PRODEINEXTRA paracetamol 500mg & codeine phosphate hemihydrate 15mg film coated tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

paracetamol, Quantity: 500 mg; codeine phosphate hemihydrate, Quantity: 15 mg

Disponibil de la:

Sanofi-Aventis Australia Pty Ltd

INN (nume internaţional):

codeine phosphate hemihydrate,Paracetamol

Forma farmaceutică:

Tablet, film coated

Compoziție:

Excipient Ingredients: microcrystalline cellulose; stearic acid; maize starch; pregelatinised maize starch; potassium sorbate; purified talc; magnesium stearate; povidone

Calea de administrare:

Oral

Unități în pachet:

12, 24, 6, 20, 40

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

For the relief of acute moderate pain and fever

Rezumat produs:

Visual Identification: White to off-white capsule shaped tablets,; Container Type: Blister Pack; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Statutul autorizaţiei:

Registered

Data de autorizare:

2013-02-04

Prospect

PRODEINEXTRA
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
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.
1.
WHY AM I USING PRODEINEXTRA?
Prodeinextra contains the active ingredients paracetamol and codeine
phosphate hemihydrate. Prodeinextra is used to relieve acute
moderate pain and fever. For more information, see Section 1. Why am I
using Prodeinextra? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE PRODEINEXTRA?
Do not take if you have ever had an allergic reaction to Prodeinextra
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 OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Prodeinextra? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Prodeinextra 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 TAKE PRODEINEXTRA?
The standard dose for adults and children aged 12 years and over for
this medicine is 2 caplets, taken every 4 to 6 hours if
necessary.
More instructions can be found in Section 4. How do I use
Prodeinextra? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PRODEINEXTRA?
THINGS YOU
SHOULD DO
•
REMIND ANY DOCTOR, DENTIST OR PHARMACIST YOU VISIT THAT YOU ARE USING
PRODEINEXTRA.
•
TALK TO YOUR DOCTOR ABOUT PAIN CONTROL IF THE MEDICINE IS NOT HELPING.
•
TELL YOUR DOCTOR IF YOU BECOME PREGNANT WHILE TAKING PRODEINEXTRA.
THINGS YOU
SHOULD NOT DO
•
Do not take more than the recommended dose unless your doctor tells
you to.
•
Do not take more than 8 tablets a day.
•
Do not give Prodeinextra to children under 12.
•
Do not take high doses of the medicine for lo

Caracteristicilor produsului

prodextra-ccdsv5-piv16-03dec21
Page 1
AUSTRALIAN PRODUCT INFORMATION – PRODEINEXTRA
(PARACETAMOL AND CODEINE PHOSPHATE HEMIHYDRATE) FILM
COATED TABLET
WARNINGS
LIMITATIONS OF USE
BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, PRODEINEXTRA
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
PRODEINEXTRA 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 PRODEINEXTRA. 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 PRODEINEXTRA.
prodextra-ccdsv5-piv16-03dec21
Page 2
1
NAME OF THE MEDICINE
Paracetamol and codeine phosphate hemihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule-shaped tablet (caplet) contains paracetamol 500 mg and
codeine phosphate
hemihydrate 15 mg.
Excip