Israel - English - Ministry of Health
PatiEnt PackagE inSERt in
accoRDancE With thE PhaRmaciStS’
REguLationS (PREPaRationS) – 1986
The medicine is dispensed
without a doctor’s prescription
Each tablet contains doxylamine succinate
*For inactive ingredients in the preparation -
refer to Section 6 in this leaflet.
Read this leaflet carefully in its entirety
before using the medicine. This leaflet
contains concise information about the
medicine. If you have further questions,
refer to the doctor or pharmacist.
The medicine is not intended for children
under 12 years of age. Consult the doctor
for children under this age.
You must swallow it correctly. Consult
the pharmacist if you need additional
If insomnia continues consecutively for
longer than two weeks, stop using the
medicine and consult the doctor. Insomnia
can be a symptom of some other background
1. What iS thE mEDicinE intEnDED
Aid for the relief of temporary sleep
therapeutic group: antihistamines.
2. BEfoRE uSing thE mEDicinE
Do not use the medicine if:
you are sensitive (allergic) to the active
ingredient or any of the other ingredients
you are pregnant or breastfeeding.
Special warnings regarding use of the
Before beginning treatment with Sleep
aid, tell the doctor if:
∘ you have or have had breathing
problems such as: asthma, emphysema,
or chronic bronchitis.
∘ you have or have had problems urinating
due to an enlarged prostate.
∘ you are sensitive to any food or
∘ 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 nutritional supplements,
tell the doctor or pharmacist. Especially
inform the doctor or pharmacist if you are
medicines from the following groups:
medicines which affect the central
nervous system (such as: sedatives,
epilepsy medication, hypnotics, medicines
for parkinsonism, antiallergics, surgical
anesthetics and narcotic analgesics),
antidepressants, anticholinergics or
medicines with anticholinergic activity
(such as preparations for abdominal
spasms), other anesthetics.
use of the medicine and alcohol
Do not consume alcohol (wine and alcoholic
beverages) during treatment with the
Pregnancy and breastfeeding
The medicine must not be used during
pregnancy 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, and the
important information about some of
the ingredients in the medicine
The medicine contains sodium.
Do not use this medicine frequently and
for longer than two consecutive weeks
without consulting the doctor!
take this medicine only before going to
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.
5. hoW ShouLD thE mEDicinE BE
Avoid poisoning! This medicine, and any
other medicine, should be kept in a safe
place out of sight and reach of children
and/or infants in order to avoid poisoning.
Do not induce vomiting unless explicitly
instructed to do so by the doctor.
Do not use the medicine after the expiry
date (exp. date) appearing on the package.
The expiry date refers to the last day of
Store below 25°C. Store in original
6. fuRthER infoRmation
In addition to the active ingredient, the
medicine also contains: Microcrystalline
Cellulose, Anhydrous Dibasic Calcium
Phosphate, Dibasic Calcium Phosphate
Dihydrate, Sodium Starch Glycolate,
Magnesium Stearate, FD&C blue #1
Amount of sodium in each tablet:
What does the medicine look like and
what are the contents of the package
A light-blue, oval tablet, with a score line
on one side and “L441” engraved on the
The medicine is supplied in a 16-tablet
Registration holder: Perrigo Israel Agencies
Ltd., 29 Lehi St., Bnei Brak 51200.
Manufacturer: Perrigo, Allegan, Michigan,
This leaflet was checked and approved by
the Ministry of Health in June 2014.
Registration number of the medicine in the
National Drug Registry of the Ministry of
Check with the doctor or pharmacist if you
The standard dosage for adults and children
from 12 years of age and up is: one half
tablet to one tablet about an half hour before
This medicine is not intended for infants and
children under 12 years of age.
Do not exceed the recommended dose.
Swallow the medicine with water
take out the tablet by peeling the foil seal
on the corner of the blister, where the
word PEEL is printed. Do not forcefully
push the tablet through the foil seal; this
might break the tablet.
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
if you accidentally take a higher dosage
If you have taken 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.
How can you contribute to the success of
Do not take medicines in the dark! Check
the label and the dose each time you take
the medicine. Wear glasses if you need
If you have further questions regarding
use of the medicine, consult the doctor or
4. SiDE EffEctS
As with any medicine, use of Sleep Aid may
cause side effects in some users. Do not be
alarmed by the list of side effects. You may
not suffer from any of them.
Stop treatment and contact the doctor as
soon as possible if you have:
continuous insomnia for longer than two
weeks. Insomnia can be a symptom of
some other serious disease.
fever, sore throat (rare).