NUROFEN COLD AND FLU

Valsts: Izraēla

Valoda: angļu

Klimata pārmaiņas: Ministry of Health

Aktīvā sastāvdaļa:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Pieejams no:

RECKITT BENCKISER (NEAR EAST) LTD

ATĶ kods:

M01AE51

Zāļu forma:

TABLETS

Kompozīcija:

IBUPROFEN 200 MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG

Ievadīšanas:

PER OS

Receptes veids:

Not required

Ražojis:

RECKITT BENCKISER HEALTHCARE (LTD), UK

Ārstniecības grupa:

IBUPROFEN, COMBINATIONS

Ārstniecības joma:

IBUPROFEN, COMBINATIONS

Ārstēšanas norādes:

Relief of symptoms of cold and flu in the presence of fever or pain with associated congestion.

Autorizācija datums:

2021-06-30

Lietošanas instrukcija

CUSTOMER INFO:
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0000001001(1032)
NA
RB Nottingham
NA
3128009
Nurofen
Adult
Cold & Flu
Ibuprofen & Pseudoephedrine
24Pack
RB472692
Please note that any low resolution paper Canon colour copies
associated with this job should be referred to for content, layout
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STUDIO USE ONLY
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Israel
10/02/22
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Ayyanar Vengatesan
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نﻷ ,ﻦﻴﺳﻮﺘﻴﺴﻛوأ
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ﻦﻣ ﺮﺛﺄﺘﺗ وأ
ىﺮﺧأ
ﺔﻨﯿﻌﻣ ﺔﯾودأ
ﺮﺛﺆﺗ ﺪﻗ
.ىﺮﺧأ
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Produkta apraksts

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nurofen Cold and Flu
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
Quantity
Ibuprofen
200mg
Pseudoephedrine
Hydrochloride
30mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
A yellow, round, biconvex film-coated tablet with an identifying logo
in black.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of symptoms cold and flu accompanied by pains, fever
and nasal
congestion.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For short-term use only.
The lowest effective dose should be used for the shortest duration
necessary to
relieve symptoms. The patient should consult a doctor if symptoms
persist or
worsen, or if the product is required for more than 10 days.
POSOLOGY
Adults and children 12 years of age and over:
Take 1 tablet every 4 to 6 hours while symptoms persist. If symptoms
do not
respond to 1 tablet, 2 tablets may be used.
Do not use more than 6 tablets in any 24-hour period unless directed
by a doctor.
METHOD OF ADMINISTRATION:
For oral administration with water.
PAEDIATRIC POPULATION: Nurofen Cold and Flu is not indicated for
children under
12 years old.
Page 2 of 13
4.3
CONTRAINDICATIONS
Hypersensitivity to ibuprofen, pseudoephedrine or any of the
excipients in the
product.
Patients who have previously shown hypersensitivity reactions (e.g.
asthma,
rhinitis, angioedema, or urticaria) in response to acetylsalicylic
acid (aspirin)
or other non-steroidal anti-inflammatory drugs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more
distinct
episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to
previous NSAIDs
therapy.
Severe coronary heart disease and cardiovascular disorders. Severe
hypertension.
Severe heart failure, renal failure or hepatic failure (see section
4.4)
Last trimester of pregnancy (see section 4.6)
Not to be used in children under the age of 12 years.
Monoamine oxidase inhibitors (MAOIs), or