NUROFEN COLD AND FLU

Quốc gia: Israel

Ngôn ngữ: Tiếng Anh

Nguồn: Ministry of Health

Thành phần hoạt chất:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Sẵn có từ:

RECKITT BENCKISER (NEAR EAST) LTD

Mã ATC:

M01AE51

Dạng dược phẩm:

TABLETS

Thành phần:

IBUPROFEN 200 MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG

Tuyến hành chính:

PER OS

Loại thuốc theo toa:

Not required

Sản xuất bởi:

RECKITT BENCKISER HEALTHCARE (LTD), UK

Nhóm trị liệu:

IBUPROFEN, COMBINATIONS

Khu trị liệu:

IBUPROFEN, COMBINATIONS

Chỉ dẫn điều trị:

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

Ngày ủy quyền:

2021-06-30

Tờ rơi thông tin

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RB Nottingham
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3128009
Nurofen
Adult
Cold & Flu
Ibuprofen & Pseudoephedrine
24Pack
RB472692
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Đặc tính sản phẩm

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