MAXYDOL tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

codeine phosphate hemihydrate,doxylamine succinate,paracetamol

Available from:

Cipla Australia Pty Ltd

INN (International Name):

codeine phosphate hemihydrate,doxylamine succinate,Paracetamol

Authorization status:

Registered

Patient Information leaflet

Maxydol
1
MAXYDOL
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 MAXYDOL?
Maxydol contains the active ingredient paracetamol, codeine phosphate
hemihydrate and doxylamine succinate. Maxydol is
used for temporary relief of acute moderate pain when other analgesics
have proven not to be effective. For more
information, see Section 1. Why am I using Maxydol? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MAXYDOL?
Do not use if you have ever had an allergic reaction to Maxydol 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
Maxydol? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Maxydol 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 MAXYDOL?
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 Maxydol? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MAXYDOL ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist when you visit that you are
using Maxydol.
•
Talk to your doctor or pharmacist if this medicine is not relieving
your pain.
•
Tell your doctor or pharmacist, if you become pregnant while you are
taking this medicine.
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 this medicine to children under 12

Summary of Product characteristics

1
AUSTRALIAN
PRODUCT
INFORMATION-MAXYDOL
(PARACETAMOL,
CODEINE
PHOSPHATE HEMIHYDRATE, AND DOXYLAMINE SUCCINATE) TABLETS
WARNINGS
_Limitations of use _
Because of the risks associated with the use of opioids, Maxydol
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 _
Maxydol 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 Maxydol. 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 Maxydol.
1
NAME OF THE MEDICINE
Paracetamol, Codeine phosphate hemihydrate and Doxylamine succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paracetamol 500mg, codeine phosphate hemihydrate
10mg, and doxylamine
succinate 5.1mg.
For the full list of excipients, see Section 6.1 List of