TONIGHT

Israel - English - Ministry of Health

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Active ingredient:
DOXYLAMINE SUCCINATE
Available from:
CTS CHEMICAL INDUSTRIES LTD
ATC code:
R06AA09
Pharmaceutical form:
TABLETS
Composition:
DOXYLAMINE SUCCINATE 25 MG
Administration route:
PER OS
Prescription type:
Not required
Manufactured by:
CTS CHEMICAL INDUSTRIES LTD
Therapeutic group:
DOXYLAMINE
Therapeutic area:
DOXYLAMINE
Therapeutic indications:
An aid to the relief of temporary sleep disturbance.
Authorization number:
118 20 29793 00
Authorization date:
2020-03-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

14-09-2016

PATIENT LEAFLET IN ACCORDANCE

WITH THE PHARMACISTS’

REGULATIONS

)PREPARATIONS( – 1986

This medicine is dispensed without a doctor's

prescription

Tonight tablets 25 mg

Each tablet contains 25 mg Doxylamine Succinate

Doxylamine Succinate 25mg

Inactive ingredients in the preparation – see

section 6 in the leaflet.

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 physician or the

pharmacist.

The medicine is not intended for children under the

age of 12. Below this age – contact the doctor.

Make sure the medicine is completely swallowed.

Consult the pharmacist if you have further

questions.

If the insomnia persists continuously for more

than two weeks, stop the medicine and refer to

the doctor. The insomnia may be a symptom for

another underlying disease.

1. What is the medicine intended for?

This medicine is indicated as an aid for relief of

temporary sleep disorder.

Therapeutic class: Anti-histamines.

2. Before using the medicine:

Do not use this medicine if:

You are pregnant or breastfeeding.

You are sensitive )allergic( to the active ingredient

or any of the additional components the medicine

contains )See section 6(.

Special warnings regarding the use of the

medicine:

Before beginning treatment with Tonight,

consult the doctor if:

If you have or have had breathing problems

such as: asthma, emphysema or chronic

bronchitis.

If you have or have had problems urinating due

to an enlarged prostate.

You are sensitive to any food or medicine.

You have or have had impaired function of

the heart and/or blood vessels, eyes )such as

glaucoma(, digestive system )such as an ulcer(,

thyroid.

If you are taking or have recently taken

other medicines including non-prescription

medicines and food supplements, tell the

physician or the pharmacist. Especially

inform the doctor or pharmacist if you are taking

medicines from the following groups: medicines

which affect the central nervous system )such as:

sedatives, hypnotics, medicines for Parkinson

disease, medicines for epilepsy, antiallergics,

surgical anesthetics and narcotic analgesics(

antidepressants, anticholinergics or medicines

with anticholinergic activity )such as products for

abdominal spasms(, other anesthetics.

Use of the medicine and Alcohol consumption.

Do not consume alcohol )wine and other alcoholic

beverages( during treatment with the medicine.

Pregnancy and breastfeeding:

The medicine must not be used if you are pregnant

or breastfeeding.

Driving and operating machinery:

Exercise caution when driving a car, operating

dangerous machinery and during any activity that

requires alertness while using the medicine. This is

because using this medicine may impair alertness.

Children should be cautioned against riding a

bicycle or playing near a road etc.

Important information about some ingredients

of the medicine:

Each Tonight tablet contains about 0.4 mg of

Sodium.

Do not use this medicine frequently and for

longer than two consecutive weeks without

consulting the doctor!

Take this medicine only before bedtime.

3. How should you use the medicine?

Check with the doctor or pharmacist if you are

uncertain.

The standard dosage for adults and children 12

years of age and older is: half a tablet to one tablet

about half an hour before bedtime.

This medicine is not intended for infants and

children under 12 years of age.

The medicine may be taken with food.

Do not exceed the recommended dose.

The medicine should be taken with water.

Duration of treatment - Do not take for more

than two consecutive weeks unless approved

by the doctor.

Do not chew; the tablet may be split in half.

If you accidentally take a higher dosage

If you took an overdose or by mistake a child

swallowed this medicine, go to the doctor or the

emergency room of the hospital immediately and

take the package of the medicine with you.

How can you contribute to the success of the

treatment?

Do not take medicines in the dark! Check the label

and the dosage every time you take the medicine.

Wear glasses if you need them.

If you have any other questions regarding the

use of the medicine, consult the physician or the

pharmacist.

4. Side effects:

As with any medicine, use of Tonight 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 treatment and contact the doctor as soon

as possible if you suffer from:

Continuous insomnia for longer than two weeks.

Insomnia can be a symptom of some other

serious disease.

Fever, sore throat )rare(.

Additional side effects:

Dry mouth, blurred vision.

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

worsens, or if you suffer from a side effect not

mentioned in the leaflet, consult with the 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://forms.gov.il/globaldata/

getsequence/getsequence.

aspx?formType=AdversEffectMedic@moh.gov.il

5. How to store the medicine?

Avoid poisoning! This medicine and any other

medicine should be kept in a closed place out

of sight and reach of children and/or infants in

order to avoid poisoning. Do not induce vomiting

without an explicit instruction from the physician.

