Migraleve Yellow

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL, CODEINE PHOSPHATE

Available from:

McNeil Products Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom

ATC code:

N02CX

INN (International Name):

PARACETAMOL 500 mg CODEINE PHOSPHATE 8 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PARACETAMOL 500 mg CODEINE PHOSPHATE 8 mg

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2006-08-10

Patient Information leaflet

 If you have taken any other painkillers in the last four hours.
 If you are allergic to paracetamol, codeine or buclizine or any of
the other
ingredients of this medicine (listed in section 6).
 If you are taking other medicines containing paracetamol.
 In children under 12 years of age.
 In children and adolescents (0-18 years of age) after removal of
their tonsils or
adenoids for obstructive sleep apnoea syndrome.
 If you have recently developed shallow breathing.
 If your bowel is obstructed or does not work properly.
 If you have a head injury or raised pressure in your skull (may
cause painful eyes,
change in vision or headache behind the eyes).
 If you know that you metabolise codeine into morphine very
rapidly.
 If you are breastfeeding.
If any of these apply to you, get advice from a doctor or pharmacist
without
using MIGRALEVE
®
.
Talk to your doctor or pharmacist...
 If you suffer from liver or kidney disease.
 If you suffer from alcoholic liver disease or alcoholic
dependence.
 If you are taking any other medicines.
 If you have closed angle glaucoma (increased pressure in the eye).
 If you have difficulty passing water or unable to pass water.
 If you have prostate disease.
 If you suffer from fits.
 If you suffer from asthma or breathing problems or other lung
disease.
 If you are taking any other medicines including:
 _metoclopramide_ or _domperidone_ (used to treat nausea and
vomiting)
 _cholestyramine_ (used to treat high cholesterol)
 if you are taking or have taken in the last two weeks, _Monoamine
Oxidase Inhibitors_
(MAOIs such as moclobemide, phenelzine, tranylcypromine or selegiline)
for
depression or other conditions.
 _anticoagulants_ (drugs that thin the blood, such as warfarin)
 _anticonvulsants _such as carbamazepine, phenytoin, fosphenytoin,
phenobarbital or
primidone (used to treat epilepsy)
 _antimuscarinic drugs e.g. _
_atropine_ (drug given prior to surgery and for some eye
and bowel conditions)
 Drugs

Summary of Product characteristics

Version No:18.0
Draft
1
SNAS No: BV 2965
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Migraleve Yellow
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Migraleve Yellow tablet contains:
Paracetamol DC 96%
520 mg
(equivalent to Paracetamol 500 mg)
Codeine Phosphate
8 mg
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Yellow, capsule-shaped, film-coated tablets marked MGE on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the short term treatment of acute moderate pain which is not
relieved by
Paracetamol, ibuprofen or aspirin alone such as migraine attacks
including the
symptoms of migraine headache, nausea and vomiting.
Codeine is indicated in children 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
Route of administration – oral.
The duration of treatment should be limited to 3 days and if no
effective pain
relief is achieved the patients/carers should be advised to seek the
views of a
physician
Adults and Children 16 years and over: 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.
Version No:18.0
Draft
2
SNAS No: BV 2965
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 less than 12 years: Codeine should not be used in
children below
the age of 12 years because of the risk of opioid toxicity due to the
variable and
unpredictable metabolism of codeine to morphine (see sections 4.3 a