Advil Cold & Flu Coated Tablets

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

Mevcut itibaren:

Pfizer Healthcare Ireland 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland

ATC kodu:

M01AE51

INN (International Adı):

IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

Farmasötik formu:

COATED TABLET

Kompozisyon:

IBUPROFEN 200 milligram(s) ; PSEUDOEPHEDRINE HYDROCHLORIDE 30 milligram(s)

Reçete türü:

OTC

Terapötik alanı:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2007-08-03

Bilgilendirme broşürü

1641_PIL _15 117 v2
– Patient Information Leaflet
Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ADVIL* COLD & FLU _COATED TABLETS
IBUPROFEN 200 MG / PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG
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. 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 3 days.
WHAT IS IN THIS LEAFLET
1. What _Advil Cold & Flu _is and what it is used for
2. What you need to know before you take _Advil Cold & Flu_
3. How to take _Advil Cold & Flu_
4. Possible side effects
5. How to store _Advil Cold & Flu_
6. Contents of the pack and other information
1. WHAT _ADVIL COLD & FLU _IS AND WHAT IT IS USED FOR
_Advil Cold & Flu _is used for the relief of nasal/sinus congestion
with headache, fever and pain
associated with the common cold and flu.
This medicine contains ibuprofen, a Non-Steroidal Anti-Inflammatory
Drug (NSAID) which works
by relieving pain and reducing high temperature and fever. The tablets
also contain pseudoephedrine
hydrochloride, a decongestant, which helps clear the nasal passages
and ease nasal congestion.
Only use this product if you have a blocked nose together with
headache, pain and/or fever. Do not
use it if you have only one of the symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _ADVIL COLD & FLU _
DO NOT TAKE _ADVIL COLD & FLU _IF YOU:

are allergic to or have previously experienced skin rash, hives,
itching, difficulty breathing,
tightness in the chest, swelling of the mouth, face, lips or tongue on
taking ibuprofen, aspirin,
other NSAIDs, or any ingredients contained in this product. See
section 6.


Ürün özellikleri

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Advil Cold & Flu Coated Tablets
Ibuprofen 200 mg
Pseudoephedrine Hydrochloride 30 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
PER TABLET
Ibuprofen
200 mg
Pseudoephedrine Hydrochloride
30 mg
Excipients with known effect: Each tablet contains 174.6 mg sucrose,
0.003 mg methyl
parahydroxybenzoate (E 218), and 0.002 mg propyl parahydroxybenzoate
(E 216).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablets.
Oval shaped, butterscotch coloured, sugar coated tablets and imprinted
‘200/30’ in black ink
on one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic relief of nasal/sinus congestion with headache, fever and
pain
associated with the common cold and flu. Advil Cold & Flu is indicated
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.
Adults, older people, and young persons over 12 years:
Undesirable effects may be minimised by using the lowest effective
dose for the
shortest duration necessary to control symptoms (see section 4.4). The
patient should
consult a doctor if symptoms persist or worsen, or if the product is
required for more
than 3 days.
Page 2 of 15
Posology
Adults, older people and young persons over 12 years:
Take 1 or 2 tablets every 4-6 hours to a maximum of 6 tablets in any
24 hour period.
Paediatric population
_ _
Advil Cold & Flu is contraindicated in children under the age of 12
(see section 4.3).
Renal and hepatic insufficiency
No dose reduction is required in patients with mild to moderate renal
or hepatic
impairment
_. _(see section 4.4) The lowest effect