OXACATIN

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

BENZOIC ACID AS SODIUM; GUAIACOLSULFONATE AS POTASSIUM; OXOMEMAZINE

Saadav alates:

TARO PHARMACEUTICAL INDUSTRIES LTD

ATC kood:

R06AD08

Ravimvorm:

SYRUP

Koostis:

OXOMEMAZINE 1.65 MG / 5 ML; BENZOIC ACID AS SODIUM 33.3 MG / 5 ML; GUAIACOLSULFONATE AS POTASSIUM 33.3 MG / 5 ML

Manustamisviis:

PER OS

Retsepti tüüp:

Required

Valmistatud:

TARO PHARMACEUTICAL INDUSTRIES LTD

Terapeutiline rühm:

OXOMEMAZINE

Terapeutiline ala:

OXOMEMAZINE

Näidustused:

Antitussive expectorant.

Loa andmise kuupäev:

2022-12-31

Infovoldik

Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986_ _
This medicine is dispensed with a doctor’s prescription only_ _
Oxacatin
_®_
Syrup
Active ingredients_ _
Each 5 ml contain:
oxomemazine 1.65 mg
potassium guaiacol sulphonate 33.30 mg
Inactive ingredients and allergens in this medicine: see section 2
"Important information
about some of this medicine’s ingredients" and section 6 "Additional
information".
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor
or 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 medical condition is similar to
yours._ _
1. What is this medicine intended for?
Antitussive syrup, expectorant.
Therapeutic group:
Oxomemazine - cough suppressant antihistamine of the phenothiazine
group.
Potassium guaiacol sulphonate – expectorant.
2. Before using this medicine:_ _
Do not use this medicine:
•
If you are sensitive (allergic) to the active ingredients
(oxomemazine_ _or
potassium guaiacol sulphonate) or to any of the other ingredients in
this
medicine (see section 6)._ _
•
If you are allergic to an antihistaminic medicine used to treat
allergies.
•
In children under 2 years of age.
•
If you have ever had a significant decrease in the level of certain
white blood
cells (granulocytes) in the blood (agranulocytosis).
•
If you experience difficulty urinating (prostate problem or other
problems).
•
If you are at risk of angle-closure glaucoma (high intraocular
pressure that may
impair eyesight).
•
If you are taking a medicine containing cabergoline or quinagolide
(used to
inhibit excessive prolactin production) (see section "Drug
interactions").
_ _
Special warnings about using this medicine:
_ _
•
If the cough persists despite using Oxacatin syrup, do not increase
the dosages.
Consult your doctor. Cough is actually

Toote omadused

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OXACATIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
oxomemazine ................ ..………..1.65 mg/5 ml
potassium guaiacol sulphonate…..33.3 mg/5 ml
Excipients with known effect: sugar, sorbitol, propylene glycol,
sodium benzoate and
sodium.
For the complete list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup
4.
CLINICAL DATA
4.1.
Therapeutic indications
Antitussive expectorant
4.2.
Dosage and method of administration
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 2 YEARS OLD.
In adults: 10 ml per dose, 4 times a day.
_Paediatric population _
In children: the daily dosage depends on the weight of the child (1 ml
of syrup per kg of
body weight per day), or as a general guide :
•
Children from 13 to 20 kg (2 to 6 years): 5 ml per dose, 2 to 3 times
a day,
•
Children from 20 to 30 kg (6 to 10 years): 10 ml per dose, 2 to 3
times a day,
•
Children from 30 to 40 kg (10 to 12 years): 10 ml per dose, 3 to 4
times a day
•
Children over 40 kg (12 years): 10 ml per dose, 4 times a day.
The sockets are to be renewed if necessary and spaced at least 4 hours
apart.
Method of administration
Oral. Use the measuring cup.
Vesperal intake should be preferred because of the sedative effect of
oxomemazine,
especially at the beginning of treatment.
4.3.
Contraindications
This medication is CONTRAINDICATED in the following cases:
•
Hypersensitivity to the active substances or to any of the excipients
listed in section
6.1,
•
Hypersensitivity to antihistamines,
•
Due to the presence of oxomemazine
o
infant (less than 2 years of age) (see section 4.4),
o
history of agranulocytosis,
o
risk of urinary retention related to urethro-prostate disorders,
o
risk of narrow angle glaucoma,
•
In combination with cabergoline or quinagolide (see section 4.5).
Page 2 of 7
4.4.
Special warnings and precautions for use
Special warnings:
Productive coughs, which are a fundamental element of bronchopulmonary
defense,
should be allowed to occu