Advil Cold & Flu Coated Tablets Ibuprofen 200 mg Pseudoephedrine Hydrochloride 30 mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC code:

M01AE51

INN (International Name):

IBUPROFEN 200 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg

Pharmaceutical form:

COATED TABLET

Composition:

IBUPROFEN 200 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2007-08-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ADVIL COLD & FLU _200 MG / 30 MG 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.
•
suffer from, or have suffered from stomach ulcer

Summary of Product characteristics

1471_SmPC_20_016
SUMMARY OF PRODUCT CHARACTERISTICS
1471_SmPC_20_016
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 the 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.
Posology
Adults and older people:
1471_SmPC_20_016
Take 1 or 2 tablets every 4-6 hours to a maximum of 6 tablets in any
24 hour period.
Paediatric population
Children over 12 years of age:
Take 1 or 2 tablets every 4-6 hours to a maximum of 6 tablets in any
24 hour period.
Children under 12 years of age:
Advil Cold & Flu is contraindicated in children under the age of 12
(see section 4.3).
Renal and hepatic ins