Migraleve Pink tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Buclizine hydrochloride; Paracetamol; Codeine phosphate

Available from:

McNeil Products Ltd

ATC code:

N02BE51

INN (International Name):

Buclizine hydrochloride; Paracetamol; Codeine phosphate

Dosage:

6.25mg ; 500mg ; 8mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 04070401; GTIN: 5010123711320 5010123711443 5010123711207

Patient Information leaflet

n If you have taken any other painkillers in the last four hours.
n If you are allergic to paracetamol, codeine or buclizine or any of
the other
ingredients of this medicine (listed in section 6).
n If you are taking other medicines containing paracetamol.
n In children under 12 years of age.
n In children and adolescents (0-18 years of age) after removal of
their tonsils or
adenoids for obstructive sleep apnoea syndrome.
n If you have recently developed shallow breathing.
n If your bowel is obstructed or does not work properly.
n If you have a head injury or raised pressure in your skull (may
cause painful eyes,
change in vision or headache behind the eyes).
n If you know that you metabolise codeine into morphine very rapidly.
n 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...
n If you suffer from liver or kidney disease.
n If you suffer from alcoholic liver disease or alcoholic dependence.
n If you are taking any other medicines.
n If you have closed angle glaucoma (increased pressure in the eye).
n If you have difficulty passing water or unable to pass water.
n If you have prostate disease.
n If you suffer from fits.
n If you suffer from asthma or breathing problems or other lung
disease.
n If you are taking any other medicines including:
n _metoclopramide_ or _domperidone_ (used to treat nausea and
vomiting)
n _cholestyramine_ (used to treat high cholesterol)
n 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.
n _anticoagulants_ (drugs that thin the blood, such as warfarin)
n _anticonvulsants _such as carbamazepine, phenytoin, fosphenytoin,
phenobarbital or
primidone (used to treat epilepsy)
n _antimuscarinic drugs e.g. _
_atropine_ (drug given prior to surgery and for some eye
and bowel conditions)
n Drugs affecting the brain:
- drugs used to decrease anxiet

Summary of Product characteristics

OBJECT 1
MIGRALEVE PINK
Summary of Product Characteristics Updated 21-Dec-2017 | McNeil
Products Ltd
1. Name of the medicinal product
Migraleve Pink
2. Qualitative and quantitative composition
Each Migraleve Pink tablet contains:
Paracetamol DC 96%
520 mg
(equivalent to Paracetamol 500 mg)
Codeine Phosphate
8 mg
Buclizine Hydrochloride
6.25 mg
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets.
Pink, 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.
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 se