Advil Cold & Flu Relief Soft Capsules Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE

Verfügbar ab:

Pfizer Healthcare Ireland

ATC-Code:

M01AE; M01AE51

INN (Internationale Bezeichnung):

Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE

Dosierung:

200 mg/30 milligram(s)

Darreichungsform:

Capsule, soft

Verschreibungstyp:

Product not subject to medical prescription

Therapiebereich:

Propionic acid derivatives; ibuprofen, combinations

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2016-03-16

Gebrauchsinformation

Ibuprofen 200 mg & Pseudoephedrine 30 mg soft capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADVIL COLD & FLU RELIEF SOFT CAPSULES
IBUPROFEN 200 MG / PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ADVIL COLD
& FLU RELIEF BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Advil Cold & Flu Relief is available without prescription. Always take
Advil Cold & Flu Relief
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 Advil Cold & Flu Relief is and what it is used for
2.
What you need to know before you take Advil Cold & Flu Relief
3.
How to take Advil Cold & Flu Relief
4.
Possible side effects
5.
How to store Advil Cold & Flu Relief
6.
Contents of the pack and other information
1. WHAT ADVIL COLD & FLU RELIEF IS AND WHAT IT IS USED FOR
WHAT ADVIL COLD & FLU RELIEF IS
Advil Cold & Flu Relief contains two active substances, ibuprofen and
pseudoephedrine.

Ibuprofen
belongs
to a
group of
medicines
called
‘non-steroidal
anti-inflammatory
drugs’
(NSAIDs). It helps to reduce pain and lower a high temperature
(fever).

Pseudoephedrine belongs to a group of medicines called
‘vasoconstrictors’. It helps to clear the
nasal passages and eases nasal congestion.
WHAT ADVIL COLD & FLU RELIEF IS USED FOR
Advil Cold & Flu Relief is used to treat symptoms of the common cold
and flu, including headache,
high temperature (fever), sore throat, aches and pains, blocked nose,
in adults and young people aged
12 and over.
Only use this medicine if you have a blocked nose together with the
symptoms listed above such as
headache and high temperature. Do not use

Fachinformation

Health Products Regulatory Authority
20 July 2020
CRN009T83
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Advil Cold & Flu Relief Soft Capsules Ibuprofen 200mg Pseudoephedrine
Hydrochloride 30mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
MG/CAPSULE
Ibuprofen
200
Pseudoephedrine Hydrochloride
30
Excipients with known effect: Sorbitol (E 420), soya lecithin,
potassium.
This medicine contains 15.871 mg of potassium in each capsule. For the
full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soft capsules (capsules).
A clear, oval, soft-gelatin capsule filled with a clear liquid and
printed with 200/30 in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Advil Cold & Flu Relief is indicated for the relief of symptoms of the
common cold and flu such as headache, fever, sore throat,
minor aches and pain when associated with blocked nose (nasal
congestion) and sinuses (sinusitis) in adults and adolescents
over 12 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only.
This combination product should be used where both, the decongestant
action of pseudoephedrine hydrochloride and the
analgesic and/or anti-inflammatory action of ibuprofen are required.
If one symptom (either nasal congestion or headache
and/or fever) predominates, single-agent therapy is preferable.
Posology
Adults, older people and adolescents over 12 years of age:
Take 1 capsule every 4-6 hours to a maximum of 6 capsules in any 24
hour period.
In case of more intense symptoms, 2 capsules (400 mg ibuprofen/60 mg
pseudoephedrine hydrochloride) may be taken at a
time. The dose can be repeated, if necessary, at six-hour intervals
without exceeding a maximum daily dose of 6 capsules
(1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride).
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4). Maximum duration of treatment is 5 days
un