MUCOLIT ORAL SOLUTION 250 MG 5 ML

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CARBOCISTEINE

متاح من:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC رمز:

R05CB03

الشكل الصيدلاني:

SOLUTION (ORAL)

تركيب:

CARBOCISTEINE 250 MG / 5 ML

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

المجال العلاجي:

CARBOCISTEINE

الخصائص العلاجية:

Treatment of disorders of the repiratory tract characterized by excessive or viscous mucus.

تاريخ الترخيص:

2021-10-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
This medicine is dispensed without a doctor's
prescription
MUCOLIT ORAL SOLUTION 250 MG/5 ML
The active ingredient and its concentration:
Carbocysteine 250 mg/5 ml
For inactive ingredients and allergens in the
preparation, see the section “Important information
about some 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 any other questions,
refer to the doctor or the pharmacist.
The medicine is not intended for children under the
age of 2. Take the product according to the instructions
in the dosage section of this leaflet. Consult the
pharmacist if you have further questions. 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 reduces the viscosity of the mucus and
acts as expectorant. The medicine is intended for
relief in respiratory system disorders accompanied by
excessive and/or viscous mucus.
THERAPEUTIC CLASS: expectorants.
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
You are sensitive )allergic( to carbocysteine or
to any of the additional ingredients the medicine
contains )see section 6(. Signs of allergic reaction
include: rash, breathing or swallowing problems,
swelling of the lips, face, throat or tongue.
You have a gastric or intestinal ulcer. SPECIAL WARNINGS REGARDING THE USE OF THE
MEDICINE:
BEFORE TREATMENT WITH MUCOLIT 250 ORAL SOLUTION,
INFORM THE DOCTOR IF:
You are elderly
You have had a gastric or intestinal ulcer in the past DRUG-DRUG INTERACTIONS:
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER
MEDICINES, INCLUDING NON-PRESCRIPTION MEDICINES
AND DIETARY SUPPLEMENTS, TELL THE DOCTOR OR THE
PHARMACIST. Especially if you are taking:
Other medicines that may cause gastric bleeding PREGNANCY, BREASTFEEDING AND FERTILITY:
Use of Mucolit is not recommended during pregnancy

خصائص المنتج

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mucolit 375 Capsules
Mucolit Oral Solution 250 MG/ 5 ML
Mucolit 375 honey-lemon flavor lozenges
Tiptipot Mucolit
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MUCOLIT 375 CAPSULES
Each capsule contains 375 mg of Carbocysteine.
MUCOLIT ORAL SOLUTION 250 MG/ 5 ML
Each 5 ml of oral solution contains 250 mg of Carbocysteine.
MUCOLIT 375 HONEY-LEMON FLAVOR LOZENGES
Each lozenge contains 375 mg of Carbocysteine
TIPTIPOT MUCOLIT
Each ml contains 75mg of Carbocysteine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
MUCOLIT 375 CAPSULES:
Capsules.
Opaque blue cap and opaque yellow body, containing white to off-white
powder.
MUCOLIT ORAL SOLUTION 250 MG/5 ML:
Oral Solution.
A clear, colorless to yellowish, slightly viscous and strawberry odor
liquid.
MUCOLIT 375 HONEY-LEMON FLAVOR LOZENGES:
Lozenges.
Orange, round, flat lozenges, with a honey odor and honey-lemon
flavor.
TIPTIPOT MUCOLIT:
Drops.
A slight yellowish to brownish liquid with a cream flavor.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of disorders of the respiratory tract characterized by
excessive or
viscous mucus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ _
ADULTS, INCLUDING THE ELDERLY
,
AND CHILDREN OVER THE AGE OF 12:
Dosage is based upon an initial daily dosage of 2250mg Carbocysteine
in divided
doses, reducing to 1500mg daily in divided doses when a satisfactory
response is
2
obtained e.g. two capsules/ lozenges three times a day reducing to one
capsule/
lozenge four times a day or for oral solution 15ml three times a day
reducing to
10ml three times a day.
_ _
CHILDREN:
Mucolit 375 Capsules and Mucolit 375 honey-lemon flavor lozenges are
not
recommended for children.
The normal daily dosage is 20mg-25/kg body weight in divided doses.
It is recommended that this is achieved with Mucolit Oral Solution or
Tiptipot
Mucolit only.
Oral Solution 250 mg/5 ml:
Children 2 – 5 years: The usual dose is 1.25 – 2.5 ml four times
daily
Children 6– 12