Mersyndol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Codeine phosphate hemihydrate 9.75mg;  ; Doxylamine succinate 5mg;  ;  ; Paracetamol 450mg (As Compap L 500mg);  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Codeine phosphate hemihydrate 9.75 mg

Pharmaceutical form:

Tablet

Composition:

Active: Codeine phosphate hemihydrate 9.75mg   Doxylamine succinate 5mg     Paracetamol 450mg (As Compap L 500mg)   Excipient: Magnesium stearate Maize starch Microcrystalline cellulose Purified talc Quinoline yellow Sodium starch glycolate Sunset yellow FCF

Units in package:

Blister pack, Sample, 2 tablets

Class:

Restricted

Prescription type:

Prescription

Manufactured by:

GlaxoSmithKline Australia Pty Ltd

Therapeutic indications:

For patients over the age of 12 for the symptomatic relief of acute moderate to severe pain including headache, toothache, backache or pain associated with trauma or surgery. The calmative properties may be especially useful in the treatment of tension headache, migraine and period pain and the antipyretic properties may be useful in controlling fever. Mersyndol is a suitable alternative for those individuals who cannot tolerate aspirin.

Product summary:

Package - Contents - Shelf Life: Blister pack, Sample - 2 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, Al/PVC/PVDC or Al/PVC - 20 tablets - 24 months from date of manufacture stored at or below 30°C

Authorization date:

1993-01-13

Patient Information leaflet

MERSYNDOL
®
1
MERSYNDOL
®
_Paracetamol, codeine phosphate hemihydrate, doxylamine succinate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Mersyndol.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
this medicine against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MERSYNDOL IS
USED FOR
Mersyndol is a type of analgesic used
to relieve pain and tension.
It is used for the relief of moderate to
severe pain including toothache or
pain from injury or surgery, and for
the temporary relief of headache. In
addition, the calmative properties of
Mersyndol may be especially useful
in the treatment of tension headache,
migraine and period pain.
Paracetamol and codeine work
together to stop the pain messages
from getting through to the brain.
Doxylamine is an antihistamine with
calmative effects.
Your doctor, however, may prescribe
Mersyndol for another purpose.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
IT HAS BEEN PRESCRIBED FOR YOU.
This medicine may be habit-forming
if taken frequently or over long
periods.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MERSYNDOL IF YOU HAVE:
•
AN ALLERGIC REACTION TO
PARACETAMOL, CODEINE OR
DOXYLAMINE
•
A COUGH AND COLD AND IF YOU
ARE UNDER 18 YEARS OF AGE.
•
RESPIRATORY DEPRESSION
(SHALLOW BREATHING) OR
RESPIRATORY INSUFFICIENCY
(DIFFICULTY BREATHING)
•
COMPROMISED RESPIRATORY
FUNCTION (RESPIRATORY
ILLNESS)
•
SEVERE LIVER FAILURE OR
IMPAIRED LIVER FUNCTION
•
G6PD DEFICIENCY, A HUMAN
ENZYME DEFICIENCY
•
ULTRA-RAPID METABOLISER OF
CYP 2D6
•
HAD YOUR TONSILS OR ADENOIDS
REMOVED AND ARE UNDER 18
YEARS OF AGE
•
USING ANTIDEPRESSANT
MEDICATION (MONOAMINE
I

Summary of Product characteristics

mersyndol-reg-ccdsv2-dsv18-02feb22
Property of the Sanofi group - strictly confidential
Page 1
NEW ZEALAND DATA SHEET
1
MERSYNDOL
Mersyndol, 450 mg/9.75 mg/5 mg tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Mersyndol Tablets:_
Paracetamol 450mg per tablet; Codeine Phosphate Hemihydrate 9.75mg per
tablet; Doxylamine Succinate 5mg per tablet.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Mersyndol Tablets are yellow, round, flat faced bevelled edged tablets
with a diameter of
12.7mm. One face is marked "M" within two concentric circles, the
other "MERSYNDOL 008"
and has a breakline.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For patients over the age of 12 for the symptomatic relief of acute
moderate to severe pain
including headache, toothache, backache or pain associated with trauma
or surgery.
The calmative properties may be especially useful in the treatment of
tension headache, migraine
and period pain and the antipyretic properties may be useful in
controlling fever.
Mersyndol is a suitable alternative for those individuals who cannot
tolerate aspirin.
4.2
DOSE AND METHOD OF ADMINISTRATION
_Mersyndol Tablets_
Adults, children 12 years and older: 1 or 2 tablets every four to six
hours as needed for relief.
Do not exceed 8 tablets in a 24 hour period.
Not recommended for children under 12 years.
mersyndol-reg-ccdsv2-dsv18-02feb22
Property of the Sanofi group - strictly confidential
Page 2
4.3
CONTRAINDICATION
•
Known hypersensitivity to paracetamol, codeine, doxylamine succinate,
other opioids or
any excipients of Mersyndol Tablets
•
Concomitant treatment with Monoamine inhibitors (MAOIs) or treatment
within 14 days
of stopping MAOIs (see Section 4.5 Interaction with other medicines
and other forms of
interaction)
•
Severe hepatocellular insufficiency
•
Pre-existing or acute respiratory depression
•
Respiratory insufficiency
•
Obstructive airways disease
•
Acute asthma attack
•
Patients with known glucose-6-phosphate-dehydrogenase deficiency
•
Patients with k