Nurofen 400 Double Strength

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ibuprofen 400mg;  ;  

Available from:

Reckitt Benckiser (New Zealand) Limited

INN (International Name):

Ibuprofen 400 mg

Dosage:

400 mg

Pharmaceutical form:

Coated tablet

Composition:

Active: Ibuprofen 400mg     Excipient: Acacia Carmellose sodium Colloidal silicon dioxide Croscarmellose sodium Macrogol 6000 Opacode red S-1-15094 Purified talc Sodium citrate Sodium laurilsulfate Stearic acid Sucrose Titanium dioxide

Units in package:

Blister pack, PVC/Al, 2 tablets

Class:

Restricted

Prescription type:

Restricted

Manufactured by:

Strides Shasun Limited

Therapeutic indications:

Nurofen 400 Double Strength is indicated for the temporary relief of pain and /or inflammation associated with headache, migraine headache, tension headache, sinus pain, dental pain, backache, muscular aches and pains, period pain, sore throat, arthritic pain, colds and flu symptoms. Reduces fever.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 2 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 4 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 8 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 12 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 24 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 36 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 40 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 48 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 50 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2006-01-26

Summary of Product characteristics

Page 1 of 14
NEW ZEALAND DATA SHEET
NUROFEN 400 DOUBLE STRENGTH
1.
PRODUCT NAME
Nurofen 400 Double Strength coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 400 mg of ibuprofen.
Excipient(s) with known effect:
Sucrose - 1 tablet contains 232.2mg of sucrose corresponding to
approximately 0.68 mmol.
Sodium - 1 tablet contains 25.1 mg of sodium corresponding to
approximately 1.09 mmol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nurofen 400 Double Strength tablets are white to off-white biconvex,
sugar coated tablets printed
with an identifying logo in red on one face.
4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Nurofen 400 Double Strength is indicated for the temporary of pain and
/or inflammation associated with
headache, migraine headache, tension headache, sinus pain, dental
pain, backache, muscular aches
and pains, period pain, sore throat, arthritic pain and the symptoms
of colds and flu. Reduces fever.
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
_ _
After assessing the risk benefit ratio in each individual patient, the
lowest effective dose for the
shortest possible duration should be used.
_ADULTS AND CHILDREN 12 YEARS AND OVER _
_ _
One tablets to be taken with or without food. Take with water. If
necessary, repeat every 4 to 6 hours
(maximum 3 tablets in 24 hours). Not to be used for more than a few
days except on medical advice.
_4.3 _
_CONTRAINDICATIONS _
•
Known hypersensitivity to ibuprofen or any of the inactive ingredients
(see section 6.1).
•
Hypersensitivity (e.g. asthma, rhinitis or urticaria) to aspirin or
other nonsteroidal anti-
inflammatorydrugs.
•
History of gastrointestinal bleeding or perforation, related to
previous NSAID therapy.
•
History of ulcerative colitis, Crohn’s disease, recurrent peptic
ulceration or gastrointestinal
hemorrhage (defined as two or more distinct episodes of proven
ulceration or bleeding).
•
Severe heart failure (NYHA IV).
Page 2 of 14
•
Severe liver failure.
•
Severe r