SLEEP AID

Israel - English - Ministry of Health

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Active ingredient:
DOXYLAMINE SUCCINATE
Available from:
PERRIGO ISRAEL AGENCIES LTD, ISRAEL
ATC code:
R06AA09
Pharmaceutical form:
TABLETS
Composition:
DOXYLAMINE SUCCINATE 25 MG
Administration route:
PER OS
Prescription type:
Not required
Manufactured by:
PERRIGO COMPANY, USA
Therapeutic group:
DOXYLAMINE
Therapeutic area:
DOXYLAMINE
Therapeutic indications:
Aid to the relief of temporary sleep disturbance.
Authorization number:
131 07 30938 01
Authorization date:
2014-06-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

PatiEnt PackagE inSERt in

accoRDancE With thE PhaRmaciStS’

REguLationS (PREPaRationS) – 1986

The medicine is dispensed

without a doctor’s prescription

Sleep aid

tablets

Each tablet contains doxylamine succinate

25 mg

*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

information.

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

disease.

1. What iS thE mEDicinE intEnDED

foR?

Aid for the relief of temporary sleep

disturbance.

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

contained

medicine

(see

Section 6).

you are pregnant or breastfeeding.

Special warnings regarding use of the

medicine

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

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 nutritional supplements,

tell the doctor or 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,

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

consumption

Do not consume alcohol (wine and alcoholic

beverages) during treatment with the

medicine.

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

like.

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

sleep.

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

StoRED?

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

that month.

Store below 25°C. Store in original

package.

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

Aluminium Lake.

Amount of sodium in each tablet:

0.412 mg.

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

other side.

The medicine is supplied in a 16-tablet

blister pack.

Registration holder: Perrigo Israel Agencies

Ltd., 29 Lehi St., Bnei Brak 51200.

Manufacturer: Perrigo, Allegan, Michigan,

USA.

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

Health: 13-107-30938.

3. hoW

ShouLD

you

uSE

thE

mEDicinE?

Check with the doctor or pharmacist if you

are uncertain.

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

bedtime.

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

half.

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

the treatment?

Do not take medicines in the dark! Check

the label and the dose each time you take

the medicine. Wear glasses if you need

them.

If you have further questions regarding

use of the medicine, consult the doctor or

pharmacist.

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).

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