Guaifenesin 200 mg syrup in sachet

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Guaifenesin

Saatavilla:

Johnson & Johnson (Ireland) Limited

ATC-koodi:

R05CA03

INN (Kansainvälinen yleisnimi):

Guaifenesin

Lääkemuoto:

Syrup in sachet

Terapeuttinen alue:

guaifenesin

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2022-01-28

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NIPENESIN 200 MG SYRUP IN SACHET
guaifenesin
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 have
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 or the adolescent must talk to a doctor if you or the adolescent
do not feel better or if you
feel worse after 5 days
WHAT IS IN THIS LEAFLET:
1. What is and what it is used for.
2. What you need to know before you take this .
3. How to take .
4. Possible side effects.
5. How to store .
6. Contents of the pack and other information
1.
WHAT IS AND WHAT IS IT USED FOR
contains guaifenesin and is used to help relieve
chesty coughs in adults and
adolescents aged 12 years and over.
help loosen mucus (phlegm) from the lungs and make it
easier to cough up.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS
DO NOT TAKE
-
if you are allergic to guaifenesin or any of the other ingredients of
this medicine (listed in
section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking if
you:

have had a cough or if you feel worse for more than 5 days or your
cough recurs or is
accompanied by a fever, rash, or persistent headache.

have a persistent cough that may be caused by asthma.

have a cough which brings up a lot of mucus (phlegm).

have severe liver or kidney problems.

have epilepsy since the product contains alcohol (see
contains ethanol,
glucose, sucrose, sodium benzoate, sodium and propylene glycol).
CHILDREN AND ADOLESCENTS
This medici

Valmisteyhteenveto

Health Products Regulatory Authority
31 January 2022
CRN009WM8
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Guaifenesin 200 mg syrup in sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml sachet contains 200 mg guaifenesin
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup in sachet
Clear yellow-brown coloured syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Guaifenesin 200 mg syrup in sachet indicated for the symptomatic
relief of productive cough in adults and adolescents of 12
years and above.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults andadolescents of12 years andabove:_
One 10ml sachet (200 mg guaifenesin) 4 times a day.
Maximum daily dose: 4 sachets (800 mg guaifenesin)
_Paediatric population _
The safety and efficacy of Guaifenesin 200 mg syrup in sachet in
children under 12 years has not yet been established
No data are available
_ _
_Elderly:_
As per adults.
_Hepatic/renalimpairment:_
Caution should be exercised in severe hepatic and severe renal
impairment (see Section 5.2).
If cough worsens or persists for more than 5 days, tends to recur, or
is accompanied by a fever, rash, or persistent headache, a
physician should be consulted.
Method of administration:
Oral route. Tear the sachet open and put the solution directly in the
mouth.
Health Products Regulatory Authority
31 January 2022
CRN009WM8
Page 2 of 5
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product should not be used for persistent or chronic cough, such
as occurs with asthma, or where cough is accompanied
by excessive secretions, unless directed by a physician.
A persistent cough may be a sign of a serious condition. If cough
worsens or persists for more than 5 days, tends to recur, or is
accompanied by a fever, rash, or persistent headache, a physician
should be consulted.
Caution should be exercis