Migraleve Pink Film-coated Tablets Paracetamol 500mg Codeine Phosphate 8mg Buclizine Hydrochloride 6.25mg

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Paracetamol; Codeine phosphate; BUCLIZINE HYDROCHLORIDE

Disponibbli minn:

Johnson & Johnson (Ireland) Limited

Kodiċi ATC:

N02BE; N02BE51

INN (Isem Internazzjonali):

Paracetamol; Codeine phosphate; BUCLIZINE HYDROCHLORIDE

Dożaġġ:

500 mg/8 mg/6.25 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Tip ta 'preskrizzjoni:

Product not subject to medical prescription

Żona terapewtika:

Anilides; paracetamol, combinations excl. psycholeptics

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

1978-04-01

Fuljett ta 'informazzjoni

MIGRALEVE
® FILM COATED TABLETS MIGRALVE PINK
MIGRALEVE YELLOW PARACETAMOL 500 MG, CODEINE PHOSPHATE 8 MG,
PARACETAMOL 500 MG, BUCLIZINE HYDROCHLORIDE 6.25 MG
CODEINE PHOSPHATE 8 MG
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This
medicine
is
available
without
prescription.
However
you
still
need
to
take
MIGRALEVE® carefully to get the best results from it.
■
Keep this leaflet. You may need to read it again.
■
Ask your pharmacist if you need more information or advice.
■
You must contact a doctor if your symptoms worsen or do not improve
after 3 days.
■
If any of the side-effects get serious or if you notice any
side-effects not listed in this
leaflet, please talk to your doctor or pharmacist.
IN THIS LEAFLET 4. Possible side-effects
1. What MIGRALEVE® is and what it is used for 5. How to store
MIGRALEVE®
2. Before you take MIGRALEVE® 6. Further information
3. How to take MIGRALEVE® 7. Facts about Migraine
1 WHAT MIGRALEVE® IS AND WHAT IT IS USED FOR
MIGRALEVE® is a medicine which is used for the treatment of migraine
attacks, including
the symptoms of migraine headache, nausea and vomiting.
There are two types of MIGRALEVE® tablet available:
■
MIGRALEVE® PINK tablets
■
MIGRALEVE® YELLOW tablets
They are available separately or together in one pack.
MIGRALEVE® PINK tablets contain paracetamol and codeine which eases
pain and
buclizine which helps relieve nausea and vomiting. The Pink tablets
therefore treat all the
symptoms of migraine. If taken at the first sign of a migraine,
MIGRALEVE® Pink tablets
can prevent an attack from developing.
MIGRALEVE® YELLOW tablets contain paracetamol and codeine for the
treatment of pain
and relief of continuing migraine symptoms. They should always be
taken after the first
dose of MIGRALEVE® Pink tablets.
MIGRALEVE® can be used in children over 12 years of age for the short
term relief of
moderate pain not relieved by other pain killers such as paracetamol
or ibuprofen alone.
MIGRALEVE® contains codeine. Cod

Karatteristiċi tal-prodott

Health Products Regulatory Authority
23 June 2022
CRN00CY7Z
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Migraleve Pink Film-coated Tablets Paracetamol 500mg Codeine Phosphate
8mg Buclizine Hydrochloride 6.25mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Migraleve Pink tablet contains:
Paracetamol 500 mg (as Paracetamol DC 96%),
Codeine phosphate 8 mg,
Buclizine hydrochloride 6.25 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet. (Tablet)
Pink film-coated capsule-shaped tablets engraved ‘MGE’ on one
face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention and treatment of migraine attacks which can include
the symptoms of migraine headache, nausea and
vomiting. Route of administration: oral.
Codeine is indicated in patients older than 12 years of age for the
treatment of acute moderate pain which is not considered to
be relieved by other analgesics such as paracetamol or ibuprofen
(alone).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Do not take for more than 3 days continuously without medical review.
If prescribed do not take for longer than directed.
Codeine-containing products should be used at the lowest effective
dose for the shortest period of time.
Adults and the elderly: One to two Migraleve Pink tablets to be
swallowed immediately it is known that a migraine attack has
started or is imminent. If further treatment is required, one to two
Migraleve Yellow tablets every 4-6 hours.
Maximum dose: 8 tablets (two Migraleve Pink and six Migraleve Yellow)
in 24 hours.
Paediatric population:
Children aged 16 – 18 years: One to two Migraleve Pink tablets to be
swallowed immediately it is known that a migraine attack
has started or is imminent. If further treatment is required, one to
two Migraleve Yellow tablets every 6 hours.
Maximum dose: 8 tablets (two Migraleve Pink and six Migraleve Yellow)
in 24 hours.
Children 12–15 years: One Migraleve Pink tablet to be swallowed
immediately it is known that a migrain