological studies

No applicable data

2. Toxicity Studies

(1) Single dose toxicity studies

Acute toxicity

Mouse (♀) Orally LD

1470mg/kg

Rat (♀) Orally LD

approx. 1900mg/kg

(2) Repeated dose toxicity studies

Subacute toxicity, chronic toxicity

6,9,10)

There were abnormal findings in subacute toxicity and chronic toxicity studies in which male

and female PVG rats were fed a diet supplemented with 0.03%, 0.1% and 0.3% W/W

triclofos sodium, and the control group was fed a normal diet. In addition, there were no

findings considered to be attributable to triclofos sodium in death rate, incidence of interval

illness, growth rate, organ weight, histological findings, hematological findings or blood

biochemical findings. Furthermore, in the results of oral administration of 67 to 100 mg/kg

disodium trichlorethyl phosphate to WAG rats for 30 days, no abnormal changes were found

in any major organs, there was no delayed growth, stomach irritation or damage to heart,

liver or kidneys.

Table: Abnormal Findings in Study of Subacute and Chronic Toxicity in PVG Rats

Test

Days

Organ weight

Histological findings

Hematological findings

Biochemical

findings

Adrenal gland

hypertrophy

Liver and kidney

hypertrophy

(Testicles) Many abnormal sperm

cells were found in one subject, but

cells were normal in other rats and

in this rat during other periods.

Same as above

(Thyroid gland) One female

presented with a swollen thymocyte

tissue nodule.

ERYTHROPOIESIS

may have been

Male,

Reduced

serum

(Adrenal gland) There were more

lipids in the males than in females,

but there were no differences from

the control group.

caused to males in the

0.3%W/W group.

inorganic

phosphorus

Test

Days

Organ weight

Histological

findings

Hematological

findings

Biochemical

findings

Same as above

Same as above

Male, Slight

increase in blood

urea, but the value

was within normal

range.

Same as above

Male, Increased

serum calcium

364

Same as above

Male, Slightly

decreased serum

calcium

Male/female,

Slightly increased

serum calcium

Possible effects of

hypertrophy of liver

and kidney, and

increased pituitary

weight in males.

Male, decreased

serum bilirubin

(Note) Blank columns indicate no apparent abnormalities.

(3) Reproductive and developmental toxicity studies

Rabbits were orally administered 300 mg/kg/day of triclofos sodium, but no abnormalities

occurred in the infant rabbits. The number of fetuses were the same as the control group.

(4) Other special toxicity

No applicable data

Pharmaceutical Particulars

1

List of excipients

Sucrose, Ethanol 95%, Sodium Hydroxide, Orange Oil 926, Lemon Oil NO, Vanillaroma 200, Saccharin

Sodium, Nipastat, Disodium Edetate, Hydrochloride acid 37%, Sodium Carbonate anhydrous, Sunset

Yellow, Purified Water

2

Incompatibilities

Not applicable.

3

Shelf life

The expiry date of the product is indicated on the packaging materials.

Shelf life after first opening: 110 days

4

Special precautions for storage

Store below 25°C

5

Nature and contents of container

100 ml of syrup in an amber transparent glass bottle (type III) with a child proof cap, tamper evident in a

carton box.

6

Special precautions for disposal and other handling

No special requirements.

Marketing Authorisation Holder and Manufacturer

CTS CHEMICAL INDUSTRIES LTD

POB 385,KIRYAT-MALACHI,ISRAEL

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

according to the guidelines of the Ministry of Health in June 2020.

וי ינ

2020

,ה/אפור ,ה/דבכנ ת/חקור

:ןודנה ןוכדע

ןולע ןכרצל אפורל ןולעו לש

ט

םנוליר

ולעה יכ םכעידוהל םישקבמ ונא

ןכרצל

כדוע ןודנבש רישכתה לש

ןולעה ןוכדע

.תורמחה ללוכ

,ףסונב

אפורל שדח ןולע ונשי

:תרשואמה היוותהה

Insomnia, daytime sedation and pre-medication in EEC.

קזוחו בכרה

ליעפ רמוח

:

TRICLOFOS SODIUM 500 MG / 5 ML

ועצוב וב עדימה אבומ ןלהלש טוריפב דבלב םייתוהמ םייוניש

יוניש לעב טסקט וא טסקט תפסות

יתועמשמ מוסמ

.הצוח וקב תנמוסמ טסקט תקיחמ .עבצב

ל ןולעב םינוכדעה ןכרצ :םיאבה םיפיעסב ושענ

2

.

:הפורתב שומישה ינפל

:םא הפורתב שמתשהל ןיא

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הפירח תיגוריס

םנולכירט

לש םינימסת ףירחמ היריפרופ

םא שמתשהל ןי .הביקה תקלדמ ת/לבוס ךנה םא וא בל ,דבכב יוקיל םייק

הפורתב שומישל תועגונה תודחוימ תורהזא

!

ינפל לופיטה

םנולכירטב

,

רפס

אפורל

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:

ךנה ב יוקילמ לבוס דבכ

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טארדיה

ששחמ

ןונימל

רתי

םיקרפתמ םירישכתה ינשו תויה רצות ותואל

תוירופו הקנה ,ןוירה

שומיש

ןוירהב םישנב ץלמומ וניא רישכתב ןוירהב תויהל תויושעש םישנב וא

.)העודי הניא ןוירהב שומישה תוחיטב(

בושח עדימ הפורתה לש םיביכרמהמ קלח לע

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ל"מ

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Sunset yellow

םורגל לולע

.תויגרלא תובוגת

3

.

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רתוי הובג ןונימ תועטב תלטנ םא

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םוד

,המישנ בלה בצקב הטאה

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ןונימ תיחפמ תוימואתפב

פקתה ןוגכ הלימג ינימסת הווחתו ןכתי ,ךשוממ שומיש רחאל

,םיסוכרפ תויזה הדרח ,דער , וכו

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ת

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העודי הניא ןתוחיכשש(

)

:

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תועפות

יאוול תופסונ

:)העודי הניא ןתוחיכשש(

הטא

בצקב

בלה

דבכ ימיזנאב הילע

ןטב באכ ,םיזג ,האקה ,הליחב

היסקטא ,ןופלע תשוחת ,תרוחרחס ,שאר בא ,ןואכד ,תיגולוריונ הערפה , ,רובידב תוערפה

.תרחואמ הציקי

ןתש תקופתב הדירי ,תקצ .ןתשב ןוטק תעפוה ,

יאוול תועפות םידליב

:

םו

מישנ יוכיד ,המישנ ית

בל םודל ליבוהל םילולעש

םיסוכר

םיינולק

)םייקלח וא

םינכדועמה םינולעה

חלשנ

ב םוסרפל תואירבה דרשמ רתאבש תופורתה רגאמ

http://www.health.gov.il

ןתינ םלבקל

ספדומ םי

חר ,מ"עב טצכ תרבחל הינפ ידי לע

שרחה

,ןורשה דוה

09-7626323

,הכרבב

ריפוא ןולא

חקור

הנוממ

טצכ

תוימיכ תוישעת

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