MEDCO PARACETAMOL 500 and CODEINE PHOSPHATE 30 paracetamol 500 mg and codeine phosphate hemihydrate 30 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

codeine phosphate hemihydrate,paracetamol

Available from:

Sanofi-Aventis Australia Pty Ltd

Authorization status:

Registered

Patient Information leaflet

Medco Paracetamol 500mg & Codeine Phosphate 30mg
®
1
MEDCO PARACETAMOL 500MG & CODEINE PHOSPHATE
30MG®
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 MEDCO PARACETAMOL 500MG & CODEINE PHOSPHATE 30MG?
This medicine contains the active ingredient paracetamol and codeine
phosphate hemihydrate, and is used to relieve severe pain.
For more information, see Section 1. Why am I using Medco Paracetamol
500mg & Codeine Phosphate 30mg? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MEDCO PARACETAMOL 500MG & CODEINE
PHOSPHATE 30MG?
Do not use if you have ever had an allergic reaction to this medicine
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. You may develop addiction, dependence and
tolerance. For more information, see Section
2. What should I
know before I use Medco Paracetamol 500mg & Codeine Phosphate 30mg? in
the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with this medicine 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 MEDCO PARACETAMOL 500MG & CODEINE PHOSPHATE 30MG?
The standard dose for adults is 1 or 2 tablets for severe pain, taken
every 4 to 6 hours if necessary. More instructions can be
found in Section 4. How do I use Medco Paracetamol 500mg & Codeine
Phosphate 30mg? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MEDCO PARACETAMOL 500MG & CODEINE
PHOSPHATE 30MG?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
this medicine
•
Talk to your doctor about pain control if the medicine is not helping.
•
Tell y

Summary of Product characteristics

medco-para-cod-ccdsv4-piv3-17feb21
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AUSTRALIAN PRODUCT INFORMATION – MEDCO
™
PARACETAMOL 500MG & CODEINE PHOSPHATE 30MG
(PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE)
1
NAME OF THE MEDICINE
Paracetamol and codeine phosphate hemihydrate
WARNINGS
LIMITATIONS OF USE
BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, MEDCO
PARACETAMOL
500MG & CODEINE PHOSPHATE 30MG 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
MEDCO PARACETAMOL 500MG & CODEINE PHOSPHATE 30MG 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 MEDCO PARACETAMOL 500MG & CODEINE PHOSPHATE 30MG. 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 MEDCO PARACETAMOL 500MG & CODEINE PHOSPHATE 30MG.
medco-para-cod-ccdsv4-piv3-17fe