APFEN PLUS 200/12.8 Milligram Film Coated Tablet

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE

Inapatikana kutoka:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

ATC kanuni:

N02AJ08

INN (Jina la Kimataifa):

IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE

Kipimo:

200/12.8 Milligram

Dawa fomu:

Film Coated Tablet

Dawa ya aina:

Product not subject to medical prescription

Eneo la matibabu:

codeine and ibuprofen

Idhini hali ya:

Authorised

Idhini ya tarehe:

2012-03-09

Taarifa za kipeperushi

Page 1 of 5
APFEN PLUS
200MG/12.8MG FILM COATED TABLETS
IBUPROFEN/CODEINEPHOSPHATE HEMIHYDRATE
PATIENT
INFORMATIONLEAFLET.
WHAT YOU SHOULD KNOW ABOUT THIS MEDICINE.
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without a prescription. However, you still
need to use Apfen Plus Tablets
carefully to get the best results from them.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must contact your doctor if your symptoms do not improve after
three days.
•
If any of the side effects get serious or if you notice any side
effect not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What are Apfen Plus Tablets and what are they for
2.
Before you take Apfen Plus Tablets
3.
How to take Apfen Plus Tablets
4.
Possible side-effects
5.
How to store Apfen Plus Tablets
6.
Further information
1.
WHAT ARE APFEN PLUS TABLETS AND WHAT ARE THEY FOR
Apfen Plus Tablets contain
IBUPROFEN
and
CODEINE
, which are both pain killing drugs. By working
on your body in different ways ibuprofen and codeine combine to
relieve pain.
IBUPROFEN
also helps
to reduce swelling and inflammation in sore muscles etc.
Apfen Plus Tablets provides effective relief from moderate pain , such
as joint, muscle and back pain,
arthritis, rheumatism, headaches (including migraine), toothache and
severe period pains.
Codeine can be used in children over 12 years of age for the
short-termrelief or moderate pain that is
not relieved by other painkillers such as paracetamol or ibuprofen
alone.
This product contains codeine. Codeine belongs to a group of medicines
called opioid analgesics
which act to relieve pain. It can be used on its own or in combination
with other pain killers such as
paracetamol.
2.
CHECK BEFORE YOU TAKE APFEN PLUS TABLETS
Anti-inflammatory/pain-killer medicines like ibuprofen may be
associated with a small increased risk
of heart attack
‘myocardial infarction’ or st

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Apfen Plus 200mg / 12.8mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ibuprofen 200mg and codeine phosphate hemihydrate
12.8 mg.
Each tablet also contains 150mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, film-coated, capsule-shaped tablets which are embossed on one
side with "+".
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of acute moderate pain in such conditions
as soft tissue injuries, including sprains, strains
and musculo-tendonitis, backache, non-serious arthritic and rheumatic
conditions rheumatic and muscular pain,
migraine, dental pain, dysmenorrhoea, which is not considered to be
relieved by other analgesics such as paracetamol
or ibuprofen alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only.
Adults (including the elderly) and children aged 12 years and over:
One or two tablets, to be taken with water, three times daily.
Apfen Plus should be used at the lowest effective dose for the
shortest period of time. The dose should not be repeated
more frequently than every six hours.
Not more than six tablets should be taken in any 24-hour period.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
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.
Children under 12 years of age:
Ibuprofen-codeine must not be given to children under 12 years of age
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: NSAIDs should be used with particular caution in elderly
patients who are more prone to adverse events. The
lowest dose compatible with adequate safe c