MIGRALEVE PINK 500/8/6.25 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARACETAMOL, CODEINE PHOSPHATE, BUCLIZINE HYDROCHLORIDE

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

N02BE51

INN (International Name):

PARACETAMOL, CODEINE PHOSPHATE, BUCLIZINE HYDROCHLORIDE

Dosage:

500/8/6.25 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Analgesics and antipyretics

Authorization status:

Authorised

Authorization date:

1998-04-01

Patient Information leaflet

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Paracetamol 500 mg, Codeine phosphate 8 mg,
Buclizine hydrochloride 6.25 mg
Paracetamol 500 mg,
Codeine phosphate 8 mg,
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17-0244
364902F
_HEALTHCARE (IRELAND) LTD._
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12 tablet pack containing 8 MIGRALEVE
® PINK and
4 MIGRALEVE
® YELLOW tablets
packs of 12 tablets
MIGRALEVE
® PINK
MIGRALEVE
®
PACKS ON SALE IN YOUR PHARMACY
FREQUENCY UNKNOWN:
■
Agitation, addiction or withdrawal symptoms (e.g., tremor, sweating,
increased
heart rate, increased breathing rate, raised blood pressure and
feeling or being
sick if the medicine is stopped too quickly).
■
Breathing difficulty.
People who use medicines containing paracetamol every day for a long
time could
get certain side-effects, including liver and kidney damage. People
taking
paracetamol in the usual way for shorter periods have not had these
problems, but
liver function tests may be affected.
REPORTING OF SIDE-EFFECTS:
If you get any side-effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side-effects not listed in this leaflet. You can also report
side-effects directly
via HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2; Tel:
[phone];
Fax: [phone] Website: www.hpra.ie; Email: [e-mail].
By reporting effects you can help provide more information on the
safety of the
medicine.
5 HOW TO STORE MIGRALEVE
®
Do not store above 30˚C.
Keep the product out of the sight and reach of children.
Do not use after the expiry date printed on the carton and blister.
6 FURTHER INFORMATION
WHAT’S IN THIS MEDICINE?
THE ACTIVE INGREDIENTS IN EACH MIGRALEVE
® PINK TABLET ARE: Paracetamol
500 mg, Codeine phosphate 8 mg and Buclizine hydrochloride 6.25 mg.
OTHER INGREDIENTS ARE: magnesium stearate, colloidal anhydrous silica,
stearic
acid, pregelatinised maize starch, gelatin, hypromellose, macrogol,
E127
(erythrosine), aluminium oxide and E171 (titanium dioxide).
THE ACTIVE INGREDIENTS IN EACH MIGRALEVE
® YELLOW TABLET ARE: Paracetamol 500
mg and Codeine phosphate 8 mg.
OTHER INGREDIENTS ARE

Summary of Product characteristics

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.
Adults, children 16 years and over, and the elderly: 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, two Migraleve Yellow tablets
every 4 hours.
Maximum dose: 8 tablets (two Migraleve Pink and six Migraleve Yellow)
in 24 hours.
Paediatric population:
Children 12 – 15 years: One Migraleve Pink tablet to be swallowed
immediately it is known that a migraine attack has
started or is imminent. If further treatment is required, one
Migraleve Yellow tablet every 4 hours.
Maximum dose: 4 tablets (one Migraleve Pink and three Migraleve
Yellow) in 24 hours.
Children aged below 12 years:
Do not give to children under 12 years because of the risk of opioid
toxicity due to the variable and unpredictable
metabolism of codeine to morphine (see Section 4.3 and Section 4.4).
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