Boots Day Cold & Flu Relief Oral Solution Paracetamol 1000mg/30mg Pholcodine 10mg/30ml Pseudoephedrine Hydrochloride 60mg/30ml

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Paracetamol; Pseudoephedrine hydrochloride; Pholcodine

Dostupné z:

The Boots Company Plc

ATC kód:

N02BE; N02BE51

INN (Medzinárodný Name):

Paracetamol; Pseudoephedrine hydrochloride; Pholcodine

Dávkovanie:

1000/60/10 mg/30ml

Forma lieku:

Oral solution

Typ predpisu:

Product not subject to medical prescription

Terapeutické oblasti:

Anilides; paracetamol, combinations excl. psycholeptics

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2003-12-18

Príbalový leták

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148mm
---------------------------
!
DAY
C
OLD
&
FLU RELIEF ORAL SOLUTION
PARACETAMOL 1000 MG/30 ML, PHOLCODINE 10 MG/30 ML,
PSEUDOEPHEDRINE HYDROCHLORIDE 60 MG/30 ML
READ ALL OF THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE BECAUSE
IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always tak
e
t
h
is m
e
dicin
e e
xactly as
:d
e
scrib
e
d in t
h
is l
e
afl
e
t or as your doctor or
I
p
h
armacist
h
as told you.
:
e K
ee
p this l
e
afl
e
t, you may n
ee
d to r
e
ad it
:
again
1
e Ask your pharmacist if you n
ee
d mor
e
:
information or advic
e
:
e If you g
e
t any sid
e e
ff
e
cts, talk to your
1
doctor or p
h
armacist. T
h
is includ
e
s any
:
possibl
e
sid
e
eff
e
cts not listed in t
h
is l
e
afl
e
t.
1
S
e
e s
e
ction 4
:
e You must talk to a doctor if you do not f
ee
l
:
b
e
tt
e
r or if you f
ee
l wors
e
:
WHAT IS IN THIS LEAFLET:
1
1
.W
h
at Boots Day Cold & Flu R
e
li
e
f Oral
:
solution is and w
h
at it is us
e
d for
1
2.What you ne
e
d to know b
e
for
e
you us
e
:
Boots Day Cold & Flu R
e
li
e
f Oral Solution
:
3. How to us
e
Boots Day Cold & Flu R
e
li
e
f
1
Oral Solution
:
4. Possibl
e
sid
e e
ff
e
cts
6.How to stor
e
Boots Day Cold & Flu R
e
li
e
f
:
Oral Solution
:
6.Cont
e
nts of t
he
pack and ot
he
r information
:
1. WHAT BOOTS DAY COLD
&
FLU
1
RELIEF ORAL SOLUTION IS AND
1
WHAT IT IS USED FOR
1
Boots Day Cold & Flu R
e
li
e
f Oral Solution
:
r
e
li
e
v
e
s t
he
symptoms of colds and flu
:
including ac
he
s and pains, f
e
v
e
r, a block
e
d or
rnnny nos
e
and dry, tickly coug
h
s.
:2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE BOOTS DAY COLD
&
FLU
1
RELIEF ORAL SOLUTION
1
00 not take Boots Day Cold & Flu R
e
li
e
f Oral
:
solution:
1
e IF YOU ARE ALLERGIC to any of t
h
e ingr
e
di
e
nts
:
e IF YOU HAVE ANGINA
:
e IF YOU HAVE HIGH BLOOD PRESSURE
1
(including t
h
at du
e
to a tumour n
e
ar your
:
kidn
e
ys)
1
e IF YOU HAVE HEART OR BLOOD VESSEL
:
DISEASE
:
e IF YOU HAVE diab
e
t
e
s, an ov
e
ractiv
e
t
h
yroid,
1
glaucoma or hyp
e
r
e
xcitability
:
e IF YOU HAVE SEVERE kidn
e
y dis
e
as
e
, liv
e

Súhrn charakteristických

Health Products Regulatory Authority
22 December 2020
CRN009S1W
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Day Cold & Flu Relief Oral Solution Paracetamol 1000mg/30mg
Pholcodine 10mg/30ml Pseudoephedrine Hydrochloride
60mg/30ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
mg/30ml
Paracetamol
1000
Pseudoephedrine hydrochloride
60
Pholcodine
10
Excipients: Ethanol 1.153g/30ml; Glucose 1.7g/30ml; Glycerol 13g/30ml;
sucrose 5.4g/30ml and sodium 35mg/30ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear orange liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of the symptoms of colds and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Take during the day.
Adults and children over 16 years: 30ml every four hours, up to a
maximum of 4 doses in 24 hours if needed.
Children under 16 years: Not to be given to children under 16 years of
age.
Elderly: There is no specific requirement for dosage reduction in the
elderly.
For oral administration.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the ingredients. Avoid in patients with
angina, cardiovascular disease, hypertension, hyperexcitability,
diabetes, hyperthyroidism, phaeochromocytoma, closed angle glaucoma,
prostatic enlargement, severe kidney disease or liver
failure and in patients with chronic bronchitis and bronchiectasis.
Use in patients who are currently receiving other
sympathomimetic drugs.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Should be given with caution to patients with impaired kidney or liver
function.
The physician or pharmacist should check that sympathomimetic
containing preparations are not simultaneously administered
by several routes i.e. orally and topically (nasal, aural and eye
preparations).
Sympathomimetic-containing products should be given with great care in
patients receiving phenothiazines or tricyclic
antidepressants.
Health Products Regulatory Authority
22 December 2020
CRN009S1W
Page 2 of 6
Sympathomimetic