Ibuprofen

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Ibuprofen 200mg;  ;  

Disponibil de la:

Viatris Limited

INN (nume internaţional):

Ibuprofen 200 mg

Dozare:

200 mg

Forma farmaceutică:

Film coated tablet

Compoziție:

Active: Ibuprofen 200mg     Excipient: Colloidal silicon dioxide Maize starch Opadry white OY-58900 Purified water Stearic acid

Unități în pachet:

Blister pack, PVC/Al, 1000 tablets

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Strides Shasun Limited

Indicații terapeutice:

? Rheumatoid arthritis ? Osteoarthritis ? Juvenile rheumatoid arthritis ? Primary dysmenorrhoea ? Pyrexia Ibuprofen is also indicated for the relief of acute and/or chronic pain states in which there is an inflammatory component.

Rezumat produs:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 20 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al - 1000 tablets - 24 months from date of manufacture stored at or below 30°C

Data de autorizare:

2010-12-16

Prospect

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
IBUPROFEN
_IBUPROFEN FILM-COATED TABLET 200 MG _
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start IBUPROFEN.
This leaflet answers some common
questions about IBUPROFEN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking IBUPROFEN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT IBUPROFEN IS
USED FOR
IBUPROFEN provides temporary
relief of pain and reduces
inflammation (swelling or redness)
that may occur:
•
in different types of arthritis
including rheumatoid
arthritis, osteoarthritis and
juvenile rheumatoid arthritis
•
in muscle and bone injuries
such as sprains, strains,
low back pain (lumbago),
rheumatism, and tendonitis,
such as tennis elbow
•
from swelling and pain after
setting broken or dislocated
bones
•
menstrual cramps (period
pain)
•
following surgery
•
due to dental pain.
IBUPROFEN also relieves fever
(high temperature).
Although IBUPROFEN can relieve
the symptoms of pain and
inflammation, it will not cure your
condition.
IBUPROFEN contains the active
ingredient ibuprofen. Ibuprofen
belongs to a group of medicines
called non-steroidal anti-
inflammatory drugs (or NSAIDs).
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Many medicines used to treat
headache, period pain and other
aches and pains contain aspirin or
NSAID medicines. If you are not
sure if you are taking any of these
medicines, ask your doctor or
pharmacist
This medicine is available only with
a doctor’s prescription.
IBUPROFEN is not addictive.
BEFORE YOU TAKE
IBUPROFEN
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE IBUPR

Caracteristicilor produsului

Page 1 of 15
NEW ZEALAND DATA SHEET
IBUPROFEN
1. PRODUCT NAME
IBUPROFEN 200 mg film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 200 mg of ibuprofen.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
IBUPROFEN 200 mg tablets are white, circular, biconvex, film coated
tablet, with "IBU 200"
embossed on one side and plain on the other side.
Do not halve tablets.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
•
Rheumatoid arthritis
•
Osteoarthritis
•
Juvenile rheumatoid arthritis
•
Primary dysmenorrhoea
•
Pyrexia
Ibuprofen is also indicated for the relief of acute and/or chronic
pain states in which there is an
inflammatory component.
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
DOSE
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for the
shortest duration should be used (see section 4.4).
_ADULTS _
The recommended initial dosage of Ibuprofen is 1200 -1800 mg per day
in divided doses. Some
patients can be maintained on 600 -1200 mg per day. In severe of acute
conditions it can be
advantageous to increase the dosage until the acute phase is brought
under control, providing that
the total daily dose does not exceed 2400 mg in divided doses.
Page 2 of 15
_PRIMARY DYSMENORRHOEA _
The initial dose is 400 - 800 mg at the first sign of pain or
menstrual bleeding, then 400 mg 4-6 hourly
with a maximum total daily dose of 1,600 mg._ _
_MAINTENANCE DOSE _
In all indications, the dose should be adjusted for each patient and
the smallest dose that results in
acceptable control of the symptoms employed. In general, patients with
rheumatoid arthritis and
osteoarthritis tend to require higher doses than patients with other
conditions.
_SPECIAL POPULATIONS _
PAEDIATRIC
The daily dosage of Ibuprofen is 20 mg per kg of body weight in
divided doses. In juvenile rheumatoid
arthritis, up to 40 mg per kg of bodyweight in divided doses may be
given. In children weighing less
than 30 kg the total dose shoul