NUROFEN 12 HOUR ibuprofen 300 mg modified release tablet blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

ibuprofen, Quantity: 300 mg

MAH:

Reckitt Benckiser Pty Ltd

pharmaceutical_form:

Tablet, modified release

composition:

Excipient Ingredients: glycine; stearic acid; silicified microcrystalline cellulose; purified water; croscarmellose sodium; silicon dioxide; Carnauba Wax; hypromellose; titanium dioxide; polysorbate 80; macrogol 400

administration_route:

Oral

units_in_package:

10, 6, 8, 12, 20, 24, 16

prescription_type:

(S3) Pharmacist Only Medicine

therapeutic_indication:

For the temporary relief of persistent pain and/or inflammation likely to last more than 6 hours associated with sinus pain, toothache, dental procedures, backache, muscular aches and pains, arthritis, osteoarthritis, rheumatic pain, period pain, fibrositis, neuralgia, sore throat, tennis elbow, and colds and flu.

leaflet_short:

Visual Identification: White to off white colored, film coated, capsule-shaped tablet, debossed with ?N12? on one side and plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

authorization_status:

Registered

authorization_date:

2020-05-04

PIL

NUROFEN
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ACTIVE INGREDIENT(S): _Ibuprofen 300mg_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Nurofen 12 Hour. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR
PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU
HAVE ANY CONCERNS OR QUESTIONS ABOUT USING NUROFEN 12
HOUR.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using Nurofen 12 Hour?
2. What should I know before I use Nurofen 12 Hour?
3. What if I am taking other medicines?
4. How do I use Nurofen 12 Hour?
5. What should I know while using Nurofen 12 Hour?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING NUROFEN 12 HOUR?
NUROFEN 12 HOUR CONTAINS THE ACTIVE INGREDIENT
IBUPROFEN. NUROFEN 12 HOUR IS A PHARMACIST ONLY
MEDICINE. Ibuprofen belongs to a group of non-steroidal
anti-inflammatory drugs (NSAID) medications that have pain
relieving and fever relieving properties. Nurofen 12 Hour is
made to release its ingredient slowly over 12 hours so you
need to take less doses than standard tablets.
NUROFEN 12 HOUR IS USED FOR THE TEMPORARY RELIEF OF PAIN
AND INFLAMMATION ASSOCIATED WITH: HEADACHE, MIGRAINE
HEADACHE, TENSION HEADACHE, SINUS PAIN, TOOTHACHE,
DENTAL PROCEDURES, BACK PAIN, MUSCULAR ACHES AND PAINS,
ARTHRITIS, OSTEOARTHRITIS, RHEUMATIC PAIN, PERIOD PAIN,
FIBROSITIS, NEURALGIA, SORE THROAT, TENNIS ELBOW, COLD AND
FLU SYMPTOMS. IT ALSO REDUCES FEVER.
2.
WHAT SHOULD I KNOW BEFORE I USE NUROFEN
12 HOUR?
WARNINGS
DO NOT USE NUROFEN 12 HOUR IF:
•
you are allergic to any medicines containing Ibuprofen,
aspirin or other NSAIDS or any of the ingredients listed at
the end of this leaflet.
Always check the ingredients to make sure you can use
this medicine.
Some of the symptoms of an allergic reaction may
include:
- shortness of breath;
- wheezing or difficulty breathing;
- swelling of the face, lips, tongue or other parts of the
body; and
- rash, itching or hives on the skin.
•
you have any of the following conditions:
- liver or kidney disease;
- he

SPC

1
AUSTRALIAN PRODUCT INFORMATION – NUROFEN 12 HOUR
(IBUPROFEN) MODIFIED RELEASE TABLETS
1
NAME OF THE MEDICINE
Ibuprofen.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NUROFEN 12 HOUR modified release tablet contain 300 mg of ibuprofen.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
NUROFEN 12 HOUR modified release tablet: White to off-white
capsule-shaped tablets debossed with
‘N12’ on one side and plain on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the temporary relief of persistent pain and/or inflammation likely
to last more than 6 hours
associated with: sinus pain, toothache, dental procedures, backache,
muscular aches and pains,
arthritis, osteoarthritis, rheumatic pain, period pain, fibrositis,
neuralgia, sore throat, tennis elbow,
and colds and flu.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Posology
The minimum effective dose should be used for the shortest time
necessary to relieve symptoms.
_Adults and children over 12 years: _
_ _
Initial dose of 600 mg. Then, if necessary, another 600 mg can be
taken. Leave at least 12 hours
between doses. Do not take more than 1200 mg in 24 hours.
The patient should be advised to seek medical advice if symptoms
persist or worsen, or if the product
is required for more than a few days, in which case the patient should
be reviewed regularly with
regards to efficacy, risk factors and ongoing need for treatment.
2
_Paediatric population: _
_ _
This medicine should not be used by children or adolescents under the
age of 12 years.
_Pregnancy: _see section 4.3 contraindications and section 4.6
Fertility, pregnancy and
lactation _ _
Method of administration
For oral use and short time use only.
The tablets should be taken together with water and swallowed whole.
Do not chew the tablets.
If pain usually lasts or is expected to last less than 6 hours,
NUROFEN 12 HOUR should not be used. It
is recommended to use regular ibuprofen tablets or capsules.
4.3
C
ONTRAINDICATIONS
NUROFEN 12 HOUR should not be taken wi