Fluimucil 200 mg granules for oral solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
02-02-2019
Summary of Product characteristics
(SPC)
30-05-2014
Active ingredient:
Acetylcysteine
Available from:
Zambon S.p.A.
ATC code:
R05CB; R05CB01
INN (International Name):
Acetylcysteine
Dosage:
200 milligram(s)
Pharmaceutical form:
Granules for oral solution
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Mucolytics; acetylcysteine
Therapeutic indications:
FLUIMUCIL is indicated in acute and chronic bronchitis and other respiratory conditions associated with the production of viscous mucus. FLUIMUCIL is also indicated for use in patients with abdominal complications associated with cystic fibrosis.
Authorization status:
Not marketed
Authorization date:
1983-07-20
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUIMUCIL 200 MG GRANULES FOR ORAL SOLUTION
Acetylcysteine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fluimucil is and what it is used for
2.
What you need to know before you take Fluimucil
3.
How to take Fluimucil
4.
Possible side effects
5.
How to store Fluimucil
6.
Contents of the pack and other information
1.
WHAT FLUIMUCIL IS AND WHAT IT IS USED FOR
This medicine is called Fluimucil 200 mg granules for oral solution.
Each sachet contains the active
substance acetylcysteine. Acetylcysteine belongs to a group of
medicines called mucolytics which
work by thinning the mucus (phlegm) so that it can be coughed up more
easily.
Fluimucil is used to treat:
-
breathing difficulties caused by too much mucus in the lungs and
airways or the mucus being too
thick and sticky to cough up easily
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUIMUCIL
_ _
DO NOT TAKE TAKE FLUIMUCIL:
-
if you are allergic (hypersensitive) to acetylcysteine, other similar
medicines (such as
carbocisteine, erdosteine or mecysteine), or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or, pharmacist or nurse before taking using
Fluimucil
-
if you suffer from asthma, as you may need to be monitored closely
whilst taking this medicine
-
if, before you start taking this medicine, you have a reduced ability
or inability to cough, then it
may be necessary to remove the mucus by suction after this medicin
Read the complete document
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA1441/001/001
Case No: 2051163
The Irish Medicines Board in exercise of the powers conferred on it by
the above mentioned Regulations hereby grants to
ZAMBON S.P.A.
VIA LILLO DEL DUCA, 10
,
20091-BRESSO
,
MILANO
,
ITALY
an authorisation, subject to the provisions of the said Regulations,
in respect of the product
FLUIMUCIL 200 MG GRANULES FOR ORAL SOLUTION
The particulars of which are set out in Part I and Part II of the
attached Schedule. The authorisation is also subject to the general
conditions as
may be specified in the said Regulations as listed on the reverse of
this document.
This authorisation, unless previously revoked, shall continue in force
from
09/10/2008
.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluimucil 200 mg granules for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient - Acetylcysteine 200 mg.
Each Fluimucil sachet contains the equivalent of 2.7 g of sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral solution
Orange granules for oral solution containe
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