Do not use the medicine after the expiry date

)exp. date( appearing on the package. The

expiry date refers to the last day of that month.

Store at temperature below 25°C. Store in the

original package.

6. Additional information:

In addition to the active ingredient the medicine

also contains:

Microcrystalline Cellulose, Dibasic Calcium

Phospate Dihydrate, Sodium Starch Glycolate,

Magnesium Stearate

What does the medicine look like and what

are the contents of the package: Oval cream-

white tablet, with a score line on one side.

The medicine is supplied in a blister package

containing 2, 5 or 10 tablets. Not all package

sizes may be marketed.

The manufacturer/registration holder: CTS

Chemical Industries ltd., 3 Hakidma st., Kiryat

Malachi, Israel.

This leaflet was checked and approved by the

Ministry of Health on October 2015

Registration number of the medicine in the

National Drug Registry of the Ministry of Health:

118-20-29793

اذإ نكمم تقو عرسأ يف بيبطلا ةعجارمو جلاعلا نع ف

ّ

قوتلا بجي :نم يناعت تنك

قرلأا نوكي دق .لصاوتم لكشب نيعوبسأ نم رثكلأ

رمتسي قرأ .رخآ ريطخ ضرمل ا

رع

.)ردان( ةرجنحلا يف ملأ ،ى

:ىرخأ ة

ّ

يبناج ضارعأ .ةيؤرلا ش

وشت ،مفلا فافج تنك اذإ وأ ،ة

يبناجلا ضارعلأا دحأ مقافت اذإ ،

يبناج ض

رع رهظ اذإ .بيبطلا ةراشتسا كيلعف ،ةرشنلا يف ركذ

ي مل

يبناج ض

رع نم يناعت طغضلا ةطساوب ة

حصلا ةرازول ة

يبناج ضارعأ نع غيلبتلا ناكملإاب دوجوملا "

يئاودلا جلاعلا بقع ة

يبناج ضارعأ نع غيلبتلا" طبارلا ىلع

)www.health.gov.il( ة

حصلا ةرازو عقومل ة

يسيئرلا ةحفصلا يف نع وأ ،ة

يبناج ضارعأ نع غيلبتلل ةلص

تملا ةرامتسلاا ىلإ ه

جوي يذلاو :طبارلا ىلإ لوخدلا قيرط

https://forms.gov.il/globaldata/

getsequence/getsequence.

aspx?formType=AdversEffectMedic@moh.gov.il

؟ءاودلا نيزخت بجي فيك .5

ناكم يف ظفح

ي نأ بجي رخآ ءاود لكو ءاودلا اذه !ممستلا بنجت عضرلا لافطلأا وأ/و دلاولأا يديأ لوانتمو ةيؤر نع ا

ديعب قلغم نم ةحيرص تاميلعت نودب ؤيقتلا ببست لا .م

مستلا ىدافتت كلذبو .بيبطلا

ةيحلاصلا ءاهتنا خيرات دعب ءاودلا لامعتسا زوجي لا

ةيحلاصلا ءاهتنا خيرات ريشي .ة

وبعلا ىلع ن

ودملا )Exp. Date( .رهشلا سفن نم ريخلأا مويلا ىلإ

يف

هن

زخ .ة

يوئم ةجرد 25 نود ةرارح ةجرد يف نيزختلا بجي .ةيلصلأا ة

وبعلا :ةيفاضإ تامولعم .6

:ىلع اضيأ ةلاعفلا ةداملل ةفاضلإاب ءاودلا يوتحي

Microcrystalline Cellulose, Dibasic Calcium

Phospate Dihydrate, Sodium Starch Glycolate,

Magnesium Stearate

نوللاب

يوضيب صرق :ة

وبعلا ىوتحم وه امو ءاودلا ودبي فيك لصي .دحاو بناج يف رط

َّ

شلل

طخ عم ،مير

كلا ىلإ لئاملا ضيبلأا لا دق .صارقأ 10 وأ 5 ،2 ىلع يوتحت تاحيول ة

وبع يف ءاودلا .تا

وبعلا ماجحأ عيمج ق

وس

،.ض.م ة

يئايميكلا تاعانصلل ط ص ك :زايتملاا بحاص /ج

تنملا .ليئارسا ،يخلام تايرك ،3 امديقاه عراش

:خيرات يف ة

حصلا ةرازو لب

ق نم ت

رق

أو تصح

ف ةرشنلا هذه

2015/10

:ةحصلا ةرازو يف يموكحلا ةيودلأا لجس يف ءاودلا لجس مقر

29793-20-118

ةغيصب ةرشنلا هذه ةغايص تمت ،ةءارقلا ليهستلو طيسبتلا لجأ نم .نيسنجلا لاكل صصخم ءاودلا نإف ،كلذ نم مغرلا ىلع .ركذملا

LFL 001 12/15

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