PECTODRILL SUGAR FREE FOR CHESTY COUGHS

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

CARBOCISTEINE

Tilgjengelig fra:

Pierre Fabre Medicament

ATC-kode:

R05CB03

INN (International Name):

CARBOCISTEINE

Dosering :

250/5 Mg/Ml

Legemiddelform:

Oral Solution

Resept typen:

Product not subject to medical prescription

Terapeutisk område:

carbocisteine

Autorisasjon status:

Not Marketed

Autorisasjon dato:

2006-03-24

Informasjon til brukeren

IE: PectoDrill sugar-free for chesty coughs 250mg/5ml oral solution.
PA 329/009/002
Last approved: 04/2016
CRN 2173519
PACKAGE LEAFLET: INFORMATION FOR THE USER
PECTODRILL SUGAR-FREE FOR CHESTY COUGHS 250MG/5 ML, ORAL SOLUTION
Carbocisteine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days
WHAT IS IN THIS LEAFLET
1.
What PectoDrill sugar-free is and what it is used for
2.
What you need to know before you take PectoDrill sugar-free
3.
How to take PectoDrill sugar-free
4.
Possible side effects
5.
How to store PectoDrill sugar-free
6.
Contents of the pack and other information.
1.
WHAT PECTODRILL SUGAR-FREE AND WHAT IT IS USED FOR
PectoDrill sugar-free contains the active substance carbocisteine
which belongs to a group of medicines
known as mucolytics or expectorants.
PectoDrill sugar-free is an oral solution for the treatment of chesty
coughs.
PectoDrill sugar-free is used for bronchial congestion associated with
certain respiratory tract disorders.
PectoDrill sugar-free is used to treat adults and children over 6
years of age.
How PectoDrill sugar-free works
PectoDrill sugar-free promotes coughing by thinning the secretions. It
helps clear your bronchi of secretions
causing congestion.
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PECTODRILL SUGAR-FREE
DO NOT TAKE PECTODRILL SUGAR-FREE:
-
if you are allergic to carbocisteine or any of the other ingredients
of this medicine (listed in section 6)
-
if you curre

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PectoDrill sugar-free for chesty coughs 250mg/5ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbocisteine 5.00 g per 100 ml of oral solution
Each 5ml contains 250mg carbocisteine
Excipients with known effect: Each 5ml contains
Methylparahydroxybenzoate (E218) 7.5mg
Sodium 33.3mg
Ethanol (alcohol) <100mg.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution
Slightly brownish, clear solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mucolytic agent for use in lower respiratory tract disorders
characterised by excessive or viscous mucus.
PectoDrill is indicated in adults and children over 6 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children 12 years and over:
The usual dose is 15 ml three times daily initially, reducing to 10 ml
three times daily when a satisfactory response has
been obtained.
The maximum daily dose for adults and children over 12 years of age is
45 ml.
15 ml of the syrup/oral solution contains 750 mg of carbocisteine.
Children aged 6 to 12 years:
One 5 ml (250 mg) measure three times daily.
The maximum daily dose for children aged 6 to 12 years is 15 ml.
Method of administration
For oral use
Treatment duration
Duration of treatment must be restricted to five days after which time
if symptoms continue, medical advice must be
sought.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_5_
_/_
_0_
_5_
_/_
_2_
_0_
_