IBUDEINE tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

codeine phosphate hemihydrate, Quantity: 12.8 mg; ibuprofen, Quantity: 200 mg

Commercializzato da:

Arrotex Pharmaceuticals Pty Ltd

INN (Nome Internazionale):

codeine phosphate hemihydrate,Ibuprofen

Forma farmaceutica:

Tablet, film coated

Composizione:

Excipient Ingredients: colloidal anhydrous silica; lactose monohydrate; purified water; magnesium stearate; glyceryl behenate; maize starch; titanium dioxide; hypromellose; macrogol 6000

Via di somministrazione:

Oral

Confezione:

30, 24

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

For temporary relief of acute moderate pain and inflammation

Dettagli prodotto:

Visual Identification: White to off-white capsule shaped, biconvex, film coated tablets with central breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2008-12-23

Foglio illustrativo

Ibudeine
1
IBUDEINE TABLETS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY [OPTIONAL]
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
[Include if applicable]
1.
WHY AM I USING IBUDEINE ?
Ibudeine contains the active ingredients Ibuprofen and Codeine
phosphate. Ibudeine is used to provide temporary relief of
acute moderate pain and inflammation.
For more information, see Section 1. Why am I using Ibudeine?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IBUDEINE ?
Do not use if you have ever had an allergic reaction to Ibudeine or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT.
You may develop addiction, dependence and tolerance. For more
information, see Section
2. What should I know before I use
Ibudeine? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Ibudeine and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE IBUDEINE?
•
The usual dose of Ibudeine is 2 tablets then, if necessary 1 or 2
tablets every 4 to 6 hours.
More instructions can be found in Section 4. How do I use Ibudeine?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IBUDEINE?
THINGS YOU
SHOULD DO
Remind any doctor, dentist or pharmacist you visit that you are using
Ibudeine.
Talk to you doctor about pain control if Ibudeine is not helping.
Tell your doctor if you become pregnant while taking Ibudeine.
THINGS YOU
SHOULD NOT DO
• Do not take more than 6 tablets in 24 hours.
• Do not give Ibudeine to children under the age of 12 years
• Do not take Ibudeine for more than three days at a time
DRIVING OR USING
MACHINES
Be careful before you drive or use any machines or tools until yo

Scheda tecnica

1 AUSTRALIAN PRODUCT INFORMATION – IBUDEINE
(IBUPROFEN & CODEINE PHOSPHATE HEMIHYDRATE) TABLETS
WARNINGS
_LIMITATIONS OF USE _
BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, IBUDEINE
SHOULD ONLY BE USED IN PATIENTS
FOR WHOM OTHER TREATMENT OPTIONS, INCLUDING NON-OPIOID ANALGESICS, ARE
INEFFECTIVE, NOT TOLERATED
OR OTHERWISE INADEQUATE TO PROVIDE APPROPRIATE MANAGEMENT OF PAIN (SEE
SECTION 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
_HAZARDOUS AND HARMFUL USE _
IBUDEINE POSES RISKS OF HAZARDOUS AND HARMFUL USE WHICH CAN LEAD TO
OVERDOSE AND DEATH. ASSESS
THE PATIENT’S RISK OF HAZARDOUS AND HARMFUL USE BEFORE PRESCRIBING
AND MONITOR THE PATIENT REGULARLY
DURING TREATMENT (SEE SECTION 4.4. SPECIAL WARNINGS AND PRECAUTIONS
FOR USE).
_LIFE THREATENING RESPIRATORY DEPRESSION _
SERIOUS, LIFE-THREATENING OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH THE USE OF IBUDEINE. BE
AWARE OF SITUATIONS WHICH INCREASE THE RISK OF RESPIRATORY DEPRESSION,
MODIFY DOSING IN PATIENTS AT
RISK AND MONITOR PATIENTS CLOSELY, ESPECIALLY ON INITIATION OR
FOLLOWING A DOSE INCREASE (SEE SECTION
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING _
_ALCOHOL _
CONCOMITANT
USE
OF
OPIOIDS
WITH
BENZODIAZEPINES,
GABAPENTINOIDS,
ANTIHISTAMINES,
TRICYCLIC
ANTIDEPRESSANTS, ANTIPSYCHOTICS, CANNABIS OR OTHER CENTRAL NERVOUS
SYSTEM (CNS) DEPRESSANTS,
INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY
DEPRESSION, COMA, AND DEATH. LIMIT
DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED; AND MONITOR PATIENTS
FOR SIGNS AND SYMPTOMS OF
RESPIRATORY DEPRESSION AND SEDATION. CAUTION PATIENTS NOT TO DRINK
ALCOHOL WHILE TAKING IBUDEINE.
1
NAME OF THE MEDICINE
Ibuprofen and codeine phosphate hemihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 200mg and codeine phosphate hemihydrate
12.8mg.
2
LBUPROFEN: It is a white or almost white powder or crystals with a
characteristic odour.
Practically insoluble in water, solu