MERSYNDOL FORTE paracetamol 450 mg / codeine phosphate hemihydrate 30 mg / doxylamine succinate 5 mg tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

codeine phosphate hemihydrate, Quantity: 30 mg; paracetamol, Quantity: 450 mg; doxylamine succinate, Quantity: 5 mg

Beschikbaar vanaf:

Sanofi-Aventis Australia Pty Ltd

farmaceutische vorm:

Tablet, uncoated

Samenstelling:

Excipient Ingredients: sodium starch glycollate; magnesium stearate; purified talc; stearic acid; povidone; pregelatinised maize starch; crospovidone

Toedieningsweg:

Oral

Eenheden in pakket:

40 tablets, 2 tablets (sample pack), 20 tablets, 10

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

INDICATIONS AS AT 9 JUNE 2020: Mersyndol Forte is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Product samenvatting:

Visual Identification: round, flat faced bevelled edge white tablet embossed "M" on one side and on the other side "MERSYNDOL" and "FORTE" either side of a breakbar; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

1991-07-08

Bijsluiter

MERSYNDOL FORTE
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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 TAKING MERSYNDOL FORTE?
Mersyndol Forte contains the active ingredients paracetamol, codeine
phosphate hemihydrate and doxylamine succinate. Mersyndol
Forte is for the short-term management of severe pain where your
doctor decides other treatment options are ineffective, are not
recommended, not tolerated, or otherwise inappropriate to manage your
pain. For more information, see Section 1. Why am I taking
Mersyndol Forte? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE MERSYNDOL FORTE?
Do not take Mersyndol Forte if you have ever had an allergic reaction
to Mersyndol Forte or any of the ingredients listed at the end
of this CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT, ARE BREASTFEEDING OR PLANNING TO BREASTFEED. For more
information, see Section 2. What should I know before I take
Mersyndol Forte? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Mersyndol Forte 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 MERSYNDOL FORTE?
•
The usual dose for adults and children between 12 and 18 years is one
or two tablets every 4-6 hours as needed for relief.
More instructions can be found in Section 4. How do I take Mersyndol
Forte? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING MERSYNDOL FORTE?
THINGS YOU SHOULD
DO
•
Remind any doctor, surgeon, dentist or pharmacist you visit that you
are using Mersyndol Forte.
•
Keep all your appointments, including those for blood tests.
•
Call your doctor straight away if you feel you need to change

Productkenmerken

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1
AUSTRALIAN PRODUCT INFORMATION – MERSYNDOL FORTE
(PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE,
DOXYLAMINE SUCCINATE)
1
NAME OF THE MEDICINE
Paracetamol, codeine phosphate hemihydrate and doxylamine succinate
WARNINGS
LIMITATIONS OF USE
BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, MERSYNDOL
FORTE 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 FORTE 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 FORTE. 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 FORTE.
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QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paracetamol 450 mg, codeine phosphate hemihydrate
30 mg,
doxylamine