Solpadeine Migraine Ibuprofen & Codeine tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Ibuprofen; Codeine phosphate

Tillgänglig från:

Omega Pharma Ltd

ATC-kod:

N02AJ08

INN (International namn):

Ibuprofen; Codeine phosphate

Dos:

200mg ; 12.8mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

Schedule 5 (CD Inv)

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 10010100; GTIN: 5000347020339

Bipacksedel

SOLPADEINE MIGRAINE IBUPROFEN & CODEINE

This medicine is for the short term treatment of acute moderate pain
when other
painkillers have not worked.

You should only take this product for a MAXIMUM OF 3 DAYS at a time.
If you need to take it
for longer than 3 days you should SEE YOUR DOCTOR OR PHARMACIST for
advice.

This medicine CONTAINS CODEINE which can CAUSE ADDICTION if you take
it continuously for
MORE THAN 3 DAYS. This can give you WITHDRAWAL SYMPTOMS from the
medicine when
you stop taking it.

If you take this medicine for headaches for MORE THAN 3 DAYS it can
MAKE THEM WORSE.
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS
MEDICINE.
This medicine is available without prescription, but you still need to
use Solpadeine
Migraine Tablets carefully to get the best results from them.

Keep this leaflet you may need to read it again.

If you have any questions, or if there is anything you do not
understand, ask your
pharmacist.
IN THIS LEAFLET:
1.
What Solpadeine Migraine Tablets do
2.
Check before you take Solpadeine Migraine Tablets
3.
How to take Solpadeine Migraine Tablets
4.
Possible side effects
5.
How to store Solpadeine Migraine Tablets
6.
Further information
1. WHAT SOLPADEINE MIGRAINE TABLETS DO
Solpadeine Migraine Tablets can be used in patients OVER 12 YEARS of
age for the SHORT‐TERM
RELIEF OF MODERATE PAIN THAT IS NOT RELIEVED BY OTHER PAINKILLERS such
as paracetamol or
ibuprofen alone. They can be used for migraine, headache, dental pain,
period pain, strains
& sprains, backache, rheumatic pain and sciatica. The active
ingredients are ibuprofen and
codeine, which are both painkillers. By working on your body in
different ways, ibuprofen
and codeine combine to relieve pain and ease stiffness. Ibuprofen
belongs to a family of
medicines called non‐steroidal anti‐inflammatory drugs (NSAIDs)
which relieve pain and
reduce inflammation. Codeine belongs to a group of medicines called
opioid analgesics
which act to relieve pain. It can be used on its own or in c

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Solpadeine Migraine Ibuprofen & Codeine Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen Ph Eur 200 mg
Codeine Phosphate Hemihydrate Ph Eur 12.8 mg
Excipients with known effect
Each Tablet contains:
200mg of Cellactose 80 (which is a one-body compound consisting of
lactose
monohydrate (73-77%) and cellulose (23-27%).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White, film-coated capsule-shaped tablets with a white core. 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 (see section 4.4).
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.
Leave at least four hours between doses and do not take more than 6
tablets in
any 24 hour period.
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 and 4.4).
Elderly:
Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with
particular
caution in
elderly patients who are prone to adverse e