MERSYNDOL CAPLETS tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

codeine phosphate hemihydrate, Quantity: 9.75 mg; doxylamine succinate, Quantity: 5 mg; paracetamol, Quantity: 450 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; purified talc; microcrystalline cellulose; sodium starch glycollate; quinoline yellow; sunset yellow FCF; stearic acid; povidone; pregelatinised maize starch; crospovidone

Administration route:

Oral

Units in package:

2, 20, 40, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the relief of acute moderate pain and fever

Product summary:

Visual Identification: Yellow, capsule-shaped tablets with "MERSYNDOL" on one side and a breakline on the other.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1996-09-17

Patient Information leaflet

MERSYNDOL
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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 MERSYNDOL?
Mersyndol contains the active ingredients paracetamol, codeine
phosphate hemihydrate and doxylamine succinate. Mersyndol is
used for short term use to relieve moderate pain and fever. For more
information, see Section 1. Why am I using Mersyndol? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MERSYNDOL?
Do not use if you have ever had an allergic reaction to Mersyndol 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
Mersyndol? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Mersyndol 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 MERSYNDOL?
•
The standard dose of this medicine for adults and children 12 years or
over is one or two tablets/caplets every 4-6 hours as
needed for pain relief.
More instructions can be found in Section 4. How do I use Mersyndol?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MERSYNDOL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Mersyndol.
•
If you are about to be started on any new medicine, tell your doctor,
dentist or pharmacist that you are
taking Mersyndol.
•
If you plan to have surgery that needs a general anaesthetic, tell
your doctor or dentist that you are taking
this medicine.
THINGS YOU
SHOULD NOT DO
•
Do not take more than 8 tablets in a 24-hour period.
•
Do not give Mersyndol to anyone else, even if

Summary of Product characteristics

mer-ccdsv2-piv19-19nov21
Page 1
AUSTRALIAN PRODUCT INFORMATION – MERSYNDOL
(PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE, AND
DOXYLAMINE SUCCINATE)
WARNINGS
LIMITATIONS OF USE
BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, MERSYNDOL
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
MERSYNDOL 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 MERSYNDOL. 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 MERSYNDOL.
mer-ccdsv2-piv19-19nov21
Page 2
1
NAME OF THE MEDICINE
Paracetamol, codeine phosphate hemihydrate and doxylamine succinate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mersyndol contains paracetamol 450 mg, codeine phosphate hemihydrate
9.75 mg, doxylamine
succinate 5 mg.
Mersyn