Solpadeine Migraine Ibuprofen & Codeine Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CODEINE PHOSPHATE, HEMIHYDRATE, IBUPROFEN

Available from:

Omega Pharma Limited 1st Floor, 32 Vauxhall Bridge Road, London SW1V 2SA, United Kingdom

ATC code:

M01AE51

INN (International Name):

CODEINE PHOSPHATE HEMIHYDRATE 12.8 mg IBUPROFEN 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CODEINE PHOSPHATE HEMIHYDRATE 12.8 mg IBUPROFEN 200 mg

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2006-10-26

Patient Information leaflet

FRONT
BACK
LEADING EDGE
LEADING EDGE
TRAILING EDGE
TRAILING EDGE
OTC.LT.012
becoming pregnant; however tell your doctor
before taking this medicine if you have
problems becoming pregnant.
DO NOT TAKE Solpadeine Migraine if you are
PREGNANT.
DO NOT TAKE Solpadeine Migraine while you are
BREASTFEEDING. Codeine and morphine passes
into breast milk.
DRIVING AND USING MACHINES
This medicine can affect your ability to drive as
it may make you SLEEPY or DIZZY.
DO NOT DRIVE while taking this medicine UNTIL
YOU KNOW HOW IT AFFECTS YOU. It is an OFFENCE
to drive if this medicine affects your ability to
drive.
However, you would NOT be committing an
offence if:
• The medicine has been taken to treat a
MEDICAL or DENTAL problem and
• You have taken it ACCORDING TO THE
INFORMATION PROVIDED with the medicine and
• It was not affecting your ability to drive
safely.
TALK TO YOUR DOCTOR or pharmacist if you are not
sure whether it is safe for you to drive while
taking this medicine.
Details regarding a NEW DRIVING OFFENCE
concerning driving after drugs have been
taken IN THE UK may be found here:
www.gov.uk/drug-driving-law
3. How to take Solpadeine Migraine
This product is intended for short term use
only. You should take the lowest effective dose
for the shortest time necessary to relieve your
symptoms.
Adults and children aged 12 years and
over:
SWALLOW 1 OR 2 TABLETS WITH WATER, EVERY
4 TO 6 HOURS AS NEEDED.
• Leave AT LEAST 4 HOURS BETWEEN DOSES.
• Do not take more than 6 TABLETS IN 24
HOURS.
• Do not take MORE THAN THE
RECOMMENDED DOSE.
• This medicine should not be taken for
more than 3 DAYS. If the pain does not
improve after 3 days, TALK TO YOUR
DOCTOR for advice.
• Solpadeine Migraine should not be
taken by children BELOW THE AGE OF 12
years, due to the risk of severe
breathing problems.
POSSIBLE WITHDRAWAL EFFECTS
This medicine contains codeine and can cause
addiction if you take it continuously for MORE
THAN 3 DAYS. When you stop taking it you may
get WITHDRAWAL SYMPTOMS. You should TALK TO
YOUR DOCTOR

Summary of Product characteristics

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Solpaflex tablets
Cuprofen PLUS
Solpadeine Migraine Ibuprofen & Codeine Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen PhEur 200 mg
Codeine Phosphate Hemihydrate PhEur 12.8 mg
3.
PHARMACEUTICAL FORM
White film-coated capsule-shaped tablets. Embossed with Solpaflex, C+
or Migraine OR
plain on both the sides.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
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.
For such conditions as soft tissue injuries, including sprains,
strains and musculo-tendonitis,
backache, non-serious arthritic and rheumatic conditions, neuralgia,
migraine, headache,
dental pain and dysmenorrhoea.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
The lowest effective dose should be used for the shortest duration
necessary to relieve
symptoms.
1-2 tablets, up to three times a day as required, preferably with or
after food.
Leave at least four hours between doses and do not take more than 6
tablets in any 24 hour
period.
Paediatric population:
Children and adolescents aged 12 – 18 years:
1 – 2 tablets, up to three times a day as required, preferably with
or after food.
Page 2 of 14
Leave at least four hours between doses and do not take more than 6
tablets in any 24 hour
period.
Children aged less than12 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 and 4.4).
Elderly:
Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with
particular caution in
elderly patients who are prone to adverse events.
Route of Administration:
For oral administration and short-term use only.
The duration of treatment should be limited to 3 days and if no
effective pain relief is
achieved the patients/carers sh