PROTHIAZINE EXPECTORANT SYRUP

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

GUAIFENESIN; IPECACUANHA; PROMETHAZINE HYDROCHLORIDE

Tilgjengelig fra:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC-kode:

R05CA10

Legemiddelform:

SYRUP

Sammensetning:

PROMETHAZINE HYDROCHLORIDE 5 MG / 5 ML; GUAIFENESIN 45 MG / 5 ML; IPECACUANHA 10 MG / 5 ML

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

Terapeutisk gruppe:

COMBINATIONS

Terapeutisk område:

COMBINATIONS

Indikasjoner:

For temporary relief of cough due to colds, allergies.

Autorisasjon dato:

2015-01-31

Informasjon til brukeren

PATIENT LEAFLET IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s
prescription only
PROTHIAZINE EXPECTORANT SYRUP
Each 5 ml contains:
Promethazine hydrochloride 5 mg
Guaiphenesin 45 mg
Ipecacuanha 10 mg
For inactive ingredients and allergens in
the preparation - see section 2 “Important
information about some of the ingredients of
the medicine” and section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING
THE MEDICINE. This leaflet contains concise
information about the medicine. If you have
additional questions, refer to the doctor or the
pharmacist.
This medicine has been prescribed for you. Do
not pass it on to others. It may harm them even
if it seems to you that their illness is similar.
The medicine is not intended for children under
the age of 6 years.
Refer to the doctor if signs of the ailment
(symptoms) worsen or do not improve after 7
days.
1. WHAT IS THE MEDICINE INTENDED
FOR?
The medicine is intended for relieving cough
and certain allergic conditions.
THERAPEUTIC CLASS:
Promethazine is an antihistamine
Guaiphenesin and ipecacuanha are
expectorants
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• The patient is under 6 years of age.
• You are breastfeeding or two weeks before
the estimated delivery date.
• You are sensitive (allergic) to the active
ingredients or to any of the other
ingredients this medicine contains (see
section 6 “Additional information”). Signs of
an allergic reaction include: rash, problems
swallowing or breathing, swelling of the
lips, face, throat or tongue.
• You are taking monoamine oxidase
inhibitors (to treat depression) or you have
completed treatment with monoamine
oxidase inhibitors in the past two weeks.
• The patient is unconscious (or in a
coma) or suffering from severe effects of
dizziness, drowsiness or headache.
• You are taking this medicine concomitantly
with another medicine for relieving cough
and cold.
• You are in a state of shock, at a risk of
developing seizu

Preparatomtale

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