Migraleve film-coated Tablets

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

BUCLIZINE HYDROCHLORIDE, PARACETAMOL, CODEINE PHOSPHATE

Saatavilla:

Johnson & Johnson (Ireland) Limited Airton Road Tallaght, Dublin 24, Dublin, Ireland

ATC-koodi:

N02AJ09

INN (Kansainvälinen yleisnimi):

BUCLIZINE HYDROCHLORIDE 6.25 mg CODEINE PHOSPHATE 8 mg PARACETAMOL 500 mg

Lääkemuoto:

FILM-COATED TABLET

Koostumus:

BUCLIZINE HYDROCHLORIDE 6.25 mg CODEINE PHOSPHATE 8 mg PARACETAMOL 500 mg

Prescription tyyppi:

OTC

Terapeuttinen alue:

ANALGESICS

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2006-08-10

Pakkausseloste

MIGRALEVE ® FILM COATED TABLETS MIGRALEVE® 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.

Valmisteyhteenveto

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Migraleve Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Migraleve combines two dosage forms, Migraleve Pink and Migraleve
Yellow
film-coated tablets.
Each Migraleve Pink film-coated tablet contains:
Paracetamol 500mg (as Paracetamol DC 96%)
Codeine Phosphate 8 mg
Buclizine Hydrochloride 6.25 mg
Each Migraleve Yellow film-coated tablet contains:
Paracetamol 500mg (as Paracetamol DC 96%)
Codeine Phosphate 8 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film coated Tablets (Tablets).
Migraleve Pink: Pink film-coated capsule-shaped tablets engraved
‘MGE’ on
one face.
Migraleve Yellow: Yellow 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.
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).
Route of administration: oral.
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.
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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 tablet