TONIGHT

Страна: Израел

Език: английски

Източник: Ministry of Health

Активна съставка:

DOXYLAMINE SUCCINATE

Предлага се от:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

АТС код:

R06AA09

Лекарствена форма:

TABLETS

Композиция:

DOXYLAMINE SUCCINATE 25 MG

Начин на приложение:

PER OS

Вид предписание :

Not required

Произведено от:

CTS CHEMICAL INDUSTRIES LTD

Терапевтична група:

DOXYLAMINE

Терапевтична област:

DOXYLAMINE

Терапевтични показания:

An aid to the relief of temporary sleep disturbance.

Дата Оторизация:

2020-03-31

Листовка

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
For a list of inactive ingredients in the
preparation - see section 6 and the section
“Important information about some ingredients
of the medicine” in this 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 doctor or the
pharmacist.
Take the product according to the instructions
in the dosage section of this leaflet. Consult the
pharmacist if you have further questions.
If the insomnia persists for more than ten
consecutive days despite using this medicine,
stop using the medicine and refer to the doctor.
The insomnia may be a symptom of another
underlying disease.
THE MEDICINE IS NOT INTENDED FOR CHILDREN
UNDER THE AGE OF 12. Below this age – contact
the doctor.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is indicated as an aid for relief of
temporary sleep disorder.
THERAPEUTIC CLASS: anti-histamines.
The mechanism of action of this medicine:
Blocking the action of histamine and other
substances produced by the body to provide
relief from allergic symptoms. In addition, this
medicine slows down the activity of the central
nervous system, which relieves insomnia.
There is no evidence that this medicine is
addictive.
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active
ingredient doxylamine succinate or to
any of the additional components this
medicine contains (see section 6).
Symptoms of an allergic reaction may
include: cough, shortness of breath,
wheezing or breathing difficulty; swelling
of the face, lips, tongue, throat or other
parts of the body; rash, itching or skin
hives; fainting or hay fever-like symptoms.
If you think you are having an allergic
reaction, stop taking the medicine and
refer imm

Данни за продукта

1
PRODUCT INFORMATION-TONIGHT (DOXYLAMINE SUCCINATE)
1.
NAME OF THE MEDICINE
Doxylamine succinate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg doxylamine succinate.
For the full list of excipients, see Section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
Oval cream-white tablets with score line on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
An aid to the relief of temporary sleep disturbance.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS:
Half a tablet to one tablet about an hour before bedtime.
Tonight should not be used for more than ten days consecutively.
CHILDREN:
Do not give to children under 12 years of age
IMPAIRED HEPATIC AND RENAL FUNCTION
: Dosage reduction may be necessary.
4.3
CONTRAINDICATIONS
Patients with hypersensitivity to doxylamine, other antihistamines in
the ethanolamine
class, or any of the excipients listed in Section 6.1 should not use
this product.
Doxylamine should not be given to premature or new born infants due to
their
heightened susceptibility to antimuscarinic effects.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid concurrent use with alcohol and medications which suppress the
CNS as the
effects of both may be enhanced.
A risk-benefit approach should be adopted for patients with glaucoma.
Increased
ocular pressure could precipitate an attack of angle closure glaucoma.
Use with
caution in patients with asthma, bladder neck obstruction, urinary
retention, chronic
bronchitis, stenosing peptic ulcer, pyloroduodenal obstruction,
symptomatic prostatic
hypertrophy and epilepsy.
USE IN HEPATIC IMPAIRMENT:
Use with caution.
2
USE IN RENAL IMPAIRMENT
Use with caution.
USE IN THE ELDERLY:
Use with caution as studies indicate a longer duration of action
especially for elderly
men. This and enhanced susceptibility to antimuscarinic side effects
suggest dosage
reduction may be necessary.
PAEDIATRIC USE:
Do not give to children under 12 years of age due to heightened
sensitivity towards paradoxical stimulation.
EFFECTS ON LABORATORY TESTS:
Antihista