Robitussin Chesty Cough 100mg/5ml Oral Solution

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Malta Medicines Authority

सक्रिय संघटक:

GUAIFENESIN

थमां उपलब्ध:

Pfizer Healthcare Ireland 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland

ए.टी.सी कोड:

R05CA03

INN (इंटरनेशनल नाम):

GUAIFENESIN 20 mg/ml

फार्मास्यूटिकल फॉर्म:

ORAL SOLUTION

रचना:

GUAIFENESIN 20 mg/ml

प्रिस्क्रिप्शन प्रकार:

OTC

चिकित्सीय क्षेत्र:

COUGH AND COLD PREPARATIONS

प्राधिकरण का दर्जा:

Withdrawn

प्राधिकरण की तारीख:

2007-08-20

सूचना पत्रक

SUB-INS-00108.indd 1
2020-05-22 12:16 PM
ROBITUSSIN CHESTY COUGH 100MG/5ML ORAL SOLUTION
GUAIFENESIN
READ ALL OF THIS LEA
FL
ET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use
ROBITUSSIN CHESTY COUGH medicine carefully to get the best results
from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your doctor or pharmacist if you need more information or advice.
•
If any of the side effects get serious, or if you notice any side
effect not listed
in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1
What ROBITUSSIN CHESTY COUGH medicine is and what it is used for
2
Before you take ROBITUSSIN CHESTY COUGH medicine
3
How to take ROBITUSSIN CHESTY COUGH medicine
4
Possible side effects
5
How to store ROBITUSSIN CHESTY COUGH medicine
6
Further information
1 WHAT ROBITUSSIN CHESTY COUGH MEDICINE IS AND WHAT IT IS USED FOR
ROBITUSSIN CHESTY COUGH medicine contains the active ingredient
guaifenesin.
This active ingredient belongs to a group of medicines called cough
expectorants.
ROBITUSSIN CHESTY COUGH medicine helps loosen phlegm (mucus) to make
your
cough more productive and relieve chest congestion.
2 BEFORE YOU TAKE ROBITUSSIN CHESTY COUGH MEDICINE
Do not use in combination with any other medication unless your doctor
approves it.
DO NOT TAKE THIS MEDICINE IF:
•
You are allergic (hypersensitive) to guaifenesin or any of the other
ingredients of
ROBITUSSIN CHESTY COUGH medicine. Please see section 6 for a full list
of
the ingredients.
•
You are taking any other cough and cold medicine.
TALK TO YOUR DOCTOR BEFOR
E TAKING THIS MEDICINE IF:
•
You are taking other medications, even those not prescribed,
(including herbal
medicines).
•
You have had a cough for a long time (as a result of smoking), or if
you have
asthma or emphysema.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to
have a baby, ask your doctor or pharmacis

उत्पाद विशेषताएं

RESTRICTED
Pfizer Consumer Healthcare
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Robitussin Chesty Cough 100mg/5ml Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 100 mg guaifenesin
This product also contains ethanol (107mg per 5ml), maltitol (E965)
and sorbitol
(E420).
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral solution
A deep wine-russet coloured oral solution with a raspberry odour and
taste.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Expectorant used as an adjunct in the treatment of productive cough.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN OVER 12
YEARS:
The usual daily dose is 10ml four times
daily
CHILDREN
under 12 years
:
Do not use
4.3.
CONTRAINDICATIONS
Use in children under 12 years of age.
Hypersensitivity to the active substance or to any of the excipients.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution should be exercised in patients with
chronic cough as occurs with
smoking or chronic lung disease such as asthma or emphysema.
A doctor or healthcare professional should be sought if cough lasts
more than
5 days, comes back, or is accompanied by fever, rash, or persistent
headache.
These could be signs of a serious condition.
Not more than 4 doses should be given in any 24 hours. Do not exceed
the
stated dose.
This product should not be taken with any other cough and cold
medicine.
RESTRICTED
Pfizer Consumer Healthcare
This medicinal product contains 2.7% v/v ethanol (alcohol), up to 214
mg per
dose, (equivalent to approx 2 ml wine per dose). Harmful for those
suffering
from alcoholism. To be taken into account in pregnant or
breast-feeding
women and high-risk groups such as patients with liver disease, or
epilepsy.
4.5
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
None stated
4.6
PREGNANCY AND LACTATION
Consult a doctor before use
4.7
EFFECT ON ABILITY TO DRIVE AND USE MACHINES
None Stated
4.8
UNDESIRABLE EFFECTS
_Immune system disorders _
Hypersensiti