Mersynofen

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ibuprofen 200mg; Paracetamol 500mg

Available from:

sanofi-aventis new zealand limited

Pharmaceutical form:

Film coated tablet

Composition:

Active: Ibuprofen 200mg Paracetamol 500mg Excipient: Croscarmellose sodium Magnesium stearate Maize starch Microcrystalline cellulose Opadry silver special effects 63F97546 Opadry white 321A180025 Pregelatinised maize starch Purified talc Sodium laurilsulfate

Prescription type:

General sale

Therapeutic indications:

Temporary relief of acute pain and/or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, rheumatic pain and arthritis and the aches and pains associated with colds and flu.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 2 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 4 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 6 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 8 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 10 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 12 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 16 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 18 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 20 tablets - 24 months from date of manufacture stored at or below 30°C

Authorization date:

2020-03-09

Patient Information leaflet

mersynofen-cmiv03-24nov23
Page 1
MERSYNOFEN®
Ibuprofen and Paracetamol
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common
questions about Mersynofen.
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 using this
medicine against the benefits they
expect it will have for you.
If you have any concerns about
using this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Mersynofen is
used for
Mersynofen is an analgesic (pain
reliever). It works to relieve acute
(short term) pain and/or inflammation
associated with headache, migraine
headache, tension headache, sinus
pain, toothache, dental procedures,
backache, muscular aches and pains,
period pain, sore throat, tennis elbow,
rheumatic pain and arthritis, and the
aches and pains associated with colds
and flu.
It contains ibuprofen and paracetamol.
Ibuprofen belongs to a group of
medicines called non-steroidal anti-
inflammatory drugs (NSAIDs).
Paracetamol works to stop the pain
messages from getting through to the
brain.
Ask your doctor or pharmacist if
you have any questions about this
medicine.
This medicine is not addictive.
It is only available from your
pharmacist.
Before you use it
When you must not take it
Do not take Mersynofen if you
have an allergy to:
 any medicine containing ibuprofen,
aspirin or other NSAIDs
 any medicine containing
paracetamol
 any of the ingredients listed at the
end of this leaflet. Always check the
ingredients to make sure you can use
this medicine.
 any other medicine for pain relief.
Some of the symptoms of an allergic
reaction may include:
 shortness of breath
 wheezing or difficulty breathing
 swelling of the face, lips, tongue or
other parts of the body
 rash, itching or hives on the skin.
Do not take Mersynofen if you
have any of the followi

Summary of Product characteristics

mersynofen-ds-v4-24nov23
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Mersynofen, ibuprofen 200mg and paracetamol 500mg, film coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ibuprofen 200mg and paracetamol 500mg
3
PHARMACEUTICAL FORM
Film coated tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mersynofen is indicated for the temporary relief of acute (short term)
pain and/or inflammation
associated with headache, migraine headache, tension headache, sinus
pain, toothache, dental
procedures, backache, muscular aches and pains, period pain, sore
throat, tennis elbow, rheumatic
pain and arthritis, and the aches and pains associated with colds and
flu.
4.2
DOSE AND METHOD OF ADMINISTRATION
For oral use
Adults under 65 and children from 12 years: 1 or 2 tablets every 6 to
8 hours as necessary
(maximum 6 tablets in 24 hours). Do not divide the tablets. Keep to
the recommended dose.
Mersynofen should not be used for more than 3 days at a time (or not
more than 2 days at a time
for adolescents aged 12 to 17 years).
It is recommended that patients with sensitive stomachs take
Mersynofen with food.
mersynofen-ds-v4-24nov23
Page 2
If taken shortly after eating, the onset of actions of Mersynofen may
be delayed. If this happens,
do not take more Mersynofen than recommended or until the correct
re-dosing interval has
passed.
•
Not recommended for children under 12 years of age.
•
Not recommended for adults 65 years and over.
Monitoring advice: if symptoms persist or worsen please consult your
healthcare professional.
4.3
CONTRAINDICATIONS
This product is contraindicated:
•
In patients with a known hypersensitivity to ibuprofen, paracetamol or
any other
constituent of the medicinal product
•
In patients with a history of hypersensitivity reactions (e.g.
bronchospasm, angioedema,
rhinitis or urticaria) associated with aspirin (acetylsalicyclic acid)
or other non-steroidal
anti-inflammatory drugs or analgesic drugs
•
unclarified blood-formation disturbances
•
cerebrovascular or other active bleedin