Codeine 15mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Codeine phosphate

Inapatikana kutoka:

Teva UK Ltd

ATC kanuni:

R05DA04

INN (Jina la Kimataifa):

Codeine phosphate

Kipimo:

15mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

Schedule 5 (CD Inv)

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 04070200; GTIN: 5017007050735

Taarifa za kipeperushi

Patient Information Leaflet
SOVEREIGN
MEDICAL
CODEINE PHOSPHATE 15 mg, 30 mg and 60 mg Tablets
READ ALL OF THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE

Please keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.

If any of the side effects becomes serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets are and what
they are used for
2. Before you take Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets
3. How to take Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets
4. Possible side effects
5. How to store Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets
6. Further information
1. WHAT CODEINE PHOSPHATE TABLETS 15 MG, 30 MG, AND 60 MG TABLETS ARE
AND
WHAT THEY ARE USED FOR
The name of your medicine is Codeine Phosphate 15mg, 30mg or 60mg
Tablets. The active
ingredient is codeine phosphate.
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 painkillers such
as paracetamol.
Codeine can be used in children 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.
It can also be used to prevent coughs and to treat the symptoms of
chronic diarrhoea.
2. BEFORE YOU TAKE CODEINE PHOSPHATE 15 MG, 30 MG AND 60 MG TABLETS
DO NOT TAKE THIS MEDICATION:

if you have ever had an allergic reaction to any of the ingredients of
Codeine Phosphate 15
mg, 30 mg and 60 mg tablets or any other medicines that you may have
taken to relieve pain.
(allergic reactions include mild symptoms such as itching and/or rash.
More severe
symptoms include swelling of the face, lips, tongue an

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Codeine Phosphate 15 mg Tablets BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15mg Codeine Phosphate.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, biconvex tablets, marked ‘APS’ on one side and
‘15/0507’ on the
reverse; or marked ‘APS’ over ‘0507’ on one side and plain on
the reverse.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Codeine Phosphate Tablets are indicated in patients older than 12
years of age for the
treatment of mild to moderate acute pain which is not relieved by
other analgesics
such as paracetamol or ibuprofen (alone), diarrhoea and troublesome
cough.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to starting treatment with opioids, a discussion should be held
with patients to put
in place a strategy for ending treatment with codeine in order to
minimise the risk of
addiction and drug withdrawal syndrome (see section 4.4).
Posology
Codeine should be used at the lowest effective dose for the shortest
period of time.
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 _
Analgesic use
30-60 mg every four hours when necessary, up to a maximum of 240 mg
daily.
Anti-diarrhoeal use
30 mg three to four times daily.
Antitussive use
15-30 mg three to four times daily.
_Paediatric population _
_ _
Children under 12 years
Not suitable.
Codeine Phosphate is contraindicated in children below the age of 12
years for the
symptomatic treatment of cough (see section 4.3). 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).
Children aged 12 years to 18 years:
Analgesic use
The recommended dose for children 12 years or older should be 30-60 mg
every 6
hours when necessary up to