PROTHIAZINE 25 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PROMETHAZINE HYDROCHLORIDE

Available from:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC code:

R06AD02

Pharmaceutical form:

TABLETS

Composition:

PROMETHAZINE HYDROCHLORIDE 25 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

PROMETHAZINE

Therapeutic area:

PROMETHAZINE

Therapeutic indications:

Antihistaminic, antiemetic, sedative.

Authorization date:

2023-02-28

Patient Information leaflet

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PROTHIAZINE SYRUP بارش نيزايتورپ
:ىلع )للم 5( ةريغص ةقعلم لك يوتحت
ديرولكورديه نيزاتيمورپ( Promethazine
Hydrochloride 5 mg
)غلم 5
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ديرولكورديه نيزاتيمورپ( Promethazine
Hydrochloride 25 mg
)غلم 25
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Prothiazine 25 mg Tablets
Prothiazine Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg of the active substance Promethazine
hydrochloride.
Each 5ml syrup contains 5mg of the active substance Promethazine
hydrochloride.
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Prothiazine tablets are purple, round, and biconvex.
Prothiazine syrup is a clear orange-colored liquid.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antihistaminic, Antiemetic, Sedative.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
Not for use in children under the age of 2 years (see section 4.3).
FOR TREATMENT OF ALLERGIES:
Children aged 2-5 years:
5-15 ml of syrup in one dose, to be taken at night or 5 ml two to
three times a day. Do not
administer more than 15 ml per day.
Children aged 6-12 years:
10-25 ml of syrup in one dose to be taken at night, or 10 ml twice a
day. Do not administer
more than 25 ml per day.
Children above the age of 12 and adults:
Begin treatment by taking one tablet at night. The dosage can be
increased to a maximum of
one tablet twice a day, as required.
FOR TREATMENT AND PREVENTION OF NAUSEA AND VOMITING:
Children aged 2-5 years:
5 ml of syrup every 4-6 hours up to a maximum of 15 ml per day.
Children aged 6-12 years:
A dose of 10 ml of syrup; wait 4-6 hours before administering another
dose. Up to two doses
per day can be administered (a total of 20 ml per day).
Children above the age of 12 and adults:
One tablet every 4-6 hours, up to a maximum of 4 tablets per day.
FOR SHORT-TERM USE AS A SEDATIVE, WITH THE DOCTOR’S INSTRUCTION
ONLY:
Children aged 2-5 years:
5-15 ml of syrup as a single dose to be taken at night, at bedtime.
Children aged 6-12 years:
10-20 ml of syrup as a single dose to be taken at night, at bedtime.
Children above the age of 12 and adults:
One to three tablets as a single dose, to be taken at night, at
bedtime.
4.3 CONTRAINDICATIONS
Prothiazine should