ADVIL COLD & SINUS

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Tilgjengelig fra:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC-kode:

M01AE51

Legemiddelform:

CAPSULES LIQUID FILLED

Sammensetning:

IBUPROFEN 200 MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG

Administreringsrute:

PER OS

Resept typen:

Not required

Produsert av:

FAREVA RICHMOND INC, USA

Terapeutisk gruppe:

IBUPROFEN, COMBINATIONS

Terapeutisk område:

IBUPROFEN, COMBINATIONS

Indikasjoner:

Temporarily relieves symptoms associated with the common cold, or flu: in the presence of fever or pain with associated congestion.

Autorisasjon dato:

2021-10-31

Informasjon til brukeren

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed without a doctor's prescription
ADVIL COLD & SINUS
200 MG/30 MG LIQUI-GEL CAPSULES
ACTIVE INGREDIENTS:
Each Liqui-Gel capsule contains:
Ibuprofen 200 mg (present as the free acid and potassium salt)
Pseudoephedrine HCl 30 mg
For the list of inactive ingredients and allergens in the medicine see
section 2,
subsection “Important information about some of the ingredients of
the medicine” and
section 6 “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains
concise information about the medicine. If you have any other
questions, refer to the
doctor or the pharmacist.
Take the preparation according to the instructions in the dosage
section of this
leaflet. Consult the pharmacist if you need more information. Refer to
the doctor if
signs of the ailment (symptoms) worsen or do not improve after 10
days.
1. WHAT IS THE MEDICINE INTENDED FOR?
For the temporary relief of symptoms associated with common cold or
flu in the
presence of fever or pain accompanied by nasal congestion.
THERAPEUTIC CLASS:
Ibuprofen belongs to the class of non-steroidal anti-inflammatory
drugs (NSAIDs).
Pseudoephedrine belongs to the class of vasoconstrictors (blood vessel
constrictors),
and acts on the nasal blood vessels to relieve nasal congestion.
2. BEFORE USING THE MEDICINE
X DO NOT USE ADVIL COLD & SINUS IF:
•
You are sensitive (allergic) to ibuprofen or pseudoephedrine, or to
any of the other
ingredients the medicine contains, as detailed in section 6, or if you
have had an
allergic reaction to a similar medicine in the past, such as
aspirin/acetylsalicylic acid
or other non-steroidal anti-inflammatory drugs (NSAIDs). Signs of an
allergic
reaction include skin rash, hives, itching, breathing difficulties,
chest pressure,
swelling of the mouth, face, lips or tongue.
•
You are under 12 years old.
•
You are pregnant or breastfeeding.
•
You have a stomach ulcer

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ADVIL COLD & SINUS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
MG/CAPSULE
Ibuprofen
200
Pseudoephedrine Hydrochloride
30
Excipients with known effect: Sorbitol (E 420), soy lecithin blend,
potassium.
This medicine contains 17.8 mg of potassium in each capsule. For the
full list of excipients, see
section 6.1.
3.
PHARMACEUTICAL FORM
Liquid filled capsules.
A clear, light orange to light yellow with a slight orange hue, oval
softgel filled with clear liquid,
printed "Advil C&S" with black ink, compiled in a blister.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the temporary relief of symptoms associated with common cold or
flu symptoms in the presence
of fever or pain with associated congestion.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see
section 4.4).
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 10 days.
Paediatric population
_ _
Advil Cold & Sinus is contraindicated in children under the age of 1