MUCOLIT 375 MG LOZENGES HONEY-LEMON FLAVOUR

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CARBOCISTEINE

متاح من:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC رمز:

R05CB03

الشكل الصيدلاني:

LOZENGES

تركيب:

CARBOCISTEINE 375 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

المجموعة العلاجية:

CARBOCISTEINE

المجال العلاجي:

CARBOCISTEINE

الخصائص العلاجية:

Treatment of disorders of the respiratory tract characterised by excessive or viscous mucus.

تاريخ الترخيص:

2014-11-30

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
This medicine is dispensed without a doctor's prescription
MUCOLIT 375 MG LOZENGES HONEY-LEMON FLAVOUR
The active ingredient and its quantity:
Each lozenge contains: carbocysteine 375 mg
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. 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, 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 and
breastfeedin

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